Totus Medicines Announces First Patient Dosed in Phase 1 Trial of TOS-358 for the Treatment Of Select Solid Tumors
TOS-358 is the first highly specific, potent inhibitor of PI3Kα
Excerpt from the Press Release:
EMERYVILLE, Calif. , April 13, 2023 /PRNewswire/ — Totus Medicines, the drug discovery and development company committed to ending the era of untreatable disease, announced today the dosing of the first patient in a Phase 1 clinical trial of TOS-358, the company’s first-in-class covalent PI3Kα inhibitor for the treatment of numerous cancers with known PIK3CA mutations.
The Totus Accel™ Platform delivers the first biosearch technology that scans, maps, and decodes effective new drugs thousands of times faster than traditional drug discovery processes. As a result, Totus was able to file an Investigative New Drug application with the FDA in a mere 18 months after the TOS-358 program was discovered and developed. Totus uses proprietary molecular tags that track drug binding in individual cells to screen billions of drug molecules across thousands of genes in parallel. By combining this approach with breakthrough machine learning techniques, the company has developed the next generation of cellular analysis. The Totus Accel™ Platform is more effective, less costly, and thousands of times faster than legacy drug discovery methods, enabling the rapid translation of therapies to patients.
The Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TOS-358 as a single agent in 241 trial participants with select solid tumors. 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 gynecologic cancers (ovarian cancer, cervical cancer, or endometrial cancer) with known PIK3CA mutations.
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