A promising vaccine for the most common serious infection in people with HIV could reach clinical trials next year if it can attract $2.5 million to $3 million in investments this year.
MiniVax Inc.’s lead product is MVX-504, a vaccine to prevent the fungal infection Pneumocystis pneumonia (PCP), which often develops in the lungs of people with compromised immune systems like HIV/AIDS patients, cancer patients undergoing chemotherapy and organ transplant recipients. It causes pneumonia, fever and respiratory symptoms, and if not treated effectively, can be fatal.
The vaccine uses the antigen “mini-kexin,” part of a protein derived from Pneumocystis, to stimulate an anti-PCP immune response. A secondary product, MVX-505, is being developed as a therapeutic antibody to treat immunocompromised individuals who are already suffering from PCP.
With promising results in early stage studies, MiniVax plans to take its vaccine into clinical trials mid- to late next year, according to CEO A. Ray Chaudhuri. He said the company expects to find out within the next month whether the U.S. Food and Drug Administration will grant orphan drug status to the therapeutic antibody, which will allow an expedited approval path. If it receives orphan drug status, it will run on about the same time line as the vaccine, Chaudhuri said. If not, it will run a few quarters behind.
Currently, the standard of treatment for preventing and treating PCP is trimethoprim/sulfamethoxazole (TMP/SMX), a combination oral antibiotic drug sold under the names Bactrim (Roche), Septra (Monarch Pharmaceuticals) and various generics. It’s inexpensive and thought to be generally effective, but at least one-third of people who take it have an allergic reaction in the form of a skin rash or fever, or develop digestive side effects. Drug resistance with TMP/SMX is also a growing concern.
“Even though there’s competition in this market, there’s no one doing the vaccine for PCP that I’m aware of,” Chaudhuri said. “We’re trying to position it as a product that’s cheaper and more effective in preventing the infection.”
If the vaccine succeeds in trials, it would initially tap into a market comprising 1.1 million Americans with HIV/AIDS (and, eventually, 33 million people across the world). But there’s at least one problem that would remain unsolved: PCP is common in people who do not know they are infected with HIV.
Founded in 2011 with a $600,000 Small Business Innovative Research grant from the National Institutes of Health, MiniVax is now on the hunt for investors and pharmaceutical partners. Chaudhuri estimated the company would need $2.5 million to $3 million to push the vaccine through clinical trials and another $10 million to $12 million over the next two to three years to advance the therapeutic and another bacterial vaccine candidate against the hospital-acquired infection Klebsiella pneumoniae.
MiniVax is a spinout of Louisiana State University Health and Sciences Center, and is housed at the New Orleans BioInnovation Center.
[Photo from piyaphantawong]