Acrivon Therapeutics launches internal CLIA-certified laboratory in Watertown

Acrivon Therapeutics announced the completion and certification of its internal, wholly-owned and operated CLIA-certified laboratory, located on premises in Watertown. The facility has received CLIA certification from the state of Massachusetts with full license to conduct patient testing and develop companion diagnostics, and is expected to become fully operational during the first half of 2026.

The CLIA certification signifies that the lab operates in accordance with CLIA regulations, which are federal standards applicable to all U.S. facilities testing human specimens for health assessment, diagnosis, prevention, or treatment of diseases and ensures high standards for accuracy and reliability in laboratory testing. By bringing CLIA operations in-house, the company gains enhanced capabilities to support the development of its current and future targeted therapeutic agents.

The company said this includes full control over the identification of predictive biomarkers, the development of companion diagnostics, indication finding, and the streamlining of potential co-regulatory approvals and co-commercialization of therapeutic and diagnostic products. The lab is also expected to increase speed and cost-efficiency in precision medicine drug development and will be leveraged for business development and potential partnering opportunities for internally developed assets, externally partnered programs, or in-licensed therapies.

Acrivon said the laboratory complements its proprietary Generative Phosphoproteomics AP3 platform, which is designed to interpret and quantify global compound-specific, drug-regulated effects in the intact cell and is deployed for rational drug design and predictive clinical development. The platform is comprised of internally-developed tools including the AP3 Data Portal, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome.

The company is currently advancing ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2, in a potentially registrational Phase 2 trial for endometrial cancer. It has received Fast Track designation from the FDA for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer, and the FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.

Acrivon is also developing ACR-2316, its second clinical stage asset, as part of its co-crystallography-driven, internally discovered pipeline programs.