Compugen Announces First Patient Dosed in COM701 Global Platform Trial in Platinum Sensitive Ovarian Cancer
Compugen (NASDAQ: CGEN) has announced the dosing of the first patient in its global randomized sub-trial 1 of the MAIA-ovarian adaptive platform trial. The study evaluates COM701, a potential first-in-class anti-PVRIG antibody, as maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer.
The trial is supported by strong biological evidence showing high PVRIG pathway expression in ovarian cancer. Previous clinical data demonstrated that COM701, in combination with PD-1 and TIGIT blockade, achieved durable responses in heavily pre-treated platinum-resistant ovarian cancer patients. An interim analysis is planned for the second half of 2026, with researchers considering a three-month improvement in progression-free survival over the six-month benchmark to be clinically meaningful.
Compugen (NASDAQ: CGEN) ha annunciato la somministrazione della prima dose al primo paziente nel sottostudio randomizzato globale 1 della piattaforma adattativa MAIA-ovarian. Lo studio valuta COM701, un potenziale anticorpo anti-PVRIG di prima classe, come terapia di mantenimento in pazienti con carcinoma ovarico recidivante sensibile al platino.
La sperimentazione è supportata da solide evidenze biologiche che mostrano un'elevata espressione della via PVRIG nel carcinoma ovarico. Dati clinici precedenti hanno dimostrato che COM701, in combinazione con il blocco di PD-1 e TIGIT, ha ottenuto risposte durature in pazienti con carcinoma ovarico resistente al platino e fortemente pretrattati. Un'analisi intermedia è prevista per la seconda metà del 2026, con i ricercatori che considerano clinicamente significativa un miglioramento di tre mesi nella sopravvivenza libera da progressione rispetto al parametro di riferimento di sei mesi.
Compugen (NASDAQ: CGEN) ha anunciado la dosificación del primer paciente en su subensayo global aleatorizado 1 del ensayo adaptativo de plataforma MAIA-ovarian. El estudio evalúa COM701, un posible anticuerpo anti-PVRIG de primera clase, como terapia de mantenimiento en pacientes con cáncer de ovario sensible al platino y en recaída.
El ensayo cuenta con un sólido respaldo biológico que muestra una alta expresión de la vía PVRIG en el cáncer de ovario. Datos clínicos previos demostraron que COM701, en combinación con el bloqueo de PD-1 y TIGIT, logró respuestas duraderas en pacientes con cáncer de ovario resistente al platino y muy pretratados. Se planea un análisis intermedio para la segunda mitad de 2026, considerando los investigadores que una mejora de tres meses en la supervivencia libre de progresión sobre el punto de referencia de seis meses es clínicamente significativa.
Compugen (NASDAQ: CGEN)이 전 세계 무작위 배정 하위 시험 1인 MAIA-ovarian 적응형 플랫폼 시험에서 첫 환자 투여를 발표했습니다. 이 연구는 재발한 백금 민감성 난소암 환자에서 유지 요법으로서 COM701, 잠재적 1세대 항-PVRIG 항체를 평가합니다.
이 시험은 난소암에서 높은 PVRIG 경로 발현을 보여주는 강력한 생물학적 증거에 기반합니다. 이전 임상 데이터는 COM701이 PD-1 및 TIGIT 차단과 병용 시, 다중 치료를 받은 백금 내성 난소암 환자에서 지속적인 반응을 이끌어냈음을 보여줍니다. 2026년 하반기에 중간 분석이 예정되어 있으며, 연구진은 무진행 생존 기간이 6개월 기준점보다 3개월 향상되는 것을 임상적으로 의미 있다고 판단합니다.
Compugen (NASDAQ : CGEN) a annoncé la première administration du traitement au premier patient dans son sous-essai randomisé mondial 1 de l'essai adaptatif de plateforme MAIA-ovarian. L'étude évalue COM701, un anticorps anti-PVRIG potentiellement de première classe, en tant que thérapie d'entretien chez des patientes atteintes d'un cancer de l'ovaire rechutant et sensible au platine.
L'essai est soutenu par des preuves biologiques solides montrant une forte expression de la voie PVRIG dans le cancer de l'ovaire. Des données cliniques antérieures ont démontré que COM701, en association avec le blocage de PD-1 et TIGIT, a obtenu des réponses durables chez des patientes lourdement prétraitées atteintes d'un cancer de l'ovaire résistant au platine. Une analyse intermédiaire est prévue pour le second semestre 2026, les chercheurs considérant qu'une amélioration de trois mois de la survie sans progression par rapport à la référence de six mois est cliniquement significative.
Compugen (NASDAQ: CGEN) hat die Dosierung des ersten Patienten in seiner globalen randomisierten Substudie 1 der adaptiven Plattformstudie MAIA-ovarian bekanntgegeben. Die Studie bewertet COM701, einen potenziellen First-in-Class Anti-PVRIG-Antikörper, als Erhaltungstherapie bei Patienten mit rezidivierendem platin-sensitivem Eierstockkrebs.
Die Studie wird durch starke biologische Evidenz gestützt, die eine hohe Expression des PVRIG-Signalwegs bei Eierstockkrebs zeigt. Frühere klinische Daten zeigten, dass COM701 in Kombination mit der Blockade von PD-1 und TIGIT dauerhafte Ansprechraten bei stark vorbehandelten Patienten mit platinn-resistentem Eierstockkrebs erzielte. Eine Zwischenanalyse ist für die zweite Hälfte des Jahres 2026 geplant, wobei die Forscher eine dreimonatige Verbesserung des progressionsfreien Überlebens gegenüber dem sechsmonatigen Referenzwert als klinisch bedeutsam ansehen.
- Strong biological rationale with high PVRIG pathway expression in ovarian cancer
- Previous clinical data showed durable responses in platinum-resistant ovarian cancer patients
- Single-agent COM701 achieved response lasting over 18 months in one patient
- Potential to address significant unmet medical need in ovarian cancer maintenance therapy
- Interim analysis results not expected until second half of 2026
- Requires three-month improvement over placebo to be considered clinically meaningful
Insights
Compugen's COM701 enters clinical trials for ovarian cancer maintenance therapy, with interim results expected H2 2026.
Compugen has reached a significant milestone with the dosing of the first patient in their global randomized sub-trial evaluating COM701 as maintenance therapy for relapsed platinum-sensitive ovarian cancer. This potential first-in-class anti-PVRIG antibody represents an important advancement in their clinical pipeline.
The trial's scientific foundation appears solid, built on two key pillars: high PVRIG pathway expression in ovarian cancer and encouraging clinical data showing durable responses in heavily pre-treated platinum-resistant patients. Most notably, previous studies demonstrated efficacy both as a monotherapy (with one patient showing response >18 months) and in triple combination with PD-1 and TIGIT blockade.
The company has established clear efficacy benchmarks - they're targeting a 3-month improvement in progression-free survival over the historical standard of approximately 6 months. This represents a 50% improvement, which would be clinically meaningful for this patient population.
This trial specifically addresses patients who aren't candidates for current maintenance standards (bevacizumab or PARP inhibitors), highlighting an unmet medical need. The interim analysis planned for H2 2026 will be crucial in determining COM701's registration pathway and potential for combination therapies.
While still early-stage, this trial progression represents important momentum for Compugen's immunotherapy platform targeting the PVRIG pathway, a potentially novel mechanism in ovarian cancer treatment.
- Randomized sub-trial 1 of a global adaptive platform trial of COM701 maintenance therapy in patients with relapsed platinum sensitive ovarian cancer
- Trial supported by strong biological rationale and clinical data from patients with advanced ovarian cancer
- Interim analysis planned for the second half of 2026
HOLON,
"We are delighted to advance the development of COM701 as a maintenance therapy for patients with relapsed platinum sensitive ovarian cancer, potentially addressing a significant unmet medical need," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "This global trial is underpinned by a strong biological rationale, with high PVRIG pathway expression levels observed in ovarian cancer. In addition, clinical data showed that COM701 in triple combination with PD-1 and TIGIT blockade achieved durable responses and was well tolerated in patients with heavily pre-treated platinum resistant ovarian cancer typically not responding to immunotherapy. A response of greater than 18 months was also achieved in a patient treated with COM701 as a single agent."
Dr. Cohen-Dayag continued, "Based on historical data, we anticipate the benchmark for progression-free survival to be around six months and consider a three-month improvement over placebo to be clinically meaningful for these patients. An interim analysis of sub-trial 1 of MAIA-ovarian is planned to take place in the second half of 2026. We believe positive data could inform a registration path for COM701 monotherapy and an opportunity to combine COM701 with other agents, broadening COM701's opportunities within the ovarian cancer population."
Ruth Peres, M.D., Ph.D., Medical Oncologist in the Division of Oncology, Head of Women's Cancers Research Lab and Head of Phase 1 Clinical Trials in the Clinical Research Institute at Rambam Healthcare Campus,
About MAIA-ovarian
(MAintenance Immunotherapy with an Anti-PVRIG antibody: COM701, as maintenance monotherapy or combination therapy in patients with relapsed platinum sensitive ovarian cancer.)
MAIA-ovarian is a global adaptive platform trial to evaluate the safety and efficacy of COM701 as maintenance monotherapy or combination therapy in patients with relapsed platinum sensitive ovarian cancer. The purpose of sub-trial 1 is to assess if COM701 delays the progression of ovarian cancer in patients with relapsed platinum sensitive ovarian cancer and further assess its safety profile in this disease setting. The adaptive-platform design enables additional sub-trials. Sub-trial 1 is a double-blind, randomized placebo-controlled trial in which 60 patients will be randomized in a 2:1 ratio to COM701 or placebo. Subsequent sub-trials may evaluate COM701 in combination with other anticancer drugs. For more information about this trial, visit clinicaltrials.gov, NCT06888921.
About Compugen
Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive AI/ML powered computational discovery platform (Unigen™) 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. GS-0321 (previously COM503), a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which is in Phase 1 development is licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of research programs aiming to address various mechanisms to activate the immune system against cancer. 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 regarding our expectations regarding the advancements of COM701 as a maintenance therapy for patients with relapsed platinum sensitive ovarian cancer; statements regarding the benchmark for progression free survival and improvement over placebo; statements regarding the timing of interim analysis; statements regarding the potential outcome of positive data from such interim analysis, which could inform a registration path for COM701 monotherapy and an opportunity to combine COM701 with other agents, broadening COM701's potential use within the ovarian cancer population; statements regarding the potential durable responses and favorable safety profile as maintenance therapy of COM701; statements regarding the potential of COM701 as a single agent to delay disease progression; and statements regarding subsequent sub-trials and the purposes thereof. 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 clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including
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Email: ir@cgen.com
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SOURCE Compugen Ltd.
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