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Avila Therapeutics Pursuing Rival to Lung Cancer Drug in Dana-Farber Lawsuit

An experimental lung cancer drug discovered at Boston’s Dana-Farber Cancer Institute is currently at the center of a lawsuit involving Dana-Farber, Swiss drug giant Novartis, and Millbrae, CA-based Gatekeeper Pharmaceuticals. But while that complicated case continues to unfold, Waltham, MA-based biotech startup Avila Therapeutics is working on a similar molecule, which is designed to treat certain drug-resistant forms of lung cancer.

Avila, founded in 2007, has gained wide attention for its covalent drug chemistry, which enables drug molecules to form strong bonds with disease proteins and block their activity. Its lead molecules target hepatitis C virus as well as a protein involved in certain B cell cancers and autoimmune diseases. The durable bonds its drugs are designed to form with disease proteins offer potential advantages such as reducing the dosages patients need to take for the therapy to be effective and limiting treatments’ toxic side effects.

Since this spring, Avila has been applying its covalent drug technology in a $209 million partnership with Boulder, CO-based Clovis Oncology to discover new treatments for non-small cell lung cancers that are resistant to Roche and OSI Pharmaceuticals’ blockbuster cancer pill erlotinib (Tarceva) and AstraZeneca’s gefitinib (Iressa). The cancer’s resistance to those existing therapies is often linked to a mutation (called the T790M mutation) in the gene for a protein called an epidermal growth factor receptor (EGFR).

There’s a huge amount of interest in new lung cancer treatments among drug developers. Lung cancer is the leading cause of cancer deaths among men and women in the U.S., according to the National Cancer Institute. Non-small cell lung cancer, the most common type of lung cancer, is fueling a lot of the activity; New York-based drug giant Pfizer and German drug maker Boehringer Ingelheim both have drugs for this type of lung cancer in late-stage clinical trials, for example. There are many more companies at earlier stages of developing drugs against non-small cell lung cancer.

Even though Avila’s and Dana-Farber’s efforts in this crowded field are relatively young, both are notable because they aim to produce drugs that target tumor cells with a specific mutation of EGFR linked to drug resistance while sparing healthy tissues. Studies indicate that most patients who take erlotinib or gefitinib develop resistance to the drugs most often after a year, and the T790M mutation is involved in half of those cases of resistance. “That’s a real motivator to try to develop a drug candidate as soon as possible,” said Katrine Bosley, Avila’s CEO. “I think that’s why there is such a strong interest in this area—because it’s such a real clinical problem.”

Avila and Clovis are hoping to ask the FDA for permission to begin human studies with a drug from their ongoing research collaboration by the end of … Next Page »

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