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a small molecule drug, idelalisib, that’s designed to selectively hit the “delta” variation of the PI3 kinase molecular target. The PI3 kinase family is involved in tumor growth and proliferation, and has been one of the hot targets in cancer biology for years. Calistoga had already shown some impressive data from early clinical trials that said its drug was potent for patients with chronic lymphocytic leukemia, slow-growing or “indolent” non-Hodgkin’s lymphoma, and mantle cell lymphoma. Gilead presented data in December that said this new drug, given in combo with Genentech’s rituximab (Rituxan) and bendamustine chemotherapy, shrank tumors and lymph nodes in 87 percent of patients with chronic lymphocytic leukemia. The study was small, just 52 patients, but the side effects of the new drug were minimal, and it had a long-lasting effect. About 63 percent of the patients still hadn’t seen any tumor progression after two years of follow-up.
If you wonder whether Gilead might have overpaid, consider this: Cambridge, MA-based Infinity Pharmaceuticals (NASDAQ: INFI) has seen its valuation climb to $2.3 billion mainly because of some encouraging, preliminary data for its rival drug that also inhibits the PI3 kinase “delta” variation. And Infinity’s program is years behind Gilead’s in clinical development, by my estimation. Given how many patients could benefit, the likely high price, and the need for patients to stay on this well-tolerated drug for years, it’s easy to imagine it becoming a multi-billion dollar seller in the latter half of this decade.
March 2011: Gilead looked to strengthen its cancer drug discovery capabilities through a sponsored research agreement with Yale University. Gilead agreed to pay $40 million over four years, with an option to extend the deal to 10 years, in exchange for the first shot at commercializing innovations that arise from the partnership.
August 2011: Gilead, traditionally strong in small-molecule chemistry, agreed to acquire a 70,000-square-foot biotech drug manufacturing facility in Oceanside, CA, from Genentech. This deal gave Gilead tons of equipment and infrastructure for making antibody drugs, plus 55 employees from Genentech who know how to make biologic drugs at commercial scale. The facility, Gilead said, would be used to start making larger batches of the antibody drug it acquired from Arresto Biosciences for fibrotic diseases and cancer.
April 2012: Gilead struck a partnership with Lebanon, NH-based Adimab, a prolific antibody drug discovery shop, asking Adimab to make optimal antibodies against two undisclosed molecular targets. Later that month, Gilead formed another partnership with an innovative biotech company, San Diego-based AnaptysBio, another company with considerable antibody discovery skills.
December 2012: Gilead announced a deal to pay $510 million to acquire Mississauga, Ontario-based YM Biosciences. This takeover, like the previous CGI and Calistoga deals, enabled Gilead to get into another one of the competitive fields of cancer and inflammation biology, by getting drugs that go after the JAK1 and JAK2 molecular targets. As Bruce Booth, a partner at Atlas Venture, pointed out on his blog March 13, Wilmington, DE-based Incyte (NASDAQ: INCY) became a $3 billion company on the basis of its JAK2 inhibitor, called ruxolitinib (Jakafi). Pfizer also has a JAK1/3 inhibitor on the market, and Johnson & Johnson, AstraZeneca, and Novartis are all active in this field.
January 2013: Gilead formed a collaboration with Rockville, MD-based Macrogenics, that could be worth more than $1 billion over time to the little company. This deal gave Gilead access to technology for developing “bispecific” antibodies that can precisely hit two molecular targets simultaneously, not just one. Many of the biggest players in biologics—Genentech, Amgen, and Biogen Idec for sure—have been pouring resources into bispecifics because of their potential in treating complex autoimmune diseases.
OK, that’s a lot of action over two years. Roll it all together, and here’s what it says to me: Gilead is for real in cancer and inflammation. It has gotten its hands on some of the very best small-molecule cancer drug candidates that are going after some of the hottest targets in biology — Syk, PI3k delta, and JAK1/2. In places where small-molecules aren’t the best, it has built up capabilities for discovering, developing, and manufacturing targeted antibodies. It has decided to lean on some of the best small companies in the antibody field. It has gotten in touch with some of the best academic cancer researchers at Yale, who are thinking further in the future. It lured away Baynes from Amgen a little more than a year ago, and gave him the opportunity to build a franchise in cancer and inflammatory drugs.
Baynes is a low-key guy when you meet him in person, but if you listen carefully to what he’s saying, it’s audacious.
“Our goal is to get to a steady-state pipeline by about 2015,” Baynes says of the cancer portfolio. That means, he says, that Gilead wants to have a variety of drug programs at the early discovery stage, in preclinical development, and moving along in all three phases of clinical trials.
That’s bold talk for a company that doesn’t have a single cancer drug on the market. A ton of things could go wrong.
But Gilead is showing there’s a clear strategy, and discipline, at work. It isn’t afraid to spend some big money to go after this opportunity it sees. The PI3 kinase drug that it acquired from Calistoga, for example, is moving ahead in five simultaneous Phase III clinical trials of patients with relapsed forms of chronic lymphocytic leukemia and indolent non-Hodgkin’s lymphoma. Baynes wouldn’t disclose the budget for this clinical development plan, or the timeline for when results are expected, but these five trials are all well-designed, randomized studies that are recruiting a total of 1,585 patients.
Not far behind in development, Baynes says, Gilead is looking at the drug’s potential to move into first-line treatment, where it can benefit even more patients. Besides this compound, idelalisib, it has four other drug candidates in various stages of clinical trials.
Some people are starting to notice what’s up at Gilead, and some haven’t noticed, but that’s OK, Baynes says. Soon enough, they’ll see.
“I’d say awareness is growing, but we’re certainly not at the zenith, if you will, of oncology name recognition,” Baynes says. “A slow ramp is also not a bad thing. We want to get the work done, and let the results speak for themselves.”