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Cogent Biosciences Announces Bezuclastinib Presentations at the 66th Annual American Society of Hematology (ASH) Meeting

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Cogent Biosciences (NASDAQ: COGT) announced two presentations featuring bezuclastinib at the 66th Annual ASH Meeting in December 2024. The presentations will cover long-term follow-up data from two clinical trials: the APEX trial for Advanced Systemic Mastocytosis (AdvSM) and the SUMMIT trial for Nonadvanced Systemic Mastocytosis (NonAdvSM). Dr. Daniel DeAngelo from Dana-Farber Cancer Institute will present APEX data on December 8, while Dr. Lindsay Rein from Duke University will present SUMMIT data on December 9. The company will host an investor webcast on December 9 to review both presentations.

Cogent Biosciences (NASDAQ: COGT) ha annunciato due presentazioni riguardanti il bezuclastinib durante il 66° Congresso Annuale ASH previsto per dicembre 2024. Le presentazioni tratteranno i dati di follow-up a lungo termine di due studi clinici: lo studio APEX per la Mastocitosi Sistemica Avanzata (AdvSM) e lo studio SUMMIT per la Mastocitosi Sistemica Non Avanzata (NonAdvSM). Il Dr. Daniel DeAngelo del Dana-Farber Cancer Institute presenterà i dati dell'APEX l'8 dicembre, mentre il Dr. Lindsay Rein della Duke University presenterà i dati del SUMMIT il 9 dicembre. L'azienda ospiterà una webcast per gli investitori il 9 dicembre per rivedere entrambe le presentazioni.

Cogent Biosciences (NASDAQ: COGT) anunció dos presentaciones sobre bezuclastinib en la 66ª Reunión Anual de ASH programada para diciembre de 2024. Las presentaciones cubrirán los datos de seguimiento a largo plazo de dos ensayos clínicos: el ensayo APEX para la Mastocitosis Sistémica Avanzada (AdvSM) y el ensayo SUMMIT para la Mastocitosis Sistémica No Avanzada (NonAdvSM). El Dr. Daniel DeAngelo del Dana-Farber Cancer Institute presentará los datos de APEX el 8 de diciembre, mientras que la Dra. Lindsay Rein de la Universidad de Duke presentará los datos de SUMMIT el 9 de diciembre. La empresa organizará un webcast para inversores el 9 de diciembre para revisar ambas presentaciones.

코전 바이오사이언스 (NASDAQ: COGT)는 2024년 12월에 열리는 제66회 ASH 연례 회의에서 bezuclastinib과 관련된 두 가지 발표를 발표했습니다. 이러한 발표는 두 가지 임상 시험의 장기 추적 데이터에 대한 내용을 포함할 것입니다: APEX 시험은 고급 전신 비만세포증(AdvSM)에 대한 것이고, SUMMIT 시험은 비고급 전신 비만세포증(NonAdvSM)에 대한 것입니다. Dana-Farber Cancer Institute의 Daniel DeAngelo 박사가 12월 8일에 APEX 데이터를 발표할 예정이며, Duke University의 Lindsay Rein 박사가 12월 9일에 SUMMIT 데이터를 발표할 예정입니다. 회사는 두 발표를 검토하기 위해 12월 9일에 투자자 웹캐스트를 개최할 예정입니다.

Cogent Biosciences (NASDAQ: COGT) a annoncé deux présentations concernant le bezuclastinib lors de la 66e Réunion Annuelle de l'ASH prévue pour décembre 2024. Les présentations porteront sur des données de suivi à long terme provenant de deux essais cliniques : l'essai APEX pour la Mastocytose Systémique Avancée (AdvSM) et l'essai SUMMIT pour la Mastocytose Systémique Non Avancée (NonAdvSM). Le Dr. Daniel DeAngelo de l'Institut Dana-Farber présentera les données de l'APEX le 8 décembre, tandis que le Dr. Lindsay Rein de l'Université Duke présentera les données du SUMMIT le 9 décembre. L'entreprise organisera un webinaire pour les investisseurs le 9 décembre afin de passer en revue les deux présentations.

Cogent Biosciences (NASDAQ: COGT) hat zwei Präsentationen über Bezuclastinib auf der 66. Jahrestagung der ASH im Dezember 2024 angekündigt. Die Präsentationen werden langfristige Follow-up-Daten aus zwei klinischen Studien behandeln: die APEX-Studie zur fortgeschrittenen systemischen Mastocytose (AdvSM) und die SUMMIT-Studie zur nicht fortgeschrittenen systemischen Mastocytose (NonAdvSM). Dr. Daniel DeAngelo vom Dana-Farber Cancer Institute wird die APEX-Daten am 8. Dezember präsentieren, während Dr. Lindsay Rein von der Duke University die SUMMIT-Daten am 9. Dezember vorstellen wird. Das Unternehmen wird am 9. Dezember ein Webcast für Investoren veranstalten, um beide Präsentationen zu besprechen.

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Company to host webcast on December 9, 2024 at 8:00am ET/5:00am PT

WALTHAM, Mass. and BOULDER, Colo., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced two presentations featuring bezuclastinib at the 66th Annual Meeting of the American Society of Hematology (ASH) being held December 7-10, 2024 in San Diego, California.

The first presentation will describe long term follow-up from patients in Part 1 of the ongoing APEX trial. APEX is a global, open-label, multi-center, two-part Phase 2 clinical trial evaluating the safety, efficacy, pharmacokinetic and pharmacodynamic profiles of bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM).

The second presentation will describe long term follow-up from patients who participated in the Open Label Extension portion of the ongoing SUMMIT trial. SUMMIT is a randomized, double-blind, placebo-controlled, global, multicenter Phase 2 trial evaluating bezuclastinib in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM).

Details for the presentations are as follows:

Apex Part 1: Updated Assessment of Bezuclastinib (CGT9486), a Selective KIT D816V Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis (AdvSM)
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Advancing Treatment Paradigms in Myeloproliferative Neoplasms and Mastocytosis
Presenter: Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School
Session Date and Time: Sunday, December 8, 2024, 4:30 PM - 6:00 PM PT (7:30pm – 9:00pm ET)
Presentation time: 5:30pm PT (8:30pm ET)
Publication Number: 659
Location: Manchester Grand Hyatt, San Diego Grand Hall D

Updated Efficacy and Safety Results of Patients Receiving Selected 100mg Bezuclastinib Dose and Participating in the Open-Label Extension of Summit: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial of Bezuclastinib in Adult Patients with Nonadvanced Systemic Mastocytosis
Presenter: Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellular Therapy at Duke University
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Session Date and Time: Monday, December 9, 2024, 6:00 PM - 8:00 PM PT (9:00pm-11:00pm ET)
Publication Number: 4556
Location: San Diego Convention Center Halls G-H

Full abstracts are available for online viewing via the ASH Annual Meeting website: https://www.hematology.org/meetings/annual-meeting.

Investor Webcast Details
Cogent will host a webcast on Monday, December 9, 2024 at 8:00am ET (5:00am PT) led by Cogent’s President and CEO, Andrew Robbins which will include a review of the SUMMIT and APEX data presentations by Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School. The speakers and additional members of Cogent leadership will be available during the Question and Answer session.

The live webcast will be accessible on the Investors and Media page of Cogent’s website at investors.cogentbio.com/events. After completion of the event, an archived replay will also be available.

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. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2, 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 clinical development plans and timelines, as well as upcoming data presentations. 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

When will Cogent Biosciences (COGT) present bezuclastinib data at ASH 2024?

Cogent Biosciences will present bezuclastinib data at ASH 2024 on December 8 (APEX trial) at 5:30 PM PT and December 9 (SUMMIT trial) at 6:00 PM PT.

What clinical trials will Cogent Biosciences (COGT) present at ASH 2024?

Cogent Biosciences will present data from two trials: the APEX Phase 2 trial for Advanced Systemic Mastocytosis and the SUMMIT Phase 2 trial for Nonadvanced Systemic Mastocytosis.

When is Cogent Biosciences (COGT) hosting its investor webcast for ASH 2024 data?

Cogent Biosciences will host an investor webcast on December 9, 2024, at 8:00 AM ET/5:00 AM PT to review the SUMMIT and APEX trial data presentations.

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