Atavistik Bio Names ATV-1601 as Precision Oncology Candidate

Atavistik Bio, a biotechnology firm based in Cambridge, Massachusetts, specializes in developing precision allosteric therapeutics. These therapeutics are inspired by the body's natural regulators. The company recently announced ATV-1601, an orally bioavailable, selective allosteric small molecule inhibitor targeting AKT1 E17K-driven cancers, as its latest oncology development candidate. ATV-1601 was developed using Atavistik Bio’s AMPS™ technology, which is integrated with an AI-enabled drug discovery engine, facilitating rapid progress from discovery to development.

Bryan Stuart, CEO of Atavistik Bio, highlighted that the nomination of ATV-1601 marks a significant milestone for the company, demonstrating the effectiveness of their proprietary platform in discovering and advancing new precision allosteric therapeutics. Stuart emphasized the company's commitment to advancing ATV-1601 to clinical trials swiftly to establish early clinical proof of concept. He believes that ATV-1601 has several advantages for targeting the challenging AKT1 E17K mutation, potentially improving the lives of many cancer patients.

The AKT1 E17K mutation is a clinically validated oncogene affecting over 40,000 cancer patients annually in the United States, particularly prevalent in breast, endometrial, and prostate cancers. Furthermore, early evidence suggests that the AKT1 E17K mutation is an emerging mechanism of resistance to PI3Kα-targeted cancer therapies. A selective allosteric AKT1 E17K inhibitor could offer a transformative treatment for this validated oncogenic driver and resistance mutations from PI3Kα-targeted therapies.

Currently, the only approved AKT-targeted therapy is a pan-AKT inhibitor, which blocks all three AKT isoforms (AKT1, AKT2, and AKT3). However, these pan-AKT inhibitors provide limited efficacy for patients with AKT1 E17K-driven tumors due to insufficient inhibition of the AKT1 E17K mutation. They are also associated with significant adverse events, such as AKT2-driven hyperglycemia, rash, and diarrhea, which can lead to treatment discontinuation or dose reductions in many patients.

ATV-1601, as a selective allosteric AKT1 E17K inhibitor, promises enhanced target inhibition, superior efficacy, and improved tolerability compared to pan-AKT inhibitors for AKT1 E17K-driven cancers. Atavistik Bio plans to initiate a first-in-human study with ATV-1601 in patients with AKT1 E17K-mutant tumors in early 2025.

Marion Dorsch, Ph.D., President and Chief Scientific Officer at Atavistik Bio, mentioned that ATV-1601 is just the beginning. The company has a robust pipeline of precision oncology programs derived from the AMPS platform. Dorsch expressed eagerness to advance the internal pipeline while also expanding the platform's reach through partnerships to discover new allosteric therapeutics across various diseases.

Atavistik Bio will present preclinical data on ATV-1601 at the EORTC-NCI-AACR Symposium on October 23, 2024. The presentation will feature a poster session titled "ATV-1601 is a Potent and Selective Allosteric Inhibitor of AKT1 E17K and Shows Profound and Durable Regressions in AKT1 E17K-Driven Patient-Derived Xenograft Models."

Atavistik Bio is dedicated to developing transformative precision allosteric therapeutics to address serious unmet patient needs, particularly in oncology. The company is led by a team of experienced drug developers with a proven track record of creating marketed small molecule therapies. Atavistik Bio is supported by prominent investors, including The Column Group, Nextech Invest, and Lux Capital.