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Tyme Technologies Begins Cancer Metabolism-Based Therapy Trial in Breast Cancer Patients

NEW YORK – Tyme Technologies said on Monday it has dosed the first patient in its Phase II OASIS trial of SM-88 in previously treated metastatic hormone receptor (HR)-positive HER2-negative breast cancer patients.

The investigator-initiated study at Georgetown University will initially enroll 30 patients with metastatic HR-positive HER2-negative breast cancer who have previously received at least two lines of endocrine therapy and progressed on treatment with a CDK4/6 inhibitor. The patients will be tested using immunohistochemistry or fluorescence in situ hybridization to ensure they have HER2-negative tumors. They will then receive SM-88, Tyme's cancer metabolism-based therapy, along with three conditioning agents: methoxsalen, phenytoin, and sirolimus.

If three or more patients have an objective response to the treatment, the trial will be expanded to include a total of 50 patients. The primary endpoint is objective response rate, and the researchers will also measure patients' duration of response, progression-free survival, clinical benefit rate, safety, and changes in cell-free DNA on treatment.

Researchers will collect cell-free DNA from patients at baseline, during treatment, and at disease progression, in the hopes of identifying biomarkers that can inform future drug development. Separately, Tyme and Georgetown University are conducting preclinical research to explore SM-88's effect in breast cancer models, specifically models with CDK4/6 inhibitor resistance.

Tyme CEO Richie Cunningham said in a statement that SM-88 has already shown broad anti-tumor activity within a first-in-human trial and through the company's compassionate-use program. "We believe the compelling data support our strategic decision to further evaluate oral SM-88 in this setting, and we are hopeful that we will repeat the promising early activity," Cunningham said.

Bedminster, New Jersey-based Tyme is also studying SM-88 in second-line pancreatic cancer and high-risk sarcoma patients. The company has another cancer metabolism-based therapy, TYME-18, in preclinical studies.