Cogent Biosciences Announces KRAS Poster Presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Cogent Biosciences (Nasdaq: COGT) presented updated preclinical data for its pan KRAS(ON) program at the 2025 AACR-NCI-EORTC conference on Oct 24, 2025. The poster describes CGT1263, a KRAS inhibitor with reported picomolar activity across KRAS mutant cell lines and selectivity over HRAS and NRAS. The company also detailed CGT1815, a prodrug designed to optimize human pharmacokinetics with supporting multi‑species PK data. Cogent says CGT1815 showed superior tumor growth inhibition versus RMC-6236 in KRASG12D and KRASG12V preclinical models, and the company aims to file an IND in 2026.
Cogent Biosciences (Nasdaq: COGT) ha presentato dati preclinici aggiornati per il suo programma pan KRAS(ON) al congresso 2025 AACR-NCI-EORTC il 24 ottobre 2025. Il poster descrive CGT1263, un inibitore di KRAS con attività riportata a livello picomolare sulle linee cellulari mutanti KRAS e una selettività su HRAS e NRAS. L'azienda ha anche dettagliato CGT1815, una pro-druge progettata per ottimizzare la farmacocinetica umana con dati PK multi-specie di supporto. Cogent afferma che CGT1815 ha mostrato una superiore inibizione della crescita tumorale rispetto a RMC-6236 in modelli preclinici KRASG12D e KRASG12V, e l'azienda punta a presentare un IND nel 2026.
Cogent Biosciences (Nasdaq: COGT) presentó datos preclínicos actualizados para su programa pan KRAS(ON) en la conferencia 2025 AACR-NCI-EORTC el 24 de octubre de 2025. El cartel describe CGT1263, un inhibidor de KRAS con actividad reportada en rango de picomolar en líneas celulares mutantes de KRAS y selectividad sobre HRAS y NRAS. La empresa también detalló CGT1815, una prodroga diseñada para optimizar la farmacocinética humana con datos PK de múltiples especies que la respaldan. Cogent dice que CGT1815 mostró una inhibición del crecimiento tumoral superior frente a RMC-6236 en modelos preclínicos KRASG12D y KRASG12V, y la compañía busca presentar un IND en 2026.
Cogent Biosciences (Nasdaq: COGT)은 2025 AACR-NCI-EORTC 학회에서 파넬 KRAS(ON) 프로그램에 대한 업데이트된 전임상 데이터를 2025년 10월 24일에 발표했다. 포스터는 CGT1263, KRAS 돌연변이 세포주에서 KRAS에 대한 피코몰 농도 범위의 활성을 보이고 HRAS 및 NRAS에 대한 선택성을 가진 KRAS 억제제를 설명한다. 또한 회사는 CGT1815, 다종 종에서의 PK 데이터를 뒷받침하여 인체 약물동태를 최적화하도록 설계된 프리프로드에 대해 자세히 설명했다. Cogent는 CGT1815가 KRASG12D 및 KRASG12V 전임상 모델에서 RMC-6236보다 종양 성장 억제 우수를 보였다고 말하며, 2026년에 IND를 제출할 계획이다.
Cogent Biosciences (Nasdaq: COGT) a présenté des données précliniques actualisées pour son programme pan KRAS(ON) lors de la conférence 2025 AACR-NCI-EORTC le 24 octobre 2025. L’affiche décrit CGT1263, un inhibiteur de KRAS avec une activité rapportée au niveau picomolaire sur des lignées cellulaires mutantes KRAS et une sélectivité vis-à-vis de HRAS et NRAS. L’entreprise a également détaillé CGT1815, une pro-drogue conçue pour optimiser la pharmacocinétique humaine avec des données PK multi‑espèces à l’appui. Cogent affirme que CGT1815 a montré une inhibition supérieure de la croissance tumorale par rapport à RMC-6236 dans des modèles précliniques KRASG12D et KRASG12V, et l’entreprise vise à déposer une IND en 2026.
Cogent Biosciences (Nasdaq: COGT) präsentierte aktualisierte präklinische Daten zu ihrem pan KRAS(ON)-Programm auf der 2025 AACR-NCI-EORTC-Konferenz am 24. Oktober 2025. Das Poster beschreibt CGT1263, einen KRAS-Inhibitor mit berichteter Picomolar-Aktivität über KRAS-mutante Zelllinien hinweg und eine Selektivität gegenüber HRAS und NRAS. Das Unternehmen erläuterte auch CGT1815, eine Prodrug-Form, die darauf ausgelegt ist, die menschliche Pharmakokinetik mit unterstützenden PK-Daten aus mehreren Spezies zu optimieren. Cogent sagt, CGT1815 habe eine überlegene Tumorwachstumshemmung gegenüber RMC-6236 in KRASG12D- und KRASG12V-Präklinikenmodellen gezeigt, und das Unternehmen plant, eine IND im Jahr 2026 einzureichen.
Cogent Biosciences (Nasdaq: COGT) قدمت بيانات قبل سريرية محدثة لبرنامجها الشامل KRAS(ON) في مؤتمر AACR-NCI-EORTC 2025 في 24 أكتوبر 2025. يصف الملصق CGT1263، مثبِّط KRAS مع نشاط مُبلَّغ عنه بمستوى البكو مول على خطوط خلايا KRAS المتحورة وبخصوصية على HRAS وNRAS. كما فسرت الشركة CGT1815، وهو دواء-برو-دوغ مصمم لتحسين الفارماكوكينتيك البشرية مع بيانات PK من عدة أنواع تدعم ذلك. وتقول Cogent إن CGT1815 أظهر قمعاً أقوى لنمو الورم مقارنةً بـ RMC-6236 في نماذج قبل السريرية KRASG12D وKRASG12V، وتخطط الشركة لتقديم IND في 2026.
- CGT1263 shows picomolar activity across KRAS mutant cell lines
- Reported selectivity of CGT1263 over HRAS and NRAS
- CGT1815 prodrug has multi‑species pharmacokinetics data
- CGT1815 showed superior tumor inhibition versus RMC-6236
- Company aims to file an IND in 2026
- Data are preclinical; no clinical (human) data reported
- IND filing stated as a goal, not a completed regulatory filing
- Comparative efficacy reported only in preclinical tumor models
Insights
Updated preclinical KRAS data and an IND target of
Cogent’s announcement reports preclinical evidence that CGT1263 potently inhibits a broad set of KRAS mutant cell lines at picomolar potency and shows selectivity versus HRAS and NRAS; the program also includes a prodrug, CGT1815, with cross‑species pharmacokinetic data and a stated IND goal of
The biological mechanism is straightforward: a pan‑KRAS(ON) inhibitor aims to target multiple oncogenic KRAS variants directly, which could translate into broader tumor coverage than allele‑restricted agents; however, the disclosed facts are limited to in vitro potency, selectivity, and preclinical PK and efficacy comparisons versus RMC‑6236, so clinical benefit remains unproven.
Watch for three concrete, monitorable items: posterior publication/access on Cogent’s posters page (immediate), any IND filing or acceptance by the FDA in
Preclinical PK and head‑to‑head efficacy claims are informative but not decisive for clinical outcomes.
The announcement highlights that CGT1815 is a prodrug engineered to optimize human pharmacokinetics and that animal PK and tumor inhibition data versus RMC‑6236 favor CGT1815 in KRASG12D and KRASG12V models; this suggests the team focused on improving exposure and in vivo activity.
Risks and dependencies are explicit in the content: all results reported are preclinical and comparative efficacy in animal models does not guarantee human safety, exposure, or efficacy. Key near‑term items to monitor include the availability of full PK datasets on the posters page, any toxicology package submissions that support an IND, and the actual IND filing timeline in
WALTHAM, Mass. and BOULDER, Colo., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced updated preclinical data from the company’s potent and selective pan KRAS(ON) inhibitor in a poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place in Boston, MA, October 22-26, 2025.
“We are excited today to share updated data from our pan KRAS(ON) program which demonstrates a potential best-in-class profile for our lead molecule,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We look forward to advancing this program with the goal of filing an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in 2026.”
Poster Details
The poster will be accessible on the ‘Posters and Publications’ page of Cogent’s website.
Title: Identification of CGT1263, a Potent KRAS Inhibitor with Selectivity for Mutant KRAS over HRAS and NRAS
Session Date and Time: Poster Session B, Friday, October 24, 2025 – 12:30 p.m. – 4:00 p.m. ET
Poster Number: B024
Abstract Number: B024
Mutations in KRAS are among the most prevalent mutations found in cancer, occurring most often in colorectal cancer, non-small cell lung cancer and pancreatic cancer. The poster presented today describes Cogent’s internally developed KRAS(ON/OFF) inhibitor CGT1263, showing clear selectivity over HRAS and NRAS, with picomolar (pM) activity across a broad panel of KRAS mutant cell lines. In addition, the poster also characterizes CGT1815 (the prodrug of CGT1263), which is designed to optimize human pharmacokinetic performance, supported by pharmacokinetics data from both CGT1815 and CGT1263 across multiple species. Finally, the poster highlights that CGT1815 demonstrates superior efficacy in KRASG12D and KRASG12V tumor growth inhibition studies when compared to RMC-6236.
About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2/3 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the potential best-in-class profile of the company’s lead molecule in its pan KRAS(ON) program and the goal of filing an IND for this program in 2026. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653
FAQ
What did Cogent Biosciences (COGT) present at AACR on October 24, 2025?
What is CGT1263 and how potent is it according to Cogent (COGT)?
How does Cogent say CGT1815 performed versus RMC-6236 in preclinical models?
Does Cogent (COGT) plan to seek FDA approval for its KRAS program?
Are the KRAS results from Cogent (COGT) clinical or preclinical?
