Alterome Therapeutics Announces First Patient Dosed in Phase 1 Study of ALTA2618 in AKT1 E17K-mutant solid tumors (AKTive-001)

AKTive-001 is a Phase 1/1b study of ALTA2618 in adults with AKT1 E17K-mutant solid tumors

ALTA2618 is the first clinical mutant-selective inhibitor of AKT

SAN DIEGO--(BUSINESS WIRE)--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.

ALTA2618 is the first mutant-selective allosteric inhibitor of AKT1 E17K and is designed to avoid on-target toxicities associated with inhibition of AKT family kinases. AKT1 E17K is a clinically validated oncogene that drives ~5% of breast cancer, particularly hormone positive disease, and 1-2% of all cancer, including endometrial (~3%) and prostate (~2%) cancers.

“Dosing the first patient in the AKTive-001 trial marks a significant milestone for Alterome as we advance the first program from our mutation-selective and isoform-selective discovery pipeline to the clinic,” said Eric Murphy, Ph.D., co-founder and CEO of Alterome Therapeutics. “ALTA2618 was designed to selectively target the AKT1 E17K mutation by pioneering a novel covalent approach to capture the lysine mutation. From concept to clinic, ALTA2618 illustrates the relentless execution of our team and dedication to developing novel mutation-selective therapies that will improve outcomes for patients with cancer.”

AKTive-001 is a Phase 1/1b, open-label, dose escalation and multiple expansion cohort study evaluating ALTA2618 as an oral monotherapy. The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of ALTA2618 in patients aged 18 years or above with AKT1 E17K-mutated advanced unresectable or metastatic solid tumors (NCT06533059). Additional clinical sites across Europe, Asia and Australia will initiate enrollment over the next year.

About Alterome Therapeutics, Inc.

Alterome Therapeutics, Inc. is a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by an expert team of precision oncology R&D leaders with a history of developing marketed oncology small molecule drugs.

For more information, visit www.alterome.com.

Follow us on LinkedIn and Twitter.