Acrivon Therapeutics, Inc. announced that the company plans to present initial positive clinical data from the ongoing registrational-intent Phase 2 ACR-368 clinical trials, which showed prospective validation of the proprietary ACR-368 OncoSignature patient selection biomarker test with a 50% confirmed objective response rate (ORR) in patients with ovarian and endometrial cancers. Acrivon is also sharing new preclinical data for ACR-2316, now with accelerated IND filing timelines, as well as actionable findings with the machine learning-enabled AP3 platform. Company Provides Program and Data Highlights: An overview of the broad, actionable scientific capabilities and clinically demonstrated deliverables of the AP3 platform.

Initial ACR-368 clinical data in patients with ovarian or endometrial cancers (n=26; 10 OncoSignature-positive and 16 OncoSignature-negative) in the ongoing registrational-intent Phase 2b trial are being presented (data cut as of April 1, 2024). A confirmed ORR (per RECIST 1.1) of 50% was observed in the prospective cohort of OncoSignature-positive patients who were efficacy-evaluable. All confirmed responders continue to be on treatment, median duration of response (DoR) has not yet been reached.

Notably, endometrial cancer is a new tumor type with significant unmet medical need that was identified and predicted to be sensitive to ACR-368 by AP3 indication screening. Initial, prospective validation of the AP3-based ACR-368 OncoSignature assay demonstrating its ability to identify ovarian and endometrial patients sensitive to ACR-368 monotherapy in the ongoing clinical trial, with clear segregation of RECIST responders in the OncoSignature-positive (50% confirmed ORR in 10 patients) versus OncoSignature-negative (0% ORR in 16 patients) arms (p-value=0.0038). In the OncoSignature-negative arm with ovarian or endometrial cancers, encouraging signs of clinical activity were observed in response to ACR-368 with ultra-low dose gemcitabine at the recommended Phase 2 combination dose, with 8 out of 16 patients achieving stable disease.

Consistent with past trials, the ACR-368 treatment-related adverse event profile was predominantly reversible and transient with only mechanism-based, hematological adverse events. ACR-2316, a potential first-in-class, potent WEE1/PKMYT1 inhibitor continues to advance rapidly with IND filing now expected in third quarter 2024 (vs. previous guidance of fourth quarter 2024) and the initiation of a clinical trial is anticipated in fourth quarter 2024.

ACR-2316 is uniquely designed by AP3 for superior single-agent activity and to overcome limitations of current WEE1 inhibitors and PKMYT1 inhibitors. A preview of the AP3 Interactome, which is a proprietary, machine-learning-enabled interactive platform used to uncover actionable drug-induced pathway effects across all studies.