Acrivon Therapeutics reports Q1 FY25 results, positive data for ACR-368 in endometrial cancer.

• Acrivon Therapeutics reports Q1 2025 financial results and business highlights • ACR-368 data in endometrial cancer patients shows cORR of 35%, mDOR >5.6 months • ACR-368 data in BM+ patients shows cORR of 50%, mDOR >10 months • ACR-2316 Phase 1 trial completes three dose escalation cohorts • Tumor shrinkage observed at DL3, below recommended Phase 2 dose • AACR presentation reveals mechanisms underlying ACR-2316's preclinical activity • ACR-2316 uses AP3 Generative for potent mitotic tumor cell death.

Acrivon Therapeutics (NASDAQ: ACRV) has reported its Q1 2025 financial results and business highlights, showcasing significant progress in its clinical pipeline and financial position. The company reported a net loss of $19.7 million for the quarter, compared to $16.5 million in Q1 2024, primarily driven by increased research and development expenses of $15.4 million, up from $11.5 million year-over-year. General and administrative expenses remained consistent at $6.2 million. As of March 31, 2025, Acrivon had $164.8 million in cash and equivalents, providing sufficient funding for operations into Q2 2027 [1].

The company's lead asset, ACR-368, demonstrated compelling clinical data in endometrial cancer patients. The confirmed overall response rate (cORR) in OncoSignature-positive (BM+) patients who had received prior anti-PD-1 and platinum-based chemotherapy was 35%, with a median duration of response (mDOR) exceeding 5.6 months. Remarkably, BM+ patients who had relapsed on last prior therapy showed a 50% response rate with a duration of response exceeding 10 months. These results address a significant unmet need in second-line treatment options for endometrial cancer [1].

Acrivon's second clinical asset, ACR-2316, also exhibited promising activity. In a Phase 1 trial, three dose escalation cohorts were completed, and tumor shrinkage of approximately 25% was observed at dose level 3, well below the projected recommended Phase 2 dose. This suggests potential for greater efficacy at higher doses. The safety profile appeared clean, with no dose-limiting toxicities through the first three cohorts. The company's recent presentation at the American Association for Cancer Research (AACR) revealed mechanisms underlying ACR-2316's preclinical activity, showing potent mitotic tumor cell death using its AP3 Generative Phosphoproteomics platform [1].

The appointment of Dr. Mansoor Raza Mirza as CMO further strengthens Acrivon's clinical development capabilities. Dr. Mirza's experience in leading registrational trials in gynecological cancers will be invaluable as ACR-368 advances towards potential registration. The company's focus on biomarker-selected patient populations through its AP3 platform demonstrates a precision medicine approach, historically yielding higher success rates in oncology drug development [1].

Acrivon's financial position remains solid, with $164.8 million in cash providing runway into Q2 2027. The company's burn rate appears well-managed given its cash runway projection. The clinical data for ACR-368 represents a potential significant advancement in endometrial cancer treatment, addressing a clear unmet need. The 35% response rate in biomarker-positive patients who had all progressed after standard treatments, and the 50% response rate with a duration of response exceeding 10 months in relapsed patients, are particularly noteworthy. For context, current second-line treatment options in this population typically show response rates below 15% [1].

The preliminary activity of ACR-2316 at dose level 3 signals promising efficacy potential. Early signs of tumor shrinkage at this stage suggest significant upside as dosing escalates. The confirmation of target engagement through their AP3 platform validates their technological approach. The appointment of Dr. Mirza as CMO adds considerable credibility to their clinical strategy. His experience with successful registrational trials in gynecological cancers aligns perfectly with Acrivon's lead program [1].

References:
[1] https://www.stocktitan.net/news/ACRV/acrivon-therapeutics-reports-first-quarter-2025-financial-results-8t75jbcm28b9.html