Electronic data capture (EDC) extract from the ongoing ACR-368 registrational-intent Phase 2b monotherapy trial in OncoSignature-positive (BM+) subjects with endometrial cancer (EC) showed 39% overall response rate (ORR) and 44% in subjects with ≤2 prior lines of therapy* Analysis of data from all-comer subjects with serous subtype and ≤2 prior lines of therapy, a high unmet need population, showed a confirmed ORR (cORR) of 52%, and within BM+ subjects cORR was 67%, consistent with higher BM levels across serous subjects Arm 3 is enrolling up to 90 subjects with serous subtype and ≤2 prior lines of therapy, without requirement for a tumor biopsy, for treatment with ACR-368 plus ultra-low dose gemcitabine (ULDG) 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; global trial readiness expected mid-2026 Initial data from Phase 1 dose escalation (N=33) for ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, showed favorable tolerability; two weekly oral dosing regimens (160 mg QD, 3d on/4d off and 240 mg QD, 2d on/5d off) established with a bi-weekly regimen initiated Tumor shrinkage was observed at ≥120 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, not previously shown sensitive to WEE1 inhibitors in development 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 Company to hold video conference call and webcast today at 8:30 a.m. ET WATERTOWN, Mass.
