- Mirati Therapeutics Inc. is cutting off funding to two of its clinical programs, including one of its most advanced, to funnel more resources into pipeline assets that represent "superior investment opportunities."
- Moving forward, the San Diego biotech is prioritizing development of its multi-targeted receptor tyrosine kinase (RTK) inhibitor sitravatinib, which is in Phase 2 testing in combination with Bristol-Myers Squibb Co.'s Opdivo as a treatment for non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma. Mirati's pre-clinical KRAS inhibitor program will also be a central focus.
- Conversely, Mirati is suspending investments for glesatinib, its other RTK-inhibitor in mid-stage testing, as well as its preclinical Lysine (K)-Specific Demethylase 1A (LSD1) program. The company is looking to partner on both programs.
Mirati announced the reprioritization on Monday, and subsequently watched its stock fell nearly 15% to $13.20 per share the next day, likely due to glesatinib being set aside. Not only has the drug gone further in the clinic than most of Mirati's other candidates, but it has also demonstrated hints of a promising efficacy and safety profile.
In January, for instance, Mirati unveiled data from a Phase 2 study of glesatinib in patients with NSCLC characterized by specific MET mutations. The data showed that, of eight evaluable patients, investigators identified tumor reduction in six. What's more, there was one confirmed partial response and two unconfirmed partial responses.
Mirati noted its decision to stop investing in glesatinib had less to do with its therapeutic potential and more to do with the company's other drugs.
"Glesatinib has demonstrated clinical activity and acceptable tolerability in MET-altered NSCLC patients," Mirati said in a Monday statement. "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 decision to double down on sitravatinib comes just a couple months after Mirati announced positive preliminary data from Phase 1b and Phase 2 trials that tested the drug — as a single agent and paired with Opdivo (nivolumab), respectively — in patients with NSCLC. Cancer drug manufacturers have taken an increasing interest in I/O combination treatments over the past few years, convinced they will be key growth drivers as the therapeutic area becomes more crowded.
"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," Mirati CEO Charles Baum said in the Nov. 13 statement. "This is a patient population with poor prognosis and limited treatment options."
Mirati expects the resource shuffling will give the company enough money to operate until late 2019. As of Sept. 30, the company had $20.8 million in cash and equivalents.
During the first nine months of 2017, Mirati spent $42.8 million on R&D. Glesatinib proved the most expensive of the company's programs, accounting for $13.7 million of the $31.5 million shelled out on third party R&D.
In spite of the company's Tuesday stock hit, it remains far from its 52-week low of $2.70 per share. The per share price has been in the teens since early October, buoyed by a Sept. 14 announcement of the positive sitravatinib data.