Alterome Therapeutics Begins Phase 1 Trial Dosing for ALTA2618 in AKT1 E17K-Mutant Tumors

Alterome Therapeutics has announced the commencement of their Phase 1/1b clinical trial, AKTive-001, focusing on ALTA2618 for adult patients with AKT1 E17K-mutant advanced solid tumors. This milestone underscores the company's commitment to advancing innovative, selective therapies targeting specific cancer mutations.

ALTA2618 represents the first targeted allosteric inhibitor designed specifically for the AKT1 E17K mutation. This mutation has been identified as a significant oncogene, contributing to approximately 5% of breast cancers, particularly those that are hormone-positive, and 1-2% of all cancers, including about 3% of endometrial and 2% of prostate cancers. The inhibitor aims to mitigate the toxicities commonly associated with the inhibition of AKT family kinases, providing a more tailored approach to cancer treatment.

Dr. Eric Murphy, co-founder and CEO of Alterome Therapeutics, expressed his enthusiasm for reaching this pivotal point in their research and development. He highlighted that ALTA2618's design and development reflect the company's dedication to creating mutation-specific therapies that have the potential to significantly enhance patient outcomes. The drug employs a novel covalent approach to capture the lysine mutation, marking a notable advancement from concept to clinical trial.

The AKTive-001 trial is an open-label study involving dose escalation and multiple expansion cohorts. It will investigate ALTA2618 as an oral monotherapy, assessing its safety, tolerability, pharmacokinetics, and initial clinical activity. The trial will include participants aged 18 and above who have advanced, unresectable, or metastatic solid tumors harboring the AKT1 E17K mutation. The clinical trial identifier for this study is NCT06533059. Enrollment is set to expand over the next year, with additional clinical sites expected to open across Europe, Asia, and Australia.

Alterome Therapeutics, Inc. is a biotech company specializing in precision oncology and is led by a team of experts with a track record in developing marketed oncology drugs. Their focus is on creating therapeutics that specifically address high-value oncogenic drivers, employing a precision approach to cancer treatment.

In summary, the dosing of the first patient in the AKTive-001 trial marks a significant achievement for Alterome Therapeutics. The company's innovative approach with ALTA2618 demonstrates their commitment to advancing precision oncology and developing treatments that target specific cancer mutations, potentially offering improved outcomes for patients with cancers driven by the AKT1 E17K mutation.