Acrivon Therapeutics (ACRV) investor relations material

Program highlights and clinical updates

• Lead asset ACR-368, a CHK1/2 inhibitor, is in phase II-B registration-intent trials for endometrial cancer, showing a 44% overall response rate in biomarker-positive patients and 52% in the serous subtype with up to two prior lines of therapy.

• The OncoSignature assay enables prospective responder prediction, identifying serous endometrial cancer as highly sensitive to ACR-368, leading to rapid enrollment in new trial arms.

• Disease control rate in serous endometrial cancer approaches 75%, with a clinical benefit rate of 65% at or above 16 weeks, far exceeding standard of care.

• Interim analysis for arms three and four is planned for early Q4, with independent analysis to select the optimal arm for registrational advancement.

• Confirmatory phase III trial is designed as switch maintenance, combining ACR-368 with immune checkpoint inhibitors, targeting serous and pMMR all-comers.

Pipeline and platform advancements

• ACR-2316, a dual WEE1/PKMYT1 inhibitor, is entering expansion phase after demonstrating single-agent activity and favorable safety, especially in lung cancer.

• The AP3 platform predicted and confirmed lung cancer sensitivity to ACR-2316, with durable responses and minimal adverse events, mainly transient neutropenia.

• CDK11 inhibitor program (ACR-6840) shows complete regression in aggressive AML models, with IND planned for first half of 2027.

• Both ACR-368 and ACR-2316 exhibit strong synergy with immune checkpoint and topoisomerase inhibitors, supporting future combination strategies.

Market opportunity and strategic direction

• Serous endometrial cancer, though only 8-10% of new cases, accounts for up to 50% of endometrial cancer mortality, with a significant unmet need and addressable market.

• Standard of care in second-line serous endometrial cancer yields only a 13% response rate and 10 months overall survival, highlighting the impact of ACR-368's results.

• Rapid enrollment in serous cohorts is driven by high KOL enthusiasm and the urgent need for effective therapies.

• Interim analysis will guide selection of the registrational arm and may trigger initiation of phase III and potential partnership discussions by year-end.

• Expansion of trials into Europe accelerates enrollment and broadens patient access.