Acrivon’s ACR-368 Shows 52% Response Rate, Expands Trials with Two New Cohorts
Acrivon’s Phase 2b ACR-368 trial in serous endometrial cancer achieved a 52% confirmed overall response rate (n=23) versus 22% in non-serous subjects and is adding two all-comer cohorts (Arm 3 with ultra low-dose gemcitabine, Arm 4 monotherapy) in H1 2026. The company held $118.6M cash, funding operations into Q2 2027.
1. Phase 2b ACR-368 Study Results
An interim analysis of the registrational-intent Phase 2b ACR-368 trial in serous endometrial cancer reported a 52% confirmed overall response rate (n=23) among subjects with up to two prior lines of therapy, compared to 22% in non-serous EC (n=37). All participants received ACR-368, a CHK1/CHK2 inhibitor, to assess efficacy in this high-mortality subtype.
2. Trial Expansion Plans
Building on these data, Acrivon initiated Arm 3 in late 2025 to evaluate ACR-368 plus ultra low-dose gemcitabine in all-comer serous EC patients without biomarker stratification, with U.S. sites enrolling and 20 EU sites activating by end-Q1 2026. The company also announced Arm 4 will launch in H1 2026 to test ACR-368 monotherapy under identical inclusion criteria.
3. ACR-2316 Early Clinical Activity
Initial Phase 1 monotherapy data for ACR-2316, a WEE1/PKMYT1 inhibitor, demonstrated favorable tolerability and tumor shrinkage in heavily pre-treated small cell and squamous non-small cell lung cancer subjects, highlighting potential in AP3-predicted solid tumors not previously sensitive to this class of inhibitors.
4. Financial Position and Runway
As of December 31, 2025, Acrivon held $118.6 million in cash, cash equivalents and marketable securities, expected to fund operations into Q2 2027. The company reported a Q4 net loss of $19.0 million and a full-year loss of $77.9 million, reflecting continued investment in pipeline development.