Kura Wins FDA Clearance for Tumor Treatment

Kura Oncology, Inc. (NASDAQ: KURA) shares gained ground Tuesday, on receiving the clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for KO-2806, the Company's next-generation farnesyl transferase inhibitor (FTI), for the treatment of advanced solid tumors. The Company intends to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 first-in-human study as a monotherapy and in combination with other targeted therapies.

"Although we have seen significant advances in the development of targeted therapies for the treatment of various solid tumors, the reality is that most patients still eventually develop resistance and their cancer progresses on therapy," said CEO Troy Wilson. "Over the past several years, we have pioneered the development of farnesyl transferase inhibitors as combination agents to prevent or delay emergence of resistance to certain classes of targeted therapy. Clearance of the IND for KO-2806 marks an important next step for this program, and we look forward to starting the Phase 1 study later this year.”

The Phase 1 first-in-human study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 when administered as a monotherapy and in combination therapy in adult patients with advanced solid tumors. Following completion of the dose escalation as a monotherapy, Kura plans to evaluate KO-2806 in dose escalation combination cohorts in advanced solid tumors. The Company expects to initiate the Phase 1 study in the third quarter of 2023.

KURA shares grabbed 26 cents, or 1.9% to $14.23