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Ocean Biomedical (NASDAQ: OCEA) Congratulates Joint Venture Partner, Virion Therapeutics, on Positive Immunogenicity Results from Their Lead Checkpoint Modifier-Containing Immunotherapy, VRON-0200, for HBV Functional Cure, at EASL 2024

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Ocean Biomedical (NASDAQ: OCEA) congratulated its JV partner Virion Therapeutics on presenting successful Phase 1b data for VRON-0200, a novel immunotherapy aiming for an HBV functional cure, at EASL 2024 Congress.

The data showcased that VRON-0200, using glycoprotein D as a checkpoint modifier, is safe, well-tolerated, and immunogenic for chronic HBV patients after a single intramuscular injection. This treatment could stimulate T cell responses even in patients with little to no prior HBV immunity.

This development could support Virion's other pipeline programs, such as VRON-0300 for advanced tumors. The global chronic HBV treatment market is expected to reach $6.5 billion by 2032, reflecting the high demand for new treatments.

Positive
  • VRON-0200 showed safety and immunogenicity in Phase 1b trials with chronically HBV-infected patients.
  • The treatment stimulated T cell responses in most patients with little to no prior HBV immunity.
  • This outcome supports Virion's platform and other pipeline programs like VRON-0300.
  • VRON-0200 is an intramuscular injection that acts locally, reducing risk for serious adverse events.
  • Chronic HBV treatment market is projected to reach $6.5 billion by 2032.
  • Potential for VRON-0200 to become an interferon-sparing treatment option for chronic HBV.
Negative
  • No long-term efficacy data yet available for VRON-0200.
  • Phase 1b trial results, while promising, still need further validation in advanced trial stages.
  • Potential risk of competition in the growing $6.5 billion chronic HBV market.

Medical Research Analyst Insight: The positive immunogenicity results from Virion Therapeutics' lead immunotherapy, VRON-0200, represent a significant milestone in the treatment of chronic HBV (Hepatitis B Virus). Immunogenicity refers to the ability of a substance, such as a vaccine or drug, to provoke an immune response in the body. In this context, the immunogenic response in the majority of patients following a single low-dose injection is promising because it shows potential for a functional cure for chronic HBV infection, which affects about 300 million people worldwide.

Context and Potential: Current treatments for chronic HBV aim to manage the virus but often fall short of achieving a functional cure where the virus is undetectable in the bloodstream without continuous treatment. The novel approach of checkpoint modifiers, as opposed to traditional monoclonal antibodies, suggests a new path for achieving this goal by stimulating T cell responses that are usually dormant in chronic infections. This could significantly change the landscape of HBV treatment. Additionally, the local administration of the drug through an intramuscular injection, which limits adverse events, offers a safer and more patient-friendly treatment option compared to intravenous methods.

Long-Term Implications: If VRON-0200 continues to show positive results in further clinical trials, it could revolutionize HBV treatment and provide a competitive edge in a projected $6.5 billion market by 2032. However, it is essential to recognize that these are early-phase trial results and subsequent trials must confirm safety and efficacy across a broader patient population.

Financial Analyst Insight: The positive Phase 1b trial results for VRON-0200 are highly impactful for both Ocean Biomedical and its partner Virion Therapeutics. From a financial perspective, successful clinical trial results often lead to increased investor confidence and can positively affect the stock price of the companies involved. The potential market for HBV treatments is substantial, with an estimated value exceeding $6.5 billion by 2032. Achieving even a small market share could significantly boost revenues.

Short-Term and Long-Term Impacts: In the short term, these results might result in a notable uptick in OCEA’s share price as they generate positive investor sentiment and potential for future profitability. Long-term impacts depend on the progression through subsequent trial phases and eventual regulatory approval. Successful advancement into later stages of clinical trials will likely drive further stock appreciation and potential partnership opportunities, including licensing deals or acquisitions.

Risks and Considerations: Investors should remain aware of the inherent risks in biotech investments, particularly those in early-stage trials. The transition from promising Phase 1b results to final market approval is fraught with potential hurdles, including regulatory challenges, additional safety and efficacy trials and commercial-scale production requirements.

Market Research Analyst Insight: The unveiling of positive immunogenicity data for VRON-0200 positions Ocean Biomedical and Virion Therapeutics favorably within the biopharma market. Checkpoint modifier-containing immunotherapies are innovative, offering a potential paradigm shift in chronic HBV treatment, which could disrupt existing therapeutic approaches. Given the chronic nature of HBV and the current reliance on long-term antiviral therapies, a functional cure represents a highly attractive value proposition.

Competitive Landscape and Market Potential: The HBV treatment landscape is competitive, with several companies developing novel therapies. However, if VRON-0200 can demonstrate superior efficacy and safety profiles in larger trials, it could capture significant market share. The differentiation strategy of utilizing checkpoint modifiers to amplify T cell responses provides a distinct competitive advantage over traditional monoclonal antibody treatments.

Strategic Implications: Strategic partnerships, such as the one between Ocean Biomedical and Virion Therapeutics, enhance resource pooling and accelerates R&D efforts, potentially bringing VRON-0200 to market faster. The potential $6.5 billion annual market by 2032 underscores the high stakes and lucrative opportunities for successful entrants.

Providence, RI, June 05, 2024 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharma company working to accelerate the development of compelling discoveries from top research scientists, today congratulates its JV partner Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T cell-based immunotherapies, on its late breaker presentation highlighting the first-ever human immunogenicity data from its novel checkpoint modifier immunotherapy for HBV functional cure (VRON-0200), at the EASL 2024 Congress (The European Association for the Study of the Liver), taking place in Milan, Italy from June 5 - 8.

The late breaker Phase 1b data presented today, (for more information, go to VirionTx.com), which includes Virion’s first checkpoint modifier, glycoprotein D (gD), demonstrated that VRON-0200 was not only safe and well tolerated, but immunogenic in the majority of chronically HBV-infected patients, following a single intramuscular injection. “Chronic HBV infection severely impairs a patient’s ability to clear the virus. A single low dose injection of VRON-0200 was able to stimulate T cell responses in the majority of patients, most of whom had little, to no, documented HBV immunity prior to treatment” said Virion’s CEO, Dr. Andrew Luber. Luber added,VRON-0200 is our lead clinical program and these clinical safety and immunogenicity data will further support our proprietary platform technologies and other pipeline programs in development, including VRON-0300, which is for patients with advanced solid tumors.”

Unlike monoclonal antibody checkpoint inhibitors which attempt to “rescue” already activated, but exhausted, CD8+ T cells, Virion’s checkpoint modifiers alter T cell activation to amplify and broaden a patient’s own immune response; this may include regions of a tumor or infectious disease that are not normally stimulated during a chronic disease, thereby potentially producing a “new” immune response. Additionally, after it is administered through an intramuscular injection, the checkpoint modifiers act locally, at the injection site, and not throughout the body, thereby limiting the risk for serious adverse events such as those seen following the intravenous administration of monoclonal antibody checkpoint inhibitors.

Ocean Biomedical co-founder and Executive Chairman Dr. Chirinjeev Kathuria, commented: “We congratulate Virion on these exciting data, as they continue to advance VRON-0200, not only as a safe, well tolerated, and easy to administer treatment, but also, now with positive clinical immunogenity data, which is advancing their goal of an interferon-sparing treatment option for the 300 million persons worldwide infected with Chronic HBV. Treatments for chronic HBV are in high demand and could capture an estimated global market of $6.5+ billion by 2032. Ocean is pleased to partner with Virion and we look forward to helping accelerate this, and other programs, in development.”

About Chronic Hepatitis B

Despite a preventative vaccine, cases of chronic hepatitis B (HBV) continue to rise, with an estimated 296 million persons infected worldwide and 820,000 deaths per year from HBV-related liver complications. This includes almost 100 million persons in China who are affected by this disease. Chronic HBV remains a global health issue with a high unmet medical need since there is no cure available. The current standard of care requires lifelong antiviral therapy to maintain control of the virus.

About VRON-0200

VRON-0200 is a therapeutic immunotherapy, administered by intramuscular injection, designed with the goal of providing a functional cure for chronic HBV infection. While the virus itself stimulates HBV-specific CD8+ T cells, for those patients that can’t clear the initial infection, their T cells soon become exhausted, placing limits on their ability to proliferate and control the virus. Preclinical data support the hypothesis that VRON-0200, through checkpoint modification, can amplify, broaden, and enhance T cell responses which may include T cells that are not normally activated during a chronic HBV infection, which results in improved viral control.

About Virion Therapeutics (Virion)

Virion Therapeutics, LLC is a clinical-stage company developing novel T cell-based immunotherapies to cure cancer and chronic infectious diseases that utilize proprietary genetically encoded checkpoint modifiers to enhance and broaden CD8+ T cell responses to a tumor or chronic infection. Founded in early 2018 to advance technology licensed from The Wistar Institute, an international leader in biomedical research, Virion has since developed a robust pipeline, including its lead VRON-0200 clinical program, and several additional IND-enabling programs, including its VRON-0300 oncology program for advanced solid tumors, leveraging its proprietary platform technologies. In early Fall 2023, Virion and Ocean Biomedical entered a joint venture to accelerate and expand Virion’s pipeline of novel immunotherapies.

To learn more, visit www.VirionTx.com

About Ocean Biomedical

Ocean Biomedical, Inc. is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world’s toughest problems, for the people who need it most.

To learn more, visit www.oceanbiomedical.com.

Forward-Looking Statements

The information included herein and in any oral statements made on behalf of Ocean Biomedical, Inc. (the “Company”) or otherwise in connection herewith include “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target,” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and performance metrics and expectations; the expected timing and success of IND filings for our initial product candidates; statements regarding the expected timing of our IND-enabling studies; the frequency and timing of filing additional INDs; expectations regarding the availability and addition of future assets to our pipeline; the advantages of any of our pipeline assets and platforms; the potential benefits of our product candidates; potential commercial opportunities; the timing of key milestones for our programs; the future financial condition, results of operations, business strategy and plans, and objectives of management for future strategy and operations; and statements about industry trends and other companies in the industry. These forward-looking statements are based on various assumptions, whether or not identified herein, and on the current expectations of the Company’s management, and they are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions.

Any discoveries announced by the Company are based solely on laboratory and animal studies. The Company has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that any treatment tested by the Company will prove safe or effective in humans, and that any clinical benefits of any such treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away.

Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and in the Company’s subsequent Quarterly Reports on Form 10-Q and other documents filed by the Company from time to time with the SEC and which are available at www.sec.gov. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. We do not undertake any obligation to update any forward-looking statements made by us. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts: 
Ocean Biomedical Investor Relations
connect@oceanbiomedical.com
Kevin Kertscher
Communications Director

Virion Therapeutics, LLC 
scurrie@viriontx.com
Dr. Sue Currie 
Chief Operating Officer 


FAQ

What positive results were presented by Virion Therapeutics for VRON-0200?

Virion Therapeutics presented Phase 1b data at EASL 2024, showing VRON-0200 as safe, well-tolerated, and immunogenic in chronic HBV patients.

How does VRON-0200 work?

VRON-0200 uses glycoprotein D as a checkpoint modifier to stimulate T cell responses, aiming to create a new immune response in chronic HBV patients.

Why is the chronic HBV market significant for Ocean Biomedical (NASDAQ: OCEA)?

The chronic HBV treatment market is projected to reach $6.5 billion by 2032, indicating high demand for new treatments.

What are the potential risks mentioned for VRON-0200?

Potential risks include the lack of long-term efficacy data and the need for further validation in advanced trials.

What future developments are expected from Virion Therapeutics?

Future developments include pipeline programs like VRON-0300 for advanced tumors, supported by the positive Phase 1b data of VRON-0200.

Ocean Biomedical, Inc.

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