Cogent Biosciences
COGT
announced promising initial efficacy and safety data from its phase II study — APEX — evaluating its KIT D816V inhibitor candidate, bezuclastinib, in patients with advanced systemic mastocytosis (AdvSM).
Shares of Cogent surged 58.7% on Jun 10, following the promising initial data readout from the mid-stage study on its lead pipeline candidate. However, shares of the company have declined 8.3% so far this year compared with the
industry
’s decrease of 27.4%.
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Initial data from the study included 11 patients who were evaluated for signs of clinical activity. These patients have received either of four doses — 50 mg BID, 100 mg BID, 200 mg BID or 400 mg QD — of bezuclastinib. These patients were aged between 48 years and 87 years and had either aggressive systemic mastocytosis, systemic mastocytosis with associated hematologic neoplasm and mast cell leukemia. Two of these 11 patients were treated previously with other KIT D816V inhibitors — avapritinib or midostaurin.
All the 11 patients achieved a reduction in serum tryptase by a median of 89%, with two of them achieving levels of less than 20 ng/mL. Elevated serum tryptase is one of the characteristics of AdvSM.
Data from all evaluable patients (8 patients) demonstrated more than 50% reduction in bone marrow mast cells and decreases in KIT D816V variant allele fraction. Six of these patients achieved complete clearance of bone marrow mast cell aggregates.
Initial safety data from the study on bezuclastinib were also encouraging. There were no grade 4 adverse events but three patients had grade 3 events, including anemia, neutropenia and hypersensitivity/mediator flare. There were also no reports of periorbital/peripheral edema, cognitive effects or intracranial bleeding events associated with other KIT inhibitors.
Other KIT D816V inhibitors available for treating AdvSM have tolerability challenges, which may lead to treatment discontinuation. Cogent believes that its selective KIT D816V inhibitor with limited CNS penetration, bezuclastinib, has the potential to provide meaningful clinical activity to all systemic mastocytosis patients and overcoming the tolerability challenges.
Cogent believes that bezuclastinib has strong potential as an effective treatment option for AdvSM patients with lower safety issues. Based on the initial data from the APEX study, the company plans to accelerate investments for bezuclastinib development and expects to complete the study faster. The company expects another data readout from the APEX study by the end of this year.
Cogent is also evaluating bezuclastinib in non-AdvSM patients in another phase II study — SUMMIT. Data from this study is expected in the first half of 2023.
Zacks Rank & Stocks to Consider
Cogent currently has a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Some better-ranked biotech stocks are
Alkermes
ALKS
,
Sesen Bio
SESN
and
Aeglea BioTherapeutics
AGLE
. While Alkermes and Sesen sport a Zacks Rank #1, Aeglea carries a Zacks Rank #2 (Buy).
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The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has narrowed from 33 cents to 32 cents per share in the past 60 days. Shares of SESN have declined 85.1% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.
The Zacks Consensus Estimate for Aeglea’s 2022 loss has narrowed from $1.44 to $1.16 per share in the past 60 days. Shares of AGLE have declined 10.6% in the year-to-date period.
Earnings of Aegleas beat estimates in two of the last four quarters and missed the mark twice, the average surprise being 9.47%.
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