Totus Medicines initiated an expansion study for TOS-358, a first-in-class covalent PI3Kα inhibitor, after a successful Phase 1 trial. The Phase 1 study showed promising results, including 95% target engagement, early signs of clinical activity, and no high-grade toxicities at low doses. Concurrent with this development, Totus appointed Zelanna Goldberg, M.D., M.A.S. as Chief Medical Officer, leveraging her extensive oncology drug development experience.
The positive Phase 1 results for TOS-358 are notable because PI3Kα inhibition is a key target in cancer treatment, but existing inhibitors often face challenges with toxicity and limited efficacy. Achieving high target engagement with minimal toxicity at low doses suggests TOS-358 could potentially address these limitations, opening the door for combination therapies with other anticancer agents like CDK4/6 inhibitors and SERDs. This could lead to improved outcomes for patients with various cancers, including breast, endometrial, urothelial, and head and neck cancers, which are the focus of the expansion trial.
Technically, the 95% target engagement at low doses is a critical achievement, differentiating TOS-358 from other PI3Kα inhibitors. Strategically, the appointment of Dr. Goldberg reinforces Totus Medicines’ commitment to advancing its clinical programs. Her expertise in leading clinical trials, particularly in oncology, positions the company to effectively navigate the next stages of TOS-358’s development.
The promising early clinical data and strategic leadership appointment position Totus Medicines for continued progress in the PI3Kα inhibitor space. The initiation of the expansion trial will provide further data to validate the efficacy and safety profile of TOS-358, potentially leading to a new treatment option for patients with difficult-to-treat cancers. The development of TOS-358 could also influence the direction of future PI3Kα inhibitor research, encouraging further exploration of covalent inhibitors.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
