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2011 or early 2012, Bosley said. It’s unclear when the Dana-Farber molecule is going to begin being tested in humans; the case is pending, and the parties involved in the case at Dana-Farber, Gatekeeper, and Novartis have declined to comment on the program.
Dana-Farber’s researchers’ work in this area predates the collaboration that Avila and Clovis announced in May, however. The Dana-Farber scientists and their colleagues published their findings about a molecule against drug-resistant lung cancer in a 2009 paper in the prestigious journal Nature. The group showed its molecule could bond covalently with mutated forms of the EGFR protein while having limited effects on the normal form of the protein in lab experiments. Since the normal EGFR protein plays important roles throughout the body, limiting a drug’s interaction with it could potentially reduce side effects on healthy tissues.
“The Nature paper from the Dana-Farber folks certainly brought more attention to the area in terms of demonstrating the possibility of hitting this profile that really matches up with the clinical need,” Avila’s Bosley said.
In March 2009, Dana-Farber researchers and others co-founded Gatekeeper to commercialize their molecule and related ones as treatments for resistant lung cancer. The firm gained an option to license the technology in June 2009 from Dana-Farber. In August, however, Dana-Farber informed the startup that it believed the technology was subject to the cancer institute’s collaborative research agreement with Novartis. The Swiss drug maker has the first option to license discoveries at the cancer institute that are funded through that agreement. In September, Dana-Farber filed suit against Gatekeeper, asking the court to declare that it has “complied with its obligations under the Gatekeeper Option Agreement” and to excuse the cancer institute from “any further performance under” the agreement.
The dispute calls into question which company will take Dana-Farber’s molecule into clinical trials. Yet the rival program at Avila appears to moving ahead with financial support from Clovis.
Avila’s drug is designed to block multiple mutations of EGFR, including T790M, with a single molecule, making it a potential first-option treatment for non-small cell lung cancer as well as a potential treatment for patients whose tumors have developed resistance to erlotinib or gefitinib. Avila’s potential edge over others in developing such a molecule is that it has a broad platform and proven track record discovering covalent drugs against specific targets, Bosley says, and its partner, Clovis, has extensive experience in cancer drug development.
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