Dr. David Schenkein, a hematologist and CEO of Agios Pharmaceuticals, has worked with the FDA and others on crafting guidelines for the coveted "Breakthrough Therapy" stamp and accelerated approvals from the agency. Toward his company's ambitions to advance its own breakthrough cancer drugs, Agios has teamed up with Foundation Medicine--a 2012 Fierce 15 company--to find patients with the genetic profiles most suited to treatment on Agios therapies concerning two cancer metabolism targets.
"Absolutely core and central to the Breakthrough Therapy concept is identifying the right patient," Schenkein, a former Genentech and Millennium research executive, said in an interview with FierceBiotech, "and that's where Foundation Medicine comes in as an important player, so that we have a roadmap [and] know who to treat."
Launched in 2008, Cambridge, MA-based Agios has raised an impressive $261 million to gain an inside track on new therapies against metabolic targets in cancer and genetic disorders. The 2009 Fierce 15 company has scored more than half of those funds from pharma player Celgene ($CELG), which has gambled heavily on Agios in a major cancer metabolism partnership. The deal gives Celgene dibs on licensing compounds at the heart of the biotech startup's new collaboration with Foundation, where Schenkein has served on the board of directors since 2010. Agios and Foundation, which did not disclosed financial details of their agreement, share a common investor in Third Rock Ventures as well.
From different sides, both Cambridge-based Foundation and Agios were built to support personalized cancer treatment--Foundation with a genomic sequencing test that matches a patients' genes with appropriate drugs, and Agios to create targeted therapies. The FDA has also shown enthusiasm for the targeted approach, awarding developers this year with "Breakthrough Therapy" status for compounds that show major benefits for patients in early trials and giving those companies a shot at relatively rapid approvals on those drugs.
Within the next 12 to 18 months, Schenkein said, Agios expects to begin clinical development of the candidates involved in the Foundation agreement. The compounds home in on metabolic enzymes from mutated isocitrate dehydrogenase 1 (IDH1) and 2 (IDH2) genes, which are corrupted in a variety of blood and solid tumors and produce metabolites that drive cancer growth. The mutations are found in about a quarter of adult cases of acute leukemia, more than 70% of patients with brain cancer known as glioma and about one in 5 cases of bile duct cancer, according to the CEO.
After initial PCR-enabled tests qualify patients with IDH1 or IDH2 mutations for Phase I trials, Schenkein said, Foundation Medicine is expected to analyze samples from study patients to home in on co-mutations to enable Agios to characterize which patients are the best candidates for its therapies. Foundation adds Agios to a list of other pharma collaborators such as Celgene, Novartis ($NVS), Sanofi ($SNY), Johnson & Johnson ($JNJ) and AstraZeneca ($AZN).
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| Michael J. Pellini, CEO of Foundation Medicine |
"Foundation Medicine's comprehensive cancer genomic profile helps match a patient's individual molecular alterations with relevant targeted therapies," Foundation CEO Michael Pellini said in a press release. "For this reason, it is important for us to partner with innovative biopharmaceutical companies like Agios to help expand the number of targeted therapies available and open new treatment options for patients."
For Agios, the data from Foundation would help the biotech develop a companion diagnostic for therapies that pass muster in clinical trials. Schenkein, a practicing physician specializing in hematological cancers at Tufts, has been committed to pairing targeted drugs with diagnostics since working at Genentech on treatments such as Herceptin, which requires breast cancer patients to get a HER2 test before they begin treatment. He took his passion for drug-diagnostic combos Agios, where he became CEO in 2009.
"It's been a core value for us here at Agios," Schenkein said, "that ... we're not going to move any oncology molecules into the clinic unless we can identify the right patient as early as Phase I using some kind of companion diagnostic."
- here's the Foundation release
Special Reports: Agios Pharmaceuticals - 2009 Fierce 15 | Foundation Medicine - 2012 Fierce 15