Terremoto Biosciences Granted FDA Fast Track Designation for TER-2013, an AKT1-Selective Small Molecule Inhibitor for Breast Cancer

Fast Track Designation granted for TER-2013 in HR+/HER2- breast cancer with AKT/PI3K/PTEN-alterations following endocrine therapy and CDK4/6 inhibitor therapy

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Terremoto Biosciences, a biotechnology company developing highly targeted, small molecule medicines, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for TER-2013, the Company’s lead AKT1-selective inhibitor, in patients with locally advanced, unresectable or metastatic HR+/HER2- breast cancer harboring one or more AKT/PI3K/PTEN alterations following progression on at least one endocrine-based therapy and CDK4/6 inhibitor for advanced disease.

Fast Track Designation is intended to facilitate the development and expedite the review of therapies for serious conditions with unmet medical need. The designation allows for more frequent interactions with the FDA regarding development plan, clinical trial design and data requirements to support potential approval. If relevant criteria are met, programs with Fast Track designation are eligible for accelerated approval and priority review.

“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”

TER-2013 is an investigational, orally bioavailable small-molecule inhibitor designed to selectively target AKT1, maximizing target engagement within tumor cells. TER-2013 is being evaluated in a Phase 1 clinical trial (NCT-07109726) in patients with solid tumors harboring AKT/​PI3K/​PTEN pathway alterations.

“Our preclinical data demonstrated potent and sustained inhibition of AKT1 while sparing AKT2, AKT3 and other off-target proteins,” said James Christensen, Ph.D., President, Head of Research & Development of Terremoto Biosciences. “TER-2013 was designed to selectively target AKT1 with the goal of addressing the limitations of earlier pan-AKT inhibitors. This profile is intended to maximize the coverage of the disease-driving isoform while sparing toxicities linked to AKT2 or other off-target proteins.”

The dose-escalation portion of the first-in-human trial has been completed and selection of an optimal dose for POC expansion in patients with cancers harboring AKT/PI3K/PTEN pathway alterations is ongoing. The Company also plans to evaluate expansion opportunities in additional patient populations.

About TER-2013

TER-2013 is an investigational, orally bioavailable small-molecule inhibitor designed to selectively target AKT1, maximizing target engagement within tumor cells. In preclinical studies, TER-2013 demonstrated potent and sustained inhibition of AKT1, while sparing AKT2, AKT3 and other off-target proteins at efficacious doses. This selectivity enables robust tumor response and durable anti-tumor activity across multiple xenograft models harboring PIK3CA, AKT1, or PTEN genetic alterations—without AKT2-dependent hyperglycemia, or other toxicities such as rash or diarrhea, observed with earlier pan-AKT inhibitors. TER-2013 is currently being evaluated in a Phase 1 clinical trial (NCT-07109726).

About Terremoto Biosciences

Terremoto Biosciences is a clinical-stage biotechnology company creating highly targeted, small molecule medicines with unmatched selectivity, potency and efficacy designed to deliver superior therapeutic benefit to patients. Terremoto is a private company supported by world-class investors and is based in South San Francisco and San Diego, California. More information is available at www.terremotobio.com.