Acrivon Therapeutics (ACRV) investor relations material

AP3 platform overview and validation

• AP3 is an AI-driven, phosphoproteomics-based precision medicine platform enabling indication finding, patient responder identification, and rational drug design across all development stages.

• The platform generates high-resolution, proprietary data on over 100 compounds, supporting both internal and in-licensed assets and benchmarking against competitors.

• AP3 uniquely matches drug mechanisms to disease-driving pathways, quantifying nearly 200,000 phosphorylation sites for actionable insights.

• The approach overcomes limitations of genetics-based precision medicine, identifying responders where genomics failed.

• AP3's applications extend beyond oncology, with an I&I Target Explorer to identify new opportunities in immunology and inflammation.

Pipeline progress and clinical strategy

• Lead asset ACR-368 (CHK1/2 inhibitor) is in phase II-B registrational intent trial for serous endometrial cancer, with interim data expected in the second half of Q4.

• ACR-2316, a dual WEE1/PKMYT1 inhibitor, advanced from lead to human dosing in 15 months and is now in phase II for multiple tumor types, including lung cancer.

• CDK11 inhibitor is preclinical, with IND submission targeted for early next year, showing complete regression in aggressive AML models.

• The company aims to accelerate programs to phase II proof-of-concept, then pursue strategic business development for value creation.

• Capital allocation is focused on innovation and speed, leveraging the platform to expand the pipeline efficiently.

Clinical data and regulatory outlook

• In serous endometrial cancer, ACR-368 showed ~50% response rate in interim readout, with a target response rate of 30% considered sufficient for accelerated approval.

• The safety database includes over 500 patients treated at RP2D, with mainly transient, mechanism-based hematologic AEs and no irreversible toxicities.

• FDA alignment supports registrational intent, with the possibility to file based on strong interim data and a preference for monotherapy due to simplicity.

• Confirmatory trial options include frontline switch maintenance or second-line post-ADC/post-checkpoint inhibitor, with the latter seen as increasingly attractive.

• Commercial opportunity in serous endometrial cancer is significant, with 16,000–18,000 annual deaths in the US and Europe and high unmet need post-standard therapies.