Acrivon Therapeutics Announces Positive ACR-368 Phase 2b Endometrial Cancer Clinical Data with EU Expansion to Accelerate Enrollment, Initial ACR-2316 Clinical Data, and ACR-6840, its Next AP3-Enabled Development Candidate, Targeting CDK11

Core Insights - Acrivon Therapeutics has reported significant progress in its clinical pipeline, particularly with ACR-368 for endometrial cancer, showing a 39% overall response rate (ORR) in monotherapy and 44% in subjects with ≤2 prior lines of therapy [1][5] - The company is advancing ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, with initial Phase 1 data indicating favorable tolerability and tumor shrinkage in various cancer types [1][2] - Acrivon has nominated ACR-6840, a potential first-in-class CDK11 inhibitor, for preclinical development, with an IND submission planned for Q4 2026 [1][3] ACR-368 Program - The ongoing Phase 2b trial of ACR-368 has shown a confirmed overall response rate (cORR) of 52% in serous endometrial cancer subjects with ≤2 prior lines of therapy, and 67% in biomarker-positive (BM+) subjects [1][5] - Arm 3 of the trial will enroll up to 90 subjects with serous subtype and ≤2 prior lines of therapy, without requiring a tumor biopsy, with enrollment completion expected in Q4 2026 [1][5] - A Phase 3 confirmatory protocol for ACR-368 in combination with anti-PD-1 therapy has been submitted to the FDA, with global trial readiness anticipated by mid-2026 [1][2] ACR-2316 Development - Initial data from the Phase 1 dose escalation study of ACR-2316 (N=33) demonstrated favorable tolerability and tumor shrinkage at doses ≥120 mg, including confirmed partial responses in endometrial cancer and unconfirmed responses in small cell lung cancer (SCLC) [1][2][5] - The study has established two weekly oral dosing regimens, with a bi-weekly regimen initiated to enhance dosing flexibility [1][5] ACR-6840 Nomination - ACR-6840 has been nominated as the next preclinical development candidate, targeting CDK11, with an IND submission expected in Q4 2026 [1][3][12] - The development of ACR-6840 is based on its potential to achieve optimal on-target pathway effects, leveraging the company's proprietary AP3 platform [1][12] Financial Position - As of December 31, 2025, Acrivon reported preliminary cash, cash equivalents, and investments of approximately $119 million, expected to fund operations into Q2 2027 [8][9]