Celgene backs Cleave in $37M financing to tame protein homeostasis

MD Anderson protein ZMYND8

Cleave Biosciences aims to create novel small molecules that work to control protein homeostasis to treat blood and solid cancers. Now, oncology giant and prolific biotech partner Celgene ($CELG) has joined as an investor in its $37 million Series B round.

The financing will go toward the clinical development of lead candidate CB-5083--a first-in-class, oral inhibitor of p97, which is an enzyme involved in protein homeostasis. It’s being developed for solid and hematologic cancers; it’s in a pair of ongoing Phase I trials in patients with advanced disease.

One of these trials is in solid tumors, and the other is in lymphoid hematologic malignancies, including multiple myeloma. CB-5083 already had Orphan Drug Designation from the FDA to treat multiple myeloma. The round will also help fund further discovery work based on Cleave’s AAA ATPase platform.

“We have been characterizing the safety and tolerability of CB-5083 in cancer patients for about 18 months, and the financing allows us to finalize our dose escalation, (and determine the) maximum tolerated dose, the recommended Phase II dose and regimen of CB-5083,” Cleave CEO Laura Shawver told FierceBiotech.

She added, “We will then evaluate CB-5083 in expansion cohorts in hematological and solid tumor indications. P97 is in a validated pathway in multiple myeloma, so we will be particularly focused on understanding the activity in the multiple myeloma expansion cohort."

Shawver was an Entrepreneur in Residence for 5AM Ventures starting in the fall of 2010; Cleave was founded the following year with Shawver at the helm. The Burlingame, CA-based startup raised a Series A round that originally dates back to 2011, but was bumped up to $52 million in 2013.

“We’ve had ongoing discussions with Celgene about the importance of p97 as a target for cancer therapy--particularly in multiple myeloma,” said Shawver.

In addition to Celgene, new investors in the latest round include Nextech Invest and Arcus Ventures. A slew of high-profile existing investors also participated: 5AM Ventures, Clarus Ventures, New Enterprise Associates, Orbimed Advisors, U.S. Venture Partners, Astellas Venture Management and Osage University Partners.

Alfred Scheidegger of Nextech and Carol Gallagher of NEA are joining the board as part of the financing. Nextech invested from its dedicated cancer fund.

“Our investment strategy is to basically join at the level where we can evaluate the science and the exit path is understood well that is supported by strong investors,” Scheidegger said. “Cleave fits this definition precisely, we were intrigued by the data for which we expect to achieve clinical proof of concept next year.”

- here's the release

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