First Patient Dosed in Alterome’s Phase 1 Trial of ALTA2618 for AKT1 E17K-Mutant Solid Tumors

Alterome Therapeutics, Inc., a biopharmaceutical company at the clinical development stage that is leading advancements in next-generation small molecule targeted therapies for cancer treatment, has announced the administration of the first dose to a patient in the AKTive-001 trial. This Phase 1/1b study is investigating ALTA2618 in adult patients with advanced solid tumors harboring the AKT1 E17K mutation.

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ALTA2618 stands out as the inaugural mutant-selective allosteric AKT1 E17K inhibitor, specifically engineered to minimize the on-target adverse effects typically linked with AKT family kinase inhibition. The AKT1 E17K mutation is an established oncogene implicated in approximately 5% of breast cancer cases, especially those that are hormone receptor-positive, as well as 1-2% of all cancers, which includes about 3% of endometrial cancers and 2% of prostate cancers.

"We are thrilled to announce the first patient dosing in the AKTive-001 study, marking a key achievement for Alterome as we transition our initial project from our mutation-selective and isoform-selective drug discovery pipeline to clinical trials," expressed Eric Murphy, Ph.D., co-founder and CEO of Alterome Therapeutics. "ALTA2618 was specifically engineered to focus on the AKT1 E17K mutation using an innovative covalent strategy to target the lysine alteration. This journey from concept to clinical application demonstrates our team’s unwavering commitment to developing cutting-edge mutation-selective therapies aimed at enhancing cancer patient outcomes."

The AKTive-001 trial is a Phase 1/1b, open-label study featuring dose escalation along with multiple expansion cohorts to assess ALTA2618 as a single-agent oral treatment. This study aims to investigate the safety, tolerability, pharmacokinetics, and initial clinical efficacy of ALTA2618 in patients aged 18 years and older suffering from advanced unresectable or metastatic solid tumors with the AKT1 E17K mutation (NCT06533059). In the upcoming year, additional clinical sites across Europe, Asia, and Australia will commence patient enrollment.

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According to the data provided by the Synapse Chemical, As of October 31, 2024, there are 51 investigational drugs for the Akt-1 target, including 121 indications, 85 R&D institutions involved, with related clinical trials reaching 156, and as many as 5683 patents.

ALTA-2618 is a small molecule drug developed by Alterome Therapeutics, Inc. that targets the Akt-1 protein. The drug is being developed for the treatment of neoplasms, skin and musculoskeletal diseases, and urogenital diseases. Its active indications include advanced malignant solid neoplasm, AKT1 mutation positive solid tumors, breast cancer, endometrial carcinoma, and neoplasm metastasis.