Global licensing agreement formed for innovative protein therapeutics for inflammatory indications

Shanghai-based biopharmaceutical company, Zai Lab, and developer of multi-functional biologics, Crescendo Biologics, have entered a worldwide licensing agreement for the development, commercialisation and manufacture of innovative protein therapeutics for inflammatory indications.

Under the terms of the agreement Zai Lab will develop, commercialise and manufacture a topical, innovative antibody VH domain therapeutic for potential application in inflammatory indications. The product candidate from Crescendo Biologics, was developed using the company’s transgenic platform, which generates novel, small, robust and potent therapeutics based on fully human VH domain building blocks. Zai Lab anticipates filing an investigational new drug (IND) for this therapeutic candidate for clinical studies in psoriasis next year (2019).

“Biologics-based therapies are increasingly effective in psoriasis and other skin conditions, but are often associated with treatment-limiting immunosuppressive side effects,” commented Dr Harald Reinhart, chief medical officer, Autoimmune and Infectious Diseases at Zai Lab. “We see a clear benefit with topically administered dermatologic preparations which offers strong clinical efficacy and potentially safer for chronic administration.”

“We are pleased to sign this agreement with Zai Lab, a foremost developer of innovative medicines across diverse therapeutic areas where there are substantial unmet needs in global markets,” commented Peter Pack, CEO of Crescendo Biologics. “We’re delighted with the pace and efficiency of Zai Lab’s plan to develop clinical proof of concept with our Humabody. Crescendo Biologics is dedicated to advancing therapies with enhanced efficacy and improved safety profiles, and we believe there are significant synergies for our approach with the Zai Lab pipeline of autoimmune programmes.”

As part of this agreement, Crescendo Biologics has granted a worldwide exclusive licence to develop and commercialise its drug candidate for all indications. Zai Lab will be responsible for conducting all regulatory filings, clinical studies, and commercialisation activities, with both companies participating in a Joint Development Committee.

Furthermore, Zai Lab has made an upfront cash payment to Crescendo Biologics and will provide development, regulatory and commercial milestones for multiple indications. Crescendo Biologics will also be eligible to receive tiered royalties on global sales.