ATV-1601 / Atavistik Bio - LARVOL DELTA

Roche taps Atavistik Bio in USD 1.9bn allosteric drug discovery deal (AllSci Corp) - "The deal gives Roche access to Atavistik’s AMPS allosteric drug-discovery platform, which is designed to identify functional binding pockets on disease targets that have been difficult to modulate with conventional small molecules....The collaboration extends Atavistik’s platform beyond its internally focused hematology and vascular-disease pipeline. The company’s lead asset, ATV-1601, is an oral allosteric AKT1-selective inhibitor in clinical development for hereditary hemorrhagic telangiectasia, while a separate JAK2V617F-selective program is being advanced for myeloproliferative neoplasms."

JAK2V617F • Licensing / partnership • Genetic Disorders • Myeloproliferative Neoplasm

ATV-1601-102: Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT) (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Atavistik Bio, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders

Atavistik Bio…announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for the Harmony-HHT study, a Phase 1/2 trial evaluating ATV-1601 in individuals with moderate to severe Hereditary Hemorrhagic Telangiectasia (The Manila Times) - "In addition to the IND clearance, Atavistik Bio also announced that ATV-1601 has been granted Fast Track Designation by the FDA. The FDA’s clearance of the Harmony-HHT Phase 1/2 study design allows Atavistik Bio to leverage existing clinical data with ATV-1601 and proceed directly into a randomized study. "

Fast track • IND • Trial status • Genetic Disorders

Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT) (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Atavistik Bio, Inc

New P1/2 trial • Hematological Disorders

ATV-1601, a potent and selective allosteric inhibitor of AKT1E17K, demonstrates profound and durable regressions in multiple patient and cell derived xenograft models [WITHDRAWN] (AACR 2025) - "Abstract is embargoed at this time."

Late-breaking abstract • Preclinical • Oncology

ATV-1601-101: A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations (clinicaltrialsregister.eu) - P1 | N=64 | Recruiting | Sponsor: Atavistik Bio Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

ATV-1601-101: A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations (clinicaltrialsregister.eu) - P1 | N=64 | Recruiting | Sponsor: Atavistik Bio Inc.

New P1 trial • Breast Cancer • Oncology • Solid Tumor

ATV-1601-101: A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations (clinicaltrialsregister.eu) - P1 | N=64 | Active, not recruiting | Sponsor: Atavistik Bio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations (clinicaltrials.gov) - P1 | N=134 | Active, not recruiting | Sponsor: Atavistik Bio, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Breast Cancer • Cervical Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • Urology • Uterine Cancer • AKT1 • HER-2

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations (clinicaltrials.gov) - P1 | N=134 | Recruiting | Sponsor: Atavistik Bio, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Cervical Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • Urology • Uterine Cancer

Atavistik Bio Announces First Patient Dosed in Phase 1 Clinical Trial of ATV-1601 in Patients with AKT1 E17K-mutant Solid Tumors (GlobeNewswire) - "Atavistik Bio...announced the dosing of the first patient in its Phase 1 study of ATV-1601 in adults with AKT1 E17K-mutant solid tumors....The first-in-human, open-label Phase 1a/1b study (NCT07038369) will evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic AKT1 E17K-mutant solid tumors, and in combination with fulvestrant in participants with AKT1 E17K-mutant HR-positive/HER2-negative breast cancer."

Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations (clinicaltrials.gov) - P1 | N=134 | Not yet recruiting | Sponsor: Atavistik Bio, Inc

New P1 trial • Breast Cancer • Cervical Cancer • Endometrial Cancer • Genito-urinary Cancer • Gynecologic Cancers • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • Urology • Uterine Cancer

ATV-1601 is a Potent and Selective Allosteric Inhibitor of AKT1E17K and Shows Profound and Durable Regressions in AKT1E17K-Driven Patient Derived Xenograft Models (SABCS 2024) - "ATV-1601 demonstrates exceptional efficacy with a favorable in vivo tolerability profile and data supports advancing toward clinical development."

Preclinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer • AKT2 • ER • HER-2 • PLEK

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 (EORTC-NCI-AACR 2024) - "ATV-1601 demonstrates exceptional efficacy with a favorable in vivo tolerability profile and data supports advancing toward clinical development."

Preclinical • Brain Cancer • Breast Cancer • CNS Tumor • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Meningioma • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • AKT1 • AKT2 • ER • HER-2 • PLEK

Atavistik Bio Presents Preclinical Data on Precision Oncology Development Candidate, ATV-1601, a Selective Allosteric AKT1 E17K Small Molecule Inhibitor, at EORTC-NCI-AACR Symposium (GlobeNewswire) - "Atavistik Bio...presented preclinical data at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Meeting 2024 in Barcelona for ATV-1601, the company’s orally bioavailable selective allosteric small molecule inhibitor for AKT1 E17K-driven cancers. The preclinical data demonstrated that as a selective allosteric AKT1 E17K inhibitor, ATV-1601 provides enhanced target inhibition, superior efficacy and improved tolerability compared to pan-AKT inhibitors in preclinical models. Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K mutant tumors in early 2025."

New trial • Preclinical • Solid Tumor

Atavistik Bio Announces Nomination of Precision Oncology Development Candidate, ATV-1601, a Selective Allosteric AKT1 E17K Small Molecule Inhibitor (GlobeNewswire) - "Atavistik Bio...announced its precision oncology development candidate ATV-1601, an orally bioavailable selective allosteric small molecule inhibitor for AKT1 E17K-driven cancers....Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K-mutant tumors in early 2025....Preclinical data on ATV-1601 to be presented at the EORTC-NCI-AACR Symposium on October 23, 2024."

New molecule • New trial • Oncology