Small-Cap Acrivon Showcases Tumor Reduction and Clinical Advancement in Major Trials, Shares Decline

Acrivon Therapeutics Shares Clinical Progress Updates

Acrivon Therapeutics Inc. (NASDAQ: ACRV) announced new developments on Thursday regarding its ACR-368 Phase 2 program and shared early results from the ACR-2316 Phase 1 trial.

Latest Findings from the ACR-368 Program

In the Phase 2b trial of ACR-368 targeting endometrial cancer, interim results from Arm 1 revealed an overall response rate (ORR) of 39%. Among participants who had undergone more than two previous treatments, the ORR increased to 44%.

Due to higher response rates observed in patients with serous endometrial cancer (also known as uterine serous carcinoma) across both Arm 1 and Arm 2, Arm 3 will now specifically enroll individuals with serous cancer who have received two or fewer prior therapies.

Further interim analysis showed that BM+ patients (N=12) with serous endometrial cancer achieved a confirmed ORR of 67%.

When evaluating both BM+ and BM- groups, the confirmed ORR was 52% (N=23) for those with serous cancer, compared to 22% (N=37) for non-serous endometrial cancer patients. All participants in this analysis had received up to two previous lines of therapy.

Initial patient recruitment in Europe is anticipated to begin in the first quarter of 2026, while enrollment at existing U.S. sites will proceed as planned.

ACR-2316 Phase 1 Study Highlights

The ongoing Phase 1 dose-escalation study for ACR-2316 has dosed 33 patients using two different weekly oral regimens.

Early clinical data established two weekly dosing schedules: 160 mg once daily for three days on and four days off, and 240 mg once daily for two days on and five days off. Both regimens demonstrated good tolerability.

A new cohort has been started to test a bi-weekly schedule of two days on and twelve days off, aiming to enhance single-agent activity and offer more flexibility for future combination treatments.

Clinical responses were seen at doses of 120 mg and higher, with tumor reduction observed in 9 out of 20 evaluable patients diagnosed with small cell lung cancer or squamous non-small cell lung cancer.

Pipeline and Financial Update

Acrivon has selected ACR-6840, an oral CDK11 inhibitor and potential first-in-class therapy, as its next AP3-enabled preclinical candidate. The company plans to submit an IND application in the fourth quarter of 2026.

As of December 31, 2025, Acrivon reported preliminary, unaudited cash, cash equivalents, and investments totaling approximately $119 million. This funding is expected to support operations and capital needs through the second quarter of 2027.

Stock Performance

ACRV Share Price: At the time of the announcement on Thursday, Acrivon Therapeutics' stock had declined by 28.81%, trading at $2.10, according to Benzinga Pro.

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