Cleave Biosciences Nabs $42M, Veteran Execs, to Chase Personalized Cancer Therapies

Xconomy San Francisco — 

Some big money is being put behind big names at a new biotech company called Cleave Biosciences.

The company in Burlingame, CA, founded in the summer of 2010, is emerging from stealth mode today with a $42 million Series A financing from US Venture Partners, 5AM Ventures, Clarus Ventures, OrbiMed Advisors, and Astellas Venture Management. The CEO is Laura Shawver, the former chief executive at Phenomix and president of Sugen, who was drawn to Cleave during a recent stint as an entrepreneur in residence at 5AM Ventures. She’s joined on the management team by president and chief scientist Mark Rolfe, who previously worked at CytomX Therapeutics, Facet Biotech, and Millennium: The Takeda Oncology Company.

The big idea at Cleave is to develop small-molecule chemical compounds that will interact with certain protein pathways that get thrown out of whack in patients with cancer. Cleave is still at a very early scientific stage, seeking to prove not only that its protein pathways are good targets for cancer drug development, but also that its chemistry is valid, Shawver says. The concept is built on growing understanding of how protein networks can remain in a stable state of homeostasis, or how they can deteriorate over time and give rise to cancer. None of Cleave’s drug candidates are ready yet for clinical trials, but the financing will give the company three to four years of operating cash to pursue that goal.

“Our targets are novel, our chemistry is novel, and we need to prove out the principles,” Shawver says. “It will take a significant amount of money. But this way, the company can focus on executing for the long run, rather than executing a little bit and then going out and raising more money.” She adds: “Raising money can be distracting.”

The science underpinning this new venture comes from Raymond Deshaies and Francesco Parlati at Caltech and Seth Cohen at UC San Diego. Shawver didn’t disclose which specific forms of cancer the new company is pursuing, or what protein targets are high on its priority list. Cleave currently has five employees, and plans to grow to about 15 by the end of its first year, she says.

The name for the company comes from a pretty familiar concept in biology, which is that “cleave” means to cut, which is what a lot of enzymes do in the protein homeostasis network.

Cleave is certainly not the only startup with big aspirations for making drugs based on new knowledge of protein homeostasis. Cambridge, MA-based Proteostasis Therapeutics, which is seeking to develop neurological drugs in partnership with Elan, raised a similarly big $45 million Series A venture round in September 2008.

Cancer drug development has become quite a competitive business, as many companies pile in to chase hot targets like the PI3 kinase pathway, MET, MEK, hsp90, hedgehog, and more. It’s not all that often that startup biotech companies openly state they want to push the frontiers even further by going after biological targets that have less scientific validation.

Cleave hopes to minimize some of that risk by matching up its drugs, which are targeted at its specific pathways, with patients in clinical trials whose tumors are thought to be driven by the pathway. Although companies have talked about this type of personalized medicine for years, few have succeeded.

But Shawver, an ovarian cancer survivor and the founder of the Clearity Foundation which seeks to support molecular profiling of ovarian cancer patients, stresses that the new company will pursue a similar concept.

“We foresee a future when the majority of cancer patients will be treated based on the molecular profile of their tumors, regardless of whether the cancer invades the lung, pancreas, liver or elsewhere,” Shawver said in a statement. “We believe this therapeutic approach ultimately stacks the odds in favor of the patient, the physician, as well as the payor.”

Peter Thompson, a co-founder of Cleave and a venture partner at OrbiMed, added in an e-mail that he believes this approach has a chance to make a difference for patients, and be rewarded in the marketplace.

“While oncology remains a challenging arena, it also represents a therapeutic area where, conditional on results, pricing remains robust and strategic partner interest remains keen, suggesting that above-market returns will continue to be achievable for the right investments,” Thompson says.

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