Like many small biotechs, San Antonio, TX-based GenSpera has plenty of options for developing its cancer drug and limited resources to do so.
While GenSpera’s treatment, called mipsagargin or G-202, has potential to treat cancers ranging from brain to liver to prostate, the company is limited by funding. GenSpera raised $2.5 million in December, which it is targeting to help pay for an ongoing Phase 2 study for G-202’s use in glioblastoma multiforme, a fast-growing brain tumor.
So far, the study has been primarily conducted at the University of California San Diego Moores Cancer Center and is now being expanded to the John Wayne Cancer Institute in Santa Monica, CA, the company said in a letter to shareholders in January. GenSpera (OTC: GNSZ) is using the expanded study to attempt to include more patients who have a high level of an enzyme that triggers the company’s drug, which subsequently kills the tumor cells, after already finding success in those patients in early tests, says CEO Craig Dionne.
While the company has operated on a lean budget over the last few years, raising a few million dollars here and there to fund its clinical studies, Dionne says he expects the results of the coming tests will help build out the business so it can move into advanced clinical trials. Founded in 2003, GenSpera has for years been testing and seeking partnerships to develop its novel cancer treatment, which Xconomy’s Bernadette Tansey profiled in an engaging and detailed story in 2014.
“It allows us to collect more [glioblastoma multiforme] data, and especially go to the FDA and get buy-in on our clinical development plan,” Dionne says about the new funding. “We’ve been talking to potential partners for a couple of years. Scientists are skeptical folks. You walk in the door with great data, and they say, ‘Where did this come from?’ … They get to know you. Then they realize it’s real.”
If all goes well with the Phase 2 study at John Wayne, GenSpera may be looking for another larger funding round in late 2016 to pay for a randomized study for the brain cancer treatment. And, Dionne says, the company is exploring other options for the drug candidate.
GenSpera has completed a Phase 2 study for its treatment for liver cancer, which has a sizeable patient population in East Asia—700,000 diagnoses in mainland China each year, compared with as many as 13,000 annually in the U.S., Dionne says. (Statistics vary about the number of annual diagnoses; 75 percent of new worldwide liver cancer cases in men and two-thirds of the world’s new liver cancer cases in women occur in 15 Asian countries, according to a 2008 study from Pfizer.) The company is seeking a partner to help develop the treatment for the disease there, and has put development on the backburner until it finds one, he says.
GenSpera is also working on using G-202 on prostate cancer patients with highly progressed tumors. The company is beginning a Phase 2 study of at the University of Texas Health Science Center at Houston in the second quarter this year, Dionne says.
Developed by Dionne and collaborators at Johns Hopkins University in the 1990s, GenSpera’s therapy is based in a toxin, thapsigargin, which is found in a weed called Thapsia Garganica. Converting the toxin into a drug that is safe to use in the body is complicated because of its potential to destroy any kind of cells, not just tumors, as Xconomy reported in 2014. The resultant drug is based on the scientists’ chemical tinkering.
As GenSpera enters into the study at John Wayne, where GenSpera’s board member, Santosh Kesari, is the chair of the Department of Translational Neuro-Oncology and Neurotherapeutics, the company has enough funding to carry it through late 2016, Dionne says. It has raised approximately $35 million to date through the sales of equity and the exercise of warrants.