Ocean Biomedical Announces Breakthrough Findings in EGFR-Mutant Lung Cancer and Plans for FDA Alignment on Next-Stage Development
Ocean Biomedical (NASDAQ: OCEA) has announced breakthrough research findings showing their cancer immunotherapy candidates effectively interact with tyrosine kinase inhibitors (TKI) in treating non-small cell lung cancer (NSCLC). The research, published in Translational Oncology, demonstrates the therapy's ability to restore treatment sensitivity in osimertinib-resistant cases and suppress tumor growth when combined with TKI therapies.
The company's proprietary antibody suppresses CHi3L1 activity, leading to significant tumor reduction in preclinical models. Ocean Biomedical has also developed bispecific antibodies combining anti-CHI3L1 with anti-PD-1 or anti-CTLA4, showing efficacy in NSCLC, melanoma, and glioblastoma models.
The company plans to initiate preclinical studies and engage with the FDA this year for first-in-human trials. This development aligns with industry trends toward bispecific antibodies, highlighted by Merck's recent $588 million acquisition of LaNova's LM-299.
Ocean Biomedical (NASDAQ: OCEA) ha annunciato risultati di ricerca innovativi che dimostrano come i loro candidati per l'immunoterapia contro il cancro interagiscano in modo efficace con gli inibitori della tirosina chinasi (TKI) nel trattamento del cancro ai polmoni non a piccole cellule (NSCLC). La ricerca, pubblicata su Translational Oncology, dimostra la capacità della terapia di ripristinare la sensibilità al trattamento nei casi resistenti a osimertinib e di sopprimere la crescita tumorale quando combinata con terapie TKI.
Il loro anticorpo proprietario sopprime l'attività di CHi3L1, portando a una significativa riduzione del tumore in modelli preclinici. Ocean Biomedical ha inoltre sviluppato anticorpi bispecifici che combinano anti-CHI3L1 con anti-PD-1 o anti-CTLA4, mostrando efficacia nei modelli di NSCLC, melanoma e glioblastoma.
L'azienda prevede di avviare studi preclinici e di interagire con la FDA quest'anno per i primi trial sugli esseri umani. Questo sviluppo è in linea con le tendenze del settore verso gli anticorpi bispecifici, messo in evidenza dall'acquisizione recente da 588 milioni di dollari di Merck nei confronti di LaNova e del suo LM-299.
Ocean Biomedical (NASDAQ: OCEA) ha anunciado hallazgos de investigación innovadores que demuestran que sus candidatos a inmunoterapia contra el cáncer interactúan de manera efectiva con los inhibidores de tirosina quinasa (TKI) en el tratamiento del cáncer de pulmón no microcítico (NSCLC). La investigación, publicada en Translational Oncology, demuestra la capacidad de la terapia para restaurar la sensibilidad al tratamiento en casos resistentes a osimertinib y suprimir el crecimiento tumoral cuando se combina con terapias TKI.
El anticuerpo propietario de la compañía suprime la actividad de CHi3L1, lo que lleva a una reducción significativa del tumor en modelos preclínicos. Ocean Biomedical también ha desarrollado anticuerpos bispecíficos que combinan anti-CHI3L1 con anti-PD-1 o anti-CTLA4, mostrando eficacia en modelos de NSCLC, melanoma y glioblastoma.
La empresa planea iniciar estudios preclínicos y participar con la FDA este año para ensayos en humanos. Este desarrollo está alineado con las tendencias de la industria hacia los anticuerpos bispecíficos, destacado por la reciente adquisición de Merck de 588 millones de dólares de LaNova y su LM-299.
오션 바이오메딸 (NASDAQ: OCEA)는 그들의 암 면역 치료 후보가 비소세포 폐암(NSCLC) 치료에 있어 티로신 키나제 억제제(TKI)와 효과적으로 상호작용한다는 혁신적인 연구 결과를 발표했습니다. Translational Oncology에 발표된 이 연구는 이 치료법이 오시메르티닙에 저항력이 있는 경우에서도 치료 민감성을 회복하고 TKI 치료와 결합했을 때 종양 성장을 억제하는 능력을 보여줍니다.
회사의 독점 항체는 CHi3L1 활동을 억제하여 전임상 모델에서 종양 크기를 크게 줄입니다. 오션 바이오메딸은 또한 anti-CHI3L1과 anti-PD-1 또는 anti-CTLA4를 결합한 이중 특이성 항체를 개발했으며, 이는 NSCLC, 흑색종 및 교모세포종 모델에서 효과를 보였습니다.
회사는 올해 중으로 최초의 인간 임상 시험을 위한 전임상 연구를 시작하고 FDA와 협력할 계획입니다. 이 발전은 최근 메르크가 LaNova의 LM-299를 5억 8,800만 달러에 인수한 것을 강조하는 등의 업계 트렌드에 부합합니다.
Ocean Biomedical (NASDAQ: OCEA) a annoncé des résultats de recherche révolutionnaires montrant que leurs candidats à l'immunothérapie contre le cancer interagissent efficacement avec des inhibiteurs de la tyrosine kinase (TKI) dans le traitement du cancer du poumon non à petites cellules (NSCLC). La recherche, publiée dans Translational Oncology, démontre la capacité de la thérapie à restaurer la sensibilité au traitement dans les cas résistants à l’osimertinib et à supprimer la croissance tumorale lorsqu'elle est combinée avec des thérapies TKI.
L'anticorps propriétaire de la société supprime l'activité de CHi3L1, entraînant une réduction significative de la tumeur dans des modèles précliniques. Ocean Biomedical a également développé des anticorps bispécifiques combinant anti-CHI3L1 avec anti-PD-1 ou anti-CTLA4, montrant une efficacité dans des modèles de NSCLC, de mélanome et de glioblastome.
La société prévoit de commencer des études précliniques et d'engager un dialogue avec la FDA cette année pour des essais sur l'homme. Ce développement s'inscrit dans la tendance de l'industrie vers les anticorps bispécifiques, illustrée par l'acquisition récente par Merck de 588 millions de dollars de LaNova et de son LM-299.
Ocean Biomedical (NASDAQ: OCEA) hat bahnbrechende Forschungsergebnisse angekündigt, die zeigen, dass ihre Krebsimmuntherapiekandidaten effektiv mit Tyrosinkinaseinhibitoren (TKI) zur Behandlung von nicht-kleinzelligem Lungenkrebs (NSCLC) interagieren. Die Forschung, die in Translational Oncology veröffentlicht wurde, demonstriert die Fähigkeit der Therapie, die Behandlungsempfindlichkeit in Fällen, die gegen Osimertinib resistent sind, wiederherzustellen und das Tumorwachstum in Kombination mit TKI-Therapien zu unterdrücken.
Der firmeneigene Antikörper unterdrückt die Aktivität von CHi3L1 und führt zu einer signifikanten Tumorverkleinerung in präklinischen Modellen. Ocean Biomedical hat auch bispezifische Antikörper entwickelt, die anti-CHI3L1 mit anti-PD-1 oder anti-CTLA4 kombinieren und deren Wirksamkeit in NSCLC-, Melanom- und Glioblastom-Modellen zeigen.
Das Unternehmen plant, in diesem Jahr präklinische Studien zu initiieren und mit der FDA in Kontakt zu treten, um die ersten Versuche an Menschen zu starten. Diese Entwicklung steht im Einklang mit den Branchentrends hin zu bispezifischen Antikörpern, wie der kürzliche Erwerb von Merck für 588 Millionen Dollar von LaNova's LM-299 hervorhebt.
- Breakthrough findings showing therapy effectiveness with TKIs in NSCLC treatment
- Demonstrated ability to restore treatment sensitivity in drug-resistant cases
- Development of bispecific antibodies showing efficacy in multiple cancer types
- Strategic positioning in the growing bispecific antibody market
- Multiple potential therapeutic applications identified
- Still in early research phase, requiring FDA approval and clinical trials
- No immediate revenue potential as product development is in preclinical stage
Insights
Ocean Biomedical's breakthrough in targeting CHi3L1 in EGFR-mutant lung cancer represents a potential paradigm shift in oncology treatment. The discovery that their immunotherapy candidates can restore sensitivity to osimertinib is particularly significant, as drug resistance remains one of the most challenging aspects of cancer treatment. EGFR-mutant NSCLC affects approximately 15% of lung cancer patients in Western populations and up to 40% in Asian populations, representing a substantial market opportunity.
The synergistic effect with TKIs like osimertinib (which generated over
The company's development of bispecific antibodies combining anti-CHI3L1 with checkpoint inhibitors (anti-PD-1 or anti-CTLA4) demonstrates strategic foresight. The recent
Key near-term catalysts include:
- FDA feedback on the regulatory pathway
- Initiation of IND-enabling studies
- Potential partnership discussions given the growing interest in bispecific antibodies
The bispecific antibody market is experiencing explosive growth, projected to reach
The
However, investors should consider several factors:
- The company will require substantial capital for clinical development
- Manufacturing complexity and costs for bispecific antibodies
- Increasing competition in the immunotherapy space
- Regulatory timeline uncertainties
The opportunity in EGFR-mutant NSCLC alone represents a
Company Poised to Enter Booming Bispecific Antibody Market Amid Growing Pharma Interest
Providence, RI, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Ocean Biomedical (NASDAQ: OCEA) today announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI), such as osimertinib that are used to treat non-small cell lung cancer (NSCLC). Specifically, they demonstrate that Ocean’s immunotherapy candidates provide synergy with the TKI therapies (gefitinib and osimertinib) to suppress tumor growth and progression. In addition, the paper’s findings demonstrate that its proprietary cancer immunotherapy candidates have a remarkable ability to restore treatment sensitivity following development of osimertinib resistance. This breakthrough offers a potential paradigm shift in the treatment of Epidermal Growth Factor Receptor (EGFR)-mutant NSCLC and could expand treatment options for patients whose tumors are no longer responding to tyrosine kinase inhibitors.
These findings, led by Ocean Biomedical’s Scientific Co-founder Dr. Jack A. Elias in collaboration with researchers at Yale University and Brown University, were published in Translational Oncology and mark the first description of the role of chitinase 3-like-1 (CHi3L1) in EGFR-mutant cancers. The research underscores the ability of Ocean Biomedical’s novel antibody to suppress CHi3L1 activity, leading to significant tumor reduction and, crucially, the reversal of drug resistance in preclinical models.
As part of its continued commitment to developing next-generation cancer therapeutics, Ocean Biomedical is initiating preclinical studies to advance its immunotherapy program and will engage with the FDA this year to align on a regulatory pathway for first-in-human trials.
Industry Momentum: Bispecific Antibodies Leading a ‘Gold Rush’ in Oncology
Ocean Biomedical’s advancements come at a time when the oncology field is shifting its focus towards bispecific antibodies, an innovative therapeutic class designed to target multiple cancer mechanisms simultaneously. Bispecific antibodies that target PD-1/PD-L1 and VEGF have shown remarkable efficacy in recent clinical studies, with leading biotech and pharmaceutical companies rapidly investing in this space.
Merck’s recent
Ocean has also developed bispecific antibodies that combine its anti-CHI3L1 antibody and anti-PD-1 or anti-CTLA4. Studies with these bispecific antibodies have highlighted their impressive efficacy in suppressing tumor growth and progression in preclinical models of NSCLC, malignant melanoma and glioblastoma.
Ocean’s Board Chair and Co-Founder Statement on Market Potential and Investor Opportunity
“Our latest findings open an exciting new avenue in lung cancer treatment by demonstrating a potential solution to osimertinib resistance, a critical unmet need for patients worldwide,” said Dr. Chirinjeev Kathuria, Ocean’s Board Chair and Co-Founder. “With the industry shifting towards next-generation bispecific antibodies, Ocean Biomedical is strategically positioned to capitalize on this momentum in a variety of diseases including NSCLC, malignant melanoma and glioblastoma. The recent
Expanding Therapeutic Applications
The company’s lead oncology program is poised for multiple therapeutic applications:
- As a standalone therapy for EGFR-mutant NSCLC,
- In combination with existing TKIs to extend therapeutic response duration,
- As a salvage therapy to restore treatment efficacy in resistant tumors.
Next Steps: FDA Alignment and Preclinical Advancements
With plans to initiate preclinical studies this year, Ocean Biomedical is actively preparing for discussions with the FDA to determine the regulatory pathway for clinical development. This milestone marks a significant step toward bringing its innovative cancer therapy to patients in need.
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 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. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of the Company’s management and 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.
The announced discoveries were based solely on laboratory and animal studies. Ocean Biomedical has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that this treatment will prove safe or effective in humans, and that any clinical benefits of this 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. Important factors, among others, that may affect actual results or outcomes include (i) the outcome of any legal proceedings that may be instituted against the Company; (ii) changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iii) changes in domestic and global general economic conditions; (iv) risk that the Company may not be able to execute its growth strategies; (v) risks related to the ongoing COVID-19 pandemic and response, including supply chain disruptions; (vi) risk that the Company may not be able to develop and maintain effective internal controls; (vii) the risk that the Company may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; (viii) the ability to develop, license or acquire new therapeutics; (ix) the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that the Company experiences difficulties in managing its growth and expanding operations; (xi) the risk of product liability or regulatory lawsuits or proceedings relating to the Company’s business; (xii) the risk of cyber security or foreign exchange losses; (xiii) the risk that the Company is unable to secure or protect its intellectual property.
The foregoing list of factors is not exhaustive. 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, 2023 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and which are described in the “Risk Factors” section of the Company’s definitive proxy statement filed by the Company on January 12, 2023, and other documents to be filed by the Company from time to time with the SEC and which are and will be 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. Readers are cautioned not to put undue reliance on forward-looking statements. 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 filing. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Ocean Biomedical Investor Relations info@oceanbiomedical.com
Ocean Biomedical Media Relations connect@oceanbiomedical.com
Source: Ocean Biomedical, Inc.
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