hook together proteins in such a way as to overcome one of the fundamental challenges that has plagued immunotherapy for years. The idea is to assemble the proteins so that the immune system truly recognizes them as an invader that must be attacked, and not just another protein that looks like healthy tissue, and should be avoided.
This gets into some heavy duty, complicated immunology in a hurry, which I’m not going to dive into here. But in its prospectus to investors, Kaleetan certainly describes an interesting concept. Kaleetan isn’t saying which antigens—protein markers on cancer cells—it is pursuing, although it says its method will allow it to activate specific receptors on dendritic cells “potently and selectively.” This is different than a lot of classic vaccine approaches in the past, which often stimulate a generalized heightened state of immunity, and which struggle to really unmask cancer cells as invaders and attack them, because they often look to the immune system like healthy cells.
Kaleetan is still in its very early days. It is essentially aiming to raise about $3 million, to run a lean operation that should enable it to manufacture small batches to run experiments in dogs, Risdon says. The company’s prospectus says it is focusing on carcinomas, and blood cancers, as well as an immune-boosting treatment for chronic hepatitis B.
One reason for choosing dogs for cancer studies is that they have similar antigens to those found in humans, and another is that more and more canine oncology centers are springing up around the country with capabilities of running multi-center, randomized preclinical trials. The plan is to treat 30 to 50 dogs, on a budget of about $1 million to make the drug and conduct the trial, which could yield the data needed to enter a clinical trial. With $3 million to $6 million, Kaleetan figures it could get through a Phase I clinical trial.
With all the buzz around Dendreon, and the big-time scientific founders, I remarked to Risdon that in years past, an idea like Kaleetan’s could have easily gotten $5 million or more in seed funding. Not so in 2010, as investors have grown more skeptical of some very basic assumptions about biotech. The multi-year slog toward getting valuable data and the many years of big losses no longer seem worth it, given the paltry returns of so many companies. For every Dendreon, there are probably 100 other companies that burned through their capital and never generated value. It’s a sobering lesson to entrepreneurs, and it’s forcing lots of resourceful thinking, about things like getting the maximum bang for the buck in a dog trial, and getting through Phase I on a shoestring. But that’s what Kaleetan is seeking to do, and will have to do, if it wants to ever approach what Dendreon has done for prostate cancer.
“We think we can get an early signal of efficacy, and our hope is that we can get there without very much investment,” Risdon says.
