Acrivon Therapeutics will announce clinical data for ACR-368 and ACR-2316 on January 8, 2026.
Quiver AI Summary
Acrivon Therapeutics, a clinical-stage biotechnology company, announced it will release clinical data and updates for its products ACR-368 and ACR-2316 on January 8, 2026. The press release will detail interim clinical data from a Phase 2b trial of ACR-368 and an update on a new tumor biopsy-independent Phase 2b arm, as well as initial Phase 1 data for ACR-2316, a WEE1/PKMYT1 inhibitor. Acrivon leverages its proprietary Generative Phosphoproteomics AP3 platform for drug development, allowing for detailed analysis of drug effects within cells. The company is also advancing its drug candidate pipeline, including an undisclosed preclinical program targeting cell cycle regulation. The event will be accessible via a live webcast on their investor website.
Potential Positives
- Acrivon will provide updated interim clinical data from the ongoing registrational-intent Phase 2b study of ACR-368, which may bolster investor confidence and interest in the company's programs.
- The company has received Fast Track designation from the FDA for ACR-368, indicating a potential expedited development pathway and increased visibility for the treatment in endometrial cancer.
- ACR-2316, another clinical asset under development, has shown promising early clinical activity with tumor shrinkage observed, highlighting the potential of Acrivon's pipeline.
- The nomination of a new preclinical development candidate for its AP3-driven cell cycle program suggests ongoing innovation and expansion of Acrivon's research portfolio.
Potential Negatives
- Updates on clinical data may reveal underwhelming results, leading to concerns about the efficacy and safety of ACR-368 and ACR-2316, which could impact investor confidence.
- The reliance on forward-looking statements implies uncertainty about the clinical development of their drugs, potentially causing skepticism among stakeholders regarding the company’s future prospects.
- The announcement of a new preclinical development candidate without specific details may raise questions about the pipeline's robustness and the company's strategic direction.
FAQ
What is the date and time of the Acrivon press release?
The press release is scheduled for January 8, 2026, at 7:30 a.m. ET.
What clinical data will Acrivon provide during the conference call?
Acrivon will present updated interim ACR-368 clinical data and initial ACR-2316 safety and activity data.
How can I access the Acrivon conference call and webcast?
The conference call and webcast will be available through the Events & Presentations page on Acrivon's investor website.
What is the significance of the ACR-368 trial?
ACR-368 is in a potentially registrational Phase 2b trial for endometrial cancer and has FDA Fast Track designation.
What makes Acrivon's AP3 platform unique?
The AP3 platform provides unbiased insights into drug-regulated effects at the cellular level, enhancing rational drug design.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
WATERTOWN, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify global compound-specific, drug-regulated effects in the intact cell which is deployed for rational drug design and predictive clinical development, today announced it will be providing ACR-368 and ACR-2316 clinical data and other updates via a press release at 7:30 a.m. ET, and conference call and webcast at 8:30 a.m. ET, both on Thursday, January 8, 2026.
Topics will include:
- Updated interim ACR-368 clinical data from the ongoing registrational-intent Phase 2b study as well as an update on the additional recently initiated tumor biopsy-independent Phase 2b arm, and the planned confirmatory Phase 3 trial
- Initial clinical data from the ongoing Phase 1 study of ACR-2316, a potential first- and best-in-class WEE1/PKMYT1 inhibitor, including safety data, dosing regimen, and early clinical activity across AP3-prioritized solid tumor types
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Nomination of new preclinical development candidate, including target disclosure, for Acrivon’s AP3-driven cell cycle program
A live webcast of the event will be available through a link on the Events & Presentations page within the investor section of the company’s website at https://ir.acrivon.com/news-events/events-presentations .
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery, and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.
Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2b trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.
In addition to ACR-368, Acrivon is also leveraging its proprietary Generative Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing with enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our preclinical and clinical results, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon undertakes no duty to update such information except as required under applicable law.
Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.
[email protected]
Alexandra Santos
[email protected]