EVOTEC LEVERAGES INDIGO PLATFORM TO ACCELERATE THE DEVELOPMENT OF CARNA'S PROGRAMME CB-1763 THROUGH TO IND FILING
IND-FILING ENVISAGED FOR FIRST HALF OF 2019
INDIGO, A KEY VALUE-DRIVING COMPONENT OF EVOTEC'S EVT EXECUTE BUSINESS SEGMENT, ACCELERATES EARLY DRUG CANDIDATES INTO THE CLINIC BY REDUCING TIME FROM NOMINATION TO REGULATORY SUBMISSION
HAMBURG—(BUSINESS WIRE)—Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) today announced a strategic collaboration with Carna Biosciences, Incorporated ("Carna"). Carna will access Evotec's INDiGO platform to accelerate the development of its programme CB-1763, which is being developed for the treatment of blood cancer, through to the submission of an Investigational New Drug Application ("IND") with the U.S. Food and Drug Administration.
"We are excited to initiate IND-enabling studies for our next-generation non-covalent BTK inhibitor, CB-1763, in collaboration with Evotec", said Dr Masaaki Sawa, Chief Scientific Officer at Carna Biosciences. "We've been working with Evotec from last year and found they are a really reliable partner. We believe Evotec's INDiGO programme and their team will help us to accelerate the development of our CB-1763 and we are confident that we will achieve our goal to reach IND-filing in the first half of 2019."
Dr Mario Polywka, Chief Operating Officer of Evotec, added: "This development of Carna's key project directly reflects the success of our comprehensive and industry-unique INDiGO service. We are delighted to support Carna's CB-1763 inhibitor programme, an innovative approach to blood cancer, through to the clinic. Additionally, working with Carna also highlights our increasing presence in the Japanese market."
Carna has another reversible BTK inhibitor in pre-clinical development, AS-871, a novel non-covalent BTK inhibitor targeting autoimmune diseases. AS-871 is also undergoing IND-enabling studies in collaboration with Evotec.
About Evotec's INDiGO platform The INDiGO platform is a key value-generating component of Evotec's broad EVT Execute business segment. INDiGO accelerates early drug candidates into the clinic by reducing time from nomination to regulatory submission in 52 weeks, and under circumstances, even less. We achieve accelerated development by tightly integrating traditional drug silos into a single project managed under one roof. The programme has been proven to reduce time and cost while achieving a quality data package for CTA/IND level regulatory filings.
Evotec's INDiGO projects are managed by our most experienced, dedicated project managers and leading world-class drug development professionals implementing tailored development strategies designed specifically for the molecule, therapeutic area and strategic needs. The project plan is designed to integrate development areas: API Manufacture, Formulation Development, Clinical Supply, Safety Assessment, DMPK, Bioanalysis Studies and Regulatory Submission Documents Preparation.
ABOUT CARNA BIOSCIENCES, INC.
Carna Biosciences is a biopharmaceutical company focused on the discovery and development of kinase inhibitor drugs to address serious unmet medical needs. Carna has intensively focused its research efforts primarily in the areas of oncology and autoimmune/inflammation, where the company believes its extensive expertise in kinases can be most effectively leveraged. Taking advantage of Carna's proprietary platform technologies and highly focused kinase expertise, the company continues to challenge to identify and develop innovative drugs. Carna is a publicly traded company in the JASDAQ of the Tokyo Stock Exchange with securities code 4572.
CB-1763 is a highly selective, orally bioavailable, non-covalent inhibitor of Bruton's tyrosine kinase (BTK) with a potential application in the treatment of blood cancer. Recent studies have indicated that the emergence of BTK mutations causes ibrutinib resistance. A selective and non-covalent BTK inhibitor is therefore highly demanded to overcome the emerging unmet medical need of ibrutinib resistance. CB-1763 is a next-generation non-covalent BTK inhibitor, designed to inhibit both BTK wild type and BTK C481 mutants in a highly selective and reversible manner.
FORWARD LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.
Gabriele Hansen, +49.(0)40.56081-255
VP Corporate Communications & Investor Relations