Clovis Oncology Announces FDA Acceptance of Investigational New Drug Application for Oral EGFR Mutant-Selective Inhibitor CO-1686

January 19, 2012 at 09:35 pm

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Clinical studies to begin Q2 2012 Initial development focused on T790M mutation in NSCLC T790M is the dominant cause of acquired resistance to Tarceva®/Iressa® in mutant EGFR NSCLC Unmet medical need with no approved targeted therapy

Clovis Oncology, Inc. (Nasdaq: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's investigational new drug (IND) application to begin clinical investigation of CO-1686, a novel, oral, targeted covalent inhibitor of epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC).

Initial Phase I/II studies are expected to commence in the U.S. and Europe during the second quarter of 2012 and in Asia during the third quarter of 2012. Following the establishment of the appropriate dose, Clovis intends to study CO-1686 in an expansion cohort of NSCLC patients who have failed either Tarceva^® or Iressa^® and have developed a secondary mutation, T790M, which is the dominant resistance mechanism to Tarceva and Iressa. Clovis is developing a companion diagnostic in collaboration with its partner Roche Molecular Systems, Inc. to identify patients with the T790M mutation.

"We are pleased to advance the CO-1686 development program into the clinic and we look forward to initiating clinical studies in the U.S., Europe and Asia over the next several months," said Patrick J. Mahaffy, president and CEO of Clovis Oncology. "This patient population represents a very important unmet medical need. Our focus on NSCLC patients with T790M mutations is a further example of our commitment to developing patient-specific therapies with a companion diagnostic to identify those most likely to benefit from their use."

EGFR activating mutations occur in approximately 10 to 15 percent of NSCLC cases in Caucasian patients and approximately 30 to 35 percent in East Asian patients. These patients experience significant tumor response to Tarceva and Iressa, which are first-generation EGFR inhibitors. However, most patients ultimately progress on Tarceva and Iressa therapy, with approximately 50 percent of patients developing acquired resistance from a second, or "gatekeeper" mutation, T790M.

Clovis, in collaboration with Avila Therapeutics, Inc, designed and developed CO-1686 to selectively target both the initial activating EGFR mutations as well as the T790M mutation, while sparing wild-type, or "normal" EGFR. Because CO-1686 spares wild-type EGFR, it has the potential to cause a lower incidence of skin rash and diarrhea, the primary toxicities associated with other EGFR inhibitors.

Because CO-1686 inhibits the initial activating mutations of EGFR as well as T790M mutations, it also has the potential to effectively treat first-line NSCLC patients. CO-1686 may prevent the T790M resistance from occurring, which could result in responses of greater duration and, because it does not inhibit wild-type EGFR, it may possess a more tolerable side-effect profile.

CO-1686 is a targeted covalent, or permanent, inhibitor of EGFR mutations. As a covalent drug, CO-1686 forms a durable bond with its target mutations in a highly directed and controlled manner. Preclinical data presented in late 2011 demonstrated that CO-1686 causes tumor shrinkage in T790M-driven NSCLC xenograft models, and resulted in significant tumor growth inhibition at a variety of doses.

About Lung Cancer

Lung cancer is the most common cancer worldwide with 1.35 million new cases annually, with NSCLC accounting for almost 85 percent of all lung cancers. NSCLC progresses rapidly with a five-year survival rate in advanced NSCLC patients of less than five percent. Activating EGFR mutations are key drivers of NSCLC malignancies in 10 to 15 percent of patients of Caucasian descent and approximately 30 to 35 percent of patients of East Asian descent.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK.