A clinical-stage pharmaceutical company with a vaccine it says uses a single antigen to protect against both fungal and bacterial infections is looking for a series B round to fund phase 2 trials for hospital-associated infection and women’s health applications next year.
NovaDigm Therapeutics’ lead product, the NDV-3 vaccine, targets the fungal infection candida and the bacterial infection staphylococcus aureus (including MRSA). It contains a protein called Als3, which is found on the surface of candida cells and allows them to attach to and invade human host cells. Structurally, the protein is similar to proteins on the surface of staph or MRSA, and in preclinical studies, the vaccine reduced mortality in otherwise lethal doses of both pathogens.
The synthetic version of the protein used in the vaccine is produced by the fermentation of yeast cells, according to CEO Timothy Cooke.
NovaDigm just released positive data for a phase 1 trial of the vaccine, which demonstrated that a single dose was safe, well tolerated and induced strong antibody and T-cell immune response in healthy humans.
The company’s next study, slated to begin next year, will test the vaccine when used to prevent chronic vaginal yeast infections in women with recurrent vulvovaginal candidiasis. There is an apparent market need for prevention and treatment of this condition, which affects 5 million women, Cooke said. And because of the large patient pool and frequency of recurrence in this condition, the trials will be much cheaper and smaller than trials for use of the vaccine in a hospital setting.
Although the company plans to continue working in parallel with both applications of the vaccine, a vaccine for prevention of vulvovaginal candidiasis will likely be the company’s first product to market. Cooke said NovaDigm has enough money to get through a phase 2 trial for the vulvovaginal candidiasis application but is currently looking for a series B round to fund the staph studies.
An estimated 1.7 million nonsocomial infections are diagnosed each year in the U.S. and about one-third of them are preventable, according to the Centers for Disease Control and Prevention. Although the market for antibiotics has suffered from the introduction of generics, a market report from the Freedonia Group forecasts that the demand for infection prevention products will rise through 2015.
Cooke said NovaDigm’s vaccine looks so promising because it appears to increase antibody levels and T-cell activation in humans, and to do so fairly quickly. “A lot of what we think is important is getting not just the antibody side of the immune response, but getting the T-cell immune response for staph,” he said. “We have both in our vaccine.”
Staph infections have been a target among Big Pharma companies — Pfizer, GSK and Novartis all have phase 1 vaccine projects, and up until they pulled the plug on a clinical trial last year, Merck and Intercell were leading the pack. The market for candida vaccines is less competitive, with Novartis and two other smaller biotechs in the mix.