Acrivon Therapeutics, Inc. develops drugs for clinical treatment. Its unique precision medicine platform is Acrivon Predictive Precision Proteomics (AP3). AP3 is used to generate proprietary OncoSignature companion diagnostics to identify patients who will benefit from the medicine. The company was founded by Peter Blume-Jensen and Kristina Masson in 2018 and is headquartered in Watertown, MA.
Clinical Trials
2
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2018
Recruiting
2
100.0%
No approval data available
- Acrivon Therapeutics' CHK1/2 inhibitor ACR-368 demonstrated a 44% overall response rate in biomarker-positive endometrial cancer patients, with 52% response in the serous subtype during phase II-B registration-intent trials. - The company's OncoSignature assay enables prospective responder prediction, identifying serous endometrial cancer as highly sensitive to ACR-368 and driving rapid enrollment in new trial arms. - Disease control rate in serous endometrial cancer approaches 75% with a clinical benefit rate of 65% at or above 16 weeks, significantly exceeding the 13% response rate of standard second-line care. - Interim analysis for trial arms three and four is planned for early Q4 to select the optimal arm for registrational advancement, with a confirmatory phase III trial designed as switch maintenance therapy.
- Acrivon Therapeutics has completed and received CLIA certification from Massachusetts for its wholly-owned laboratory in Watertown, expected to become fully operational in the first half of 2026. - The internal laboratory will enable the company to develop companion diagnostics and identify predictive biomarkers with minimal dependency on outside partners, supporting its precision medicine approach. - The facility will enhance development capabilities for Acrivon's pipeline, including ACR-368 in Phase 2 trials for endometrial cancer and ACR-2316 showing initial clinical activity in multiple solid tumor types. - The laboratory is expected to increase speed and cost-efficiency in precision medicine drug development while providing strategic advantages for business development and partnering opportunities.
- Dr. Mansoor Raza Mirza, a globally recognized gynecologic oncology expert with extensive experience in registrational trials, joins Acrivon Therapeutics as Chief Medical Officer effective April 9, 2025. - Dr. Mirza will lead clinical development of ACR-368, currently in Phase 2b registrational-intent trials for endometrial cancer, and ACR-2316, a WEE1/PKMYT1 inhibitor in Phase 1 studies for solid tumors. - Acrivon's proprietary AP3 platform enables precision oncology through proteomics-based drug discovery and companion diagnostics to identify patients most likely to benefit from specific treatments.
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- Acrivon Therapeutics will host a virtual R&D event on March 25, 2025, featuring presentations on their Generative Phosphoproteomics AP3 platform and updates on clinical programs ACR-368 and ACR-2316. - The event will include insights from leading gynecologic oncology experts and will highlight Acrivon's proprietary OncoSignature companion diagnostics, which has received FDA Breakthrough Device designations for ovarian and endometrial cancers. - Acrivon's lead candidate ACR-368 (prexasertib) is advancing in a potentially registrational Phase 2 trial with FDA Fast Track designation for platinum-resistant ovarian and endometrial cancers.
- Acrivon Therapeutics has received FDA Breakthrough Device designation for its ACR-368 OncoSignature assay, designed to identify endometrial cancer patients likely to respond to ACR-368 treatment. - The diagnostic platform, developed using Acrivon's AI-driven AP3 technology, demonstrated significant correlation between biomarker-positive patients and treatment response in recent ESMO 2024 clinical data. - The company continues to advance its clinical programs, including the Phase 2b trial of ACR-368 and Phase 1 study of ACR-2316, a WEE1/PKMYT1 inhibitor targeting cell cycle regulation.
- The FDA has awarded Breakthrough Device designation to Acrivon Therapeutics' ACR-368 OncoSignature assay, designed to identify endometrial cancer patients most likely to respond to ACR-368 treatment. - In a Phase II trial, the ACR-368 OncoSignature assay demonstrated impressive results, with OncoSignature-positive endometrial cancer patients showing a 62.5% confirmed overall response rate. - The multiplex immunofluorescence assay is expected to enhance treatment effectiveness for life-threatening conditions, marking a significant advancement in precision oncology.
- Acrivon Therapeutics has granted equity awards to employees under its 2023 Inducement Plan, consisting of options to purchase 61,950 shares of common stock. - The stock options vest over time, contingent upon continued employment, with 25% vesting after one year and the remainder in monthly installments. - These inducement grants were approved by Acrivon's Board of Directors, adhering to Nasdaq Rule 5635(c)(4) as a material incentive for employment. - Acrivon is advancing ACR-368 (prexasertib) in Phase 2 trials and developing ACR-2316, a WEE1/PKMYT1 inhibitor, utilizing its AP3 precision medicine platform.
- Acrivon Therapeutics has dosed the first patient in a Phase 1 clinical trial of ACR-2316, a novel WEE1/PKMYT1 inhibitor, for treating selected solid tumors. - ACR-2316 was developed using Acrivon's AP3 platform and is designed to induce complete tumor regression through potent activation of CDK1, CDK2, and PLK1. - The Phase 1 trial will assess the safety, tolerability, and optimal dosage of ACR-2316, with initial clinical data expected in the second half of 2025. - Acrivon's AP3 platform facilitated the rapid advancement of ACR-2316 into clinical trials, showcasing the company's efficient drug discovery process.
- Acrivon Therapeutics reported a 62.5% response rate in endometrial cancer patients treated with ACR-368, selected using the OncoSignature assay, with ongoing treatment and no median duration of response reached. - The FDA has cleared Acrivon's ACR-2316 for Phase 1 trials, with dosing scheduled to commence in Q4 2024, marking a significant milestone in the drug's development. - Acrivon Therapeutics maintains a strong financial position, with sufficient funding to sustain operations until the second half of 2026, supporting ongoing research and development efforts.
