eClinical Technology and Industy News

Totus Medicines Announces Successful Completion of a Phase 1 Dose-Escalation Study and Initiation of an Expansion Trial Evaluating TOS-358, a Covalent PI3Ka Selective Therapy for the Treatment of Select Solid Tumors and Appoints Zelanna Goldberg as Chief Medical Officer

Successfully completed a Phase 1 dose-escalation study demonstrating pan-mutant clinical activity, 95% target engagement and no grade 3 or 4 toxicities at doses as low as 5 mg BID

Initiating an expansion trial in breast, endometrial, urothelial and head and neck cancers at 5 & 8 mg BID

Appoints Zelanna Goldberg, M.D., M.A.S. as Chief Medical Officer

Excerpt from the Press Release:

EMERYVILLE, Calif., Jan. 10, 2025 (GLOBE NEWSWIRE) — Totus Medicines, a company revolutionizing small molecule drug discovery and development using covalent DNA-encoded libraries and AI tools, today announced the initiation of an indication expansion study of TOS-358, the first covalent PI3Kα inhibitor in clinical development and the appointment of Zelanna Goldberg, M.D., M.A.S., as Chief Medical Officer.

“Following the successful completion of our Phase 1 TOS-358 dose-escalation study, we have now initiated an expansion study, marking an important milestone for Totus and the use of covalent inhibitors in the PI3Ka field,” said Nassim Usman, Ph.D., President & CEO of Totus Medicines. “The Phase 1 study results to date have demonstrated 95% saturating target engagement of PI3Ka in patients, initial clinical activity with an unconfirmed complete response and no grade 3/4 toxicities at several low dose levels. Importantly, several patients dosed are now progression-free for over 6 months. The high target engagement, initial clinical activity, and low toxicity profile at low doses bodes well for the use of TOS-358 in combination with CDK4/6 and SERDs in the future. The addition of Dr. Goldberg, with her extensive knowledge in oncology drug development, comes at the right time for Totus as we advance our clinical-stage programs. We look forward to having her as part of our leadership team.”

“I am thrilled to join the Totus team at such an exciting time and look forward to bringing my drug development expertise to support the progress of the Company’s pipeline in areas of unmet medical need across multiple targets,” said Zelanna Goldberg, M.D., M.A.S. “TOS-358 has demonstrated a best-in-class profile in the PI3Ka space, and I am eager to work with the team to develop Totus’ clinical programs.”

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