Avila Announces Selection of Clinical Drug Candidate in EGFR Mutant-Selective Inhibitor Alliance with Clovis Oncology

IND Filing Expected in First Half of 2012

WALTHAM, Mass.--(BUSINESS WIRE)--Avila Therapeutics, Inc. a biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, announced that it has achieved a significant goal in its alliance with Clovis Oncology, Inc. Together, the partners have selected a drug candidate to advance into clinical development from the Epidermal Growth Factor Receptor (EGFR) Mutant-Selective Inhibitor (EMSI) alliance with Clovis Oncology.

The selected drug candidate, CO-1686 (AVL-301), has demonstrated encouraging tumor regression activity in animal models carrying both the activating mutation of EGFR and the T790M ("gatekeeper") mutation that is resistant to approved drug therapies. CO-1686 demonstrates no significant inhibition of normal ("wildtype") EGFR, which is a source of dose-limiting toxicities for current EGFR-targeted therapies. Clovis is now advancing the drug candidate in preclinical development for the treatment of non-small cell lung cancer (NSCLC). Developing in parallel a corresponding molecular companion diagnostic with Roche Molecular Diagnosticsin parallel, Clovis plans to file an IND application for CO-1686 in the first half of 2012.

"We have made excellent progress in advancing this EGFR Mutant-Selective Inhibitor program, further validating the robustness of Avila's platform and our ability to design targeted covalent drugs," said Katrine S. Bosley, CEO of Avila Therapeutics. "This partnered program with Clovis, along with Avila's proprietary clinical program targeting Bruton's Tyrosine Kinase (Btk), show our advancement of drug candidates and exemplify the range of important problems that can be solved with targeted covalent drugs."

About Lung Cancer and the EMSI Program

 Lung cancer is the most common cancer worldwide with 1.35 million new cases annually, and NSCLC accounting for almost 85 percent of all lung cancers. Activating EGFR mutations are key drivers of NSCLC malignancy in 10-15% of patients of European descent and approximately 30% of patients of East Asian descent. Currently, agents for the treatment of NSCLC patients include Tarceva® and Iressa®, both non-selective EGFR inhibitors. Both agents have significant side effects related to inhibition of the wild-type (normal) EGFR, and acquired resistance to both agents occurs after a median of 12 months, driven in approximately 50% of cases by a "gatekeeper mutation" called T790M. Patients with tumors containing this secondary mutation are resistant to both current therapy and second generation pan-ErbB inhibitors currently in clinical development.

By inhibiting both T790M and the initial activating mutations, the EMSI program offers the prospect of effective drug treatment for first and second-line NSCLC patients with activating EGFR mutations. With sparing of the wild-type EGFR, the EMSI program could also offer a much improved therapeutic window compared to current therapies in a first-line setting.

About Targeted Covalent Drugs

 Covalent drugs are uniquely able to establish a strong and enduring ‘bond' - exceeding the more temporary ‘binding' of conventional drugs - to completely shut down the activity of, and silence, a disease-causing protein. Covalent drugs may provide prolonged duration of action through this silencing of the disease target, and have the potential for unique therapeutic benefits because they are targeted and effective against mutations.

Avila currently has three covalent drug programs in development, both proprietary and partnered, including partnerships with sanofi-aventis, Clovis Oncology and Novartis Option Fund.

About the Avila Alliance with Clovis Oncology

 Avila and Clovis Oncology entered into a partnership for the worldwide development and commercialization of a EGFR Mutant-Selective Inhibitor (EMSI) in May 2010. Under the terms of the agreement, the two companies collaborated on the preclinical development of the EMSI program and Clovis Oncology is fully responsible for worldwide development and commercialization, including development of companion diagnostics to prospectively identify patients with clinically-arising resistance mutations of the EGFR. Avila is eligible to receive development, regulatory and sales-based milestone payments, with a total potential value of $209 million, as well as tiered royalties on potential future product sales.

About Avila TherapeuticsTM, Inc.

 Avila Therapeutics is a clinical-stage biotechnology company focused on the design and development of targeted covalent drugs to achieve best-in class outcomes. This approach, called "protein silencing", cannot be achieved through traditional chemistry techniques. The company's product pipeline has been built using its proprietary AvilomicsTM platform and is currently focused on cancer, viral infection and autoimmune disease. Avila's most advanced product candidate, AVL-292, a potential treatment for cancer and autoimmune diseases, is currently in Phase 1 clinical testing. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners. For additional information, please visit http://www.avilatx.com.

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