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

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.”

Prior to joining Totus Medicines, Dr. Goldberg held leadership positions with increasing responsibilities (Medical Director, Senior Director, SVP, and CMO), at several companies, including Alpine Immune Sciences, Iovance Biotherapeutics, Inc., Pfizer, and Sunesis Pharmaceuticals. Dr. Goldberg most recently served as Chief Medical Officer at Replicate Biosciences, and as a consultant to multiple immuno-oncology biotech start-up companies, where she provided clinical and corporate development strategies, fund-raising, external engagement of corporate and scientific/medical communities and company building, foundational strategy, asset assessment, and operational roll-out. During her career, she has led a broad array of clinical drug development, including registrational strategy, global clinical trial design, including Phase 3 registrational trials and design and execution for Phase 1 and Phase 2 clinical trials in early-stage molecules. Dr. Goldberg is board certified in Radiation Oncology through the American Board of Radiology and the Royal College of Physicians of Canada and holds an active California Medical License. She has several patents, is an accomplished author for numerous peer-reviewed journal publications, an active founding member on behalf of Replicate Bioscience of the Alliance for mRNA Medicines (AMM) and maintains several active memberships (Regulatory Subcommittee at AMM, SITC, AACR, ASGCT, and ASCO).

About Totus Medicines
Totus Medicines is discovering and developing small molecule medicines using a novel DNA-encoded covalent library technology combined with artificial intelligence/machine learning (AI/ML). With the unprecedented ability to screen several hundred million drug candidates against multiple targets simultaneously, the company’s novel platform can find drugs that are dramatically superior to molecules discovered through previous technologies, including drug candidates for currently undrugged and difficult to drug targets. Totus is developing TOS-358, a covalent PI3Kα inhibitor in a Phase 1b clinical trial and is developing potent and selective covalent inhibitors of several other targets internally and has a drug discovery partnership with Lilly.

For more information, please visit totusmedicines.com and follow Totus on LinkedIn and Twitter/X.

Contact:
ir@totusmedicines.com

External Contact:
Brian Mullen
LifeSci Advisors, LLC
Managing Director
bmullen@lifesciadvisors.com
+1.203.461.1175