Release – Opregen Data Update Will Be Featured at 54th Annual Retina Society Meeting in Podium Presentation by Christopher D. Riemann M.D.


Opregen® Data Update Will Be Featured at 54th Annual Retina Society Meeting in Podium Presentation by Christopher D. Riemann, M.D.

 

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported today that updated interim results from a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be featured in a podium presentation at the 54th Annual Scientific Meeting of the Retina Society, to be held at the Ritz-Carlton Hotel in Chicago, IL (September 29 – October 2, 2021). The presentation, “Phase 1/2a Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results, will be presented on September 30, 2021 at 9:52 am EDT by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine.

Lineage also intends to present updated interim results from the Phase 1/2a study later this month, which will include a minimum of 9 months of follow-up in all 24 patients treated with OpRegen, including all 12 patients treated in Cohort 4, which had better baseline vision and smaller areas of GA at baseline than earlier cohorts.

The Retina Society was founded in 1968 exclusively for educational and scientific purposes concerning the diagnosis, care and treatment of diseases and injuries to the retina. For more information on the Retina Society or its annual scientific meeting, please visit https://www.retinasociety.org/ or follow the association on Twitter @RetinaSociety.

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 geographic atrophy (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 retinal pigmented epithelium (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 subacute 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.

Contacts

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

QuickChek – September 13, 2021



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Opregen® Data Update Will Be Featured at 54th Annual Retina Society Meeting in Podium Presentation by Christopher D. Riemann, M.D.

Lineage Cell Therapeutics announced that updated interim results from a Phase 1/2a study of its lead product candidate, OpRegen, will be featured in a podium presentation at the 54th Annual Scientific Meeting of the Retina Society

Research, News & Market Data on Lineage Cell Therapeutics

Watch recent presentation from Lineage Cell Therapeutics



White House Coordinates Efforts of Departments of Energy, Transportation, and Agriculture to Meet the Grand Challenge: Reduce Aviation Carbon Footprint by 50 Percent by 2050

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Opregen® Data Update Will Be Featured at 54th Annual Retina Society Meeting in Podium Presentation by Christopher D. Riemann, M.D.


Opregen® Data Update Will Be Featured at 54th Annual Retina Society Meeting in Podium Presentation by Christopher D. Riemann, M.D.

 

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported today that updated interim results from a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be featured in a podium presentation at the 54th Annual Scientific Meeting of the Retina Society, to be held at the Ritz-Carlton Hotel in Chicago, IL (September 29 – October 2, 2021). The presentation, “Phase 1/2a Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results, will be presented on September 30, 2021 at 9:52 am EDT by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine.

Lineage also intends to present updated interim results from the Phase 1/2a study later this month, which will include a minimum of 9 months of follow-up in all 24 patients treated with OpRegen, including all 12 patients treated in Cohort 4, which had better baseline vision and smaller areas of GA at baseline than earlier cohorts.

The Retina Society was founded in 1968 exclusively for educational and scientific purposes concerning the diagnosis, care and treatment of diseases and injuries to the retina. For more information on the Retina Society or its annual scientific meeting, please visit https://www.retinasociety.org/ or follow the association on Twitter @RetinaSociety.

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 geographic atrophy (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 retinal pigmented epithelium (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 subacute 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.

Contacts

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

Ayala Pharmaceuticals (AYLA) – Looking Forward To AL101 Data Presentation

Friday, September 10, 2021

Ayala Pharmaceuticals (AYLA)
Looking Forward To AL101 Data Presentation

Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company’s current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    AL101 Data Expected Shortly.  Ayala plans to present data from AL101 at the European Society for Medical Oncology (ESMO) Virtual Congress 2021, to be held September 16-September 21, 2021. The first presentation is from the Phase 2 ACCURACY clinical trial testing AL101 in recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) with Notch-activating mutations. A second preclinical study testing AL101 as combination therapy for dual targeting of Notch dysregulated tumors will also be presented.

    Data Presentation Is From The Second Dose Level.  The data will be from the second cohort in the ACCURACY trial that received the 6 mg dose. This cohort enrolled 42 patients with recurrent or metastatic adenoid cystic carcinoma (R/M ACC) and Notch-activating mutations. In September 2020, data from the first cohort of 45 patients receiving a 4mg dose of AL101 showed a disease control rate of 68% …



This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Seven Charts Showing The 18 Month Pandemic Journey


Eighteen Months of the Pandemic – a Retrospective in Seven Charts

 

This article was republished with permission from  The
Conversation
, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of 
Katelyn Jetelina, Assistant Professor of Epidemiology, University of Texas Health Science Center at Houston

 

A year and a half into what the World Health Organization officially declared a pandemic on March 11, 2020, it’s an understatement to say that Americans are exhausted.

I’m an epidemiologist and an internationally recognized science communicator, and I’ve often found myself running between COVID-19 meetings asking, “how did we get here?”

Figuring out the “how” is essential to preparing for the future. In trying to make sense of these past 18 months, I’ve found it helpful to broadly categorize the U.S. pandemic journey thus far into five phases: Scramble, Learn, Respond, Test and Hope.

 

 

Scramble: What’s Going On?

 

In early 2020, SARS-CoV-2, the virus that causes COVID-19, hit the United States. The first documented case was a traveler who landed in Seattle from Wuhan, China on Jan. 15. Only later did public health officials find that SARS-CoV-2 was already spreading throughout the community.

It wasn’t until March that Americans were forced to take the pandemic seriously, as states began to implement stay-at-home orders. While civilians were struggling to figure out child care, working from home and Immunology 101, epidemiologists started to react.

But maybe a better word is “scramble.” The U.S. did not have the public health infrastructure in place to effectively respond. A chronically underfunded and politicized public health system hampered the nation’s real-time response.

 

 

Epidemiologists were scrambling, left to rely on volunteers to report national level public health data because there was no centralized public health data system in the U.S. Public health officials were scrambling to enact safety recommendations and contact trace because of limited resources. Data scientists, like those at Johns Hopkins University, were scrambling to share accessible data for decision-making. Scientists were scrambling to develop COVID-19 tests. And everyone was scrambling to figure out how to communicate the evolving threat of the virus to American lives. From the beginning, the seeds were sown for a reactive, rather than proactive, approach.

 

Learn: Are We Doing Anything
Right?

Once the Northeast started to get under control, June 2020 was fairly quiet across the nation. Is this done? Maybe the decrease is due to weather? People started relaxing.

Then July hit. In one month, cases in the South were as high as they had been in the Northeast months earlier. The West started creeping up, too. The game of whack-a-mole began as there still wasn’t a coordinated, national response.

Health departments were expanding capacity for testing, tracing and surveillance. A multitude of multidisciplinary, academic teams were forming to understand COVID-19 from microscopic-level virology all the way to population-level social implications.

This is when published, peer-reviewed data on COVID-19 started coming through. In fewer than five months, scientific literature database Scopus indexed more than 12,000 publications. Researchers started discovering long COVID-19 symptoms and figuring out effective protective measures like social distancing and wearing a mask. Researchers also learned more about super spreader events and how COVID-19 is transmitted through the air – although this wasn’t officially recognized by the WHO or the Centers for Disease Control and Prevention until about a year later.

 

 

While the flood of evidence provided scientists and clinicians with critical information, a wave of retractions pulling papers with erroneous or unreliable data began to appear. This, coupled with lack of accurate scientific communication from unbiased sources, fueled a concurrent infodemic – an epidemic of misinformation and public health threats that researchers, social media companies and public health officials are still learning how to identify, mitigate and treat.

 

Respond: Bring it on, Virus!

Then came winter, which proved to be a perfect storm of pandemic fatigue and holiday travel. This resulted in our biggest pandemic wave yet. More than 3,000 people were dying per day in the U.S.

Thankfully, help was on its way: vaccines. And not just pretty good vaccines – vaccines that blew efficacy out of the water. The Pfizer-BioNTech vaccine proved to have an efficacy of 95%, significantly above the threshold target of 50%. Thanks to over 500,000 clinical trial volunteers, decades of mRNA research, an estimated US$39.5 billion and fast-moving scientists, the vaccines got to the public in record time. And, while the vaccine rollout was rough, more than 260 million doses were administered by May 2021 in the U.S.

With vaccines, though, came new challenges: a new fight against disinformation (no, mRNA does not change your DNA) and a struggle to understand breakthrough infections.

In the meanwhile, new COVID-19 variants arrived on the scene. Suboptimal genomic surveillance made it difficult to identify where and what variants were spreading. The race between vaccination and variant spread was upon us. The fight was far from over.

 

 

Test: We’re Tired

Early summer 2021 for Americans was blissful. The U.S. reached an all-time pandemic low in terms of COVID-19 cases. People who were vaccinated were told they could take off their masks, while some unvaccinated people took this carte blanche. More Americans started traveling again and getting back to working in person.

But then the delta variant knocked on the door. Significantly more transmissible and severe than the original strain of the coronavirus, it first created a tsunami of cases in the South that then spread to every corner of the United States.

 

 

Unfortunately, pandemic fatigue has settled in. And the pandemic is pushing the U.S. response to its limits. It’s testing the amount of pressure vaccines can withstand. It’s testing health care system capacity. It’s testing the resilience of public health and health care workers. It’s testing the ability of scientists to effectively communicate ever-evolving research findings. And it’s testing the public’s patience as pediatric vaccines undergo clinical trials.

Hope: This Will End

Every epidemic curve comes down. And this one will too. But even after it comes down, the pandemic will still be far from over.

There’s still trauma to be addressed. Families were robbed of proper funerals and goodbyes. Friendships were ripped apart by politically charged misinformation and disinformation. Millions of people lost their jobs. And frontline workers are still not OK. A survey of public health workers across the U.S. found that more than half reported symptoms of at least one mental health condition from March to April 2021.

 

 

The U.S. will also need to self-reflect as a nation. In order to deal effectively with the next infectious disease crisis, the U.S. will need to create centralized public health systems and expand genomic surveillance, hospital networks and testing capabilities. Scientists need to revamp how they accessibly communicate science and research so the CDC can build public trust again. And by removing politics from public health, science might be able to infiltrate echo chambers instead of feeding them.

 

 

Americans need to prepare so when the next pandemic hits, everyone will be ready to mount a proactive, effective fight against a common enemy: the virus.

 

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Release – PDS Biotech Completes Enrollment of Lead-In Safety Cohort in VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA in Recurrent or Metastatic Head and Neck Cancer


PDS Biotech Completes Enrollment of Lead-In Safety Cohort in VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer

 

FLORHAM PARK, N.J., Sept. 09, 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 that it has completed the enrollment of the lead-in safety cohort of its VERSATILE-002 Phase 2 study evaluating the efficacy and safety of the combination of PDS0101, a clinical stage immunotherapy to treat cancers caused by infection with the human papillomavirus (HPV), and KEYTRUDA® (pembrolizumab), a checkpoint inhibitor (CPI). The combination is being studied for the treatment of advanced human papillomavirus (HPV16)-associated head and neck cancer that has returned or spread. The trial is being conducted in collaboration with Merck & Co.

The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that will enroll approximately 100 patients across approximately 25 sites in the U.S. Today the study achieved an important milestone by completing the enrollment of the lead-in safety cohort. Consistent with the study design, further recruitment for the study will commence after a formal analysis by the drug monitoring committee.

VERSATILE-002 is being studied in two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group have not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including CPI therapy (CPI refractory).

The advancement of the VERSATILE-002 trial follows the previously disclosed presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting of interim data in a separate Phase 2 trial (NCT04287868) being led by the National Cancer Institute (NCI). That trial is evaluating the combination of PDS0101 with two investigational immunotherapies in patients with advanced HPV-related cancers who have failed prior treatment. Objective responses measured according to RECIST 1.1 (tumor reduction of 30% or more) were reported in 83% (5/6) of HPV16-positive patients who had failed chemotherapy and radiation but were CPI naive. In CPI refractory patients, tumor reduction was reported in 58% (7/12) and objective responses in 42%. Two patients, one in each group were reported to have a complete response (no evidence of disease) at the time of reporting. Current standard of care is reported to result in objective responses of approximately 20% and 10% in CPI naïve and refractory patients respectively. More information on this study can be found on PDS Biotech’s website.

“The early data from these initial studies suggest that Versamune®-based immunotherapies administered in combinations that include a checkpoint inhibitor, may have the potential to enhance the immune system’s ability to induce a more powerful and targeted anti-tumor response,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “There is an enormous unmet medical need for more effective treatment of advanced HPV-related cancers and specifically, head and neck cancer. We believe the combination of PDS0101 and KEYTRUDA® has the potential to significantly improve clinical outcomes for these patients who have limited treatment options. We look forward to sharing data from this trial as they become available.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products have demonstrated the potential to 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 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. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and locally advanced cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

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 or monitoring committees’ or other third parties’ 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, significance of milestones, 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

PDS Biotech Completes Enrollment of Lead-In Safety Cohort in VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer


PDS Biotech Completes Enrollment of Lead-In Safety Cohort in VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer

 

FLORHAM PARK, N.J., Sept. 09, 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 that it has completed the enrollment of the lead-in safety cohort of its VERSATILE-002 Phase 2 study evaluating the efficacy and safety of the combination of PDS0101, a clinical stage immunotherapy to treat cancers caused by infection with the human papillomavirus (HPV), and KEYTRUDA® (pembrolizumab), a checkpoint inhibitor (CPI). The combination is being studied for the treatment of advanced human papillomavirus (HPV16)-associated head and neck cancer that has returned or spread. The trial is being conducted in collaboration with Merck & Co.

The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that will enroll approximately 100 patients across approximately 25 sites in the U.S. Today the study achieved an important milestone by completing the enrollment of the lead-in safety cohort. Consistent with the study design, further recruitment for the study will commence after a formal analysis by the drug monitoring committee.

VERSATILE-002 is being studied in two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group have not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including CPI therapy (CPI refractory).

The advancement of the VERSATILE-002 trial follows the previously disclosed presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting of interim data in a separate Phase 2 trial (NCT04287868) being led by the National Cancer Institute (NCI). That trial is evaluating the combination of PDS0101 with two investigational immunotherapies in patients with advanced HPV-related cancers who have failed prior treatment. Objective responses measured according to RECIST 1.1 (tumor reduction of 30% or more) were reported in 83% (5/6) of HPV16-positive patients who had failed chemotherapy and radiation but were CPI naive. In CPI refractory patients, tumor reduction was reported in 58% (7/12) and objective responses in 42%. Two patients, one in each group were reported to have a complete response (no evidence of disease) at the time of reporting. Current standard of care is reported to result in objective responses of approximately 20% and 10% in CPI naïve and refractory patients respectively. More information on this study can be found on PDS Biotech’s website.

“The early data from these initial studies suggest that Versamune®-based immunotherapies administered in combinations that include a checkpoint inhibitor, may have the potential to enhance the immune system’s ability to induce a more powerful and targeted anti-tumor response,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “There is an enormous unmet medical need for more effective treatment of advanced HPV-related cancers and specifically, head and neck cancer. We believe the combination of PDS0101 and KEYTRUDA® has the potential to significantly improve clinical outcomes for these patients who have limited treatment options. We look forward to sharing data from this trial as they become available.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products have demonstrated the potential to 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 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. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and locally advanced cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

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 or monitoring committees’ or other third parties’ 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, significance of milestones, 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

Release – Ocugen Inc. to Present at Upcoming Citi and H.C. Wainwright Investment Conferences


Ocugen, Inc. to Present at Upcoming Citi and H.C. Wainwright Investment Conferences

 

MALVERN, Pa., Sept. 07, 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 fight COVID-19, today announced that it will be participating in Citi’s 16th Annual BioPharma Virtual Conference being held on September 8-10, 2021 and at the H.C. Wainwright Global Investment Conference being held on September 13-15, 2021.

Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will present virtually at Citi’s conference and Sanjay Subramanian, CFO and Head of Corporate Development will present virtually at H.C. Wainwright. Both will provide updates on COVAXIN™, the investigational COVID-19 vaccine which the company is co-developing with Bharat Biotech for the U.S. and Canadian markets. They will also present information about Ocugen’s breakthrough modifier gene therapy platform, which has generated product candidates that are expected to enter Phase 1/2a clinical trials in ophthalmic disease states over the next 18 months.

Citi/Ocugen Fireside Chat
Date/Time: Wednesday, September 8, 2021, from 3:15PM-4:00PM Eastern Time
Registration link: https://kvgo.com/citi-16th-annual-biopharma-vc/ocugen-inc-sept-2021

H.C. Wainwright Global Investment Conference
Date/Time: Presentation available on-demand starting at 7:00AM Eastern Time on September 13, 2021
Registration link: https://journey.ct.events/view/705764c5-88a7-4a4c-afff-d1688de5a5d9

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. and Canadian markets. 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 statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as risks and uncertainties regarding market and other conditions and the timing of our planned clinical trials. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “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:
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com 

Ocugen, Inc. to Present at Upcoming Citi and H.C. Wainwright Investment Conferences


Ocugen, Inc. to Present at Upcoming Citi and H.C. Wainwright Investment Conferences

 

MALVERN, Pa., Sept. 07, 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 fight COVID-19, today announced that it will be participating in Citi’s 16th Annual BioPharma Virtual Conference being held on September 8-10, 2021 and at the H.C. Wainwright Global Investment Conference being held on September 13-15, 2021.

Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will present virtually at Citi’s conference and Sanjay Subramanian, CFO and Head of Corporate Development will present virtually at H.C. Wainwright. Both will provide updates on COVAXIN™, the investigational COVID-19 vaccine which the company is co-developing with Bharat Biotech for the U.S. and Canadian markets. They will also present information about Ocugen’s breakthrough modifier gene therapy platform, which has generated product candidates that are expected to enter Phase 1/2a clinical trials in ophthalmic disease states over the next 18 months.

Citi/Ocugen Fireside Chat
Date/Time: Wednesday, September 8, 2021, from 3:15PM-4:00PM Eastern Time
Registration link: https://kvgo.com/citi-16th-annual-biopharma-vc/ocugen-inc-sept-2021

H.C. Wainwright Global Investment Conference
Date/Time: Presentation available on-demand starting at 7:00AM Eastern Time on September 13, 2021
Registration link: https://journey.ct.events/view/705764c5-88a7-4a4c-afff-d1688de5a5d9

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. and Canadian markets. 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 statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as risks and uncertainties regarding market and other conditions and the timing of our planned clinical trials. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “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:
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com 

The Netflix Model for Pharmaceuticals


New Gene Therapies May Soon Treat Dozens of Rare Diseases, but Million-Dollar Price Tags Will Put them out of Reach for Many

 

Zolgensma – which treats spinal muscular atrophy, a rare genetic disease that damages nerve cells, leading to muscle decay – is currently the most expensive drug in the world. A one-time treatment of the life-saving drug for a young child costs US$2.1 million.

While Zolgensma’s exorbitant price is an outlier today, by the end of the decade there’ll be dozens of cell and gene therapies, costing hundreds of thousands to millions of dollars for a single dose. The Food and Drug Administration predicts that by 2025 it will be approving 10 to 20 cell and gene therapies every year.

 

This article was republished with permission from  The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Kevin Doxzen, Hoffmann Postdoctoral Fellow,

 

I’m a biotechnology and policy expert focused on improving access to cell and gene therapies. While these forthcoming treatments have the potential to save many lives and ease much suffering, health care systems around the world aren’t equipped to handle them. Creative new payment systems will be necessary to ensure everyone has equal access to these therapies.

The Rise of Gene Therapies

Currently, only 5% of the roughly 7,000 rare diseases have an FDA-approved drug, leaving thousands of conditions without a cure.

But over the past few years, genetic engineering technology has made impressive strides toward the ultimate goal of curing disease by changing a cell’s genetic instructions. The resulting gene therapies will be able to treat many diseases at the DNA level in a single dose.

Thousands of diseases are the result of DNA errors, which prevent cells from functioning normally. By directly correcting disease-causing mutations or altering a cell’s DNA to give the cell new tools to fight disease, gene therapy offers a powerful new approach to medicine.

There are 1,745 gene therapies in development around the world. A large fraction of this research focuses on rare genetic diseases, which affect 400 million people worldwide.

We may soon see cures for rare diseases like sickle cell disease, muscular dystrophy and progeria, a rare and progressive genetic disorder that causes children to age rapidly.

Further into the future, gene therapies may help treat more common conditions, like heart disease and chronic pain.

 

Sky-High Price Tags

The problem is these therapies will carry enormous price tags.

Gene therapies are the result of years of research and development totaling hundreds of millions to billions of dollars. Sophisticated manufacturing facilities, highly trained personnel and complex biological materials set gene therapies apart from other drugs.

Pharmaceutical companies say recouping costs, especially for drugs with small numbers of potential patients, means higher prices. The toll of high prices on health care systems will not be trivial. Consider a gene therapy cure for sickle cell disease, which is expected to be available in the next few years. The estimated price of this treatment is $1.85 million per patient. As a result, economists predict that it could cost a single state Medicare program almost $30 million per year, even assuming only 7% of the eligible population received the treatment.

And that’s just one drug. Introducing dozens of similar therapies into the market would strain health care systems and create difficult financial decisions for private insurers.

 

Lowering Costs, Finding New Ways to Pay

One solution for improving patient access to gene therapies would be to simply demand drugmakers charge less money, a tactic recently taken in Germany. But this comes with a lot of challenges and may mean that companies simply refuse to offer the treatment in certain places.

I think a more balanced and sustainable approach is two-fold. In the short term, it’ll be important to develop new payment methods that entice insurance companies to cover high-cost therapies and distribute risks across patients, insurance companies and drugmakers. In the long run, improved gene therapy technology will inevitably help lower costs.

For innovative payment models, one tested approach is tying coverage to patient health outcomes. Since these therapies are still experimental and relatively new, there isn’t much data to help insurers make the risky decision of whether to cover them. If an insurance company is paying $1 million for a therapy, it had better work.

In outcomes-based models, insurers will either pay for some of the therapy upfront and the rest only if the patient improves, or cover the entire cost upfront and receive a reimbursement if the patient doesn’t get better. These models help insurers share financial risk with the drug developers.

Another model is known as the “Netflix model” and would act as a subscription-based service. Under this model, a state Medicaid program would pay a pharmaceutical company a flat fee for access to unlimited treatments. This would allow a state to provide the treatment to residents who qualify, helping governments balance their budget books while giving drugmakers money upfront.

This model has worked well for improving access to hepatitis C drugs in Louisiana.

On the cost front, the key to improving access will be investing in new technologies that simplify medical procedures. For example, the costly sickle cell gene therapies currently in clinical trials require a series of expensive steps, including a stem cell transplant.

The Bill & Melinda Gates Foundation, the National Institute of Health and Novartis are partnering to develop an alternative approach that would involve a simple injection of gene therapy molecules. The goal of their collaboration is to help bring an affordable sickle cell treatment to patients in Africa and other low-resource settings.

Improving access to gene therapies requires collaboration and compromise across governments, nonprofits, pharmaceutical companies, and insurers. Taking proactive steps now to develop innovative payment models and invest in new technologies will help ensure that health care systems are ready to deliver on the promise of gene therapies.

 

Suggested Reading:



Genetics Now Touch All Areas of Life Sciences



Small Caps in the Covid 19 Treatment Space





Are Biotech Scientists on the Road to a Cure for Type One Diabetes?



Stem Cells Role in the Anti-Aging Process

 

Stay up to date. Follow us:

 

Release – Lineage Announces Appointment of General Counsel


Lineage Announces Appointment of General Counsel

 

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

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it has appointed George A. Samuel III as Lineage’s General Counsel and Corporate Secretary.  Mr. Samuel will lead the Company’s legal operations, bringing extensive corporate, transactional, intellectual property and commercial expertise which spans nearly 15 years across the life sciences and technology sectors as well as in private practice.

“We are pleased to welcome George to our leadership team and look forward to his contributions as we build Lineage into a leading cell therapy and cell transplant company,” stated  Brian M. Culley, Lineage CEO. “George’s diverse experience across legal and other operational areas will be invaluable as we continue to execute on our clinical development plans. In particular, his transactional successes in business development and his intellectual property experience will be key resources as we evaluate partnership opportunities and expand collaborations for our OpRegen, OPC1 and VAC2 programs and work to unlock additional value from our extensive intellectual property portfolio.”

“I am looking forward to joining this dynamic and experienced team by leading Lineage’s legal operations at this exciting and transformative time,” stated George A. Samuel III. “The field of cell therapy is undergoing rapid growth and I’m delighted to have this opportunity to contribute to it.”

Prior to joining Lineage,  Mr. Samuel most recently served as Director, Senior Counsel for 
Lytx, Inc., where he managed the commercial legal operations for an international video telematics SaaS company. Prior to that,  Mr. Samuel served as VP, General Counsel and Corporate Secretary for Cardiff Oncology, Inc. (formerly known as 
Trovagene, Inc.), a clinical-stage biotechnology company focused on developing treatments in oncology. While at Cardiff Oncology, he advised on strategic, business development and operational decisions; oversaw capital raising efforts, regulatory compliance as well as 
SEC reporting; and managed intellectual property, including technology transfer and licensing.  Mr. Samuel has also practiced corporate law at major law firms, including 
DLA Piper LLP and 
Cooley LLP, where he served as outside counsel to public and private companies in a variety of commercial transactions.  Mr. Samuel received a J.D. from 
Columbia University School of Law, and a B.A. in Philosophy from 
Tufts University and is a member of the 
State Bar of California and 
New York.

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 three allogeneic (“off-the-shelf”) clinical programs are in markets with billion dollar opportunities: (i) OpRegen®, an investigational 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 investigational oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, with investigational immunotherapy VAC2 currently in 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,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” “look forward to” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s ability to become a leading cell therapy and cell transplant company, to expand collaborations for its product candidate programs, and to unlock value from its intellectual property portfolio, and the commercial potential for cell therapy products. 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 discussed in Lineage’s filings with the 
Securities and Exchange Commission (the 
SEC). Further information regarding these risks, uncertainties and factors is included under the heading “Risk Factors” in Lineage’s periodic and other reports filed with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available from the SEC’s website. 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. 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.

Release – ProMIS Neurosciences appoints accomplished biotechnology executive Josh Mandel-Brehm to its Board of Directors


ProMIS Neurosciences appoints accomplished biotechnology executive, Josh Mandel-Brehm, to its Board of Directors

 

TORONTO, Ontario and CAMBRIDGE, Massachusetts – Sept.1, 2021– ProMIS Neurosciences, Inc. (TSX: PMN); (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced the appointment of Josh Mandel-Brehm to its Board of Directors with immediate effect. 

“I am delighted to welcome Josh Mandel-Brehm as a member of the ProMIS Board of Directors at this time”, said Eugene Williams, Executive Chairman of ProMIS Neurosciences. “Josh has built a productive platform company in CAMP4, which experience is very relevant to ProMIS and our unique platform opportunity. Combined with his tremendous background in business development, capital formation, and strategy, we believe Josh will make significant contributions to the ProMIS Board.”

“I am very pleased to join the Board of Directors of ProMIS”, stated Josh Mandel-Brehm. “PMN310 has the potential to change the lives of many patients suffering from Alzheimer’s Disease and I am especially impressed by the technology platform and the team. ProMIS is well positioned to build a portfolio of next generation, differentiated antibody-based therapeutics in neurodegenerative and other mis-folded protein diseases, an area that I expect will be of increasing interest to investors and large pharma.” 

Josh Mandel-Brehm is President & Chief Executive Officer of CAMP4 Therapeutics and holds a dual appointment as entrepreneur partner with Polaris Partners. He is also a co-founder and board member for Vico Therapeutics, an oligonucleotide-based RNA modulating Company focused on developing therapeutics for patients suffering from rare CNS disorders.

Mr. Mandel-Brehm previously held key business development and operations leadership roles at leading biotech companies. Most recently he served as part of the Business Development group at Biogen, where he led multiple strategic activities and corresponding transactions, which included expanding Biogen’s non-malignant hematology franchise, overseeing seminal investments to enter the ophthalmology field and advancing Biogen’s gene therapy strategy. Prior to Biogen, Mr. Mandel-Brehm held several roles of increasing responsibility at Genzyme as part of the business development group for the company’s rare disease business unit.

Mr. Mandel-Brehm earned a BA in Biology from Washington University in St. Louis and holds an MBA from the University of Michigan.

About ProMIS Neurosciences, Inc.

ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and PD.  ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:

Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

ProMIS Neurosciences appoints accomplished biotechnology executive, Josh Mandel-Brehm, to its Board of Directors


ProMIS Neurosciences appoints accomplished biotechnology executive, Josh Mandel-Brehm, to its Board of Directors

 

TORONTO, Ontario and CAMBRIDGE, Massachusetts – Sept.1, 2021– ProMIS Neurosciences, Inc. (TSX: PMN); (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced the appointment of Josh Mandel-Brehm to its Board of Directors with immediate effect. 

“I am delighted to welcome Josh Mandel-Brehm as a member of the ProMIS Board of Directors at this time”, said Eugene Williams, Executive Chairman of ProMIS Neurosciences. “Josh has built a productive platform company in CAMP4, which experience is very relevant to ProMIS and our unique platform opportunity. Combined with his tremendous background in business development, capital formation, and strategy, we believe Josh will make significant contributions to the ProMIS Board.”

“I am very pleased to join the Board of Directors of ProMIS”, stated Josh Mandel-Brehm. “PMN310 has the potential to change the lives of many patients suffering from Alzheimer’s Disease and I am especially impressed by the technology platform and the team. ProMIS is well positioned to build a portfolio of next generation, differentiated antibody-based therapeutics in neurodegenerative and other mis-folded protein diseases, an area that I expect will be of increasing interest to investors and large pharma.” 

Josh Mandel-Brehm is President & Chief Executive Officer of CAMP4 Therapeutics and holds a dual appointment as entrepreneur partner with Polaris Partners. He is also a co-founder and board member for Vico Therapeutics, an oligonucleotide-based RNA modulating Company focused on developing therapeutics for patients suffering from rare CNS disorders.

Mr. Mandel-Brehm previously held key business development and operations leadership roles at leading biotech companies. Most recently he served as part of the Business Development group at Biogen, where he led multiple strategic activities and corresponding transactions, which included expanding Biogen’s non-malignant hematology franchise, overseeing seminal investments to enter the ophthalmology field and advancing Biogen’s gene therapy strategy. Prior to Biogen, Mr. Mandel-Brehm held several roles of increasing responsibility at Genzyme as part of the business development group for the company’s rare disease business unit.

Mr. Mandel-Brehm earned a BA in Biology from Washington University in St. Louis and holds an MBA from the University of Michigan.

About ProMIS Neurosciences, Inc.

ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and PD.  ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:

Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.