Pathway Therapeutics, Inc., a company developing novel therapeutics that target the PI3K and mTOR pathways, today announced that the FDA has accepted an IND filing for PWT33597, which allows Pathway to commence Phase 1 clinical testing.
PWT33597 is a proprietary, selective, dual inhibitor of PI3K kinase alpha and mTOR, and is the first agent with this profile to enter the clinic. The phase 1 clinical trial of PWT33597 is a single agent study designed to evaluate the safety of escalating doses of PWT33597 in patients with advanced solid tumors. The study will also provide a rich dataset of pharmacokinetic and pharmacodynamic measurements, as well as an early assessment of clinical activity. Additionally, the company successfully advanced its second program, focused on the discovery and development of PI3K delta selective inhibitors, to the lead optimization stage.
Coincident with reaching these objectives, GBS Ventures and CM Capital Investments, two of Pathway Therapeutics' existing investors, have invested an additional $7.5 million into the company.
"On behalf of the board, we are extremely excited to see such rapid advancement of our first drug into the clinic," Pathway's board chairman Dr. Mark Harvey stated. "We look forward to establishing the clinical profile of PWT33597 in cancer patients."
"This is a pivotal step for Pathway," said Julie Cherrington, Pathway's president and CEO. "We have built an outstanding team and have delivered on an aggressive timeline in a very capital efficient manner. This financing will deliver significant clinical data for Pathway."
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