Drug Development

Celgene stays focused on protein homeostasis, backs Cleave’s $37M round to fuel early studies

Cleave Biosciences CEO Laura Shawver has built out her venture syndicate, adding cancer powerhouse Celgene to the mix and making key additions to the board as her biotech team preps for the next stage of clinical development. The expanded syndicate is contributing $37 million in fresh funds — bringing its total to $91 million — to complete Cleave’s navigation through a pair of early-stage cancer drug studies for its crucial lead program. And Celgene is demonstrating its renewed commitment to protein homeostasis, a field that has inspired a slate of deals in recent years.

Cleave Biosciences CEO Laura Shawver

Laura Shawver, Cleave Biosciences CEO

The Phase I effort for CB-5083 is being set up as Exhibit A in Cleave’s case that it is on to a new and better way to achieve the kind of protein degradation needed to destabilize cancer cells. By inhibiting p97, Cleave hopes to throw a monkey wrench into the workings of key enzymes that guard cancer cells, zeroing in on protein homeostasis, the body’s machinery for manufacturing and disposing proteins.

The new injection of funds “allows us to characterize the effect of 5083 in different populations,” says CEO Shawver. As the results come in, she adds, Cleave can assess the best kind of development plan needed for mid-stage work. And that may well set up a broad batch of studies, depending on what investigators see in patients with solid tumors.

Cleave is following a pathway already blazed by drugs like Velcade (Takeda) and Kyprolis (Amgen). Their p97 target lies upstream from where those drugs do their work, explains the CEO, doing it in a way that should shut down the pathway longer and harder than the marketed drugs. Or that’s the theory. And they’re taking an early shot at multiple myeloma, where Shawver sees their best chance at demonstrating proof of concept efficacy. Says Shawver:

“If you think of those tumor types with an addiction to protein degradation, multiple myeloma is the poster child for that.”

The biotech started Phase I work 18 months ago and now is in two early trials, one for a hematological malignancy and the other in solid tumors.

Cleave isn’t alone in the field. Neither is Celgene. Forma has focused on protein homeostasis, with Celgene stepping into a discovery deal in 2013. Celgene and Third Rock-backed Nurix signed a protein homeostasis deal last fall that included a $150 million upfront payment. And Takeda has a drug, pevonedistat, now in four ongoing studies after tracking some “modest” responses late last year.

Biotech vet and NEA partner Carol Gallagher, a high profile figure in West Coast industry circles, is joining the board in this round, alongside Alfred Scheidegger, the founding partner at Nextech Invest.

Nextech Invest and Arcus Ventures joined Celgene in the lead, with Cleave’s marquee band of existing investors jumping in: 5AM Ventures, Clarus Ventures, New Enterprise Associates, Orbimed Advisors, U.S. Venture Partners, Astellas Venture Management and Osage University Partners.

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