Acrivon Therapeutics (ACRV) TD Cowen 46th Annual Health Care Conference summary

Platform Overview and Strategy

• Utilizes a proteomics-based precision medicine platform powered by generative AI for drug discovery and clinical asset advancement.

• Focuses on pathway-based drug design to optimize effects and inhibit survival pathways in cancer cells.

• Recently advanced a dual WEE1/PKMYT1 inhibitor into clinical trials, aiming for superior single-agent activity.

Lead Program (ACR-368) and Clinical Data

• Lead asset ACR-368, a dual CHK1/2 inhibitor, shows strong clinical activity in serous endometrial cancer, a subtype with high mortality and limited treatment options.

• Registrational intent phase II trial shows a 44% confirmed response rate in biomarker-positive patients and about 50% in serous subgroups, with a favorable safety profile.

• Disease control rate reached 74% and clinical benefit rate at 16 weeks was 65% in serous patients with ≤2 prior therapies.

• Safety profile is notable for absence of severe adverse events common to other therapies, with only transient hematological effects and no fatal treatment-related events.

• Notable absence of gastrointestinal, interstitial lung disease, stomatitis, ocular toxicity, and peripheral neuropathy.

Clinical Development and Regulatory Strategy

• Three trial arms: Arm 1 (biomarker-driven, US only), Arm 2 (exploratory, completed), Arm 3 (serous lineage biomarker, global expansion, no pretreatment biopsy).

• Rapid US and EU enrollment in the serous endometrial cancer cohort supports registrational intent for ACR-368, with expansion to over 20 EU sites and inclusion of biopsy-independent, all-comer serous cohorts.

• Enrollment completion for Arm 3 targeted by early Q4, and overall study completion targeted for Q4 2026.

• Both Arm 1 and Arm 3 are registrational intent, targeting accelerated approval with response rates significantly above standard of care.

• Phase III confirmatory trial protocol submitted, focusing on combination with immunotherapy and potential label expansion.