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 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 analyses
• Acrivon 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 cancer patients. Notably, endometrial cancer is a tumor type that we predicted to be sensitive to single agent ACR-368 with our AP3 indication finding screening approach which we have now confirmed in the clinic. The maturing data is particularly encouraging as the lower bound of the 95% confidence interval is now 30%, above our targeted goal for this metric. Moreover, while median duration of response has not yet been reached, it is now approximately 6 months with all responding patients on therapy at time of data cut-off. Given the strength of the data we believe endometrial cancer might provide the first potential approval opportunity for ACR-368. We are actively evaluating potential confirmatory trial designs, including front line, for a potential future label expansion. We are also excited to disclose that the FDA has cleared the IND for our second clinical program, ACR-2316, well ahead of original timeline projections. Clinical trial sites have been activated and are now actively screening patients for enrollment into a Phase 1 study. Today’s update further strengthens the validation of our prospective OncoSignature patient selection method and of our differentiated AP3 platform delivering actionable data across discovery and development.”