UMRX Unum Therapeutics

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

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

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) --  (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: .

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 . 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 Follow Cogent Biosciences on social media: (formerly known as Twitter) and . Information that may be important to investors will be routinely posted on our website and .

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



617-830-1653



EN
05/11/2024

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Unum Therapeutics

 PRESS RELEASE

Cogent Biosciences Announces Planned 2025 Milestones for Bezuclastinib...

Cogent Biosciences Announces Planned 2025 Milestones for Bezuclastinib and Emerging Portfolio of Selective and Potent Targeted Therapeutics •   Plan to report top-line results from registration-directed SUMMIT trial in NonAdvSM patients in July 2025 •   Plan to report top-line results from pivotal PEAK Phase 3 trial in 2nd-line GIST patients by end of 2025 •   Plan to report top-line results from registration-directed APEX trial in AdvSM patients in 2H 2025 •   Company to present at J.P. Morgan 43rd annual healthcare conference tomorrow, Tuesday, January 14 at 7:30 a.m. PT /1...

 PRESS RELEASE

Cogent Biosciences Announces Presentation at the 43rd Annual J.P. Morg...

Cogent Biosciences Announces Presentation at the 43rd Annual J.P. Morgan Healthcare Conference WALTHAM, Mass. and BOULDER, Colo., Jan. 08, 2025 (GLOBE NEWSWIRE) --  (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that Andrew Robbins, President and Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 14, 2025 at 7:30 a.m. PT/10:30 a.m. ET. A live webcast will be available on the Investors & Media page of Cogent’s website at . A re...

 PRESS RELEASE

Cogent Biosciences Announces Updated Clinical Results from SUMMIT, Sho...

Cogent Biosciences Announces Updated Clinical Results from SUMMIT, Showcasing Powerful Symptomatic Improvement in NonAdvanced Systemic Mastocytosis Patients 56% mean improvement in Total Symptom Score (TSS) at 24 weeks with 76% of patients achieving at least a 50% reduction in TSS                   89% of patients had >50% decrease in serum tryptase by four weeks of treatment and 95% of patients with elevated baseline tryptase achieved serum tryptase levels 50% reduction from baseline in MS2D2 Total Symptom Score (TSS) with 88% of patients exceeding 30% reduction from baseline after 24 wee...

 PRESS RELEASE

Cogent Biosciences Announces Positive Updated Data from Ongoing Phase ...

Cogent Biosciences Announces Positive Updated Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM) 52% ORR per mIWG criteria, including 83% ORR for patients receiving 100 mg BID 88% ORR per PPR criteria, including 100% ORR for patients receiving 100 mg BID Median time to response 2.2 months with median duration of response and median PFS not yet reached Top-line data from APEX Part 2 on-track for mid-2025 Cogent to host investor webcast on Monday, December 9 at 8:00 a.m. ET WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 20...

 PRESS RELEASE

Cogent Biosciences Reports Recent Business Highlights and Third Quarte...

Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2024 Financial Results Top-line results from registration-directed SUMMIT, PEAK and APEX trials expected in 2025 Phase 1 trial initiated for CGT-4859, a reversible, potent, selective, FGFR2 inhibitor SUMMIT and APEX clinical presentations at upcoming ASH annual meeting Strong cash position of $346 million sufficient to fund operations into late 2026 WALTHAM, Mass. and BOULDER, Colo., Nov. 12, 2024 (GLOBE NEWSWIRE) --  (Nasdaq: COGT), a biotechnology company focused on developing precision ...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch