Totus Medicines has dosed its first patient in a Phase I clinical trial of TOS-358, a first-in-class covalent PI3Kα inhibitor for the treatment of numerous cancers with known PIK3CA mutations.
The Totus Accel Platform is designed to be the first biosearch technology that scans, maps, and decodes new drugs thousands of times faster than traditional drug discovery processes.
Totus uses molecular tags that track drug binding in individual cells to screen billions of drug molecules across thousands of genes in parallel, combined with machine learning techniques.
The Phase I clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TOS-358 as a single agent in 241 trial participants with select solid tumours.
Trial participants will have histologically confirmed diagnosis of colorectal cancer, gastric cancer, non-small cell lung cancer, human epidermal growth factor receptor 2 (HER2) negative breast cancer, squamous cell carcinoma of the head and neck, urothelial cancer, or select gynaecologic cancers (ovarian cancer, cervical cancer, or endometrial cancer) with known PIK3CA mutations.
“TOS-358 represents a promising new approach to the treatment of the root cause of nearly 15% of all cancers, and we are excited to be able to advance it into clinical development at such an accelerated rate,” said Neil Dhawan, CEO and co-founder of Totus Medicines.
The study will be conducted in two parts. A dose finding portion will determine the maximum tolerated dose, and recommended Phase II dose of TOS-358 administered orally on once a day and twice daily schedules. A dose expansion portion will evaluate safety and tolerability in tumour-specific cohorts administered TOS-358 at the recommended Phase II dose and schedule.