It has been more than 20 years since Jonathan Head began work on a vaccine for prostate cancer. Ten years since he and Dr. Robert Elliott founded Baton Rouge-based OncBioMune Pharmaceuticals Inc.,and the company won the first of three U.S. Department of Defense contracts to develop ProscaVax. Four years since the company patented its vaccine platform. Two months since the biopharma company’s shares began trading over the counter under the symbol OBMP and OncBioMune secured a $10.1 million share-purchase agreement/line of credit from equity firm Lincoln Park Capital Fund LLC.
Head, the chief executive officer of OncBioMune, and Andrew Kucharchuk, president and chief financial officer, believe the company is close to commercializing its vaccine. An FDA-approved Phase 1 trial — to make sure ProscaVax is safe for people — is nearing completion at the University of California-San Diego. “There is no toxicity,” Head said.
Next year, Harvard Health System will perform a Phase 2 trial, which will show whether the vaccine is effective.
Head and Kucharchuk expect ProscaVax will be validated.
If that happens, OncBioMune’s next business move may be adding some parking at corporate headquarters so the dump trucks will have plenty of room when they back up to unload the cash.
“If it’s successful, if you capture 10 percent of the market or 20 percent of the market, you’re looking at $1.5 billion a year in revenue,” Kucharchuk said. “Net income would probably be about $900 million.”
In 2015, an estimated 220,800 new cases of prostate cancer will be diagnosed in the United States, according to the American Cancer Society.
The market is huge, and in business terms it’s “a blue ocean,” Kucharchuk said. What that term means is ProscaVax has no real competition because in the early stages of prostate cancer, the treatment is no treatment.
Head puts it another way: “These people are just sitting there and waiting for it (the prostate cancer) to blow up.”
OncBioMune is betting that a lot of those people, and their urologists, would prefer to take some action without risking the morbidities that often accompany surgery and/or radiation: impotence and incontinence.
Prostate tumors, and health cells in the prostate gland, produce a substance known as prostate-specific antigens. Higher PSA levels are associated with prostate cancer.
Normally, the body doesn’t have an immune response to PSA, Head said. OncBioMune used PSA in designing ProscaVax. The vaccine stimulates a patient’s immune system so it attacks the prostate cancer without hurting the patient.
“You kind of switch the light bulb on,” Kucharchuk said.
Dr. Lynn Schuchter, chairwoman of the American Society of Clinical Oncology’s Cancer Research Committee and chief of hematology oncology at the University of Pennsylvania, said researchers have been trying to get cancer vaccines to work for more than 50 years with little success.
“The idea is to somehow modify the cancer cells so they’re recognized by the immune system as foreign,” Schuchter said. “Basically you’re trying to put some sort of red flag on the cancer cells saying, ‘I’m foreign. Immune system reject me.’ ”
Recently there’s been a renewed interest in vaccines because researchers have a much greater understanding of how to stimulate the immune system, she said. So vaccines that didn’t work in the past may work in the future when combined with other immunotherapies.
Head said OncBioMune has seen good results so far in the FDA-approved Phase 1 trial at UC-San Diego.
The participants have all been late-stage patients, whose PSAs continued to rise after surgery, radiation or other therapies, Head said. Of the 14 participants, 12 had lower PSA levels after the vaccinations. Two left the study because their cancer progressed, and they entered end-of-life care.
There will be a total of 20 patients in the Phase 1 trial. The Phase 2 trial will include 120 patients: 80 who will receive the vaccine and 40 who won’t.
If OncBioMune succeeds in licensing its vaccine, the company will be able to fund the research for other cancers that now lack good therapies, Head said. Those include ovarian, small cell lung, colon and pancreatic cancer — diseases where being diagnosed is like a death sentence.
The beauty of the technology is that OncBioMune can basically make a vaccine for any solid tumor, Kucharchuk said.
For a long time, no one in the world did, really.
“We went everywhere. We went to Norway. Twice. We went to England,” Kucharchuk said.
Head said he and Kucharchuk also met with potential investors in China, Ireland, Italy, Boston and California.
On Kucharchuk’s first business trip for the company, Head took him to Fargo, North Dakota. In January.
“It was 30 degrees below zero, and the wind was blowing 30 miles an hour. I’ve never been so cold in my entire life,” Kucharchuk said.
The Fargo venture capitalist was warmer, but he wasn’t buying.
Eventually, the company found its way to U.S. Rep. Walter Jones, R-N.C.
Jones was concerned about the impact of prostate cancer on the lives of military personnel and their health costs. He earmarked $5.5 million in three Department of Defense contracts, in 2006, 2009 and 2010, that allowed OncBioMune to further develop the prostate cancer vaccine.
From there OncBioMune moved to the Phase 1 and 2 trials, and the early results allowed the company to raise capital through a private placement and the agreement with Lincoln.
OncBioMune is about 18 months away from licensing agreements or discussions of them, Kucharchuk said. Once the company starts putting out data from the Phase 2 trial, OncBioMune expects to draw the attention of Big Pharma.
“There are thousands of little biotechs, but we’ve reached a certain milestone that only hundreds have,” Kucharchuk said.
Follow Ted Griggs on Twitter, @tedgriggsbr