Acrivon Therapeutics reports promising interim response rates for ACR-368 in Phase 2b trial

Watertown, Massachusetts-based Acrivon Therapeutics (NASDAQ:ACRV) provided an interim clinical update across its precision oncology pipeline, highlighted by promising response rates for its lead candidate ACR-368 in an ongoing Phase 2b trial.

In the ACR-368 study utilizing the company's proprietary EDC (estimated dose concentration) approach, interim data showed an overall objective response rate of 39%, rising to 44% in patients with two or fewer prior lines of therapy.

Notably, the confirmed objective response rate reached 67% in biomarker-positive serous endometrial cancer patients (N=12) and 52% across all serous subjects (N=23).

The company plans to expand Arm 3, evaluating ACR-368 in combination with ultra-low dose gemcitabine, to enroll up to 90 serous cancer patients without requiring biopsy.

Enrollment completion is targeted for the fourth quarter of 2026, with European sites expected to initiate in the first quarter of 2026.

Acrivon has submitted a Phase 3 protocol for ACR-368 combined with anti-PD-1 therapy and anticipates global trial readiness by mid-2026.

In the Phase 1 trial for ACR-2316, dose regimens have been established across 33 patients, with tumor shrinkage observed in nine of 20 evaluable subjects and a confirmed partial response in endometrial cancer.

The company also outlined plans to file an IND for ACR-6840, a CDK11 inhibitor, in the fourth quarter of 2026.

Acrivon ended 2025 with approximately $119 million in cash, cash equivalents, and investments as of December 31, providing financial runway into the second quarter of 2027.