For its first five years, VentiRx Pharmaceuticals had an unusual setup in which it was based in two places, with a drug development team in Seattle, and the business and administrative operation in San Diego. Now it’s all being merged together in Seattle, as the company looks to conserve cash and concentrate its efforts on doing one thing well—cancer drug development.
VentiRx co-founder and longtime executive vice president Rob Hershberg has stepped up to oversee the day-to-day operations as both president and chief medical officer, while fellow co-founder Mike Kamdar has resigned as executive vice president and chief business officer. VentiRx has finished developing its drug candidate for seasonal allergies, and is now shifting all of its efforts to an experimental immune-booster for cancer, Hershberg says. The San Diego office will be shut down at the end of this year, he says.
“It’s a natural transition for the company, given our development focus, and that our development team is in Seattle. We want to preserve resources,” Hershberg says. “There’s so much talent in Seattle, and it really makes sense as we focus on oncology, for us to focus on one site and be as efficient as we can possibly be.”
Kamdar added in an e-mail that since the company is running important trials now, and has “no fundraising/limited partnering on the horizon,” it was time for him to resign. He said he is keeping a seat on the VentiRx board, and says he’s “very optimistic” about the company’s prospects.
VentiRx will now zero in all its efforts on an immune-boosting compound for cancer that it hopes will represent the next step ahead in the field since a couple of trailblazing treatments from Dendreon and Bristol-Myers Squibb secured FDA approval. VentiRx, founded in 2006, has raised $51.6 million from a syndicate that includes MedImmuneVentures, Arch Venture Partners, Frazier Healthcare Ventures, and Domain Associates. The last round of $25 million arrived in January 2010. The company has 12 employees, and leans on a network of contract firms to get the rest of its work done.
The big idea at VentiRx, which I’ve covered here before, is to create conventional small molecule drugs that stimulate Toll-like receptors (TLRs), specifically one called TLR8. The family of TLRs are key components of the body’s innate immune system-the first-line defense that recognizes foreign invaders at their point of entry under the skin, in the mucus linings of the nose, and in the gut. VentiRx’s lead drug candidate, VTX-2337, is designed to be given in a once-weekly injection just under the skin, by a medical professional. It is meant to stimulate TLR8, Hershberg says.
The plan at VentiRx now hinges on four clinical trials at various stages, with an ultimate goal of boosting the effectiveness of existing chemotherapy or targeted antibody drugs, he says. One trial among patients with ovarian cancer is currently in early-stage testing to assess safety, although the study is designed to quickly switch into a 200-patient trial. Once VentiRx’s drug passes the initial safety phase, patients will be randomly assigned to get the immune-boosting drug from VentiRx in combination with a chemo drug known as doxorubicin, or the chemo drug alone. That study will be designed to show whether patients live longer on the combination—the gold standard of evidence for new cancer drugs, and a measurement where immune therapies have some proven track record.
The other VentiRx trial will be in patients with breast cancer, with 75 patients at the Mayo Clinic’s sites in Rochester, MN and Scottsdale, AZ, Hershberg says. A third trial, at the Fred Hutchinson Cancer Research Center in Seattle, will look at whether the VentiRx immune booster can enhance the effect of Eli Lilly’s cetuximab (Erbitux) in patients with head and neck cancer, Hershberg says. Based on animal studies, Hershberg says there’s reason to believe that the VentiRx drug can augment cetuximab’s ability to spur an anti-tumor immune reaction known as antibody-dependent cellular cytotoxicity (ADCC). A fourth study, in collaboration with Ron Levy’s lab at Stanford University, will examine whether a direct injection of the VentiRx drug into tumors, in combination with radiation, will help patients with non-Hodgkin’s lymphoma.
“We think there’s broad utility. Our clear focus now is in combination with chemotherapy and monoclonal antibodies,” Hershberg says. “For a company our size, with 12 employees, we are doing four clinical trials—two of which in early 2012 will be randomized, controlled trials, including one that’s 200 patients with a survival endpoint. We’re narrowing down on our focus, for sure. The real challenge for us is that we have an embarrassment of riches. There are so many opportunities to combine this agent, we need to be judicious with our resources to pick the best opportunities.”
If VentiRx can produce some convincing data for doctors, patients, regulators, and insurers, it could someday have a convenience advantage over a first-generation immunotherapy like Dendreon’s sipuleucel-T (Provenge). The Dendreon drug uses a genetically engineered drug to stimulate a patient’s own white blood cells to fight cancer, which are given back as an intravenous infusion. The VentiRx drug is a conventional small molecule, meaning it’s cheap and easy to make reproducibly, and it can be given in a weekly shot. Like other immunotherapies, it has shown a mild side effect profile in early studies, meaning it should be easy to combine with more conventional antitumor drugs, like chemo and antibodies, without adding much toxicity, Hershberg says.