Acrivon Therapeutics Submits Phase 3 Confirmatory Protocol for ACR-368
Acrivon Therapeutics announced significant progress across its pipeline, including updates regarding the Phase 2 ACR-368 program, initial clinical data from the ACR-2316 Phase 1 study, and the nomination of Acrivon's next AP3-enabled preclinical development candidate, ACR-6840, a potential first-in-class, oral CDK11 inhibitor. Highlights; Electronic data capture extract from the ongoing ACR-368 registrational-intent Phase 2b monotherapy trial in OncoSignature-positive subjects with endometrial cancer showed 39% overall response rate and 44% in subjects with less than or equal to2 prior lines of therapy; Analysis of data from all-comer subjects with serous subtype and less than or equal to2 prior lines of therapy, a high unmet need population, showed a confirmed ORR of 52%, and within BM+ subjects cORR was 67%; Arm 3 is enrolling up to 90 subjects with serous subtype and less than or equal to2 prior lines of therapy, without requirement for a tumor biopsy, for treatment with ACR-368 plus ultra-low dose gemcitabine as a tumor sensitizer and enrollment completion expected in fourth quarter 2026; Based on preclinical AP3 data showing strong synergy between ACR-368 and anti-PD-L1, company has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 plus anti-PD-1 therapy in frontline EC subjects; Initial data from Phase 1 dose escalation for ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, showed favorable tolerability; Tumor shrinkage was observed at greater than or equal to120 mg dose level in 9/20 subjects, including a confirmed PR in EC, and unconfirmed PRs in SCLC and sqNSCLC, two tumor types predicted sensitive by AP3; ACR-6840, a potential first-in-class AP3-derived oral CDK11 inhibitor, nominated as next preclinical development candidate, with IND submission planned for fourth quarter 2026
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Oncolytics Biotech Strengthens Leadership to Advance Clinical Programs
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