Acrivon Therapeutics (ACRV) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Platform and technology overview

• AP3 platform enables precision medicine by matching drug mechanisms to disease-driving pathways in tissues, independent of genetic alterations.

• Utilizes high-resolution mass spectrometry-based phosphoproteomics and a multiplex protein biomarker platform, validated prospectively.

• OncoSignature tests predict patient sensitivity to drugs and guide indication selection, aiming for accelerated oncology pathways.

Lead program (ACR368) and clinical data

• ACR368 (prexasertib) is a CHEK1/CHEK2 inhibitor with demonstrated single-agent activity, in-licensed from Eli Lilly.

• OncoSignature identified sensitive tumor types, focusing on endometrial cancer for potential accelerated approval.

• Phase 2 trials use OncoSignature for patient selection, with FDA-cleared protocols and registration intent.

• In endometrial cancer, confirmed overall response rate in biomarker-positive patients is 63%, with a lower confidence interval bound of 30.4%.

• Safety profile is favorable, with only reversible hematological adverse events and no significant non-hematological issues.

Competitive landscape and regulatory strategy

• New frontline therapies in endometrial cancer have shifted the standard of care, creating a gap in second-line treatment.

• Current second-line response rates are about 15%, highlighting unmet need; ACR368 shows a significant efficacy delta.

• FDA endpoints for accelerated approval are duration and overall response rate; target profile is 20-25% response and 5.5 months duration.

• Company holds two Fast Track designations and a breakthrough device designation, with ambitions for breakthrough therapy designation.

• Large safety database supports regulatory discussions, aiming for smaller patient numbers based on statistical strength.