Evotec announces Bristol Myers Squibb opt-in of EVT8683 as the first programme from iPSC-based neurodegeneration collaboration

DGAP-News: Evotec SE

/ Key word(s): Miscellaneous

02.09.2021 / 07:30

The issuer is solely responsible for the content of this announcement.

  • BRISTOL MYERS SQUIBB EXERCISES ITS OPTION TO ENTER INTO A GLOBAL LICENSE AGREEMENT FOR THE FIRST PROGRAMME FROM THE COMPANIES’ ALLIANCE IN NEURODEGENERATION
  • THE EVT8683 IND FILING HAS RECEIVED FDA CLEARANCE
  • THE PROGRAMME (EVT8683) ORIGINATES FROM A PHENOTYPIC SCREEN CONDUCTED BY EVOTEC USING ITS LEADING IPSC (INDUCED PLURIPOTENT STEM CELL) DRUG DISCOVERY PLATFORM
  • EVOTEC RECEIVES AN OPTION PAYMENT OF $ 20 M AND IS ELIGIBLE TO EARN UP TO $ 250 M IN MILESTONE PAYMENTS AND UP TO LOW DOUBLE DIGIT ROYALTIES

Hamburg, Germany, 02 September 2021:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that Bristol Myers Squibb Company (NYSE:BMY) has exercised its option to enter into an exclusive global license for EVT8683 which comes from a broader neurodegeneration collaboration. EVT8683 is a small molecule targeting a key cellular stress response that holds great promise in various neurodegenerative indications and is ready to enter clinical development. The programme originated from a phenotypic screening approach based on Evotec’s leading iPSC platform and reached IND filing within only 5 years. Under an option agreement with Celgene (which is now a Bristol Myers Squibb company), Bristol Myers Squibb has rights to additional programmes in neurodegenerative diseases.

In neurodegeneration, currently approved drugs only offer short-term management of patients’ symptoms and there is a huge unmet medical need for innovative therapies that slow down and reverse disease progression. The neurodegeneration alliance was built on Evotec’s industrialised iPSC platform using patient-derived disease models, to discover and select potentially disease-modifying approaches for neurodegenerative diseases. Evotec’s iPSC platform allows the screening of human iPSC-based disease models at high throughput in combination with unbiased transcriptome analysis. The seamless integration of the iPSC platform with Evotec’s proven small molecule discovery and development capabilities all the way to IND filing enabled the development of EVT8683 in only 5 years from a cell based phenotypic screen to successful IND filing.

Just 4.5 years after initiating the partnership, Bristol Myers Squibb has now exercised its option to enter into a global License Agreement for EVT8683. The programme targets a key cellular stress response mechanism which has the potential to deliver disease-modifying treatments for several devastating neurodegenerative diseases. Following the successful compound optimisation, the seamless integration from project initiation to IND, also using Evotec’s INDiGO platform, led to the recent registration as an Investigational New Drug (“IND”) with the U.S. Food and Drug Administration (“FDA”).

Dr Cord Dohrmann, Chief Scientific Officer of Evotec SE, commented: “We are very excited to bring a first drug candidate which originated from Evotec’s iPSC discovery platform into the clinic. EVT8683 is targeting a highly promising mechanism of the cellular stress response and has already demonstrated a very compelling pre-clinical efficacy and safety profile. We are proud to continue the further clinical development of EVT8683 together with BMS’ neuroscience team, which clearly belongs to the best in the industry.

iPSC technology is only starting to deliver on its enormous potential. Developing drug candidates with convincing efficacy in disease models which have been directly derived from patients gives us hope that these next generation of drug candidates will lead to more effective drugs and thus better outcomes for patients afflicted by neurodegenerative diseases.”

Dr Richard Hargreaves, Senior Vice President of Bristol Myers Squibb’s Neuroscience Thematic Research Center, added: “Entering the clinic for this innovative program marks a key step for BMS Neuroscience. Targeting one of the mechanisms which may play a key role within neurodegeneration makes us hopeful that our further development of the program may result in providing treatments for many people suffering from these devastating neurological disorders. Based on Evotec’s scientific expertise and seamless integration, we are delighted to continue development of this clinical candidate.”

Through this opt-in, Bristol Myers Squibb will lead further development and commercialisation. Evotec receives an option payment of $ 20 m and is eligible to earn up to $ 250 m in milestone payments and up to low double-digit royalties.

About Evotec and iPSC
Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon “for the discovery that mature cells can be reprogrammed to become pluripotent”. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec’s iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company’s proprietary EVOcells platform.

ABOUT EVOTEC SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 3,900 highly qualified people. The Company’s 14 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to
www.evotec.com and follow us on Twitter @Evotec and LinkedIn.

FORWARD-LOOKING STATEMENTS
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding completion of the offering. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Media Contact Evotec SE:
Gabriele Hansen, SVP Head of Global Corporate Communications & Marketing, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com

IR Contact Evotec SE:
Volker Braun, SVP Head of Global Investor Relations & ESG, Phone: +49.(0)40.56081-775, volker.braun@evotec.com


02.09.2021 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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