Two months after positive preliminary data showed sitravatinib in combination with Opdivo demonstrated some efficacy in treating patients with NSCLC, Mirati said it will reprioritize its R&D to focus.
Two months after positive preliminary data showed sitravatinib in combination with Opdivo demonstrated some efficacy in treating patients with non-small cell lung cancer (NSCLC), Mirati Therapeutics said it will reprioritize its R&D to focus on its immuno-oncology drug and its KRAS program – in favor of lead product glesatinib.
Glesatinib has been in Phase II development for NSCLC and other solid tumors. Mirati said it is deprioritizing investment into this drug candidate. Additionally the company said it will pursue partnerships to develop the program.
“Glesatinib has demonstrated clinical activity and acceptable tolerability in MET-altered NSCLC patients. However, in light of superior investment opportunities in its pipeline, the company will suspend further investment in glesatinib and will pursue opportunities to partner the program. The company intends to present glesatinib data at a future medical conference,” Mirati said in a statement.
In addition to its change with glesatinib, Mirati said it has also suspended development of its preclinical LSD1 inhibitor program as part of its reprioritization. In light of superior investment opportunities in its pipeline, Mirati said it will seek a partner to continue development of the program.
Funding that was initially allocated for the glesatinib will be used to advance Mirati’s other programming. The company said it has enough funds on hand to support development of sitravatinib and the KRAS programs through 2019. Mirati said it is reprioritizing in order to capitalize on encouraging data and development opportunities.
“We are very encouraged by the early results from our sitravatinib immuno-oncology program. The combination of sitravatinib and nivolumab has demonstrated durable responses and prolonged stable disease in patients with non-small cell lung cancer that have documented progression on prior checkpoint therapy. This is a patient population with poor prognosis and limited treatment options. We are focusing on accelerating this promising opportunity with sitravatinib and advancing our potentially first-in-class KRAS program, both of which address large underserved patient populations with significant market potential,” Charles Baum, Mirati’s president and chief executive officer, said in a statement.
Mirati expects Phase II data from the immuno-oncology combination of sitravatinib, a spectrum-selective kinase inhibitor, and Opdivo (nivolumab) in patients with checkpoint refractory non-small cell lung cancer (NSCLC) by mid-2018. Initial data from the ongoing Phase II included three confirmed Partial Responses in the first 11 evaluable patients. Eight of these patients exhibited tumor reduction, the company said.
Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion trial enrolling patients whose tumors harbor CBL, CHR4Q12 and RET genetic alterations in NSCLC and other tumor types.
In its announcement, Mirati said it has selected a clinical lead and backup compounds in its KRAS program that potently target KRAS G12C mutations. The company said it intends to file an Investigational New Drug Application with the U.S. Food and Drug Administration by the fourth quarter of 2018.
Investors were not happy with Mirati’s announcement. After news of Mirati’s reprioritization was announced late Monday, stockholders began dumping shares. Mirati stock fell from $15.60 per share to a low of $12.90. Share prices have rallied some back to $13.20.
