Seattle-based Dendreon’s sipuleucel-T (Provenge), has been approved by the Food & Drug Administration. Provenge uses the same PAP protein as MVI does, in a procedure that requires withdrawing a prostate cancer patient’s blood, exposing immune system cells to PAP, and infusing the cells back into the patient. But it has struggled mightily in the marketplace since its 2010 approval because of its $93,000 cost per patient and because of doubts over whether it offers meaningful benefits.
Meanwhile, DNA-based cancer vaccines have shown efficacy in animals like mice, but translating the same immune response to humans has proven difficult, says Rob Johnson, a co-founder and partner with life sciences consultant Alacrita in Cambridge, MA. Johnson worked for 10 years at a VC-backed startup, Onyvax, which was developing prostate and colorectal cancer immunotherapies. The company’s lead drug candidate failed Phase II trials, he says, and the intellectual property was sold to a South Korean company.
“Many companies have tried to develop cancer vaccines,” Johnson says. “The vast majority have failed.” Some skeptics question whether cancer vaccines will ever be successful.
This long history of disappointment means that overcoming the stigma toward cancer vaccines will be one of MVI’s challenges, says Jill O’Donnell-Tormey, CEO and director of scientific affairs of the New York-based Cancer Research Institute.
So why does Lesniewski think MVI stands a chance to succeed where bigger, better funded companies have failed?
For one, MVI is targeting the disease at an earlier stage than most therapeutic approaches, which (like Dendreon’s Provenge) are designed to fight prostate cancer after it has metastasized and is resistant to castration therapy, Lesniewski says.
“We believe the time to engage the immune system is when you have time to train it up over six to 12 weeks, and the battle it has to fight is against a relatively small number of tumor cells,” Lesniewski says.
Johnson likes MVI’s earlier-stage approach because it gives the immune system a fighting chance to control the disease, he says. He also thinks that the company’s clinical goal of delaying metastases is a sensible one that has an opportunity to get FDA approval.
MVI’s approach has other advantages over competitors. Its vaccines are designed to be “off-the-shelf,” meaning that they can be mass-produced and administered via a simple injection into the skin of the upper arm, in contrast to the multi-step, personalized process of an “autologous” treatment like Provenge. In addition, plasmid DNA vaccines are cheaper and faster to manufacture and are more stable in storage than protein or peptide vaccines, MVI says, so they wouldn’t have to be manufactured as frequently. It’s way too early to talk pricing of an unapproved MVI vaccine, but Lesniewski says, in theory, it “could be cost-effective.”
“Hopefully off the shelf would be more economical” than Provenge, says Matthew Cooperberg, a urologist and associate professor at University of California, San Francisco. “But that remains to be seen.”
To win approval from the FDA, MVI has a long, expensive road ahead. The early data show
