OCEA) Announces Positive Preclinical Oncology Data for VRON-0300 and Clinical Update from 50/50 Joint Venture Partner Virion Therapeutics at SITC 2023 Annual Meeting

Marine Biomedical Ltd.

Marine Biomedical Ltd.

Providence, Rhode Island, November 14, 2023 (GLOBE NEWSWIRE) — Marine Biomedical Co., Ltd. (Nasdaq: OCEA), a biopharmaceutical company committed to accelerating the compelling discoveries of leading research scientists, today announced that its joint venture partner Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T-cell immunotherapies, recently launched an attractive Preclinical oncology data from SITC 2023, the annual meeting of the Society for Immunotherapy of Cancer.

These new data demonstrate complete and highly reproducible tumor clearance, as well as protection against tumor rechallenge, months after the animals have cleared the initial tumor. A significant improvement in immunogenicity was also demonstrated, with a 10-fold increase in T cell responses. VRON-0300 IND support activities are ongoing with the goal of submitting the first IND within the next nine months.

Virion Therapeutics is developing novel immunotherapies utilizing proprietary genetically encoded checkpoint modifiers (CPMs) to enhance and amplify CD8+ T cell response.

gD BTLA-HVEM blockade enhances and amplifies T cell activation (www.VirionTx.com)

Preclinical studies using CPM have demonstrated consistent and extraordinary immune responses and clinical activity across different diseases. In addition to the recently presented oncology data, Virion recently initiated a Phase 1b clinical trial in patients with chronic hepatitis B virus (HBV):

  • VRON-0200 for chronic hepatitis B virus (HBV): VRON-0200 was developed with the goal of providing a functional cure for a disease that affects more than 300 million patients worldwide. It is designed to help control the infection by stimulating the patient’s own immune response, thereby helping to overcome immune failure, a key cause of chronic hepatitis B. Virion believes this novel mechanism using CPM is unlike anything others have previously studied or are currently developing. VRON-0200 has been administered to the first patients in its multi-country first-in-human study, with early clinical results expected in the first quarter of 2024. According to Precedence Research, a functional cure for chronic hepatitis B is expected to be achieved by 2032, with the market opportunity reaching $6.5B+.

“The initiation of our first clinical trial for VRON-0200 represents an important milestone in Virion’s mission to bring innovative immunotherapies to patients with cancer and chronic infectious diseases,” said Dr. Andrew Luber, CEO of Virion. “By targeting T cells Activation and checkpoint modification to enhance and amplify a patient’s own immune response are unique to Virion, and these human data will inform our proprietary platform technologies and pipeline, including VRON-0300, which is being developed for late-stage entities Developed for cancer patients,” Luber added. “These clinical milestones and new data have generated a high level of interest in our VRON-0200 and VRON-0300 programs from potential stakeholders and industry partners.”

In addition to recent major clinical and scientific milestones achieved through its joint venture partners, Ocean continues to advance immunotherapies for lung, brain and other cancers by targeting chitinase 3-like-1 expression (CHi3L1) and continues to advance other Development projects in fibrosis and the treatment and prevention of malaria.

  • Anti-cancer programs targeting CHi3L1: Ocean’s co-scientific founder Jack Elias, MD, and his colleagues at Yale and Brown University recently published data (bioRxiv reposted) showing that its cancer immunotherapy antibody candidate targeting CHi3L1 has proven effective in reducing the risk of targeting an aggressive subset of of tumors have epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC).By inhibiting CHi3L1 activity, this treatment demonstrates a surprising ability to restore sensitivity to current tyrosine kinase inhibitor (TKI) therapies After the emergence of resistance, including the third-generation TKI osimertinib (marketed by AstraZeneca under the name Tagrisso). Furthermore, recent studies have demonstrated up to 95% reduction in primary and metastatic tumor burden in mouse lung cancer models.

“I am very excited about these significant milestones in our joint venture with Virion and the progress Ocean is making across our product lines,” said Dr. Chirinjeev Kathuria, executive chairman and co-founder of Ocean. “These recent inflection points reinforce the “We are excited about the potential current and future value of our company, the joint venture’s upcoming clinical data, and Ocean’s other strategic activities.”

About marine biomedicine

Ocean Biomedical, Inc. is a Providence, Rhode Island-based biopharmaceutical company whose innovative business model accelerates the development and commercialization of scientifically compelling assets at research universities and medical centers. Marine Biomedicine leverages funding and expertise to efficiently move new treatment candidates from the laboratory to the clinic and into the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to deliver life-changing results in the prevention and treatment of lung cancer, brain cancer, pulmonary fibrosis, and malaria. Marine biomedical teams are working to solve some of the world’s toughest problems for the people who need help most.

To learn more, visit www.oceanbiomedical.com.

About Virion Therapeutics (Virion)

Virion Therapeutics, LLC is a clinical-stage company developing novel T cell-based immunotherapies to treat cancer and chronic infectious diseases utilizing proprietary genetically encoded checkpoint modifiers (CPMs) to enhance and expand CD8+ T cell responses to tumors or chronic infections. Founded in early 2018 to advance technologies licensed by Wistar Research Institute. The Wistar Institute is an international leader in biomedical research, with special expertise in vaccines, cancer and infectious disease research. Virion has a strong pipeline, including its leading clinical program with VRON-0200, as well as several additional programs leveraging its proprietary platform technology to rapidly advance human studies.

To learn more, visit www.VirionTx.com.

forward-looking statements

The information contained herein and any oral statements made on behalf of Ocean Biomedical, Inc. (the “Company”) or other information relating thereto include “forward-looking statements” within the meaning of the U.S. Safe Harbor provisions of 1995 Private Securities Litigation Reform Act of the Year. Forward-looking statements can be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect” and other words. The words “anticipate,” “believe,” “seek,” “target” or other similar expressions predict or indicate future events or trends or are statements that are not historical events, although not all forward-looking statements contain such identifying words. These forward-looking statements include, but are not limited to, statements regarding estimates and projections 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 filing of additional INDs frequency and timing; expectations regarding the availability of future assets and additions to our pipeline; the strengths of any of our pipeline assets and platforms; the potential benefits of our product candidates; potential commercial opportunities; the timing of key milestones in our plans; the future our financial condition, results of operations, business strategies and plans, and management’s objectives for future strategies and operations; and statements regarding industry trends and other companies in the industry. These forward-looking statements are based on various assumptions (whether or not identified herein) and the current expectations of the Company’s management and are not predictions of current performance. These forward-looking statements are for illustrative purposes only and are not intended to be, and shall not be relied upon by, any investor as a guarantee, guarantee, prediction or express statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from those hypothesized.

Any findings announced by the company are based solely on laboratory and animal studies. The company has not conducted any studies showing similar efficacy or safety in humans. There is no guarantee that any treatment tested by the Company will prove safe or effective in humans, and any clinical benefit from any such treatment is subject to clinical trials and final FDA approval for use in patients. If approved, it 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 therefore involve 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 beyond the company’s control, that may cause current circumstances to Results or results could differ materially from those discussed in the forward-looking statements. You should carefully consider the above factors and other risks and uncertainties described in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s subsequent quarterly reports on Form 10-Q and other filings. The Company files reports with the SEC from time to time, which are available at www.sec.gov. These documents 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 undertake no obligation to update any forward-looking statements we make. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this filing. Therefore, undue reliance should not be placed on forward-looking statements.

Contact information:
Marine Biopharmaceutical Investor Relations
connect@oceanbiomedical.com

Kevin Kercher
communications director

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