Acrivon Therapeutics Unveils Promising Data for ACR368 in Endometrial Cancer

Acrivon Therapeutics (NASDAQ: ACRV) recently presented interim clinical results for its lead drug, ACR368, targeting endometrial cancer. During a conference call led by Chief Financial Officer and Head of Investor Relations, Adam Levy, the company discussed the progress of its clinical trials and plans to expand its pipeline. Notably, the results indicate significant response rates, particularly among patients with the serous subtype of endometrial cancer.

Peter Blume-Jensen, Chief Executive Officer and Co-founder, emphasized the central role of the AP3 platform in the company’s strategy. This predictive precision proteomics platform utilizes mass spectrometry and a novel computational method known as “generative phosphoproteomics.” The aim is to identify the effects of compounds on cellular signaling pathways, paving the way for predictive biomarkers that could enhance drug efficacy and inform clinical decisions.

In the phase 2 trial for ACR368, the study involved 48 sites across the United States, focusing on patients with relapsed endometrial cancer who had previously undergone platinum-based chemotherapy and immune checkpoint inhibitors. During the interim analysis, Mansour Mirza, Chief Medical Officer, revealed that 36 patients were enrolled in the biomarker-positive arm, while 16 were in the biomarker-negative arm. In the biomarker-positive group, Acrivon reported an overall response rate (ORR) of 39% and a disease control rate (DCR) exceeding 80%. Importantly, the serous subtype showed a confirmed ORR of 67%, indicating strong efficacy for this specific group.

Mirza highlighted that serous endometrial cancer accounts for approximately 40% of endometrial cancer-related deaths, with an estimated 20,000 fatalities annually in the U.S. and EU combined. The prevalence of serous endometrial cancer is estimated between 55,000 and 60,000 patients, underscoring the urgent need for effective treatment options.

In response to the observed efficacy in serous disease, Acrivon has initiated a new Arm 3 in the trial. This arm will evaluate ACR368 in biomarker-unselected serous endometrial cancer patients who have undergone up to two prior lines of therapy. The trial is expanding from 48 U.S. sites to include more than 20 additional sites across France, Germany, Italy, and Spain. Mirza characterized Arm 3 as a potential “fastest path” to regulatory approval, as it does not require upfront biopsy or biomarker assessments.

Further strengthening its position, Acrivon submitted a phase 3 trial protocol to the FDA on November 12, 2025. This double-blind, placebo-controlled study aims to investigate the addition of ACR368 to anti-PD-1 therapy in patients with advanced or recurrent pMMR endometrial cancer. The goal is to enhance progression-free and overall survival rates, with preclinical data suggesting a synergistic effect with immunotherapy.

In addition to ACR368, Acrivon shared preliminary observations from its phase 1 trial of ACR2316, an oral dual WEE1/PKMYT1 inhibitor. In this ongoing study, 33 patients have been dosed with promising tolerability and signs of tumor shrinkage observed in nine out of twenty evaluable patients treated with higher doses. The company also introduced a new preclinical candidate, ACR6840, which targets CDK11, highlighting its selectivity and preclinical anti-tumor activity.

Levy concluded the call with financial insights, noting that Acrivon ended the quarter on December 31, 2025, with approximately $119 million in cash and investments. This financial position is expected to sustain operations into the second quarter of 2027.

Acrivon Therapeutics continues to make strides in the development of targeted therapies for RAS-driven cancers, marking significant advancements in the landscape of endometrial cancer treatment.