Mirati Therapeutics Announces First Patient Dosed In Phase 1b Clinical Trial Of Sitravatinib In Combination With Anti-PD1 Antibody Tislelizumab In Patients With Advanced Solid Tumors

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Nov 08, 2018, 16:32 ET

SAN DIEGO, Nov. 8, 2018 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced dosing of the first patient under its collaboration agreement with BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) in a Phase 1b clinical trial to assess the safety and tolerability, pharmacokinetics and preliminary anti-tumor activity of Mirati's sitravatinib in combination with BeiGene's investigational anti-PD1 antibody, tislelizumab, in patients with advanced solid tumors. The clinical trial is currently enrolling patients in China and Australia.

"We're excited to move into the next phase of our collaboration with BeiGene. BeiGene's ability to rapidly enroll patients into this clinical trial has the potential to significantly expand and accelerate our development efforts for sitravatinib and provide access to additional patient populations," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "This clinical trial also has the potential to provide proof of concept clinical data in multiple solid tumor types."

This initial open-label, multicenter, non-randomized Phase 1b clinical trial is designed to assess the safety and tolerability in patients with histologically or cytologically confirmed locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC), renal cell carcinoma, and ovarian cancer. Patients will receive 120 mg of oral sitravatinib, daily, and 220 mg of intravenous tislelizumab, every three weeks.

"This collaboration has progressed quickly, and we are pleased that we can investigate the potential complementary activity of sitravatinib and tislelizumab in patients with advanced solid tumors in China and Australia," said Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.

Under the terms of the collaboration agreement, upon initiation of the clinical trial by BeiGene, Mirati will receive a $3 million milestone payment.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO^®), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib's potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.

About Mirati Therapeutics

Mirati Therapeutics, Inc. is a clinical-stage oncology company developing product candidates to address the genetic, epigenetic and immunological promoters of cancer. Our precision oncology clinical programs utilize next-generation genomic testing to identify and select cancer patients who we believe would be most likely to benefit from targeted drug treatment. In immuno-oncology, we are advancing clinical programs where our product candidates have the potential to improve the immune environment of tumor cells and may enhance and expand the efficacy of existing cancer immunotherapy medicines when given in combination. Our pre-clinical programs include potentially first-in-class and best-in-class product candidates specifically designed to address mutations and tumors where few treatment options exist. We approach each of our discovery and development programs with a singular focus: to translate our deep understanding of the molecular drivers of cancer into better therapies and better outcomes for patients. For more information, visit www.mirati.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release regarding the business of Mirati Therapeutics, Inc. ("Mirati") that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding Mirati's development plans and timelines, potential regulatory actions, expected use of cash resources, the timing and results of clinical trials, and the potential benefits of and markets for Mirati's product candidates. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Forward-looking statements are based on current expectations of management and on what management believes to be reasonable assumptions based on information currently available to them, and are subject to risks and uncertainties. Such risks and uncertainties may cause actual results to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation potential delays in development timelines, negative clinical trial results, reliance on third parties for development efforts, changes in the competitive landscape, changes in the standard of care, as well as other risks detailed in Mirati's recent filings on Forms 10-K and 10-Q with the U.S. Securities and Exchange Commission. Except as required by law, Mirati undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

SOURCE Mirati Therapeutics, Inc.