NEA provides $10M to help fuel next-gen cancer R&D at Cleave

Closing in on the selection of its lead cancer program, San Francisco-based Cleave Biosciences has welcomed the deep-pocketed player New Enterprise Associates to its list of venture backers and topped up its Series A with a $10 million investment in its early-stage drug research work. 

The fresh contribution brings Cleave's total raise to date to $54 million, a substantial amount of cash for a fledgling biotech looking to carve out a pioneering role in targeting a novel set of pathways involved in cancer. The big idea at Cleave, inspired by some groundbreaking lab work by CalTech's Raymond Deshaies, is that protein degradation pathways play a key support role for cancer cells. And it's been busy identifying small molecule compounds that can attack cancer on this new front. Its first take on a next-gen cancer drug will likely be a program targeting p97 in ubiquitin proteasome and autophagy pathways known to control protein degradation.

"The idea is to file an IND in a year or two," says Larry Lasky, a partner at U.S. Venture Partners and a director at Cleave, which is being helmed by Laura Shawver. The money "should get the company through Phase I, Phase Ib, with one target and hopefully initiating and doing some work for a second target." 

This is a familiar field for Lasky, a 20-year Genentech vet who went into the VC field and provided key support for Proteolix when that company was developing carfilzomib. Initially, he speculated, Cleave might launch its first program for multiple myeloma, a crowded field he feels still offers some unmet needs to target. After that solid tumors look promising, particularly for p97. And Cleave's business plan bears some resemblance to the one followed by Proteolix, which scored some early proof of efficacy before raising more cash. Onyx ($ONXX) ultimately bought out the company and went on to gain an approval for the drug, now marketed as Kyprolis. 

U.S. Venture Partners joined 5AM Ventures, Clarus Ventures, OrbiMed Advisors, Astellas Venture Management and Osage University Partners in putting together the initial $44 million round for the company in the fall of 2011. The group, now joined by NEA, is supporting the kind of expensive, translational research that many venture groups have sworn off over the past few years. But Lasky and his colleagues still see this as a great niche to create new companies capable of doing something unique--which in the long run is still capable of spawning ventures and drugs that are still highly sought after by Big Pharma.

Robert Garland, Partner

"Cleave Biosciences has made substantial progress in identifying and optimizing small molecules against a number of novel targets and is progressing its lead program toward the clinic," said NEA's Robert Garland, who now joins the board. "We are pleased to join Cleave's investor syndicate to help fuel the company's momentum."

- here's the press release

Special Report: Laura Shawver - FierceBiotech's 2011 Women in Biotech

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