Prior to the open of U.S. markets today, biotech firm Cogent Biosciences Inc. (COGT:NASDAQ), which is engaged in the development of precision therapies for use in treating genetically driven diseases, announced "positive initial data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM)."
The company advised that the APEX clinical data will be presented via a poster presentation at a major European Hematology conference in Vienna later today.
Daniel DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and APEX clinical trial investigator stated, "Advanced systemic mastocytosis is a severe, debilitating hematologic disorder, and physicians and patients remain in search of more effective and better-tolerated treatment options to fight this disease…I am very impressed with the early, encouraging results presented today from the APEX study. If results like these can be shown in a larger set of patients with AdvSM, I believe bezuclastinib has the potential to help us take a big step forward in treating systemic mastocytosis patients."
Cogent Biosciences' CEO and President Andrew Robbins commented, "We are very excited to present initial clinical data from the APEX study of bezuclastinib in advanced systemic mastocytosis…These results reinforce the hypothesis that a potent, selective KIT D816V inhibitor with limited CNS penetration has the potential to provide meaningful clinical activity to all systemic mastocytosis patients, without the tolerability challenges seen with other available treatment options."
"Based on these results, we expect to accelerate our timelines and investment and look forward to providing another APEX clinical update by the end of 2022, and to presenting SUMMIT clinical data in non-advanced systemic mastocytosis (NonAdvSM) patients in the first half of 2023," Robbins added.
The company advised that the Phase 2 APEX clinical trial is an ongoing multi-center study designed to evaluate the safety and efficacy of bezuclastinib in patients diagnosed with AdvSM. The firm indicated that the trial is structured in two-parts and stated that 11 patients with a median age of 70 had been treated in Part 1 of the study as of the May 24, 2022 cutoff date. Each of the 11 patients, who were identified as having either aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematologic neoplasm (SM-AHN) or mast cell leukemia (MCL), were treated with one of four dose levels of bezuclastinib that were administered in twice-daily 50 milligrams (50 mg), 100 mg, or 200 mg doses or in a once-daily 400 mg dose.
The firm noted that thru the APEX trial's May 24th cutoff period, bezuclastinib was observed to be well-tolerated regardless of the strength of the dose patients received. The company stated that there were three Grade 3 adverse events reported (anemia, neutropenia, hypersensitivity/mediator flare) but said that there were no Grade 4 adverse events reported.
The company highlighted that initial data gathered in the APEX study showed that all 11 patients treated with bezuclastinib had achieved a 50% or greater reduction in serum tryptase levels by central assessment and that the mean reduction was 89%. In addition, the firm advised that all eight patients classified a C3D1 evaluable had achieved at least a 50% reduction in bone marrow mast cells by central review.
Cogent stated that based upon the positive results observed so far in Part 1 of its Phase 2 study, it plans to continue with additional patient enrollment. The firm intends to use the additional data from new participants to aid in determining a recommended dose level for Part 2 of the trial. The company noted that it expects to report further data from 28 new trial participants prior to the end of this year.
Cogent Biosciences concentrates its efforts on the development of precision therapies and solutions to treat genetically driven diseases. The company listed that "its 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." Bezuclastinib is presently being studied in late-stage clinical trials for potential use in the treatment of advanced systemic mastocytosis (AdvSM), systemic mastocytosis (SM), and gastrointestinal stromal tumors. In addition, the firm is conducting research that is focused on developing novel therapies targeting FGFR2 and ErbB2 to address serious genetically driven diseases.
Cogent Biosciences started off the day with a market cap of around $227.3 million with approximately 45.8 million shares outstanding and a short interest of about 4.8%. COGT shares opened 33% higher today at $6.60 (+$1.64, +33.06%) over yesterday's $4.96 closing price. The stock has traded today between $6.50 and $10.8899 per share and is currently trading at $8.38 (+$3.42, +68.95%).
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