
Acrivon Therapeutics Announces Positive Phase 2b ACRâ368 Endometrial Cancer Results, Expands EU Enrollment, Shares Initial ACRâ2316 Data and Unveils ACRâ6840 Development Candidate
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Acrivon Therapeutics, Inc. (Nasdaq: ACRV), a clinicalâstage biotechnology firm, announced positive interim data from its Phase 2b registrationalâintent trial of ACRâ368 for endometrial cancer. The electronic data capture extract showed a 39% overall response rate (ORR) in OncoSignatureâpositive subjects and 44% ORR in those with âĪ2 prior therapies. In the highâneed serous subtype group, the confirmed ORR was 52% overall and 67% among biomarkerâpositive patients. Based on these results, Acrivon has submitted a European Clinical Trial Application for Arm 3 of the study, which combines ACRâ368 with ultraâlow dose gemcitabine (ULDG) and plans to enroll up to 90 serous patients without requiring tumor biopsy. EU enrollment is expected to begin in Q1 2026 with full enrollment targeted by Q4 2026.
In addition, the company reported initial clinical activity from the Phase 1 trial of ACRâ2316, a potential firstâinâclass WEE1/PKMYT1 inhibitor, in 33 patients. Two weekly oral regimens were established, and tumor shrinkage was observed in 9 of 20 evaluable subjects, including a confirmed partial response in endometrial cancer and unconfirmed responses in small cell lung cancer and squamous NSCLC.
Acrivon also nominated ACRâ6840, an AP3âderived oral CDK11 inhibitor, as its next development candidate, with an IND submission planned for Q4Â 2026. Furthermore, the company has submitted a Phase 3 confirmatory protocol to the FDA evaluating ACRâ368 with an antiâPDâ1 therapy in frontline endometrial cancer, expecting global trial readiness by midâ2026. Acrivon reported about $119 million in cash, cash equivalents and investments as of December 31, 2025, supporting operations into Q2Â 2027.
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