Pipeline

Robust Pipeline of Precision Therapeutics

At Atavistik Bio, we are developing a pipeline of allosteric therapeutics against validated targets to address patient populations with significant unmet needs. Our AMPSTM platform has enabled us to efficiently deliver differentiated small molecule allosteric inhibitors for clinically validated targets that achieve superior efficacy and tolerability profiles to improve patient outcomes.

Program/Target Indication
Discovery Lead Optimization IND Enabling Clinical
Oncology
ATV-1601
AKT1E17K
 Breast, Prostate, Endometrial, and other Solid Tumors
Stage - IND Enabling
ATV-1601 is an orally bioavailable selective allosteric AKT1 E17K inhibitor that is designed to provide enhanced on-target inhibition with the potential to overcome the tolerability and durability challenges observed with pan-AKT inhibitors.

ATK1 E17K mutation is a clinically validated oncogene that impacts greater than 40,000 cancer patients per year in the United States, with the highest prevalence in breast, endometrial, and prostate cancer. Pan-AKT inhibitors have significant efficacy limitations resulting from insufficient AKT1 target engagement as well as on-target inhibition of AKT2, which causes hyperglycemia and results in treatment discontinuation or dose-reductions in a considerable subset of patients. ATV-1601 overcomes this limitation by selective allosteric inhibition of the disease-driving AKT1 E17K mutation.

In multiple preclinical studies in clinically relevant AKT1 E17K-driven patient-derived tumor models, 
ATV-1601 has demonstrated dose-dependent anti-tumor activity leading to profound and durable tumor regression at well-tolerated doses without causing hyperglycemia. We anticipate filing an investigational new drug (IND) application and initiating a first-in-human study in patients with AKT1 E17K mutant tumors in early 2025.
Program 2
Undisclosed
 Solid Tumors
Stage - Lead Optimization
Program 3
Undisclosed
 Myeloproliferative neoplasms
Stage - Lead Optimization
Metabolic Disease
Program 4
Undisclosed
 Hepatic Encephalopathy
Stage - Lead Optimization