Clinical trial 2

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Emeryville, CA – April 13, 2023 – Totus Medicines, a drug discovery and development company committed to ending the era of untreatable disease, today announced the dosing of the first patient in a Phase 1 clinical trial of TOS-358, its first-in-class covalent PI3Kα inhibitor for the treatment of numerous cancers with known PIK3CA mutations.

TOS-358 is a highly specific and potent inhibitor of PI3Kα, a protein that plays a key role in cell growth and survival. PIK3CA mutations are found in nearly 15% of all cancers, and are associated with poor prognosis.

The Phase 1 clinical trial is a multi-center study that will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TOS-358 as a single agent in patients with select solid tumors with known PIK3CA mutations. The trial is expected to enroll approximately 241 patients.

“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, PhD, CEO & co-founder, of Totus Medicines. “We believe that TOS-358 has the potential to make a significant difference in the lives of patients with cancer.”

The Phase 1 clinical trial of TOS-358 is currently recruiting patients. For more information, please visit

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