Helius Medical Technologies, Inc. Appoints Frederick Fantazzia as Vice President of Sales & Marketing, North America

 

NEWTOWN, Pa., June 02, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the appointment of Frederick Fantazzia to the position of Vice President of Sales & Marketing, North America, effective June 1, 2021.

“Fred is a dynamic leader with 16 years of sales and marketing experience in the field of neuromodulation, and a specific focus on developing the market for new neuromodulation technologies by building and leading high-quality sales team to raise awareness and facilitate commercial adoption,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “We are pleased to welcome him to our leadership team and look forward to his contributions as we continue our pre-commercialization initiatives and prepare to commercialize our PoNS Treatment in the United States.”

“I believe Helius is a rising star in the development of innovative neuromodulation technologies to treat conditions related to the effects of neurological disease and trauma,” said Mr. Fantazzia. “With the Company’s PoNS device now authorized for sale in the U.S., I am excited to join the team at this important inflection point. I look forward to developing the market for PoNS Treatment and bringing it to U.S. patients suffering from the effects of multiple sclerosis.”

Prior to joining Helius, Mr. Fantazzia worked for LivaNova, PLC (Nasdaq: LIVN), a global medical technology company that designs, develops, manufactures and sells innovative therapeutic solutions in the fields of neuromodulation and cardiovascular disease, from 2016 until 2021. He most recently served as Vice President of North America Sales and Marketing for LivaNova’s Epilepsy business, where he managed all aspects related to its commercialization of a neuromodulation technology for the treatment of drug-resistant epilepsy. During his time with LivaNova/Cyberonics Inc., Mr. Fantazzia also served as Vice President of Global Sales and Marketing for its Neuromodulation segment from 2015 to 2016 and Vice President of U.S. Sales from 2016 to 2018.

Prior to the merger between Sorin S.p.A. and Cyberonics Inc., which combined to form LivaNova in 2015, Mr. Fantazzia worked for Cyberonics Inc. (Nasdaq: CYBX) a medical device company with core expertise in neuromodulation. He joined the company as a Regional Sales Manager in 2005, and subsequently held a series of positions of increasing responsibility, culminating in his promotion to Vice President of Global Sales and Marketing for Neuromodulation in 2015.

Mr. Fantazzia holds a B.S. in Business Administration from Villanova University.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
investorrelations@heliusmedical.com

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future growth and operational progress, the next phase of the Company’s market development activities, clinical and regulatory development plans for the PoNS device, the timing and success of the Company’s commercialization efforts in the United States, and the ability for the Company to develop the market for PoNS Treatment and bringing it to U.S. patients suffering from the effects of multiple sclerosis.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include , uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the filings made by the Company with securities regulators, including the risks and uncertainties described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com. The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

 

PDS Biotech to Host Oncology R&D Day on June 16, 2021

 

FLORHAM PARK, N.J., June 01, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced it will host an Oncology R&D Day for analysts, investors, and the scientific community from 8:00 – 10:00 AM ET on Wednesday, June 16^th.

PDS Biotech’s Oncology R&D Day will focus on the Company’s advancements in its ongoing preclinical and clinical work and will feature presentations from:

• Dr. Frank Bedu-Addo, President and CEO, PDS Biotech
• Dr. Lauren V. Wood, Chief Medical Officer, PDS Biotech
• Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
• Dr. Julius Strauss, Principal Investigator, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
• Dr. Caroline Jochems, Staff Scientist, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
  

A copy of the presentations will be available on June 17^th on the scientific presentations and publications page of PDS Biotech’s website. Registration for PDS Biotech’s Oncology R&D Day is now open and a live webcast of the event will be available online in the investor relations section of the company’s website at https://pdsbiotech.com/investors/news-center/events. A replay will be available on the company website for 90 days following the webcast.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products may overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple investigational therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

Onconova Therapeutics Announces The Appointment Of Mark Gelder, M.D., As Chief Medical Officer

 

NEWTOWN, Pa., June 01, 2021 (GLOBE NEWSWIRE) —  Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Mark Gelder, M.D. will be joining Onconova as Chief Medical Officer (CMO), effective as of June 14, 2021.

“Mark’s extensive experience leading clinical oncology programs at all stages of development makes him an ideal fit for Onconova. He will add great depth to our management team,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “His wide ranging medical and scientific expertise, which notably covers the development of kinase inhibitors as cancer therapeutics, will be invaluable as we work to advance ON 123300’s clinical development, facilitate the progression of rigosertib’s investigator-initiated trials, and evaluate potential candidates for in-licensing. I am thrilled that Mark will be joining Onconova and eager to begin working together.”   

Dr. Gelder is an accomplished industry leader with more than 35 years of experience in clinical development, medical affairs, and medical marketing. He was most recently the CMO of Elevar Therapeutics, where he led the company’s clinical development, medical affairs, regulatory affairs, and preclinical teams. Prior to his time at Elevar, Dr. Gelder served as the CMO of Pierian Biosciences (formerly DiaTech Oncology), Accelovance, Inc., and Heron Therapeutics, Inc. Dr. Gelder also has extensive experience at large pharmaceutical companies, as he previously worked in global medical affairs and led therapeutic oncology programs for Pfizer, Wyeth, and Bayer. Dr. Gelder has led successful early- and late-stage global clinical trials and has been involved in the approval and launch of several cancer therapeutics. Prior to his career in the biopharmaceutical industry, Dr. Gelder was an investigator in multiple clinical trials and authored numerous scientific papers in the areas of women’s health and oncology. He earned his M.D. from the University of Virginia School of Medicine and completed a fellowship in gynecologic oncology. He is a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology.

Dr. Gelder commented, “The opportunity to serve as Onconova’s CMO is truly exciting, and I look forward to leading the continued development of the Company’s pipeline at this important time. ON 123300 is rapidly progressing through its two Phase 1 trials and the potential to bring a best-in-class novel agent to women with HR+ HER2- metastatic breast cancer and additional oncologic indications is a unique opportunity based on its mechanism of action to overcome CKD 4/6 resistance mechanisms. I am also highly impressed with rigosertib’s investigator-initiated program and am eager to apply my expertise towards the Company’s in-licensing strategy to expand its pipeline. I believe that my skill set and those of my new colleagues are highly complementary, which will serve us well as we seek to deliver new therapeutics to cancer patients in need.”

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of commencement of employment, Onconova’s clinical development plans, and the mechanisms and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “appoints,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, the timing of the Company’s annual stockholder meeting, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Lineage Cell Therapeutics Reports Additional Cases Of Retinal Tissue Restoration In Dry AMD Patients Treated With Opregen RPE Cells

 

• Restoration Was Observed in Two Additional Patients in a Phase 1/2a Clinical Study of OpRegen
• An Earlier and First-Known Clinical Report of Restoration Has Been Maintained for 3 Years
• Restoration Has Been Observed in Three of Four Patients Who Received OpRegen RPE Cells Across a Wide Area of Atrophy

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 1, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that restoration of retinal tissue was observed in two additional patients enrolled in the Company’s Phase 1/2a study of its lead product candidate, OpRegen. OpRegen is an allogeneic retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of age-related macular degeneration (AMD) with geographic atrophy (GA), or dry (atrophic) AMD. These new findings occurred in two of the three Cohort 4 patients treated in November of 2020, where surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen cells. Outer retinal layer restoration, which was observed using clinical high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells. These effects were most prominent in the transitional areas around the primary area of GA. In addition to positive anatomical changes, all three patients’ visual acuity increased above baseline levels within 6 months post-transplant. The totality of these findings supports the view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable.

In connection with these findings, Lineage has filed a Patent Cooperation Treaty (PCT) patent application which describes restoration of the anatomy and/or functionality of diseased retinas. The application is based on clinical trial data demonstrating, for the first time, administration of RPE cells to an atrophic retina restores structure and function to one or more retinal layers. Allowed claims of a national patent application based on the PCT application would have an estimated expiration date of at least 
May 24, 2041.

“After reporting the first case of retinal restoration last year, it is extremely exciting for me to see retinal restoration replicated in additional OpRegen-treated patients. Confirmation of restoration was performed by independent experts using multimodality imaging techniques and these new cases reinforce earlier findings that treatment with OpRegen can save dysfunctional photoreceptors and replace RPE cells in areas of geographic atrophy, which could provide a remarkable treatment opportunity for this patient population,” stated Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, 
Barcelona Macula Foundation. “It has long been hypothesized that in atrophic AMD patients, cells in the transition areas at the boundaries of the GA are dysfunctional and dying, but not completely lost. These unprecedented findings provide further evidence that the addition of new RPE cells may restore the microenvironment of the surrounding tissue and contribute to the survival and function of existing cells that otherwise, if left untreated, would inevitably progress to further expansion of the atrophic region.”

“To our knowledge, these three patients represent the only examples of an experimental treatment for dry AMD demonstrating a reduction, rather than attenuating further expansion, of an area of atrophy in humans,” stated  Brian M. Culley, Lineage CEO. “Now that these findings of retinal restoration have been confirmed in multiple patients over clinically meaningful time periods, we believe we are in a position to pioneer a new paradigm for how we and others evaluate and treat atrophic AMD. Notably, 75% of patients who received broad coverage of OpRegen across the area of GA exhibited evidence of restoration, indicating that clinical benefits may be improved by a more central and complete placement of OpRegen cells across the atrophic area. Importantly, in addition to thickening of the outer nuclear layers and restoration of retinal structures in these patients, we also have observed durable improvements in visual acuity. Additional evidence collected recently supports our belief that treatment with OpRegen can provide patients not only with improvements in the anatomy and the structure of their retina and visual acuity, but also enhance quality of life. We will discuss these new findings with our advisors in the coming weeks and months to assess implications for the clinical development and regulatory approval pathways for OpRegen. We believe these findings represent a significant advancement in the field of cell therapy, in which the directed differentiation and transplant of specific cell types to treat severe diseases and conditions may generate outcomes which have remained out of the reach of traditional molecular approaches.”

The loss of RPE cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as atrophic AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which led to a presumption that progression of GA may someday be slowed or halted but could not be reversed. The unique findings from the ongoing OpRegen clinical study support a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. Notably, in the two additional Cohort 4 patients evidencing retinal restoration, in peripheral areas of incomplete RPE and outer retinal atrophy (iRORA), away from the primary atrophic lesion, there were examples of complete resolution following OpRegen transplant in some of the iRORA lesions. Additionally, in some areas of complete RPE and outer retinal atrophy (cRORA), similar, full-thickness restoration of retinal layers was observed, particularly in areas of the outer periphery of the transition zone. The transition zone may represent the ideal area to target with cell therapy as the surviving photoreceptors may be restored to normal function with the transplant of new, allogeneic RPE. The first Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, first reported last year, continues to demonstrate areas of retinal restoration through that patient’s most recent clinical visit, which occurred approximately 3 years post-transplant. These new findings have been confirmed utilizing multiple imaging technologies, including OCT, a non-invasive test which uses light waves to take cross-sectional images of the retina, allowing for visualization of each of the distinctive layers. The use of multiple imaging modalities differs from traditional assessment of GA progression, which employs only fundus autofluorescence (FAF) to assess changes in the total surface area of the apparent GA over time. Using only FAF may fail to identify structural changes that can be observed only with the addition of OCT imaging. The use of OCT allows for a more precise determination of changes in retinal thickness, organization, and overall health of the retina in areas of potential atrophy, which are possible with cell therapy. These changes may be more likely to be associated with improvements in visual acuity, reading speed, and quality of life over time.

Overall, OpRegen has been well tolerated with no unexpected adverse events or serious adverse events, and evidence of durable engraftment of OpRegen RPE cells have extended to more than 5 years post-transplant in earliest treated patients.

Dr. Monés has served as an external expert consultant for the OpRegen program for approximately 5 years. Dr. Monés completed his retinal specialist training at the 
Massachusetts Eye and Ear Infirmary at 
Harvard University, and earned his Ph.D. degree in Medicine and Surgery at the 
University of Barcelona.

Lineage plans to host a webinar with external therapeutic area experts to discuss the findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen. The Company will announce the date and time for this event in the coming days. The webinar will be available in the Events and Presentations section of Lineage’s website.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration, or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date, including the findings of retinal restoration, from the ongoing Phase 1/2a of OpRegen, and the potential for issuance of new patents relating to OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics Reports Additional Cases Of Retinal Tissue Restoration In Dry AMD Patients Treated With Opregen RPE Cells

 

• Restoration Was Observed in Two Additional Patients in a Phase 1/2a Clinical Study of OpRegen
• An Earlier and First-Known Clinical Report of Restoration Has Been Maintained for 3 Years
• Restoration Has Been Observed in Three of Four Patients Who Received OpRegen RPE Cells Across a Wide Area of Atrophy

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 1, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that restoration of retinal tissue was observed in two additional patients enrolled in the Company’s Phase 1/2a study of its lead product candidate, OpRegen. OpRegen is an allogeneic retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of age-related macular degeneration (AMD) with geographic atrophy (GA), or dry (atrophic) AMD. These new findings occurred in two of the three Cohort 4 patients treated in November of 2020, where surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen cells. Outer retinal layer restoration, which was observed using clinical high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells. These effects were most prominent in the transitional areas around the primary area of GA. In addition to positive anatomical changes, all three patients’ visual acuity increased above baseline levels within 6 months post-transplant. The totality of these findings supports the view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable.

In connection with these findings, Lineage has filed a Patent Cooperation Treaty (PCT) patent application which describes restoration of the anatomy and/or functionality of diseased retinas. The application is based on clinical trial data demonstrating, for the first time, administration of RPE cells to an atrophic retina restores structure and function to one or more retinal layers. Allowed claims of a national patent application based on the PCT application would have an estimated expiration date of at least 
May 24, 2041.

“After reporting the first case of retinal restoration last year, it is extremely exciting for me to see retinal restoration replicated in additional OpRegen-treated patients. Confirmation of restoration was performed by independent experts using multimodality imaging techniques and these new cases reinforce earlier findings that treatment with OpRegen can save dysfunctional photoreceptors and replace RPE cells in areas of geographic atrophy, which could provide a remarkable treatment opportunity for this patient population,” stated Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, 
Barcelona Macula Foundation. “It has long been hypothesized that in atrophic AMD patients, cells in the transition areas at the boundaries of the GA are dysfunctional and dying, but not completely lost. These unprecedented findings provide further evidence that the addition of new RPE cells may restore the microenvironment of the surrounding tissue and contribute to the survival and function of existing cells that otherwise, if left untreated, would inevitably progress to further expansion of the atrophic region.”

“To our knowledge, these three patients represent the only examples of an experimental treatment for dry AMD demonstrating a reduction, rather than attenuating further expansion, of an area of atrophy in humans,” stated  Brian M. Culley, Lineage CEO. “Now that these findings of retinal restoration have been confirmed in multiple patients over clinically meaningful time periods, we believe we are in a position to pioneer a new paradigm for how we and others evaluate and treat atrophic AMD. Notably, 75% of patients who received broad coverage of OpRegen across the area of GA exhibited evidence of restoration, indicating that clinical benefits may be improved by a more central and complete placement of OpRegen cells across the atrophic area. Importantly, in addition to thickening of the outer nuclear layers and restoration of retinal structures in these patients, we also have observed durable improvements in visual acuity. Additional evidence collected recently supports our belief that treatment with OpRegen can provide patients not only with improvements in the anatomy and the structure of their retina and visual acuity, but also enhance quality of life. We will discuss these new findings with our advisors in the coming weeks and months to assess implications for the clinical development and regulatory approval pathways for OpRegen. We believe these findings represent a significant advancement in the field of cell therapy, in which the directed differentiation and transplant of specific cell types to treat severe diseases and conditions may generate outcomes which have remained out of the reach of traditional molecular approaches.”

The loss of RPE cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as atrophic AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which led to a presumption that progression of GA may someday be slowed or halted but could not be reversed. The unique findings from the ongoing OpRegen clinical study support a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. Notably, in the two additional Cohort 4 patients evidencing retinal restoration, in peripheral areas of incomplete RPE and outer retinal atrophy (iRORA), away from the primary atrophic lesion, there were examples of complete resolution following OpRegen transplant in some of the iRORA lesions. Additionally, in some areas of complete RPE and outer retinal atrophy (cRORA), similar, full-thickness restoration of retinal layers was observed, particularly in areas of the outer periphery of the transition zone. The transition zone may represent the ideal area to target with cell therapy as the surviving photoreceptors may be restored to normal function with the transplant of new, allogeneic RPE. The first Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, first reported last year, continues to demonstrate areas of retinal restoration through that patient’s most recent clinical visit, which occurred approximately 3 years post-transplant. These new findings have been confirmed utilizing multiple imaging technologies, including OCT, a non-invasive test which uses light waves to take cross-sectional images of the retina, allowing for visualization of each of the distinctive layers. The use of multiple imaging modalities differs from traditional assessment of GA progression, which employs only fundus autofluorescence (FAF) to assess changes in the total surface area of the apparent GA over time. Using only FAF may fail to identify structural changes that can be observed only with the addition of OCT imaging. The use of OCT allows for a more precise determination of changes in retinal thickness, organization, and overall health of the retina in areas of potential atrophy, which are possible with cell therapy. These changes may be more likely to be associated with improvements in visual acuity, reading speed, and quality of life over time.

Overall, OpRegen has been well tolerated with no unexpected adverse events or serious adverse events, and evidence of durable engraftment of OpRegen RPE cells have extended to more than 5 years post-transplant in earliest treated patients.

Dr. Monés has served as an external expert consultant for the OpRegen program for approximately 5 years. Dr. Monés completed his retinal specialist training at the 
Massachusetts Eye and Ear Infirmary at 
Harvard University, and earned his Ph.D. degree in Medicine and Surgery at the 
University of Barcelona.

Lineage plans to host a webinar with external therapeutic area experts to discuss the findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen. The Company will announce the date and time for this event in the coming days. The webinar will be available in the Events and Presentations section of Lineage’s website.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration, or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date, including the findings of retinal restoration, from the ongoing Phase 1/2a of OpRegen, and the potential for issuance of new patents relating to OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Onconova Therapeutics Announces The Appointment Of Mark Gelder, M.D., As Chief Medical Officer

 

NEWTOWN, Pa., June 01, 2021 (GLOBE NEWSWIRE) —  Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Mark Gelder, M.D. will be joining Onconova as Chief Medical Officer (CMO), effective as of June 14, 2021.

“Mark’s extensive experience leading clinical oncology programs at all stages of development makes him an ideal fit for Onconova. He will add great depth to our management team,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “His wide ranging medical and scientific expertise, which notably covers the development of kinase inhibitors as cancer therapeutics, will be invaluable as we work to advance ON 123300’s clinical development, facilitate the progression of rigosertib’s investigator-initiated trials, and evaluate potential candidates for in-licensing. I am thrilled that Mark will be joining Onconova and eager to begin working together.”   

Dr. Gelder is an accomplished industry leader with more than 35 years of experience in clinical development, medical affairs, and medical marketing. He was most recently the CMO of Elevar Therapeutics, where he led the company’s clinical development, medical affairs, regulatory affairs, and preclinical teams. Prior to his time at Elevar, Dr. Gelder served as the CMO of Pierian Biosciences (formerly DiaTech Oncology), Accelovance, Inc., and Heron Therapeutics, Inc. Dr. Gelder also has extensive experience at large pharmaceutical companies, as he previously worked in global medical affairs and led therapeutic oncology programs for Pfizer, Wyeth, and Bayer. Dr. Gelder has led successful early- and late-stage global clinical trials and has been involved in the approval and launch of several cancer therapeutics. Prior to his career in the biopharmaceutical industry, Dr. Gelder was an investigator in multiple clinical trials and authored numerous scientific papers in the areas of women’s health and oncology. He earned his M.D. from the University of Virginia School of Medicine and completed a fellowship in gynecologic oncology. He is a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology.

Dr. Gelder commented, “The opportunity to serve as Onconova’s CMO is truly exciting, and I look forward to leading the continued development of the Company’s pipeline at this important time. ON 123300 is rapidly progressing through its two Phase 1 trials and the potential to bring a best-in-class novel agent to women with HR+ HER2- metastatic breast cancer and additional oncologic indications is a unique opportunity based on its mechanism of action to overcome CKD 4/6 resistance mechanisms. I am also highly impressed with rigosertib’s investigator-initiated program and am eager to apply my expertise towards the Company’s in-licensing strategy to expand its pipeline. I believe that my skill set and those of my new colleagues are highly complementary, which will serve us well as we seek to deliver new therapeutics to cancer patients in need.”

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of commencement of employment, Onconova’s clinical development plans, and the mechanisms and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “appoints,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, the timing of the Company’s annual stockholder meeting, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

 

PDS Biotech to Host Oncology R&D Day on June 16, 2021

 

FLORHAM PARK, N.J., June 01, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced it will host an Oncology R&D Day for analysts, investors, and the scientific community from 8:00 – 10:00 AM ET on Wednesday, June 16^th.

PDS Biotech’s Oncology R&D Day will focus on the Company’s advancements in its ongoing preclinical and clinical work and will feature presentations from:

• Dr. Frank Bedu-Addo, President and CEO, PDS Biotech
• Dr. Lauren V. Wood, Chief Medical Officer, PDS Biotech
• Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
• Dr. Julius Strauss, Principal Investigator, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
• Dr. Caroline Jochems, Staff Scientist, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institute of Health
  

A copy of the presentations will be available on June 17^th on the scientific presentations and publications page of PDS Biotech’s website. Registration for PDS Biotech’s Oncology R&D Day is now open and a live webcast of the event will be available online in the investor relations section of the company’s website at https://pdsbiotech.com/investors/news-center/events. A replay will be available on the company website for 90 days following the webcast.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products may overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple investigational therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

FWC Fish and Wildlife Research (Flickr)

Studying Many Genes in Many Animals is Key to Understanding How Humans Can Live Longer

 

Much of longevity and aging research focuses on studying extremely long-lived species, including bats, naked mole-rats and bowhead whales, to find genetic changes that contribute to long life.

However, such work has yielded highly species-specific genetic changes that are not generalizable to other species, including humans. As a graduate student, I have studied growing evidence, including recent work from my advisers’ labs, that supports the hypothesis that lifespan is a complex and highly context-dependent trait that calls for a shift in how biologists think about aging.

 

Old Age: The Human Problem

Aging is the process by which the likelihood of death increases the longer an organism is alive. In mammals, aging is hallmarked by several molecular changes, including the breakdown of DNA, a shortage of stem cells and malfunctioning proteins.

Numerous theories that exist to explain why aging happens fall into two categories. “Wear-and-tear” theories postulate that essential processes simply wear out over time. On the other hand, “programmed death” theories assert that specific genes or processes are designed to drive aging.

Traditional definitions and aging theories are human-centric, and when we examine aging from a cross-species perspective, it becomes clear that human aging is unique. In fact, among animals there is no typical way to age.

Humans show low mortality rates until a sharp spike in mortality at very old age, around 80 years. Most mammals have relatively less increase in mortality with age and more consistent mortality through their lifespans. Some mammals, such as the tundra vole and the yellow-bellied marmot, show virtually no increase in mortality with age. In other words, older individuals are equally as likely to die as younger individuals, possibly because aging does not impact survival.

Current aging theories fail to explain the full complexity of aging across all mammals, let alone the tree of life. Such diversity not only highlights the complexity of aging and longevity but also makes it difficult to apply knowledge gained about one species to increase lifespan in another.

 

 

 

 

An Overabundance of ‘Longevity Genes’

Studies of exceptionally long-lived species have produced a plethora of so-called longevity genes. One such gene, called the insulin-like growth factor 1, or IGF1, receptor gene, promotes cell growth. IGF1 was originally associated with long life in bats and also increases lifespan in worms and mice. However, IGF1 may have the opposite effect in humans, because too much IGF1 may increase age-related illnesses like diabetes and cancer.

Another potential longevity gene called the ERCC1 gene produces a protein that helps repair DNA. The bowhead whale, the longest-lived mammal at 211 years, has a mutation in the ERCC1 gene that may contribute to the species’ exceptionally long lifespan, but the mutation is not shared by other long-lived species. Elephants have 19 copies of the TP53 gene, an essential cancer prevention gene, but adding even one extra TP53 gene to mice accelerates aging because stem cells are slower to regenerate.

Longevity genes can be inconsistent even within a single species. Studies that hunt for genetic changes common in long-lived humans, and absent from humans who lived shorter lives, have not delivered a master longevity gene. The genes detected are largely inconsistent across studies and rely heavily on the subpopulation of humans sampled and the precise definition of “exceptionally long-lived.”

 

How do we
Find Longevity Genes?

My recent work underscores the argument that aging-researchers should not be looking for individual longevity genes. Instead, biologists should be seeking many genes with similar functions working together to control longevity. Further, an effective search should not just focus on a single species, but many, to avoid species-specific elements.

As part of a research study, I used genomes from 61 mammals to detect genes that evolved in tandem with the evolution of extreme lifespan, thereby uncovering longevity-related changes universal across all mammals. At the gene level, I found few longevity genes, which makes sense in light of previous work. There is probably no single gene in all mammals that regulates lifespan.

 

 

When I looked at the big picture, however, and considered groups of genes working together to perform a similar function, I found a strong association between longevity and pathways related to controlling cancer. Examples of such groups of genes are those involved in regulating the cell cycle and programmed cell death, and pathways for immune function and DNA repair. All of these functions have been previously implicated in lifespan regulation in a wide variety of studies.

 

A New Perspective on Aging and Longevity

Species-specific and human genome-wide association studies have limitations that may be enriched by a broader analyses, both in terms of the genomic elements studied and the species considered. Rather than searching for a single gene in a single species that drives increased lifespan, broadening the search to many genes across many species can bring new insights.

One modified genome-wide approach using information about functional relationships among genes found an association between the human IGF1 pathway and longevity scattered over nine genes, a key example of broadening the search for the genetics of lifespan beyond single genes.

Similarly, comparative studies like mine that interrogate genetic similarities and differences among long-lived species have repeatedly demonstrated the power to detect longevity-related genetic changes spread over many genes and shared across many species.

While there may not be a proverbial genetic “Fountain of Youth” – one single genetic change that magically allows us all to live longer – scientists like me are continually improving our strategies to study longevity so we can someday all have longer, healthier lives.

 

This article was republished with permission from The Conversation, a news site
dedicated to sharing ideas from academic experts.  Written by: Amanda Kowalczyk Ph.D.
Candidate in Computational and Systems Biology, University of Pittsburgh

 

Suggested Reading:

 

Learning to Speak the Language of Viruses	Cells that can be Produced From Stem Cells

Preventing the Immune System from Rejecting Gene Therapy	Healthcare Panel Discussion NobleCon (January 2021)

 

 

Stay up to date. Follow us:

Stay up to date. Follow us:

Cocrystal Pharma Announces the Passing of Chairman, CEO and Co-founder Dr. Gary Wilcox

 

BOTHELL, Wash., May 28, 2021 (GLOBE NEWSWIRE) — With great sadness, Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”) announces that Gary Wilcox, Ph.D., Chairman, CEO and co-founder, suddenly passed away Wednesday, May 26 at the age of 74. The Board of Directors and staff of Cocrystal extend their deepest condolences to the Wilcox family and express their gratitude for Gary’s contributions to Cocrystal and to human health.

The Cocrystal Board of Directors has designated Sam Lee, Ph.D., President, and James Martin, CFO, to share the CEO responsibilities while seeking a successor for the position. Roger Kornberg, Ph.D., Cocrystal co-founder, Chief Scientist, Director and Chairman of the Scientific Advisory Board, has been named Chairman of the Board, and Steve Rubin, Director of Cocrystal and its predecessor company since 2008, has been named Vice Chairman. Cocrystal also announces the appointment of Richard C. Pfenniger, Jr. to the Board of Directors, maintaining membership at five. Mr. Pfenniger brings significant industry knowledge and corporate governance expertise, having served as chief executive officer, chief operating officer, general counsel, director and chairman at multiple healthcare companies.

“We are fortunate to have two highly qualified and dedicated executives in Sam and Jim to assume the CEO duties on an interim basis. Our Board has full confidence in a smooth transition and in their ability to advance our antiviral programs into clinical development,” said Dr. Kornberg. “We also welcome Richard to our Board. We will call upon his insights regarding many aspects of our business and to provide valuable operational, leadership and management advice to the Board in critical areas.

“The Cocrystal team is committed to carrying on Gary’s quest to address the growing global need for new antiviral treatments,” added Dr. Kornberg. “We will deeply miss Gary. He possessed a rare combination of scientific brilliance, business acumen and personal humility. He was an accomplished leader and earned respect throughout the biotechnology community, having achieved more in his 35 years in the industry than I can list. He brought an entrepreneurial spirit to Cocrystal that has been instrumental in deploying our novel replication technology to advance the discovery and development of antiviral candidates, and he sustained that spirit each and every day.”

Richard Pfenniger, Jr.

Mr. Pfenniger is a private investor who served as Interim CEO of Vein Clinics of America, Inc., a privately held company that specializes in the treatment of vein disease, from May 2014 to February 2015 and as Interim CEO of IntegraMed America, Inc., a privately held company that manages outpatient fertility medical centers, from January 2013 to June 2013. He served as Chief Executive Officer and President of Continucare Corporation, a provider of primary care physician and practice management services, from 2003 until 2011, and as Chairman of the Board of Directors of Continucare Corporation from 2002 until 2011. Previously, Mr. Pfenniger served as the Chief Executive Officer and Vice Chairman of Whitman Education Group, Inc. from 1997 through June 2003. Prior to joining Whitman, he served as the Chief Operating Officer of IVAX from 1994 to 1997, and, from 1989 to 1994, he served as the Senior Vice President-Legal Affairs and General Counsel of IVAX Corporation. Prior thereto he was engaged in the private practice of law.

Mr. Pfenniger currently serves as a director of OPKO Health (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, GP Strategies Corporation (NYSE: GPX), a corporate education and training company, and Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company. He also serves as the Vice Chairman of the Board of Trustees and as a member of the Executive Committee of the Phillip and Patricia Frost Museum of Science in Miami.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Noble Capital Markets Senior Research Analyst Joe Gomes sits down with Avivagen CEO Kym Anthony for this exclusive interview. Research, News, and Advanced Market Data on VIVXF View all C-Suite Interviews About Avivagen Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com.

Cocrystal Pharma Announces the Passing of Chairman, CEO and Co-founder Dr. Gary Wilcox

 

BOTHELL, Wash., May 28, 2021 (GLOBE NEWSWIRE) — With great sadness, Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”) announces that Gary Wilcox, Ph.D., Chairman, CEO and co-founder, suddenly passed away Wednesday, May 26 at the age of 74. The Board of Directors and staff of Cocrystal extend their deepest condolences to the Wilcox family and express their gratitude for Gary’s contributions to Cocrystal and to human health.

The Cocrystal Board of Directors has designated Sam Lee, Ph.D., President, and James Martin, CFO, to share the CEO responsibilities while seeking a successor for the position. Roger Kornberg, Ph.D., Cocrystal co-founder, Chief Scientist, Director and Chairman of the Scientific Advisory Board, has been named Chairman of the Board, and Steve Rubin, Director of Cocrystal and its predecessor company since 2008, has been named Vice Chairman. Cocrystal also announces the appointment of Richard C. Pfenniger, Jr. to the Board of Directors, maintaining membership at five. Mr. Pfenniger brings significant industry knowledge and corporate governance expertise, having served as chief executive officer, chief operating officer, general counsel, director and chairman at multiple healthcare companies.

“We are fortunate to have two highly qualified and dedicated executives in Sam and Jim to assume the CEO duties on an interim basis. Our Board has full confidence in a smooth transition and in their ability to advance our antiviral programs into clinical development,” said Dr. Kornberg. “We also welcome Richard to our Board. We will call upon his insights regarding many aspects of our business and to provide valuable operational, leadership and management advice to the Board in critical areas.

“The Cocrystal team is committed to carrying on Gary’s quest to address the growing global need for new antiviral treatments,” added Dr. Kornberg. “We will deeply miss Gary. He possessed a rare combination of scientific brilliance, business acumen and personal humility. He was an accomplished leader and earned respect throughout the biotechnology community, having achieved more in his 35 years in the industry than I can list. He brought an entrepreneurial spirit to Cocrystal that has been instrumental in deploying our novel replication technology to advance the discovery and development of antiviral candidates, and he sustained that spirit each and every day.”

Richard Pfenniger, Jr.

Mr. Pfenniger is a private investor who served as Interim CEO of Vein Clinics of America, Inc., a privately held company that specializes in the treatment of vein disease, from May 2014 to February 2015 and as Interim CEO of IntegraMed America, Inc., a privately held company that manages outpatient fertility medical centers, from January 2013 to June 2013. He served as Chief Executive Officer and President of Continucare Corporation, a provider of primary care physician and practice management services, from 2003 until 2011, and as Chairman of the Board of Directors of Continucare Corporation from 2002 until 2011. Previously, Mr. Pfenniger served as the Chief Executive Officer and Vice Chairman of Whitman Education Group, Inc. from 1997 through June 2003. Prior to joining Whitman, he served as the Chief Operating Officer of IVAX from 1994 to 1997, and, from 1989 to 1994, he served as the Senior Vice President-Legal Affairs and General Counsel of IVAX Corporation. Prior thereto he was engaged in the private practice of law.

Mr. Pfenniger currently serves as a director of OPKO Health (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, GP Strategies Corporation (NYSE: GPX), a corporate education and training company, and Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company. He also serves as the Vice Chairman of the Board of Trustees and as a member of the Executive Committee of the Phillip and Patricia Frost Museum of Science in Miami.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Ocugen On Track to Submit Emergency Use Authorization Application to U.S. FDA for its COVID-19 Vaccine Candidate, COVAXIN™

 

• Active discussions with FDA related to COVAXIN initiated late last year
  
• Master file submitted to FDA on March 26, 2021; awaiting feedback from FDA
  

MALVERN, Pa., May 26, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today confirmed its plan to submit its Emergency Use Authorization (EUA) application for COVAXIN to the U.S. Food & Drug Administration (FDA) in June.

“Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for COVAXIN as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA. Once the EUA application has been submitted, Ocugen intends to commence pre-biologics license application (BLA) discussions with the FDA,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“FDA’s guidance refers specifically to vaccines based on the spike protein. COVAXIN is a unique yet traditional vaccine using an inactivated version of the whole virus with a novel adjuvant that provides a broadly protective immune response beyond the spike protein, offering potential effectiveness against multiple existing and emerging variants and reducing the possibility of mutant virus escape,” said Dr. Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8^?C.

COVAXIN studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data referred to in this press release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970