Compugen Announces FDA Clearance of IND for COM503 for the Treatment of Solid Tumors
Compugen (Nasdaq: CGEN) has received FDA clearance for its investigational new drug (IND) application for COM503, a potential first-in-class, high-affinity anti-IL-18 binding protein antibody for the treatment of solid tumors. This clearance triggers a $30 million milestone payment from Gilead Sciences, Inc., Compugen's licensing partner. The company is on track to initiate a Phase 1 trial for COM503 in Q4 2024.
COM503 represents a differentiated antibody approach to harness cytokine biology for cancer therapeutics, both as monotherapy and in combination treatments. This achievement strengthens Compugen's balance sheet, extending its expected cash runway into 2027. The company's preparation for the Phase 1 trial is well-advanced, showcasing its execution capabilities and diverse pipeline developed through its computational discovery engine.
Compugen (Nasdaq: CGEN) ha ricevuto l'approvazione della FDA per la sua domanda di farmaco sperimentale (IND) per COM503, un potenziale anticorpo anti-IL-18 ad alta affinità di prima classe per il trattamento dei tumori solidi. Questa approvazione innesca un pagamento di milestone di 30 milioni di dollari da Gilead Sciences, Inc., partner di licenza di Compugen. L'azienda è sulla buona strada per avviare un trial di Fase 1 per COM503 nel Q4 2024.
COM503 rappresenta un approccio anticorpale differenziato per sfruttare la biologia delle citochine nella terapia oncologica, sia come monoterapia che in combinazioni terapeutiche. Questo traguardo rafforza il bilancio di Compugen, estendendo il suo tempo di liquidità previsto fino al 2027. La preparazione dell'azienda per il trial di Fase 1 è ben avanzata, dimostrando le sue capacità esecutive e un pipeline diversificato sviluppato attraverso il suo motore di scoperta computazionale.
Compugen (Nasdaq: CGEN) ha recibido la autorización de la FDA para su solicitud de nuevo medicamento en investigación (IND) para COM503, un anticuerpo potencial de primera clase, de alta afinidad para la proteína de unión anti-IL-18, destinado al tratamiento de tumores sólidos. Esta aprobación desencadena un pago de hito de 30 millones de dólares por parte de Gilead Sciences, Inc., socio licenciatario de Compugen. La compañía está en camino de iniciar un ensayo de Fase 1 para COM503 en el Q4 de 2024.
COM503 representa un enfoque de anticuerpos diferenciado para aprovechar la biología de citoquinas en terapias contra el cáncer, tanto como monoterapia como en tratamientos combinados. Este logro fortalece el balance de Compugen, extendiendo su tiempo de caja previsto hasta 2027. La preparación de la compañía para el ensayo de Fase 1 está bien avanzada, mostrando sus capacidades de ejecución y una cartera diversa desarrollada a través de su motor de descubrimiento computacional.
Compugen (Nasdaq: CGEN)은 고형 종양 치료를 위한 잠재적인 1세대, 고친화성 anti-IL-18 결합 단백질 항체인 COM503의 임상시험 신약(IND) 신청에 대해 FDA의 승인을 받았습니다. 이번 승인은 Gilead Sciences, Inc.로부터 3천만 달러의 마일스톤 지급을 촉발합니다. 이 회사는 2024년 4분기에 COM503에 대한 1상 시험을 시작할 계획입니다.
COM503은 면역 치료제를 위한 사이토카인 생물학을 활용하는 차별화된 항체 접근 방식을 나타내며, 단독 요법 및 병용 치료 모두에 사용될 수 있습니다. 이 성과는 Compugen의 재무 상태를 강화하여 예상 자금 조달이 2027년까지 연장됩니다. 회사의 1상 시험 준비는 잘 진행되고 있으며, 이는 실행 능력과 계산적 발견 엔진을 통해 개발된 다양한 파이프라인을 보여줍니다.
Compugen (Nasdaq: CGEN) a obtenu l'autorisation de la FDA pour sa demande de médicament expérimental (IND) pour COM503, un anticorps de liaison anti-IL-18 à haute affinité potentiellement de première classe pour le traitement des tumeurs solides. Cette autorisation déclenche un paiement d'étape de 30 millions de dollars de Gilead Sciences, Inc., le partenaire de licence de Compugen. L'entreprise est sur le point de commencer un essai de Phase 1 pour COM503 au trimestre 4 de 2024.
COM503 représente une approche anticorporelle différenciée pour exploiter la biologie des cytokines dans le cadre de traitements contre le cancer, tant en monothérapie qu'en traitements combinés. Cet accomplissement renforce le bilan de Compugen, prolongeant sa liquidité prévue jusqu'en 2027. La préparation de l'entreprise pour l'essai de Phase 1 est bien avancée, démontrant ses capacités d'exécution et un pipeline diversifié développé grâce à son moteur de découverte computationnelle.
Compugen (Nasdaq: CGEN) hat die FDA-Zulassung für seinen Antrag auf ein neues Forschungsmedikament (IND) für COM503 erhalten, ein potenzieller First-in-Class-Antikörper mit hoher Affinität gegen IL-18 zur Behandlung solider Tumoren. Diese Zulassung löst eine Meilensteinzahlung von 30 Millionen Dollar von Gilead Sciences, Inc., dem Lizenzpartner von Compugen, aus. Das Unternehmen ist auf dem besten Weg, eine Phase-1-Studie für COM503 im Q4 2024 zu starten.
COM503 stellt einen differenzierten Antikörperansatz dar, der die Zytokine-Biologie für Krebstherapeutika nutzt, sowohl als Monotherapie als auch in Kombinationstherapien. Dieser Erfolg stärkt die Bilanz von Compugen und verlängert den erwarteten verfügbaren Geldbestand bis 2027. Die Vorbereitungen des Unternehmens für die Phase-1-Studie sind weit fortgeschritten und demonstrieren seine Ausführungsmöglichkeiten sowie eine vielfältige Pipeline, die durch seine rechnergestützte Entdeckungstechnologie entwickelt wurde.
- FDA clearance for COM503 IND application received
- $30 million milestone payment triggered from Gilead Sciences
- Phase 1 trial for COM503 in solid tumors on track for Q4 2024
- Extended cash runway into 2027
- Demonstrates success of computational discovery engine
- None.
Insights
The FDA clearance of Compugen's IND for COM503 represents a significant milestone in the field of cancer immunotherapy. As an oncology research analyst, I find several aspects of this development particularly noteworthy:
- COM503's potential as a first-in-class, high-affinity anti-IL-18 binding protein antibody suggests a novel approach to cancer treatment. This mechanism of action, targeting the IL-18 pathway, could offer a new avenue for modulating the immune response in solid tumors.
- The collaboration with Gilead Sciences adds credibility to the potential of COM503. Gilead's involvement, including the
$30 million milestone payment, indicates strong industry interest in this approach. - Compugen's computational target discovery platform has once again demonstrated its value. This success reinforces the potential of AI-driven drug discovery in oncology, potentially accelerating the development of innovative cancer therapies.
However, it's important to note that while the IND clearance is promising, the true efficacy and safety of COM503 will only be determined through clinical trials. The upcoming Phase 1 trial will be critical in assessing its potential as both a monotherapy and in combination with other treatments for advanced solid tumors.
From a financial perspective, this news carries significant positive implications for Compugen:
- The
$30 million milestone payment from Gilead provides an immediate boost to Compugen's cash position. This non-dilutive funding is particularly valuable for a clinical-stage biotech company. - The extended cash runway, now projected to last into 2027, gives Compugen a considerable operational runway. This financial stability allows the company to focus on clinical development without immediate funding pressures.
- The advancement of COM503 to clinical trials diversifies Compugen's pipeline, potentially reducing risk for investors. Multiple clinical-stage assets can enhance a biotech company's valuation and attractiveness to potential partners or acquirers.
However, investors should remain cautious. While this news is positive, Compugen still faces the inherent risks of drug development, including potential clinical trial failures or regulatory hurdles. The company's long-term financial health will depend on continued clinical success and potential future partnership or commercialization revenues.
Overall, this development strengthens Compugen's financial position and validates its business model, potentially making it a more attractive investment prospect in the biotech sector.
This FDA clearance for Compugen's COM503 IND application is a testament to the growing importance of computational approaches in drug discovery. Here are some key industry implications:
- Compugen's success validates the potential of AI and machine learning in identifying novel drug targets. This could accelerate industry-wide adoption of similar approaches, potentially reducing drug discovery timelines and costs.
- The partnership model demonstrated here - where a smaller biotech company discovers a target and partners with a larger pharmaceutical company for development - continues to prove effective. This model allows for risk-sharing and leverages the strengths of both parties.
- The focus on cytokine biology, particularly the IL-18 pathway, highlights an ongoing trend in immuno-oncology. As the field matures, we're seeing more targeted approaches to modulating the immune system, moving beyond the initial wave of checkpoint inhibitors.
It's worth noting that while this news is positive for Compugen and the broader field of computational drug discovery, the biotech industry remains highly competitive and risky. Success in early stages doesn't guarantee clinical or commercial success. However, Compugen's progress does underscore the potential for innovative approaches to drive advancements in cancer therapeutics.
- FDA clearance triggers a
$30 million - Company on track to initiate a Phase 1 trial for COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics as monotherapy and in combination in advanced solid tumors in Q4 2024
HOLON,
"We are thrilled to receive FDA IND clearance for COM503 which triggers a
Dr. Cohen-Dayag added, "This achievement reflects our track record in execution and diversity in our pipeline, adding another clinical program discovered through our predictive computational discovery engine. In addition, it further strengthens our balance sheet with an expected cash runway sufficient to take us into 2027. We look forward to the initiation of the Phase 1 trial in the fourth quarter of this year, for which our preparation is well-advanced."
About COM503 Phase 1 trial
The Phase 1 trial is a first-in-human, dose escalation and dose expansion trial to assess the safety and tolerability of COM503 as a monotherapy and in combination with Gilead's anti-PD-1, zimberelimab in participants with advanced or metastatic solid tumors globally.
About the Compugen-Gilead license agreement
In 2023, Compugen and Gilead entered into a license agreement, pursuant to which Gilead was granted exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including the COM503 drug candidate. Compugen is responsible for preclinical development and the anticipated first- in-human Phase 1 trial evaluating the safety and tolerability of COM503. Gilead will have the sole right to develop and commercialize COM503 thereafter. Gilead provided Compugen with a
About Compugen
Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, is in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance, of which the most advanced program, COM503, a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which has been granted IND clearance from the FDA, is licensed to Gilead. Compugen is headquartered in
Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements relating to our expectation to expedite COM503 development and that we are on track to initiate the Phase 1 trial in solid tumors in the fourth quarter of 2024, statements regarding our cash runway and statements relating to our expectation to receive the milestone payment from Gilead. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the general market, political and economic conditions in the countries in which Compugen operates, including
Company contact:
Yvonne Naughton, Ph.D.
Head of Investor Relations and Corporate Communications
Email: ir@cgen.com
Tel: +1 (628) 241-0071
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SOURCE Compugen Ltd.
FAQ
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