The people at Seattle Genetics think they have a blockbuster-drug-in-the-making for Hodgkin’s disease. Tom Reynolds is the guy whose job it is to prove it to the world.
Few drugs ever demonstrate the kind of promise SGN-35 did in its initial clinical trial in June, says Reynolds, the company’s chief medical officer. The drug showed about half of patients had partial or total elimination of their tumors, even at much lower-than-expected doses, with limited side effects for a cancer drug. “This sounds like Gleevec. It sounds like Rituxan,” Reynolds says, referring to two of the biggest-selling cancer drugs ever, from Novartis (NYSE: [[ticker:NOVN]]) and Genentech (NYSE: [[ticker:DNA]]). With SGN-35, he says: “We are blessed. This drug will make it. It will help people.”
Seattle Genetics (NASDAQ: [[ticker:SGEN]]) has been on a roll this year, with its stock climbing 27 percent since June 3, when it announced SGN-35 results at the American Society of Clinical Oncology meeting. An estimated 8,000 patients in the U.S. are diagnosed with Hodgkin’s each year, looking for something new. Yet this is a company that’s been around for 10 years and hasn’t yet taken a drug into the final stage of clinical trials, much less delivered on its goal of creating a single marketed cancer drug. In the seven years I’ve covered the company, its lead drug candidates—SGN-10, SGN-15, and SGN-30—were never able to get over the hump with a successful Phase III clinical trial.
So what’s different now?
For one, SGN-35 is a different kind of drug. It’s an engineered antibody that can seek out cancer in the body, avoid healthy tissues, and also dump a tumor-killing dose of chemotherapy inside the tumor cells. The biggest-selling products in cancer treatment today, Genentech’s Avastin and Rituxan, are engineered antibodies that hit a specific target on cells, but they aren’t attached to toxic chemotherapy payloads that could give them more punch.
For another thing, Reynolds, 49, is there. He’s still relatively new, having started in March 2007. His resume is a little unconventional for the job. He is a scientist by training, with his Ph.D. and M.D. in biophysics from Stanford University. He was originally drafted to do development and clinical trial work at Seattle-based Targeted Genetics, he says, even though he is not a board-certified physician who treats patients. What he does have is more than 15 years’ experience in biotech drug development, making the rounds at all the major “genetics” companies in Seattle—Targeted Genetics, then ZymoGenetics, and now Seattle Genetics. He comes across as a true Northwesterner—as someone who likes to climb mountains and go kayaking in the San Juan Islands—and he complained a bit about the daily commute from his house on Mercer Island.
In his last job, at ZymoGenetics, Reynolds was vice president of medical affairs and oversaw the clinical development and new drug application for what became that company’s first marketed product, Recothrom. By his count, he’s worked on about a dozen applications to begin trials of experimental drugs, including some work with cancer treatments at Targeted Genetics.
At Seattle Genetics, the data is so promising, he says, that the company is holding meetings with the FDA to see if it can skip the middle stage of trials and go straight to a pivotal study that can prove the drug works, so it can get on the market as quickly as possible.
