Acrivon Therapeutics Inc. (NASDAQ:ACRV) on Thursday shared updates regarding the Phase 2 ACR-368 program and initial clinical data from the ACR-2316 Phase 1 study.
ACR-368 Data
In Arm 1 of the ACR-368 Phase 2b registrational-intent trial in endometrial cancer, an updated interim analysis showed an overall response rate (ORR) of 39%. In subjects with over two prior lines of therapy, the ORR was 44%.
Based on data that showed higher response rates in subjects with serous endometrial cancer (also called uterine serous carcinoma) across Arm 1 and Arm 2, Arm 3 will now focus exclusively on subjects with serous cancer and ≤2 prior treatments.
Updated interim analysis of data showed a confirmed ORR of 67% in BM+ subjects (N=12) with serous endometrial cancer.
Interim analysis across both BM+ and BM- subjects showed a confirmed ORR of 52% (N=23) in serous subjects versus 22% (N=37) in non-serous endometrial cancer subjects. All subjects in this analysis received up to two prior therapies.
Initial patient enrollment in Europe is expected in the first quarter of 2026, with enrollment at previously activated U.S. sites continuing.
ACR-2316 Data
Thirty-three (33) patients were dosed across two weekly oral dosing schedules in the ongoing Phase 1 monotherapy dose-escalation study.
Initial clinical data from the study established two weekly oral dosing regimens of 160 mg QD on a 3d on / 4d off and 240 mg QD 2d on / 5d off weekly administration schedules, with a favorable tolerability profile.
A cohort aiming to establish a bi-weekly 2d on / 12d off dosing regimen has been initiated, based on projected enhanced single-agent activity, and to provide for further dosing flexibility in potential future combination studies.
Clinical activity was observed at dose level 120 mg and above, with tumor shrinkage in 9 out of 20 evaluable patients in subjects with small cell lung cancer and squamous non-small cell lung cancer.
Acrivon nominated the next AP3-enabled preclinical development candidate, ACR-6840, a potential first-in-class, oral CDK11 inhibitor. IND submission anticipated in the fourth quarter of 2026.
As of December 31, 2025, the company had preliminary, unaudited cash, cash equivalents, and investments of approximately $119 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027.
ACRV Price Action: Acrivon Therapeutics shares were down 28.81% at $2.10 at the time of publication on Thursday, according to Benzinga Pro data.
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