Aduro BioTech - 2014 Fierce 15

Aduro BioTech
Aduro sets out to succeed with cancer vaccines, after several have failed

CEO: Stephen Isaacs
Based: Berkeley, CA
Founded: 2000
Clinical focus: Immuno-oncology
Website: www.adurobiotech.com

The scoop: The big problem with cancer vaccines is that they don't work very well. Yes, they tend to kick up a response in patients, and that clear activity has lured some big R&D teams to their doom. The response typically doesn't turn out to be very significant. Aduro, though, believes that two of these immunotherapies will work better than one. Much better. And the biotech has been tracking positive responses in mid-stage development for pancreatic cancer--one of the toughest targets in oncology--while standing out as one of the only small biotechs to break into the quite exclusive ranks of the breakthrough therapy designation (BTD) crowd at the FDA's cancer division. Johnson & Johnson ($JNJ) has helped make this a breakout year for Aduro, adding to the developer's $55 million round and partnering on a program for prostate cancer--a field in which the pharma giant is playing a leading role in establishing a new standard of care.

What makes Aduro Fierce: A strong scientific foundation, smart money and an experienced executive team have positioned Aduro for a key turning point. The company has explored several iterations of technology to get here, and now that the team has the FDA's BTD designation in hand, CEO Stephen Isaacs is clearly interested in seeing whether the biotech can carve some significant time out of the development timeline for their cancer vaccine work.

Isaacs is acutely well aware of just how limited a single cancer vaccine can be. The company in-licensed GVAX after it had failed in the clinic. Like other cancer vaccines, GVAX safely spurred an immune response, but not enough to make a major difference for patients. But in adding GVAX to a genetically modified strain of attenuated Listeria monocytogenes--the company's platfiorm technology--investigators found what they were hoping for: evidence that the combination would lead to a broad immune response.

"It's a one-two punch," says Isaacs, who's been thinking a lot about how many punches you can land on any particular cancer at any particular time. The company is already moving ahead at Johns Hopkins with a combination trial that adds Bristol-Myers Squibb's ($BMY) checkpoint inhibitor nivolumab to the mix. J&J has its own stable of drugs that can be mixed and matched, and the future possibilities are numerous.

At ASCO last summer, Aduro was on hand to review the data on a midstage study involving 93 patients with advanced pancreatic cancer. A combination of chemo plus GVAX pancreas and CRS-207 significantly outperformed GVAX and chemo, bumping up overall survival from 3.9 months to 6.1 months. That's not a big gain, but it's a sign of progress in a very tough field. In one group, the OS rate in the combo drug arm was more than double the control arm's. And a Phase IIb ECLIPSE trial with 240 patients will also do a comparison against CRS-207 alone, to confirm the synergistic effects of the earlier trial.

With a fast-growing clinical effort, Isaacs has also been adding to the staff. The roster of employees now stands at 40, and the CEO expects that number to swell to 50 by year's end, with new trials entering the clinic and more work to be done on the key vector in use. Ultimately, Isaacs says he'll have to wait and see how the company develops. It's possible to launch a product, and it's possible someone will come along to snap up the company--provided everything continues to work out for the biotech.

Investors: Johnson & Johnson Development Corporation joined the Morningside group for the company's latest C round.

For more:
J&J partner Aduro grabs an FDA 'breakthrough' nod for its immuno-oncology combo
J&J helps bankroll a $55M gamble on partner Aduro's PhIIb cancer drug study
J&J expands prostate cancer program with cancer vax tech from Aduro

-- John Carroll (email | Twitter)

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Aduro BioTech - 2014 Fierce 15