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Acrivon Therapeutics Reports Positive Endometrial Cancer Data from Ongoing ACR-368 Registrational Intent Phase 2 Study at ESMO, Advancement of ACR-2316 into Clinic Ahead of Timelines, and Progress on its AP3 Interactome for Proprietary Data Analysis
Confirmed overall response rate (ORR) = 62.5% (95% CI, 30.4-86.5) observed in prospectively-selected ACR-368 OncoSignature-positive (BM+) patients with
About this update from Acrivon Therapeutics, Inc.
[{"type":"text","content":"Confirmed overall response rate (ORR) = 62.5% (95% CI, 30.4-86.5) observed in prospectively-selected ACR-368 OncoSignature-positive (BM+) patients with endometrial cancer Achieved statistically significant segregation of responders in BM+ vs BM- subgroups based on OncoSignature patient selection (p-value = 0.009) ACR-368 endometrial cohort data maturing with all responders still on therapy; mDoR not yet reached (~6 months at time of data-cut) Endometrial cancer now anticipated to be the first tumor type with potential for ACR-368 accelerated regulatory approval IND clearance and initial sites activated ahead of timelines for ACR-2316 with first-in-human dosing anticipated in Q4 2024 AP3 Interactome generating proprietary, actionable insights, leveraging in-house data and delivering algorithm-based machine learning-enabled pathway and biomarker analysesAcrivon to host a webcast joined by endometrial cancer key opinion leader Dr. Ramez N. Eskander today, Saturday, September 14 at 9:00 a.m. ET WATERTOWN, Mass., Sept. 14, 2024 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, today presented additional positive clinical data at ESMO from the ongoing registrational intent, multicenter Phase 2 trial of ACR-368 in patients with locally advanced or metastatic, recurrent endometrial cancer. The company has also disclosed that the Investigational New Drug (IND) application for its next clinical candidate, ACR-2316, has been cleared by the FDA with initial clinical sites now activated, and first-in-human dosing for the Phase 1 study expected in the fourth quarter of 2024. “We are very excited to provide several significant, positive updates across our rapidly advancing clinical pipeline since our last R&D event in April,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “First, at ESMO earlier today, we presented an updated interim efficacy and safety data cut of our registrational intent ACR-368 Phase 2 study, which showed a confirmed ORR of 62.5% in endometrial canc...