Atavistik Bio Presents Preclinical Data on ATV-1601 at EORTC-NCI-AACR Symposium

CAMBRIDGE, MA, USA October 23, 2024 – Atavistik Bio, a biotechnology firm specializing in the creation of advanced precision allosteric therapeutics inspired by natural bodily regulators, revealed promising preclinical data for their new drug, ATV-1601. This data was presented at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, showcasing ATV-1601's potential as an orally bioavailable selective allosteric small molecule inhibitor targeting AKT1 E17K-driven cancers. The findings highlight ATV-1601's enhanced target inhibition, superior efficacy, and better tolerability compared to pan-AKT inhibitors in preclinical models. Atavistik Bio plans to begin the first human trials of ATV-1601 in early 2025 for patients with tumors harboring the AKT1 E17K mutation.

AKT1 E17K is a well-validated oncogene affecting over 40,000 cancer patients annually in the United States, with the highest occurrence in breast, endometrial, and prostate cancers. Preliminary data also suggest that the AKT1 E17K mutation might be a growing resistance mechanism to PI3Kα-targeted treatments. Presently, the only approved AKT-targeted treatment is a pan-AKT inhibitor, which blocks all three AKT isoforms (AKT1, AKT2, and AKT3). However, pan-AKT inhibitors are often less effective for patients with AKT1 E17K-driven tumors because they do not sufficiently inhibit the AKT1 E17K mutation. Moreover, pan-AKT inhibitors are associated with significant side effects like AKT2-driven hyperglycemia, rashes, and diarrhea, which frequently lead to treatment discontinuation or dose reductions.

In their poster presentation, "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 demonstrated that ATV-1601 achieves over 90% target engagement without causing hyperglycemia in preclinical models. This high level of target engagement and selectivity allowed ATV-1601 to induce substantial and lasting tumor regressions in multiple patient-derived breast and endometrial tumor models driven by the AKT1 E17K mutation, while also being well-tolerated.

Marion Dorsch, Ph.D., President and Chief Scientific Officer at Atavistik Bio, expressed enthusiasm about the preclinical results, stating, "We are excited to share these significant preclinical findings for ATV-1601 with the oncology community. As a selective allosteric AKT1 E17K inhibitor, ATV-1601 has the potential to become a transformative precision therapy against the validated AKT1 E17K oncogenic driver. The patient populations affected by the AKT1 E17K mutation have substantial unmet needs, which we are urgently working to address. We look forward to moving into clinical trials with our planned first-in-human study."

Atavistik Bio is a biotechnology company dedicated to accelerating the discovery and development of groundbreaking precision allosteric therapeutics to meet serious unmet patient needs, primarily in oncology. Led by an experienced team with a proven track record in developing market-ready small molecule therapies, Atavistik Bio is supported by top-tier investors like The Column Group, Nextech Invest, and Lux Capital.