Filing Analysis
Acrivon Therapeutics reported its Q4 and full-year 2025 financial results and provided a clinical update on its ACR-368 Phase 2b study. The company is initiating a new registrational-intent arm for endometrial cancer and has successfully completed an exploratory arm involving gemcitabine sensitization.
Key Facts
- Announced financial results for the fourth quarter and full year ended December 31, 2025.
- Initiated Arm 4 of the registrational-intent ACR-368 Phase 2b study for serous type endometrial cancer subjects with ≤2 prior lines of therapy.
- Completed exploratory Arm 2 of the study, which treated biomarker-negative (BM-) subjects with ACR-368 and ultra-low dose gemcitabine (ULDG) sensitization.
- Reported that Arm 2 objectives were achieved, supporting ULDG's role in ACR-368 efficacy for BM- subjects with a favorable tolerability profile.
Acrivon Therapeutics terminated its companion diagnostic agreement with Akoya Biosciences to bring ACR-368 OncoSignature testing in-house. The transition follows the completion of Acrivon's own CLIA-certified laboratory, granting the company full control over its diagnostic development and commercialization rights.
Key Facts
- On February 25, 2026, the company terminated the OncoSignature Companion Diagnostic Agreement with Akoya Biosciences (a Quanterix subsidiary).
- The termination involves no financial payments or penalties from either party.
- Acrivon has established its own internally-owned and operated CLIA-certified laboratory in Watertown, Massachusetts.
- Quanterix will continue to provide testing support during a transition period for the ongoing registrational-intent Phase 2b study.
- Acrivon retains full development and commercialization rights to the proprietary ACR-368 OncoSignature test.
Acrivon Therapeutics hosted a Key Opinion Leader (KOL) panel at the ESGO Congress to discuss interim Phase 2b clinical data for ACR-368. The presentation focused on the drug's registrational-intent trial and its potential to treat endometrial cancer, specifically the serous sub-type.
Key Facts
- The KOL panel took place on February 27, 2026, at the European Society of Gynecological Oncology (ESGO) Congress in Copenhagen.
- Discussion included interim clinical data from the ACR-368 Phase 2b registrational-intent trial.
- The company is targeting unmet patient needs in endometrial cancer, particularly the serous sub-type.
- Presentation slides were filed as Exhibit 99.1.