Emerging Drug Developer: Juvaris BioTherapeutics

Juvaris ramps up its clinical vaccine programs

When Kleiner Perkins Caufield & Byers set up its pandemic and biodefense fund, its lead partner on the initiative--Thomas Monath, M.D.--was impressed by what he saw at the tiny Juvaris BioTherapeutics. 

He was so impressed, the venture group ended up investing $12 million last year in the company's Series A round. And last March, Kleiner Perkins helped engineer the arrival of Grant Pickering to run the vaccine company with an eye to taking Juvaris to proof-of-concept data on a slate of vaccine development programs. 

Just weeks ago Juvaris launched its first clinical study, a Phase I trial of a vaccine adjuvant--JVRS-100--combined with a commercially available vaccine for seasonal influenza. Because it's a vaccine program, investigators are looking for a good safety profile, the right dose and a first look at efficacy in humans. 

"We've seen data of 10-fold higher antibody responses at lower doses of antigen," says Pickering. And with a cell-mediated immune response, Juvaris' approach would help avoid a repeat of the mismatch health officials saw last flu season when much of the flu vaccine that was manufactured failed to ward off the major strains in circulation. 

Burlingame, CA-based Juvaris now is positioned to have efficacy data on its lead program by the end of this year. Later, Pickering expects to find a pharma partner to take the product to commercialization as Juvaris' R&D team advances other programs. 

The 24 staffers at Juvaris have plenty of work to turn to. The company's JVRS-100 is likely to go into the clinic this summer for hepatitis C, says the CEO, with a third program being readied for acute myelogenous leukemia. 

"Before the year is out we will raise a series B," says Pickering. He isn't speculating how big that round could be, but he does note that he'll need enough money for Juvaris' Phase I and II trials. 

Pickering gives Juvaris' founding CEO Martin Cleary high marks for attracting $14 million in non-dilutive grant money and attracting Kleiner Perkins as an investor. Juvaris' academic collaborations have allowed the small biotech company to advance its science without tapping its cash.  

"We also have a promising universal flu vaccine, which is completely proprietary," says Pickering. "We believe we could have a best-in-class universal flu. That will be a key focus for us in coming months." Then there's a program in the works for herpes, and finally there's Juvaris work with pandemic flu vaccines--which is why Kleiner Perkins got interested in Juvaris to begin with. 

"We are working with the CDC right now," says Pickering, "and we've shown we can reduce the required antigen for an H5N1 vaccine dramatically--at least 10-fold less. In the seasonal vaccine area, we can reduce the antigen required by 98 percent. A shortage of pandemic flu vaccine stockpiles makes an effective adjuvant an essential defense tool and may permit health officials to plan one dose of vaccine instead of two.  

"That's the Holy Grail," comments Pickering.