Acrivon Therapeutics (ACRV) Study Update summary

AP3 Platform and Pipeline Overview

• The AP3 generative phosphoproteomics platform enables precise matching of drug mechanisms to disease-driving pathways, supporting indication finding, biomarker discovery, and drug design.

• The pipeline includes phase II-B CHK1/2 inhibitor (ACR-368), phase I dual WEE1/PKMYT1 inhibitor (ACR-2316), and preclinical CDK11 inhibitor (ACR-6840).

• AP3-driven OncoSignature test predicts tumor sensitivity, with endometrial cancer identified as a particularly sensitive type.

• AP3-driven programs are expanding into auto-immune/inflammatory indications and additional oncology targets.

ACR-368 Phase II-B Clinical Data and Program Updates

• Serous endometrial cancer shows high OncoSignature biomarker positivity and strong sensitivity to ACR-368, with a confirmed ORR of 67% in biomarker-positive and 52% in all-comer serous subjects with ≤2 prior therapies.

• Arm 3 of the trial, enrolling up to 90 all-comer serous subjects in the US and EU, is expected to complete enrollment in Q4 2026, with an initial data update in mid-2026.

• Subjects in Arm 3 will receive ACR-368 with ULDG sensitization, which may further increase response rates.

• Disease control and clinical benefit rates in biomarker-positive population were 92% and 83%, respectively.

• Serous endometrial cancer accounts for 40% of endometrial cancer deaths, with limited benefit from current therapies and a prevalence pool of 55,000-60,000 patients in the US/EU.

Phase III and Regulatory Pathway

• Phase III double-blind, placebo-controlled switch maintenance trial planned in advanced/recurrent pMMR endometrial cancer, with protocol submitted to FDA.

• The trial aims to improve PFS and OS by adding ACR-368 to anti-PD-1 in maintenance; global trial readiness anticipated mid-2026.

• Arm one (biomarker-positive) remains registrational intent; arm three (all-comer serous) could become pivotal if results hold.