Compugen Announces First Patient Dosed in Phase 1 Clinical Trial to Evaluate COM503 as Monotherapy and in Combination with Zimberelimab in Advanced Solid Tumors
Compugen (NASDAQ: CGEN) has announced the dosing of its first patient in a Phase 1 clinical trial for COM503, a potential first-in-class antibody against IL-18 binding protein licensed to Gilead Sciences. The multi-center trial will evaluate COM503's safety, tolerability, and pharmacokinetics both as a monotherapy and in combination with Gilead's anti-PD1, zimberelimab, in patients with advanced solid tumors.
The trial, initiated in Q4 2024, represents a new approach to cancer treatment through cytokine biology. Compugen's Unigen™ discovery engine identified high IL-18 expression in cancer patients' tumors, but found its anti-tumor activity is blocked by an endogenous IL-18-binding protein. COM503 works by blocking this protein, potentially enabling naturally occurring IL-18 to fight cancer within tumors, addressing limitations of systemic cytokine administration.
The first patient was dosed at the START Center for Cancer Research-Midwest in Grand Rapids, Michigan, with Compugen responsible for conducting the Phase 1 trial.
Compugen (NASDAQ: CGEN) ha annunciato la somministrazione della dose al suo primo paziente in uno studio clinico di Fase 1 per COM503, un potenziale anticorpo di prima classe contro la proteina legante IL-18, con licenza a Gilead Sciences. Lo studio multicentrico valuterà la sicurezza, la tollerabilità e la farmacocinetica di COM503 sia come monoterapia che in combinazione con l'anti-PD1 di Gilead, zimberelimab, in pazienti con tumori solidi avanzati.
Lo studio, avviato nel quarto trimestre del 2024, rappresenta un nuovo approccio al trattamento del cancro attraverso la biologia delle citochine. Il motore di scoperta Unigen™ di Compugen ha identificato un'alta espressione di IL-18 nei tumori di pazienti oncologici, ma ha scoperto che la sua attività antitumorale è bloccata da una proteina legante IL-18 endogena. COM503 agisce bloccando questa proteina, potenzialmente consentendo all'IL-18 naturale di combattere il cancro all'interno dei tumori, affrontando le limitazioni della somministrazione sistemica di citochine.
Il primo paziente ha ricevuto la dose presso il START Center for Cancer Research-Midwest a Grand Rapids, Michigan, ed è Compugen a essere responsabile della conduzione dello studio di Fase 1.
Compugen (NASDAQ: CGEN) ha anunciado la administración de la dosis a su primer paciente en un ensayo clínico de Fase 1 para COM503, un potencial anticuerpo innovador contra la proteína de unión IL-18, con licencia para Gilead Sciences. El ensayo multicéntrico evaluará la seguridad, tolerabilidad y farmacocinética de COM503 tanto como monoterapia como en combinación con el anti-PD1 de Gilead, zimberelimab, en pacientes con tumores sólidos avanzados.
El ensayo, iniciado en el cuarto trimestre de 2024, representa un nuevo enfoque para el tratamiento del cáncer mediante la biología de las citoquinas. El motor de descubrimiento Unigen™ de Compugen identificó una alta expresión de IL-18 en los tumores de pacientes oncológicos, pero encontró que su actividad antitumoral está bloqueada por una proteína de unión IL-18 endógena. COM503 funciona bloqueando esta proteína, permitiendo potencialmente que el IL-18 que ocurre naturalmente combata el cáncer dentro de los tumores, abordando las limitaciones de la administración sistémica de citoquinas.
El primer paciente recibió la dosis en el START Center for Cancer Research-Midwest en Grand Rapids, Michigan, siendo Compugen responsable de la realización del ensayo de Fase 1.
Compugen (NASDAQ: CGEN)은 COM503의 1상 임상 시험에서 첫 환자에게 첫 투약이 진행되었다고 발표하였다. COM503은 Gilead Sciences에 라이센스된 IL-18 결합 단백질에 대한 잠재적인 첫 번째 혁신 항체이다. 다기관 시험은 COM503의 안전성, 내약성 및 약동학을 monotherapy로서, 그리고 Gilead의 항-PD1인 zimberelimab과의 병용에서 평가할 것이다. 환자들은 진행성 고형 종양을 앓고 있는 환자들이다.
이번 연구는 2024년 4분기에 시작되며, 사이토카인 생물학을 통한 암 치료의 새로운 접근 방식을 나타낸다. Compugen의 Unigen™ 발견 엔진은 암 환자의 종양에서 높은 수준의 IL-18 발현을 확인했지만, 면역기체의 항종양 활동은 내인성 IL-18 결합 단백질에 의해 차단되는 것으로 확인했다. COM503은 이 단백질을 차단하여, 자체 발생하는 IL-18이 종양 내에서 암과 싸울 수 있도록 잠재적으로 돕는다. 이는 전신적으로 사이토카인을 투여할 때의 한계를 해결할 수 있다.
첫 환자는 미시간주 Grand Rapids에 있는 START Cancer Research-Midwest 센터에서 투약되었으며, 1상 시험을 수행하는 것은 Compugen이다.
Compugen (NASDAQ: CGEN) a annoncé l'administration de la dose à son premier patient dans un essai clinique de Phase 1 pour COM503, un anticorps potentiel de première classe contre la protéine liant l'IL-18, licencié à Gilead Sciences. L'essai multicentrique évaluera la sécurité, la tolérance et la pharmacocinétique de COM503, tant comme monothérapie qu'en association avec l'anti-PD1 de Gilead, le zimberelimab, chez des patients atteints de tumeurs solides avancées.
L'essai, qui a été lancé au quatrième trimestre de 2024, représente une nouvelle approche dans le traitement du cancer par la biologie des cytokines. Le moteur de découverte Unigen™ de Compugen a identifié une forte expression d'IL-18 dans les tumeurs de patients atteints de cancer, mais a découvert que son activité antitumorale est bloquée par une protéine liant l'IL-18 endogène. COM503 agit en bloquant cette protéine, permettant potentiellement à l'IL-18 naturellement présent de combattre le cancer au sein des tumeurs, en répondant aux limites de l'administration systémique de cytokines.
Le premier patient a reçu sa dose au START Center for Cancer Research-Midwest à Grand Rapids, dans le Michigan, Compugen étant responsable de la réalisation de l'essai de Phase 1.
Compugen (NASDAQ: CGEN) hat die Dosierung seines ersten Patienten in einer Phase-1-Studie für COM503 angekündigt, einem potenziellen Antikörper der ersten Klasse gegen IL-18-bindendes Protein, das an Gilead Sciences lizenziert ist. Die multizentrische Studie wird die Sicherheit, Verträglichkeit und Pharmakokinetik von COM503 sowohl als Monotherapie als auch in Kombination mit Gileads Anti-PD1, zimberelimab, bei Patienten mit fortgeschrittenen soliden Tumoren bewerten.
Die im vierten Quartal 2024 gestartete Studie stellt einen neuen Ansatz zur Krebsbehandlung durch Zytokinbiologie dar. Compugens Unigen™-Entdeckungsmaschine identifizierte eine hohe IL-18-Expression in den Tumoren von Krebspatienten, stellte jedoch fest, dass die antitumorale Aktivität durch ein endogenes IL-18-bindendes Protein blockiert wird. COM503 wirkt, indem es dieses Protein blockiert, wodurch möglicherweise das natürlich vorkommende IL-18 in der Lage ist, Krebs innerhalb der Tumoren zu bekämpfen, und die Einschränkungen der systemischen Zytokinverabreichung angeht.
Der erste Patient wurde im START Center for Cancer Research-Midwest in Grand Rapids, Michigan, dosiert, wobei Compugen für die Durchführung der Phase-1-Studie verantwortlich ist.
- First patient dosed in Phase 1 trial with potential first-in-class antibody COM503
- Strategic partnership with Gilead Sciences through licensing agreement
- Novel approach targeting IL-18 binding protein could overcome limitations of current cytokine treatments
- Early-stage Phase 1 trial with uncertain outcomes
- Safety and efficacy yet to be demonstrated
Insights
The initiation of this Phase 1 trial for COM503 marks a notable development in cancer immunotherapy. The trial's design demonstrates strategic sophistication through its dual-arm approach - evaluating both monotherapy and combination therapy with zimberelimab. The mechanism targeting IL-18 binding protein represents an innovative approach to cytokine modulation.
The trial's structure follows industry best practices with a dose escalation and expansion design, important for establishing safety parameters and optimal dosing. The collaboration with Gilead adds significant credibility and resources to the development program. Key differentiators include:
- Novel mechanism targeting naturally occurring IL-18 within tumors
- Potential advantage over systemic cytokine administration
- Strategic partnership with an established pharma company
For investors, this milestone triggers a progression in Compugen's clinical pipeline and could impact future milestone payments from Gilead. The
COM503's approach to enhancing anti-tumor immunity through IL-18 modulation represents a sophisticated understanding of tumor microenvironment biology. The strategy of blocking IL-18 binding protein, rather than directly administering cytokines, could potentially offer better safety and efficacy profiles compared to traditional cytokine therapies.
Key therapeutic advantages include:
- Localized activation within the tumor microenvironment
- Potential for reduced systemic toxicity
- Synergistic potential with PD-1 inhibition
The selection of START Midwest as the initial trial site, known for their expertise in early-phase oncology trials, suggests a well-planned clinical development strategy. The combination with zimberelimab could provide valuable insights into potential synergies with checkpoint inhibition.
- New approach to harness cytokine biology to treat cancer patients advances to the clinic
- First patient dosed with potential first-in-class anti-IL-18 binding protein antibody, COM503, licensed to Gilead Sciences, Inc.
- Phase 1 dose escalation and dose expansion trial to assess the safety and tolerability of COM503 as monotherapy and in combination for patients with advanced solid tumors
- Compugen responsible for running the Phase 1 trial
HOLON,
This Phase 1 multi-center dose escalation and dose expansion trial will evaluate the safety, tolerability, and pharmacokinetics of COM503 as monotherapy and in combination with Gilead's anti-PD1, zimberelimab in patients with advanced solid tumors. The trial was initiated in the fourth quarter of 2024 as planned.
"We are delighted to advance COM503, our antibody that provides a new and potentially differentiated approach to harness cytokine biology for cancer therapeutics, quickly into the clinic," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "Compugen's discovery engine Unigen™, identified that the tumors of patients with cancer express high levels of IL-18. However, the anti-tumor activity of IL-18 is blocked by an endogenous IL-18-binding protein, rendering it ineffective in fighting cancer. By blocking this endogenous IL-18 binding protein, COM503 presents a unique opportunity to release naturally occurring IL-18 locally within the tumors, where it can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered cytokines."
Manish Sharma, M.D., Co-Director of Clinical Research, at the START Center for Cancer Research-Midwest (START Midwest) in
About the COM503 Phase 1 trial:
The primary objectives of this trial are to assess the safety and tolerability of COM503 as a monotherapy and in combination with zimberelimab in patients with advanced solid tumors and to identify the maximum tolerated dose /maximum administered dose and/or the recommended dose of COM503 as monotherapy and in combination with zimberelimab. For more information about the Phase 1 clinical trial, visit clinicaltrials.gov, NCT06759649.
About the Compugen-Gilead license agreement
In December 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 managed the preclinical development of COM503 and is responsible for the Phase 1 trial evaluating the safety and tolerability of COM503. Thereafter, Gilead will have sole right to develop and commercialize COM503. Gilead paid Compugen
About Compugen
Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive 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. 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 programs aiming to address various mechanisms of immune resistance. Compugen is headquartered in
Compugen Forward-Looking Statements
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, statement regarding our belief that by blocking IL-18 binding protein, COM503 presents a unique opportunity to release naturally occurring IL-18 locally within the tumors, where it can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered cytokines. 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 Israel; the effect of the evolving nature of the recent war in Gaza; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
Company contact:
Yvonne Naughton, Ph.D.
VP, Head of Investor Relations, and Corporate Communications
Email: ir@cgen.com
Tel: +1 (628) 241-0071
View original content:SOURCE Compugen Ltd.
FAQ
What is the purpose of Compugen's COM503 Phase 1 trial announced in January 2024?
How does Compugen's COM503 work in cancer treatment?
What is the relationship between Compugen (CGEN) and Gilead Sciences for COM503?
Where was the first patient dosed in Compugen's COM503 trial?
When did Compugen initiate the Phase 1 trial for COM503?
