that cancer and inflammatory diseases like allergies can be treated by stimulating a target on cells of the innate immune system, called TLR8. Stimulating these cells may amp up the immune system to start killing all sorts of cancer cells alongside traditional chemotherapy. It also ought to work for allergies by creating a diversion of sorts for the immune system, so it doesn’t overreact and cause itchy eyes, and stuffy, runny nose when encountering all the usual microbes and particles people encounter everyday, Hershberg says.
Berkeley, CA-based Dynavax Technologies and Cambridge, MA-based Idera Pharmaceuticals are a couple of competitors who are pursuing similar ideas with other members of the TLR family, although VentiRx says it is the first to introduce a TLR8 stimulator into clinical trials, Hershberg says. More and more academics are writing papers about this target, providing validation for the work that VentiRx started here in 2005.
VentiRx has enrolled 18 patients in its first clinical trial of its drug candidate for cancer, and so far it appears safe. There is also some biological evidence that the drug is acting as desired, even at less-than-optimal doses. The company will keep dosing at least six more patients at a couple of higher doses before moving to the next step with this product, dubbed, VTX-2337.
The second drug does the same thing, stimulating TLR8, but it in a completely different way. VentiRx has created a new drug for this condition that is given in much lower doses, in a nasal spray given once a week. It’s supposed to create the diversion in the mucosal membranes of the nose as a way of essentially tricking the immune system in that sensitive place into not going berserk when encountering common allergens that cause allergies. About 30 million people complain of allergies in the U.S., so the market for a treatment that’s safe, effective, and convenient is potentially huge.
The company started a trial back in April in Europe, enrolled 37 healthy volunteers, and found its nasal spray was safe and well-tolerated. Now it’s getting ready for a more rigorous study in the first quarter of 2010, with about 60 patients who get a variety of doses of the VentiRx drug, VTX-1463, or a placebo. These people will be kept inside an enclosed chamber and exposed to allergens, to see if the VentiRx treatment really protects them or not.
That will cost money. While Hershberg won’t say how much gas VentiRx has left in its tank, he says it has enough to finish that study, which has potential to boost the company’s valuation a lot higher than it is now.
What will happen if VentiRx reaches it goal and finds a big partner to pick up one or both of its two drugs and take them through later stages of development? The obvious answer is that it would get acquired, like BiPar. Whether that happens eventually, or it forms a partnership, Hershberg says he can imagine similar scenarios playing out. Either way, he likes the idea of keeping his team together, prowling around for some other cancer or allergy drug that Big Pharma hasn’t yet fully appreciated, and building up its value through the early phases of development. He sees it as a way to achieve something big, while keeping the company itself small.
“We really have a good little engine,” Hershberg says. “I like our size and nimbleness.”
