tanerasertib (ALTA2618) / Alterome Therap - LARVOL DELTA

AKTive-001: A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Active, not recruiting | Sponsor: Alterome Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • AKT1

Discovery of ALTA-2618, the first allosteric, mutant-selective targeted therapy for AKT1 E17K driven cancers (AACR 2024) - "ALTA-2618 is a potent, highly mutant-selective AKT1 E17K inhibitor that demonstrates favorable PK and tolerability with oral once-daily dosing that enables prolonged tumor regressions in multiple AKT1 E17K-mutant PDX models. These data support a mid-2024 IND submission to investigate ALTA-2618 in patients with AKT1 E17K mutant cancers."

Late-breaking abstract • Breast Cancer • Endometrial Cancer • Gynecologic Cancers • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • AKT2 • HER-2

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation (Trial in Progress) (SABCS 2024) - "Sites will be opened in the US, EU, Asia and Australia. Enrollment will begin in September 2024."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AKT1 • AKT2 • ER • HER-2 • PGR

Alterome Therapeutics Announces First Patient Dosed in Phase 1 Study of ALTA2618 in AKT1 E17K-mutant solid tumors (AKTive-001) (Businesswire) - "Alterome Therapeutics, Inc., a clinical stage biopharmaceutical company pioneering the development of next generation, small molecule targeted therapies for the treatment of cancer, today announced the dosing of the first patient in AKTive-001, a Phase 1/1b trial of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors....AKTive-001 is a Phase 1/1b, open-label, dose escalation and multiple expansion cohort study evaluating ALTA2618 as an oral monotherapy....Additional clinical sites across Europe, Asia and Australia will initiate enrollment over the next year."

Trial status • Breast Cancer • Endometrial Cancer • Solid Tumor

A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Alterome Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Endometrial Cancer • Oncology • Solid Tumor

A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Alterome Therapeutics, Inc.

Metastases • New P1 trial • Breast Cancer • Endometrial Cancer • Oncology • Solid Tumor

Alterome Therapeutics Raises $132 Million in Series B Financing Led by Goldman Sachs Alternatives (Businesswire) - "Alterome Therapeutics, Inc...announced the closing of a $132 million Series B financing. Proceeds from the fundraise will be used to support the advancement of multiple wholly-owned pipeline programs into the clinic, including a highly specific AKT1 E17K inhibitor and a KRAS selective inhibitor."

Financing • Oncology

Alterome Therapeutics Presents Pre-Clinical Data Supporting the Development of Lead Program, an AKT1 E17K Inhibitor (Businesswire) - "The data are being presented in a poster presentation on April 8th at the American Association for Cancer Research (AACR) Annual Meeting 2024....This work...supports the advancement of ALTA-2618 into first-in-human clinical trials in 2024....ALTA-2618 is the first allosteric & mutant-selective drug for AKT1 E17K driven cancers. ALTA-2618 has favorable pharmacokinetic properties across multiple preclinical species. ALTA-2618 is well tolerated with daily oral dosing in tumor-bearing mice. The compound demonstrated significant anti-tumor effects in clinically-relevant PDX models driven by AKT1 E17K."

New trial • Preclinical • Oncology