Tag: Biotechnology

GeoVax Labs, Inc. (GOVX) – Positive Data From CM04S1 Phase 2 and Preclinical Trials

Posted on by cpereira@noblefcm.com


Monday, September 25, 2023

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

GEO-CM04S1Phase 2 Clinical and Preclinical Data Show Efficacy. GeoVax announced publication of initial Phase 2 data from the CM04S1 trial in immunocompromised patients that showed significant immune responses. A poster presentation at a medical meeting showed preclinical data on CM04S1 efficacy against multiple variant strains. We believe both publications support our expectations that CM04S1 can effectively stimulate both humoral and cellular immunity.

Initial Responses Seen In Immunocompromised Patients. GeoVax announced the publication of initial data from its Phase 2 trial for GEO-CM04S1 in immunocompromised patients with hematological malignancies in the journal Vaccines. The data showed both humoral and cellular immune responses in patients with reduced immune function that have difficulty responding to vaccination. The immune markers were superior or comparable to historical cohorts from healthy patients receiving the Pfizer mRNA vaccine.


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Biotech Company Abpro Poised for Growth Through Merger with SPAC

Posted on by slightbourne@noblecapitalmarkets.com

Abpro, an emerging biotechnology company developing novel antibody therapies, has entered into a definitive agreement to go public via a merger with Atlantic Coastal Acquisition Corp. II, a special purpose acquisition company (SPAC). The deal values Abpro at $725 million and will provide capital to advance its drug pipeline.

Abpro specializes in leveraging its proprietary technology platform to create next-generation antibody treatments for cancer, eye diseases, and viral infections. The company aims to develop breakthrough immunotherapies to help patients facing life-threatening conditions.

Though Abpro is still in the preclinical phase, it has made significant progress with its pipeline of antibody therapies. Its lead candidates target HER2+ cancers, which include aggressive forms of breast, gastric, and colorectal cancer. Abpro is also pursuing antibodies for COVID-19 treatment and ophthalmic conditions like wet AMD and DME.

Last year, Abpro announced a partnership with South Korea’s Celltrion to further develop ABP 102, an antibody-based treatment for HER2+ cancers. Under the deal, Abpro received a direct equity investment from Celltrion along with eligibility for up to $1.75 billion in milestone payments.

Abpro leverages its DiversImmune platform to design diverse antibody libraries and identify optimal drug candidates. The technology enables more precise targeting compared to conventional antibodies.

Take a look at Noble Capital Markets Senior Biotechnology Research Analyst Robert LeBoyer’s coverage list.

The merger with Atlantic Coastal will provide capital for Abpro to advance its most promising therapies into clinical studies. Abpro also plans to use the funds for business development activities and expanding its pipeline.

Atlantic Coastal is a SPAC focused on finding and merging with high-potential healthcare companies. The transaction is expected to close in Q2 2024, at which point the combined company will trade publicly.

Commenting on the merger, Abpro CEO Ian Chan stated: “This milestone will accelerate getting our therapies to patients needing life-changing treatments.”

Abpro represents an attractive investment opportunity within biotech. Analysts project the global antibody technology market to reach $272 billion by 2030, driven by rising demand for targeted immunotherapies. With its next-generation platform and infusion of growth capital, Abpro is well-positioned to compete in this thriving sector.

The transaction comes amidst a wave of biotech SPAC deals, as pre-revenue companies aim to access public growth financing. With its proprietary technology and strategic partnership in place, Abpro seems poised to leverage this deal to evolve from an R&D startup into a fully integrated biopharma company.

Explore other SPAC Mergers via Spactrac reports from Noble Capital Markets

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Release – Ocugen, Inc. Announces Connie Collingsworth Joins Business Advisory Board

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 21, 2023

MALVERN, Pa., Sept. 21, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Connie Collingsworth, former Chief Operating Officer of the Bill and Melinda Gates Foundation, will join the Company’s Business Advisory Board (BAB). The BAB was established in June 2023 to assist in driving public/private partnerships with governments around the world; pursuing business collaborations, partnerships, and licensing opportunities; creating awareness of the Company’s differentiated capabilities; and promoting access to the Company’s therapies around the world.

“Connie brings value-added expertise in all aspects of strategic growth and organizational governance—across a variety of industries—that will offer unique insights to the BAB,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “Connie’s deep financial background at a global level will provide meaningful counsel to Ocugen as we pursue new business development opportunities to support and evolve our clinical programs.”

Ms. Collingsworth has been a primary advisor to Bill Gates, Melinda French Gates, and Warren Buffett regarding governance. During her tenure with the Bill and Melinda Gates Foundation, she designed and implemented the core operational infrastructure and created the intellectual property strategy known as “Global Access,” as well as advising on the creation of a $2.5 billion strategic investment fund.

“I am inspired by Ocugen’s commitment to not only developing novel therapies that address unmet medical needs for patients with serious conditions, but their passion to ensure access to all patients around the world,” said Ms. Collingsworth. “I look forward to sharing my diverse experiences as an executive and a board member so that patients can potentially benefit.”

Ms. Collingsworth joins Senator Pat Toomey, Ambassador Joseph W. Westphal, Ph.D., and Dennis Carey, Ph.D. on the BAB. These advisors will work alongside the Executive Leadership Team to offer guidance to enable the Company to fulfill its mission and achieve its short- and long-term strategy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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. 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.

Contact:
Tiffany Hamilton
Head of Corporate Communications
Tiffany.Hamilton@ocugen.com

Source: Ocugen

Release – GeoVax Next-Generation COVID-19 Vaccine Data Presented at Keystone Symposia Conference

Posted on by aweinsoff@channelchek.com

Research News ad Market Data on GOVX

 

Preclinical Data for GEO-CM02 Demonstrates Single-Dose Protection

Against Multiple SARS-CoV-2 Variants

Atlanta, GA, September 20, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today the presentation of preclinical vaccine efficacy data for GEO-CM02, a multi-antigen SARS-CoV-2 vaccine. The new unpublished data were presented during the Keystone Symposia on Molecular and Cellular Biology, Vaccinology During and After COVID-19, being held in Atlanta, Georgia on September 17-20, 2023.

Presentation Details & Summary:

Abstract Title:            MVA-vectored multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models

Abstract Authors:      Shannon Stone1, Amany Elsharkawy1, Janhavi Natekar1, Sreenivasa Rao Oruganti2, Mary Hauser2, Arban Domi2, Pratima Kumari2, Anchala Guglani1, Mark Newman2, and Mukesh Kumar1

1 Georgia State University   2 GeoVax Labs, Inc.

Presenting Author:     Shannon Stone, Georgia State University

First-generation SARS-CoV-2 vaccines based on the spike (S) protein induce neutralizing antibodies provide significant levels of protection. However, vaccine efficacy is disrupted by emerging variants that contribute to neutralizing antibody evasion, requiring updating and booster doses. To address this limitation, GeoVax has designed multi-antigen SARS-CoV-2 vaccines based on the S, membrane (M), and envelope (E) proteins, which are designed to engage both the humoral (antibody) and cellular (T-cell) arms of the immune system and to broaden both the function and specificity. Efficacy of the vaccine, designated GEO-CM02, was tested using the industry standard, lethal hACE2 transgenic mouse model.

The poster presentation (viewed here), highlighted the following data:

  • The GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
  • Animals were protected prior to the detection of neutralizing antibodies, likely indicating a critical T-cell contribution.
  • GEO-CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals.

Together, these data indicate that immunization with the multi-antigen GEO-CM02 vaccine can protect against severe disease and death induced by SARS-CoV-2 infection and regardless of the variant.

Mark Newman, Ph.D., GeoVax’s Chief Scientific Officer, commented, “As noted in this presentation, the first-generation SARS-CoV-2 vaccines were designed based on the S protein of the SARS-CoV-2 virus with the goal of inducing neutralizing antibodies. While this approach was successful, the limitations in the face of continually emerging variants are now well documented. The data generated in the GEO-CM02 studies validate our hypothesis that vaccines designed to induce both antibodies and T-cells to multiple viral structural proteins can address the issue of viral variation and escape from the immune system. The multi-antigen, MVA-vectored vaccine design is currently being evaluated by GeoVax in three Phase 2 clinical trials using a similar vaccine (GEO-CM04S1).”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

Release – PDS Biotech Announces PDS0202 Elicits Active Neutralization of Multiple Influenza Strains in Preclinical Studies

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

  • PDS0202 (Infectimune® + COBRA influenza antigens) vaccination also prevented illness/weight loss
  • Vaccine protected against replication of the virus in the lungs of ferrets after challenge with the H1N1 virus
  • Data from Cleveland Clinic’s Ted Ross Lab presented at the 9th ESWI Influenza Conference

PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced its investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses. The vaccine also provided protection against infection after challenged with high doses of the H1N1 virus in ferrets not previously exposed to flu. The data were presented in an oral lecture at the 9th European Scientific Working Group on Influenza (ESWI) Conference in Valencia, Spain by James Allen, PhD, from the Cleveland Clinic laboratory of renowned influenza expert, Ted Ross, PhD.

“We are encouraged that PDS0202 has demonstrated activity in generating protective hemagglutination inhibition assay (HAI) antibody responses in pre-immune ferret studies, which are the gold standard in influenza vaccine testing. In addition to active neutralization of various influenza strains, the data demonstrated that PDS0202 prevented illness, weight loss and importantly protected the lungs of vaccinated animals from H1N1,” said Dr. Ross. “In humans, we expect PDS0202 to elicit a similar or more broadly reactive antibody profile due to humans having broader exposure to influenza and thus the recall of a more diverse population of memory B cells than the animals evaluated in our preclinical studies.”

H3N2 HAI Response


Vaccination with PDS0202 Provides broadly effective HAI antibody responses (minimum 1:40 ratio) across multiple strains of the H3N2 virus including Swtiz/13 and Kan/17 demonstrating the broad reactivity of the novel COBRA proteins. Similar results were demonstrated against multiple strains of the H1N1 virus.
Vaccination with PDS0202 Provides broadly effective HAI antibody responses (minimum 1:40 ratio) across multiple strains of the H3N2 virus including Swtiz/13 and Kan/17 demonstrating the broad reactivity of the novel COBRA proteins. Similar results were demonstrated against multiple strains of the H1N1 virus.

H1N1 Infection Results: D3 Nasal Wash Viral Titers

PDS0202 (Y2 + NG2 COBRA proteins) prevents viral replication in the lungs of ferrets after vaccination followed by viral challenge with A/Victoria/2570/2019 H1N1 flu strain (1e6 PFU/mL). The quantity of H1N1 virus stays below the detection limits. The vaccine based on the wild type HA (Mich/15 + Sing/16) and the control (Mock) do not effectively prevent replication and expansion of the H1N1 virus in the lungs of the ferrets.
PDS0202 (Y2 + NG2 COBRA proteins) prevents viral replication in the lungs of ferrets after vaccination followed by viral challenge with A/Victoria/2570/2019 H1N1 flu strain (1e6 PFU/mL). The quantity of H1N1 virus stays below the detection limits. The vaccine based on the wild type HA (Mich/15 + Sing/16) and the control (Mock) do not effectively prevent replication and expansion of the H1N1 virus in the lungs of the ferrets.

PDS0202 combines PDS Biotech’s Infectimune® novel investigational immune activating platform with proprietary Computationally Optimized Broadly Reactive Antigens (COBRA) influenza antigens. The COBRA antigens developed in the laboratory of Dr. Ted Ross were designed using an in-silico layered consensus building approach, which utilizes HA sequence data from influenza surveillance databases. PDS0202’s ability to generate broad, robust antibody and T cell responses position the vaccine to potentially provide durable protection against seasonal and pandemic strains of influenza. PDS0202 is administered through intramuscular injection in a single dose.

“We are pleased that the PDS0202 data presented at the ESWI Influenza Conference are consistent with our previously reported preclinical studies in murine models, marking encouraging progress toward a potential universal influenza vaccine,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “We look forward to our continued discussions with the National Institute of Allergy and Infectious Diseases to advance PDS0202 into clinical trials with the goal of creating a universal vaccine that provides broad protection against multiple strains of influenza.”

In previous preclinical studies, PDS0202 demonstrated the ability to promote robust induction of broadly neutralizing influenza-specific antibodies, flu-specific CD4 (helper) and CD8 (killer) T cells, as well as long-lasting memory T cells. This robust immune response to the COBRA antigens suggests strong potential for PDS0202 as a broad and long-term protecting universal influenza vaccine.

About Infectimune®
Infectimune® is a novel investigational immune activating platform that generates broad and robust antibody and T cell responses that provide durable protection against infectious disease. Infectimune® based vaccines are given by intramuscular injection and generate robust and durable protection against infectious agents in preclinical studies. Infectimune® based vaccines have demonstrated safety in preclinical studies and appear to provide more robust and longer-lasting protection against infectious disease.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. 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® and Infectimune® based product candidates; 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® and Infectimune® based product candidates 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 the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), 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; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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. 

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

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

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

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/322b8fdb-bf6b-4c74-96c9-81b581f74513

https://www.globenewswire.com/NewsRoom/AttachmentNg/f7fe4fb9-3936-4f2b-9673-f571604ed43

Release – Ocugen To Participate in Panel At Cantor Fitzgerald Global Healthcare Conference 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 20, 2023

PDF Version

MALVERN, Pa., Sept. 20, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen will participate in a panel at the annual Cantor Fitzgerald Global Healthcare Conference taking place from September 26-28, 2023 in NYC.

On the panel, Dr. Musunuri will join the CEO of Tarsier Pharma to discuss their companies’ respective work toward developing novel therapies for hard-to-treat ocular diseases. In addition, members of Ocugen’s executive team will conduct one-on-one meetings with registered investors, to showcase the Company’s business and clinical development strategy across its unique gene therapy, cell therapy, and vaccine platforms, and highlight recent corporate achievements and anticipated milestones.

Details of the presentation are as follows:

Date: Tuesday, September 26, 2023
Presentation Time: 1 p.m. ET
Location: Track 1, InterContinental Barclay Hotel, New York City

A live video webcast of the fireside chat will be available on the events page of the Ocugen investor site.

About Ocugen, Inc. 
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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. 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. 

Contact: 
Tiffany Hamilton 
Head of Communications 
IR@ocugen.com  

Boston Scientific to Acquire Relievant Medsystems for $850 Million

Posted on by slightbourne@noblecapitalmarkets.com

Medical device maker Boston Scientific announced Monday it will acquire Relievant Medsystems for $850 million upfront and additional contingent payments. Relievant has developed a minimally invasive technology to treat chronic low back pain.

The deal aims to expand Boston Scientific’s portfolio in neuromodulation, the use of devices to modulate nerve activity. Relievant’s Intracept system uses targeted radiofrequency energy to ablate the basivertebral nerve, stopping pain signals from reaching the brain. It is the only FDA-cleared device specifically for vertebrogenic pain, a type of chronic back pain originating in the vertebrae.

Relievant’s system is designed to provide long-term pain relief and improve function through an outpatient procedure. It targets an estimated 5.3 million patients in the U.S. with vertebrogenic pain from degenerative disc disease or vertebral compression fractures. Boston Scientific cited Relievant’s novel technology and strong clinical data from multiple randomized controlled trials in deciding to acquire the company.

The Intracept procedure is implant-free, sparing patients from potential complications associated with implants. It also avoids destroying the intervertebral disc. The system has been used to treat over 2,000 patients since receiving FDA clearance in 2018 based on Level 1 clinical evidence.

The deal expected to close in the first half of 2024 pending approvals. Boston Scientific said Relievant is projected to generate over $70 million in sales this year with 50%+ growth in 2024. The acquisition is forecasted to be neutral or slightly accretive to Boston Scientific’s adjusted earnings per share.

“We look forward to working with the Relievant team to expand access to care for those with chronic back pain,” said Jim Cassidy, president of Neuromodulation at Boston Scientific. Both companies aim to transform the diagnosis and treatment of vertebrogenic pain through a minimally invasive approach.

Take a moment to take a look at Noble Capital Markets Senior Research Analyst Gregory Aurand’s coverage list.

Ocugen (OCGN) – OCU400 Update Shows Improvement In Three Vision Measures

Posted on by cpereira@noblefcm.com


Thursday, September 14, 2023

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Data Shows Clinically Meaningful Improvements. Ocugen provided an update to the Phase 1/2 clinical trial data for OCU400 in retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA), two rare diseases in which genetic mutations cause loss of vision and progress to blindness. We see these data as clinically meaningful for these indications as well as providing proof-of-concept for Ocugen’s method of targeting a “master control gene” that has downstream effects on other genes.

We See Proof-of-Concept For The “Master Control Gene” Approach. RP is a group of genetic disorders with over 100 possible genetic mutations that may be present and contributing to loss of vision. This makes the course of disease highly variable and difficult to target with a single therapy. Ocugen has been developing OCU400 to target the RHO and NR2E3 genes that control pathways and regulate other genes that act later in those pathways. The data show that OCU400 can affect several genetic pathways in eye, with improvements in three measures of vision.


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Cancer Immunotherapy Developer Calidi Goes Public Via SPAC Merger

Posted on by slightbourne@noblecapitalmarkets.com

Calidi Biotherapeutics has completed its merger with special purpose acquisition company First Light Acquisition Group (FLAG), debuting as a publicly traded cancer immunotherapy company. The combined entity, now named Calidi Biotherapeutics, Inc., will commence trading on the NYSE American under ticker symbols “CLDI” and “CLDI WS” on September 13.

The merger provides Calidi with gross proceeds of approximately $28 million before expenses and debt repayments. This consists of $25 million raised in a concurrent private offering, $1 million in cash from FLAG’s trust, and $2 million in PIPE and non-redemption agreements.

Founded in 2014, Calidi is developing first-in-class immunotherapies using allogeneic stem cells to deliver targeted cancer treatments. The SPAC deal enables the company to continue advancing its pipeline as a publicly listed firm.

Calidi’s lead candidates CLD-101 and CLD-201 leverage proprietary platforms called NeuroNova and SuperNova. Both utilize allogeneic stem cells loaded with oncolytic viruses that directly infect and kill tumor cells.

CLD-101, which employs neural stem cells, is currently in a Phase 1 trial for recurrent high-grade glioma brain tumors. Interim data is expected in 2024. CLD-201 uses mesenchymal stem cells to treat advanced solid tumors, with a Phase 1/2 study slated for 2024.

Take a moment to take a look at PDS Biotechnology, a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies.

According to Calidi CEO Allan Camaisa, the IPO “will allow us to push the boundaries of cell-based virotherapies and continue to research novel ways to eradicate cancer.”

SPACs have become an increasingly popular alternative to traditional IPOs in the biotech sector. Also known as “blank check companies”, SPACs raise capital through an IPO and then merge with a private entity to take it public. This allows the operating company to avoid some of the uncertainty associated with a traditional public debut.

First Light Acquisition Group, led by CEO Tom Vecchiolla, raised $172.5 million in its own IPO in May 2021. The team then sought a merger target that could benefit from the injection of public capital. They ultimately settled on clinical-stage Calidi and its novel immunotherapy approach.

In addition to the SPAC proceeds, Calidi has secured a $10 million forward purchase agreement from several institutional investors. It also intends to execute a $50 million purchase agreement with Lincoln Park Capital Fund.

Between its strengthened balance sheet and non-dilutive financing options, Calidi believes it now has the runway to advance its programs into 2025 without need for further equity funding.

According to Vecchiolla, “We are excited to see Calidi continue to grow as they transition into a public company and look forward to their clinical pursuit of new treatment options for patients everywhere in need.”

The merger completes Calidi’s transformation into a publicly traded company. With shares soon to start trading on the NYSE American under ticker “CLDI”, the company is poised to continue developing its promising immunotherapy candidates for cancer patients in need of new treatment options.

Rocket Shares Soar as FDA Aligns on Danon Disease Gene Therapy Trial

Posted on by slightbourne@noblecapitalmarkets.com

Rocket Pharmaceuticals (NASDAQ: RCKT) announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the design of a global pivotal Phase 2 trial for its gene therapy RP-A501 in Danon Disease. This marks an important milestone on the path to delivering a potentially transformative treatment for this devastating inherited cardiomyopathy.

Danon Disease is caused by genetic mutations in the LAMP2 gene leading to fatal heart failure. There are currently no approved therapies. The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe, taking the lives of most males by age 20 and females by 40. RP-A501 aims to be the first-ever therapy to change the course of Danon Disease.

The news sent Rocket’s stock price soaring 34% to $20.46 in after-hours trading on Tuesday, as investors welcomed the positive regulatory update.

The planned Phase 2 pivotal trial will be a global, single-arm, open label study enrolling 12 Danon Disease patients. This includes a pediatric safety lead-in of 2 patients. All participants will receive a dose of 6.7 x 1013 GC/kg of RP-A501 delivered through intravenous infusion.

To support potential accelerated approval by the FDA, the co-primary efficacy endpoints at 12 months are LAMP2 protein expression and reduction in left ventricular mass, a key measure of heart damage. Expression of LAMP2, which is deficient in Danon patients, and decreased cardiac hypertrophy would signal RP-A501 is restoring cardiac function at its root genetic cause.

Take a moment to look at Ocugen Inc., a biotechnology company focused on discovering, developing and commercializing novel gene and cell therapies and vaccines.

Secondary trial endpoints consist of the biomarker troponin, heart failure questionnaires, functional classification, event-free survival, and safety. These could support eventual full approval. A concurrent global natural history study will provide an external control arm for comparison.

According to Rocket CEO Dr. Gaurav Shah, “RP-A501 has the potential to restore normal cardiac function and provide a lifetime of benefit to patients with Danon Disease who have no other viable treatment options.” The company believes this pivotal trial design sets the most rapid path to deliver RP-A501 to patients in dire need.

Rocket’s gene therapy approach involves using an engineered virus called AAV9 to deliver a functional LAMP2 gene into patients’ heart cells. The gene insert encodes LAMP2B, a key protein involved in the cellular recycling process called autophagy. Restoring LAMP2B in the heart could potentially halt the accumulation of cellular debris and improve cardiac structure and function.

The company has already manufactured sufficient high-quality RP-A501 drug product at its in-house cGMP facility to supply the full pivotal Phase 2 trial. Qualified potency assays are also in place to support quality control and regulatory compliance.

Looking ahead, Rocket plans to file a Clinical Trial Application in the EU in Q3 2023 to initiate study activities abroad. The company also recently secured an ICD-10 code from the Centers for Medicare and Medicaid Services for LAMP2 deficiency, which will support diagnostic efforts.

This alignment with the FDA represents a major achievement for both Rocket and the Danon Disease community. RP-A501 would be the first-ever approved treatment for this deadly cardiovascular condition. The gene therapy aims to be a one-time curative infusion that could provide transformative and lifelong benefits to affected patients.

Beyond Danon Disease, Rocket believes this program paves the way for developing genetic medicines against other inherited heart diseases. Cardiac gene therapy has long faced hurdles, but the company is forging a new path for treating genetic cardiovascular conditions at their root.

With the pivotal Phase 2 trial design now locked in, Rocket can move full speed ahead on enrolling patients and gathering data to support potential approval. The company expects to release initial results from the trial evaluating RP-A501 in 2024. This could lead to a approved treatment for Danon Disease in the not too distant future—bringing tremendous hope to patients and families affected by this devastating illness.

Tonix Pharmaceuticals announces poster presentation involving TNX-1700 in preclinical colorectal cancer models at the 7th International Cancer Immunotherapy Conference 2023.

Release – PDS Biotech to Host Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101 on September 27, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Company to provide updated VERSATILE-002 data on combination of PDS0101 and KEYTRUDA®

PRINCETON, N.J., Sept. 13, 2023 (GLOBE NEWSWIRE) —

Company to provide updated VERSATILE-002 data on combination of PDS0101 and KEYTRUDA®

PRINCETON, N.J., Sept. 13, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced it will host a Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101, including an update from the Phase 2 VERSATILE-002 trial, for analysts, investors and the scientific community from 8:00 – 9:00 AM EDT on Wednesday, September 27, 2023.

The Company-sponsored event will focus on current and potential treatments for HPV16-positive head and neck cancer, including the emerging use of circulating tumor DNA (ctDNA), and unmet needs of this growing patient population. The event will also include a presentation on updated data from the VERSATILE-002 study of the combination of KEYTRUDA® (pembrolizumab) and PDS0101, PDS Biotech’s novel investigational HPV-targeted immunotherapy, as well as the design for the planned VERSATILE-003 Phase 3 clinical trial due to be initiated in the fourth quarter of 2023. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:

  • Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
  • Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
  • Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
  • Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Registration of PDS Biotech’s KOL Roundtable 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://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023.   Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

About PDS0101 

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-003

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) compared with KEYTRUDA® monotherapy as the control arm. The primary end point for the study is patient overall survival (OS). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.  

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® and Infectimune® based product candidates; 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® and Infectimune® based product candidates 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 the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), 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; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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.    

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

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

Media Contacts:
Dave Schemelia
Tiberend Strategic Advisors
Phone: +1 (609) 468-9325
Email: dschemelia@tiberend.com

Eric Reiss
Tiberend Strategic Advisors
Phone: +1 (802) 249-1136
Email: ereiss@tiberend.com

(Nasdaq: PDSB) (PDS Biotech or Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced it will host a Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101, including an update from the Phase 2 VERSATILE-002 trial, for analysts, investors and the scientific community from 8:00 – 9:00 AM EDT on Wednesday, September 27, 2023.

The Company-sponsored event will focus on current and potential treatments for HPV16-positive head and neck cancer, including the emerging use of circulating tumor DNA (ctDNA), and unmet needs of this growing patient population. The event will also include a presentation on updated data from the VERSATILE-002 study of the combination of KEYTRUDA® (pembrolizumab) and PDS0101, PDS Biotech’s novel investigational HPV-targeted immunotherapy, as well as the design for the planned VERSATILE-003 Phase 3 clinical trial due to be initiated in the fourth quarter of 2023. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:

  • Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
  • Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
  • Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
  • Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Registration of PDS Biotech’s KOL Roundtable 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://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023.   Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

About PDS0101 

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-003

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) compared with KEYTRUDA® monotherapy as the control arm. The primary end point for the study is patient overall survival (OS). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.  

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® and Infectimune® based product candidates; 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® and Infectimune® based product candidates 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 the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), 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; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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.    

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

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

Media Contacts:
Dave Schemelia
Tiberend Strategic Advisors
Phone: +1 (609) 468-9325
Email: dschemelia@tiberend.com

Eric Reiss
Tiberend Strategic Advisors
Phone: +1 (802) 249-1136
Email: ereiss@tiberend.com

Release – Ocugen Announces Positive Clinical Study Update From The Phase 1/2 Trial Of OCU400, A Modifier Gene Therapy Product Candidate, For The Treatment Of Retinitis Pigmentosa (RP) And Leber Congenital Amaurosis (LCA)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 13, 2023

PDF Version

  • Favorable safety and tolerability profile of OCU400 investigational drug product in RP and LCA subjects to date
  • Clinical study update suggests continued positive trends in Best-Corrected Visual Acuity (BCVA) and Multi-Luminance Mobility Testing (MLMT), as well as positive trends in Low-Luminance Visual Acuity (LLVA) among treated eyes
  • 83% (10/12) of subjects demonstrated stabilization or improvement in treated eye either on BCVA or LLVA or MLMT scores from baseline
  • Notably, 86% (6/7) of RHO mutation subjects experienced either stabilization of or increase in MLMT scores from baseline including a subset of 29% (2/7) that demonstrated a 3 Lux luminance level improvement

MALVERN, Pa., Sept. 13, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced a clinical study update for Retinitis Pigmentosa (RP) participants treated in the Phase 1/2 trial to assess the safety and efficacy of OCU400 for RP associated with NR2E3 and Rhodopsin (RHO) mutations and Leber congenital amaurosis (LCA) with mutation(s) in the CEP290 gene. This clinical study update is an extension of results provided by Ocugen on April 14, 2023, and includes additional subjects from the high dose group. The Company believes that OCU400—Ocugen’s therapeutic approach, utilizing a proprietary modifier gene therapy platform—has the potential to be a gene-agnostic therapeutic for RP and LCA patients with inherited retinal degeneration.

“This clinical study update supports our vision to help change the lives of patients suffering from inherited retinal diseases,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We remain dedicated to our mission of pioneering breakthroughs in biotechnology and believe that OCU400 has the potential to have an impact on the future treatment of patients with RP and LCA.” 

This Phase 1/2 trial is a multicenter, open-label, dose ranging study. A total of 18 subjects with vision impairment due to RP associated with RHO and NR2E3 gene mutations received a unilateral subretinal injection of either a low dose (1.66 x 1010 vg/mL), medium dose (3.33 x 1010 vg/mL), or high dose (1.66 x 1011 vg/mL) of OCU400. The study profile included a diverse group of subjects aged 18-77 years old, with varied disease stages, racial and ethnic profiles, medical histories, and mutation subgroups. Ocugen further expanded this Phase1/2 trial to enroll LCA patients with CEP290 gene mutation and pediatric patients with NR2E3, RHO and CEP290 mutations.

Inherited retinal diseases (IRDs) such as RP and LCA encompass a group of genetic disorders that affect the retina, the light-sensitive tissue at the back of the eye. These diseases often lead to a gradual loss of vision over time and can ultimately result in blindness. Stabilization of vision is crucial for patients with IRDs due to the progressive and degenerative nature of these conditions.

Preserving remaining vision, slowing disease progression, or improving the vision can significantly impact patients’ quality of life. It not only enhances the quality of life for affected individuals but also provides hope for future treatments that may ultimately lead to vision restoration. Comprehensive care, early diagnosis, and access to emerging therapies are essential components of a strategy to stabilize vision in IRD patients.

“I am gratified to see the progress we have made in our pursuit of developing a novel gene-agnostic therapy for RP and LCA. Our team’s unwavering dedication to advancing modifier gene therapy research demonstrated positive preliminary clinical results that offer renewed hope to patients and their families. We remain resolute in our mission and vision to bring a bright future to those with inherited or age-related retinal diseases through courageous innovation and unwavering determination,” said Dr. Arun Upadhyay, Chief Scientific Officer, Head of Research, Development and Medical at Ocugen.

This clinical study update is based on the currently available data from Phase 1 (dose-escalation: Cohort 1, 2 and 3) and the Phase 2 (open enrollment) portion of the study. The exploratory efficacy update includes data for 12 subjects who have completed a minimum of 6-month follow up. The data set comprised of 2 subjects [Cohort 1] with 12-month follow-up, 5 subjects [N=2 from Cohort 1 and N=3 from Cohort 2] with 9-month follow-up, and 5 subjects [N=2 from Cohort 3 and N=3 from Open Enrollment/Phase 2] with 6-month follow-up.

“It is an important steppingstone for Ocugen and its mission to help the nearly 1.6 million patients affected by RP and LCA worldwide. For those suffering from these IRDs, this clinical trial update provides hope. It is encouraging to see a favorable safety and tolerability profile and positive efficacy readout for OCU400 in RP patients,” said Dr. Lejla Vajzovic, Associate Professor of Ophthalmology with Tenure, Director of Duke Vitreoretinal Fellowship Program at Duke Eye Center and Duke University School of Medicine and leader in gene-therapy research.

Key efficacy outcomes from 12 subjects demonstrated:
BCVA:

  • 83% (10/12) of subjects demonstrated stabilization or improvements in treated eyes in BCVA scores from baseline
  • 42% (5/12) of OCU400 treated eyes experienced 4-letter improvement and 33% (4/12) treated eyes experienced 7-letter improvement in BCVA from baseline
  • 57% (4/7) of RHO subjects’ treated eyes experienced 4-letter improvement and 43% (3/7) treated eyes experienced 7-letter improvement in BCVA scores from baseline

LLVA:

  • 83% (10/12) of subjects demonstrated stabilization or improvement in treated eyes in LLVA scores from baseline
  • 42% (5/12) of OCU400 treated eyes experienced 5-letter improvement (1 line) in LLVA from baseline, with 25% (3/7) increasing by 10 letters (2 lines)
  • 43% (3/7) of RHO subjects experienced 5-letter improvement (1 line) in treated eyes in LLVA scores from baseline, among which 29% (2/7) increased by 10 letters (2 lines)

MLMT:

  • 75% (9/12) of subjects demonstrated stabilization or improvement in treated eyes in MLMT scores from baseline
  • 33% (4/12) of subjects in the low, medium, and high dose cohorts experienced at least 1 Lux luminance level improvement from baseline in treated eyes, among which 17% (2/12) increased by 3 Lux luminance levels
  • 86% (6/7) of RHO subjects experienced either stabilization or increases in MLMT scores from baseline, among which 29% (2/7) improved by 3 lux levels

“The RHO mutation affects more than 10,000 people in the US,” said Dr. David Birch, Scientific Director, Retina Foundation of the Southwest and Principal investigator of the study. “In my view, the clinical study update supports the gene-agnostic mechanism of action of OCU400 in RHO patients. The improvements in BCVA, LLVA and MLMT in this patient population are very exciting and encouraging because stabilization alone could be considered as a treatment benefit.”

The clinical study update from the Phase 1/2 clinical trial demonstrated that OCU400 continued to be generally safe and well-tolerated in subjects across different mutations and dose levels. There were no serious adverse events (SAEs) related to the investigational product in the low and medium-dose cohorts. In the high-dose and open-enrollment cohorts, SAEs were reported for two subjects. Adverse events were mostly deemed related to the surgical procedure and resolved within a few days to weeks.

“The clinical study update released by Ocugen appears to have a tangible biological impact on Retinitis Pigmentosa associated with NR2E3 and RHO mutations,” said Dr. David Boyer, Clinical Professor of Ophthalmology USC/Keck School of Medicine Los Angeles, CA and Partner, Retina Vitreous Associates Medical Group. “These findings may indicate a huge step forward in the way we approach and treat this condition. We remain optimistic and eager to continue the trial and understand the full potential of OCU400.”

Ocugen will continue to monitor long-term safety and efficacy data from the treated patients and provide additional updates.

A webcast and conference call will take place today at 8:30 a.m. ET:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7803227

Webcast: Available on the events section of the Ocugen investor site

About Modifier Gene Therapy
Modifier gene therapy is designed to fulfill unmet medical needs related to retinal diseases, including IRDs, such as RP, LCA, and Stargardt disease, as well as dry AMD. Our modifier gene therapy platform is based on the use of Nuclear hormone receptors (NHRs), master gene regulators, which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, we believe that our modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and to address complex diseases that are potentially caused by imbalances in multiple gene networks. Currently Ocugen has three modifier gene therapy programs OCU400 (RP, LCA), OCU410 (dry AMD), OCU410ST (Stargardt disease).

About OCU400
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene-networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trial results, and anticipated timing of clinical trial updates and regulatory interactions. 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in the Phase 1/2 clinical trial or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

Release – Ocugen To Host Virtual Investor & Analyst Event on September 13, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 12, 2023

PDF Version

COMPANY TO SHARE UPDATED RESULTS FROM ONGOING PHASE 1/2 TRIAL OF OCU400 FOR THE TREATMENT OF RETINITIS PIGMENTOSA AND LEBER CONGENITAL AMAUROSIS

MALVERN, Pa., Sept. 12, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host an Investor and Analyst Event on September 13, 2023 at 8:30 a.m. ET. During the webcast and conference call, members of the Ocugen leadership team and key opinion leaders will discuss updated results from the Phase 1/2 trial of OCU400 for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA).

The event will feature:

Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-founder, Ocugen

Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research, Development & Medical, Ocugen

Huma Qamar, MD, MPH, Head of Clinical Development and Medical Affairs, Ocugen

David Birch, PhD, Scientific Director, Retina Foundation of the Southwest, Principal investigator of the study

Byron L. Lam, MD, Mark J. Daily Professor, Bascom Palmer Eye Institute, University of Miami, Principal investigator of the study

Lejla Vajzovic, MD, FASRS, Associate Professor of Ophthalmology with Tenure, Director of Duke Vitreoretinal Fellowship Program at Duke Eye Center and Duke University School of Medicine and leader in gene-therapy research

Webcast and Conference Call Details

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7803227

Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This presentation 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 include, but are not limited to, statements regarding our clinical development activities and related anticipated timelines. 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. 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 presentation speak only as of the date of this presentation. Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation whether as a result of new information, future events, or otherwise, after the date of this presentation.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com