Cleave Biosciences - 2014 Fierce 15

Cleave Biosciences
Some experienced developers take another shot at a cancer breakthrough

CEO: Laura Shawver
Based: Burlingame, CA
Founded: 2011
Clinical focus: Protein homeostasis
Website: www.cleavebio.com

The scoop: Back when Yale's Craig Crews, Raymond Deshaies at CalTech and the VC maestro and Genentech vet Larry Lasky got together to form Proteolix, they were focused on triggering cancer cell death (apoptosis) through inhibition of the proteasome, a pathway which the cancer cells relied on to survive and thrive. Their work ultimately led to the FDA-approved Kyprolis, which is now owned by Amgen ($AMGN) after the Big Biotech gobbled up Onyx for $11 billion.

A few years ago, Lasky and Deshaies set out to collaborate on another apoptosis biotech player, this time by inhibiting the p97 pathway. Well before he moved from U.S. Venture Partners to The Column Group last spring, Lasky helped seed Cleave Biosciences, which has just launched its first Phase I study for multiple myeloma, with plans to branch out its clinical work with new studies focused on subsets of patients with solid tumors most likely to depend on p97 for their survival.

What makes Cleave Fierce: After a considerable amount of screening, Cleave came up with a lead therapy--the oral CB-5083--and ran it through a successful in vivo study involving mice. Along the way they've attracted $54 million in venture backing, with NEA stepping in to add $10 million in the spring of 2013.

"We built it from the ground up," says Laura Shawver, a well-known biotech executive (as well as surfer and cancer survivor) in the Bay Area who helms the venture. Shawver also ran Phenomix, a diabetes drug developer that found itself unable to continue a DPP-4 program and had to disband. Aside from providing a lesson to be wary of regulators' shifting standards, the experience also increased her determination to stick with novel targets. And she's also been careful to stick with an experienced executive crew,

"The management team has been around the block before," Shawver says. Case in point: President and CSO Mark Rolfe spent 10 years doing oncology R&D at Millennium, a breeding ground for a whole generation of biotech entrepreneurs, before undertaking stints at Facet and CytomX.

Not long after starting the company, Shawver described the pace as "Mach 3 with your hair on fire." And the company has been moving fast to debut its lead therapy in the clinic.

Multiple myeloma is getting to be a crowded field, Shawver acknowledges, but the biotech still believes there's room to move among patients as they become treatment-resistant. Velcade, for example, works in only about 30% of patients, and they'll ultimately stop responding to the drug as well. And the treatment may be particularly effective in solid tumors with KRAS mutations.

Shawver expects to raise some more capital later as she scouts for a commercialization partner. But the big Series A along with the add-on from NEA left the company well fixed to get into the clinic before anything is nailed down.

Crews, by the way, is the scientific brains behind the launch of Arvinus, another intriguing biotech that's closely focused on protein degradation pathways, though with a different spin than Cleave is pursuing.

Cleave is another biotech in this year's Fierce 15 that's benefiting from earlier experiences, including some that didn't have a happy ending. In this case its scientists are also coming back for another round of biotech building, which is helping the West Coast R&D scene thrive. 

Investors: U.S. Venture Partners, New Enterprise Associates, 5AM Ventures, Clarus Ventures, OrbiMed Advisors, Astellas Venture Management and Osage University Partners

For more:
Special Report: FierceBiotech's 2011 Women in Biotech - Laura Shawver
NEA provides $10M to help fuel next-gen cancer R&D at Cleave
Biotech startup Cleave lands $42M A round for targeted cancer drugs

-- John Carroll (email | Twitter)

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Cleave Biosciences - 2014 Fierce 15