Mirati Therapeutics Announces FDA Clearance Of Investigational New Drug (IND) Application To Initiate Phase 1/2 Trial Of KRAS G12C Inhibitor, MRTX849

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Nov 29, 2018, 17:20 ET

SAN DIEGO, Nov. 29, 2018 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for MRTX849, a small molecule inhibitor of KRAS G12C. Mirati is developing MRTX849 for the treatment of cancers driven by KRAS G12C mutations.

"KRAS mutations, like the G12C mutation, are recognized as drivers of multiple tumor types, including non-small cell lung cancer and colorectal cancers. Efforts over the last 25 years to develop drugs to inhibit mutant KRAS have been largely unsuccessful," said James Christensen, Ph.D., Chief Scientific Officer, Mirati Therapeutics. "MRTX849 represents the culmination of significant scientific effort by our research team to design a potent and highly selective inhibitor of KRAS G12C. We believe that this scientific breakthrough has the potential to result in meaningful and lasting clinical benefit for patients with G12C mutation-positive cancers. We look forward to working with patients and physicians to evaluate the potential of MRTX849."

FDA clearance of the IND enables Mirati to initiate its planned Phase 1/2 clinical trial in patients with advanced solid tumors that harbor KRAS G12C mutations. The Phase 1 dose escalation phase of the trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MRTX849 in patients with molecularly-identified KRAS G12C-positive cancers. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose. Mirati expects the first patient to be enrolled in the trial by January 2019.

About MRTX849
MRTX849 is an orally-available small molecule that potently and selectively inhibits a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients and 5% of colorectal cancer patients. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MTRX849 has demonstrated broad-spectrum tumor regression in a large cohort of KRAS G12C-positive pre-clinical in-vivo human tumor models. MRTX849 demonstrated complete regression of tumors in a subset of models at well-tolerated dose levels. Early proof-of-concept clinical data is anticipated in 2019.

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.