Acrivon Therapeutics Advances Cancer Treatment Pipeline with Promising Clinical Data

Overview of Recent Developments

On January 8, 2026, Acrivon Therapeutics, Inc. (Nasdaq: ACRV) announced significant advancements in its clinical pipeline, including the ACR-368 Phase 2b trial for endometrial cancer, initial data from the ACR-2316 Phase 1 study, and the nomination of ACR-6840 as the next development candidate. These milestones reflect Acrivon's commitment to precision medicine through its proprietary AP3 platform, aimed at enhancing drug design and clinical outcomes.

Promising Data from ACR-368 Phase 2b Trial

The ongoing ACR-368 registrational-intent Phase 2b trial showcases promising results. An analysis of electronic data capture (EDC) reveals an overall response rate (ORR) of 39% among OncoSignature-positive (BM+) subjects. Notably, subjects with ≤2 prior lines of therapy exhibited an ORR of 44%. In a high unmet need population of serous endometrial cancer patients, data indicates a confirmed ORR (cORR) of 52%, with BM+ subjects showing a remarkable cORR of 67%.

Arm 3 of the trial, which will enroll up to 90 subjects with serous subtype and ≤2 prior lines of therapy, allows for accelerated enrollment without the need for a tumor biopsy. This iteration includes treatment with ACR-368 and ultra-low dose gemcitabine (ULDG) as a tumor sensitizer, with completion expected by the fourth quarter of 2026.

Phase 3 Trial Plans and Synergy with Anti-PD-1 Therapy

Given the strong preclinical evidence of synergy between ACR-368 and anti-PD-L1 therapy, Acrivon has submitted a Phase 3 confirmatory protocol to the FDA for combining ACR-368 with anti-PD-1 therapy in frontline endometrial cancer patients. Global trial readiness is anticipated by mid-2026, marking a significant step towards addressing the challenges faced by this patient population.

Initial Data on ACR-2316 and Future Development Candidate ACR-6840

Initial findings from the Phase 1 dose escalation study of ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, revealed a favorable tolerability profile among 33 participants. Two dosing regimens established include 160 mg QD (3 days on/4 days off) and 240 mg QD (2 days on/5 days off). Positive results demonstrated tumor shrinkage in 9 out of 20 subjects at ≥120 mg dose level, with confirmed partial responses (PRs) in endometrial cancer and unconfirmed PRs observed in small-cell lung cancer (SCLC) and squamous non-small cell lung cancer (sqNSCLC).

Additionally, Acrivon has nominated ACR-6840, a potential first-in-class oral CDK11 inhibitor, as its next development candidate, with an IND submission planned for the fourth quarter of 2026.

Expert Insights

Peter Blume-Jensen, M.D., Ph.D., CEO and co-founder of Acrivon, expressed optimism regarding the company’s progress, stating, “We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over 50% confirmed response rate.” He emphasized the opportunity for rapid enrollment across more than 20 major EU sites and in the US.

Mansoor Raza Mirza, M.D., Chief Medical Officer, added, “About a third of all second- and third-line endometrial cancer cases are of serous subtype and represent a challenging patient population.” The incorporation of feedback from the FDA reinforces Acrivon’s strategy to optimize its clinical programs for better outcomes.