Based: Rockville, MD
The Scoop: Nothing about this company fits the mold for a successful start-up. Its research relies on a toxic material to fight cancer. The biotech has been largely funded by grants or small investors. It has a tiny staff and huge aspirations. But Lawrence Tamarkin, PhD, has never given up, and now he's preparing for a Phase II trial. If he's right, CytImmune's nano-strategy is golden.
What makes it Fierce: CytImmune is all about using gold nanoparticles to deliver a payload of a very toxic cancer therapy--tumor necrosis factor--right in the tumor, where it can do the most good and the least harm.
"The doses we were able to give in clinical trial exceed the previous maximum tolerated does by threefold," says Tamarkin about his lead program, CTT-6091. "Even more interesting, the circulating exposure to TNF is 30-fold higher to what was previously experienced with TNF alone with no toxicity."
Tamarkin has good reason to be excited by the positive end of Phase I and the prospective launch of Phase II in September. CytImmune has been heading to this point on a shoestring budget, its tiny staff fuelled largely by angel investors, grants and his own money. While the headlines in the industry focus on major collaborations and monied partnerships, Tamarkin has subsisted largely on his own belief that he could be on to something big.
"A lot of people have given up on TNF," says Tamarkind. "This is a very potent therapy that has some serious questions about its safety." But that's all the more reason to be cheered by a successful safety study.
There's very little space between success and failure for CytImmune. Rededicated as a therapeutics company in the mid-90s, CytImmune now is closing in on a major milestone in its development.
"A year from now," says the CEO, "we should have a reasonable sense of whether we have something that dramatically changes the way we treat cancer, or not."
What to look for: Phase IIb will be a big influence on CytImmune's future. Tamarkin says that good data at the mid-stage level will set up partnerships for Japan and Europe. New money could propel the company forward, eventually leading to a possible IPO.