R&D projects

Anti-infectives

EVT894 - Chikungunya

In January 2021, Evotec announced that EVT894, a monoclonal antibody to treat and potentially prevent chikungunya virus infections, has entered clinical development. The Phase I, randomised, double-blind, single centre, single dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of EVT894 vs placebo in healthy volunteers (five dose-cohorts of 8 subjects) is sponsored and funded by the National Institute of Allergy and Infectious Diseases (“NIAID”).

EVT894 is a fully human monoclonal antibody that targets a viral protein and has shown potent neutralising activity in in vitro and in vivo models. The monoclonal antibody was initially developed by Sanofi and was among the projects out-licensed to Evotec as part of the transfer of Sanofi’s Lyon-based infectious disease R&D unit to Evotec in July 2018.

RESOLUTE THERAPEUTICS & CARB-X

In August 2020, Evotec announced that the Company had entered into a new partnership with the Biotech company Resolute Therapeutics to combat infectious diseases and antimicrobial resistance. The partnership aims to develop a broad-spectrum antibiotic with a new mode of action compared to antibiotics currently on the market. The global non-profit partnership CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) will fund the programme with up to $ 2.91 m over the next two years plus an additional $ 5.53 m over the three following years if certain project milestones are met, which will cover a substantial part of Evotec’s expenses.

Under the terms of the agreement, Evotec will in-license a promising research programme from Resolute currently in lead optimisation and continue the pre-clinical development on the Company’s proprietary drug discovery and development platforms. The goal of the partnership is to develop a novel broad-spectrum antibiotic with both Gram-positive and Gram-negative coverage for indications including complicated urinary tract, intra-abdominal infections and hospital-acquired pneumonia. The compounds developed within the programme engage with two validated antibacterial targets but exhibit a novel mode of action.

GNA NOW

In August 2019, Evotec and Lygature announced their cooperation in a new initiative for the development of novel antibacterial agents today: Gram-Negative Antibacterials NOW (“GNA NOW”). The new GNA NOW project, led by Evotec SE, managed by Lygature and funded by the Innovative Medicines Initiative (IMI), will work on the development of novel antibacterial agents to battle antimicrobial resistance in gram-negative bacteria. The multi-stakeholder consortium includes nine other partners from academia, industry and SMEs: Nosopharm, BIOASTER, Helmholtz Centre for Infection Research, North Bristol National Health Service Trust, University of Liverpool, Inserm, Erasmus Medical Center, Medical University of Vienna, and Fraunhofer IME.

Collectively, the GNA NOW members will progress three programmes in parallel with the goal of bringing one through completion of Phase I studies and one reaching Investigational New Drug (IND) stage and/or up to two programmes reaching clinical development candidate stage, by 2024.

Bill & Melinda Gates Foundation

In June 2019, Evotec announced that the company has entered into a five-year partnership with the Bill & Melinda Gates Foundation to discover new treatment regimens that better address tuberculosis (“TB”), a severe global health burden and one of the leading causes of death due to infectious diseases worldwide. The current standard treatment regimen for TB consists of a minimum of 6 months of treatment with 4 drugs administered under direct observation, but treatment is much longer when TB is drug resistant.

Evotec will receive a grant of approximately $ 23.8 m for a period of up to 5 years from the foundation. The main objective of the grant is to generate standardised, high-quality pre-clinical data to support novel regimen selection and development. The regimen should be safer, shorter in duration and more efficacious than the current standard of care.

GARDP

In March 2019, Evotec and The Global Antibiotic Research and Development Partnership (“GARDP”) announced the formation of a new strategic public-private partnership to tackle the growing threat of antimicrobial resistance. By joining forces, Evotec and GARDP will leverage their capabilities and networks to address drug-resistant bacterial infections. This includes bringing together GARDP’s clinical expertise and sustainable access commitment with Evotec’s leading drug discovery platform, expertise in medicinal chemistry and pharmacology, as well as its world-leading collection of bacterial pathogens. This strategic partnership focuses on accelerating the development of first-in-class antibiotic treatments for hard-to-treat bacterial infections by establishing a platform that spans the length of the drug development value chain as well as developing a joint pipeline.

Helmholtz Centre

In February 2019, Evotec and the Helmholtz Centre for Infection Research (“HZI”) announced a collaboration with the goal to address a major global health threat by developing novel antibiotics that overcome drug-resistant bacterial pathogens. Research activities will initially be focused on the optimisation of cystobactamids, a family of natural antibacterial products with innovative chemical scaffolds that are active against the most dangerous Gram-negative pathogens on the WHO priority list.

Under the terms of the agreement, Evotec and HZI will collaborate for an initial term of 3 years. The collaboration will combine HZI’s unique collection and know-how of natural products as well as access to in vitro and in vivo models of bacterial infection with Evotec’s leading drug discovery platform, expertise in medicinal chemistry and pharmacology as well as world-leading collection of bacterial pathogens.

Cardiac disease

In February 2021, Evotec SE announced that the Company has entered into a multi-year partnership with the Medical Center Hamburg-Eppendorf (“UKE”) for the development of a highly innovative first-in-class cell therapy approach for the treatment of heart failure.

Under the terms of the partnership, Evotec and UKE will leverage their complementary strengths for the development of a new cell therapy approach using Engineered Heart Tissue for the treatment of heart failure. Heart failure is frequently associated with ischemic heart disease and often comes with a poor prognosis. Mortality is comparable to that of the most common cancers, with <50% 4-year survival. Treatment of patients suffering from heart failure is expected to deliver significant patient benefit through improved heart function, ultimately leading to an improved prognosis.

Evotec leverages its industry-leading human induced pluripotent stem cells (“hiPSCs”) platform to establish GMP-compatible process development and upscaling for large-scale generation of clinical-grade heart muscle cells known as cardiomyocytes. Evotec will also contribute genetically modified GMP iPSC lines, which contain alterations preventing rejection of the cardiomyocyte-containing product by patient immune systems (“cloaking”), and include additional safety mechanisms to control unwanted proliferation of graft cells. By using these GMP-grade iPSC lines, the project will deliver off-the-shelf products, which can be implanted in broad patient populations with little to no immunosuppression. 

UKE applies its proprietary Giga Patch Method for the generation of fully functional heart tissue suitable for cardiac transplantation. Further in vivo validation and development activities will be shared jointly between the partners. Evotec will be responsible for GMP and pre-clinical activities as well as for any subsequent partnering of the programme.

Diabetes and diabetic complications

Encaps-iBeta/ Sernova

In April 2020, Evotec regained global rights to a promising beta cell replacement therapy for the treatment of diabetes from Sanofi.
Evotec has built a unique platform for iPSC-based drug discovery and cell therapy covering the generation of iPS cell lines, up to cell manufacturing of various cell types for drug screening as well as GMP production of clinical material for cell therapies. Evotec produces human beta cells in islet-like clusters from a GMP-compliant iPS cell line in a scalable bioreactor format, with extensive quality control (“QC”) procedures. The beta cell programme (now “QRbeta Therapeutics”) has already achieved pre-clinical data demonstrating that they are functionally equivalent to primary human islets in their ability to normalise blood glucose levels in in vivo models over several months.  

In 2022, Evotec and Sernova Corp. announced a partnership in the field of diabetes. Both Companies will leverage their respective strengths to develop an implantable iPSC-based beta cell replacement therapy for the treatment of insulin-dependent diabetes, including type 1 and 2.

Evotec’s iPSC-based beta cells will be combined with Sernova’s proprietary Cell Pouch™, which is the leading implantable and scalable medical device in its class. In particular, it enables vascularisation of the cell implant and thus ensures long-term survival and optimal function in patients. The combination of primary donor islets and Cell Pouch has achieved long-lasting therapeutic results in patients enrolled in Sernova’s US-based Phase I/II clinical trial, including sustained insulin-independence in high-risk Type 1 Diabetes patients who previously required insulin injections for survival.

Sernova has acquired an option for an exclusive global license to Evotec’s induced pluripotent stem cell (iPSC)-based Beta cells for use with its Cell Pouch system to treat diabetes. From an operational perspective, the pre-clinical development programme(s) will be jointly funded until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will contribute cell manufacturing through commercialisation and decide in the future on joint funding of clinical development. Upon commercialisation, there will be a profit-sharing arrangement between the two companies, with the split dependent upon Evotec’s participation in the clinical development programme.

In conjunction with the agreement, Evotec has committed to a strategic € 20 m equity investment in Sernova.

You can find more find more information about this alliance in below download.

NURTURE/ Kidney disease

In June 2017, Evotec announced that it has joined the NURTuRE consortium to drive kidney disease focused drug discovery based on patient derived-data. NURTuRE is uniquely positioned to collect clinical data at the UK Renal Registry and analyse samples of 14 kidney disease centres in the UK, constituting one of the largest kidney patient registries worldwide.

The NURTuRE consortium will initially focus on chronic kidney disease ("CKD") and nephrotic syndrome ("NS") patients and will leverage established institutions such as the UK Renal Registry and Evotec's integrated kidney drug discovery platform. Alongside other consortium members, Evotec will access patient samples including kidney biopsies, blood, serum and urine for an in-depth histological and molecular analysis to identify and validate targets and biomarkers.

Kidney disease has emerged as a global epidemic. Currently no treatment options that have the potential to slow down or stop CKD disease progression are available. Detailed understanding of patho-mechanisms based on well-characterised patient samples will allow the identification and exploration of novel genetic and metabolic components, which are key drivers of kidney diseases. This approach will lead to a new generation of drug candidates in the field of kidney diseases being developed based on human biology and pathophysiology.

About NURTuRE

Developed in the first instance to collect and store biological samples from 3,000 patients with chronic kidney disease (CKD) and at least 800 patients with nephrotic syndrome (NS), the biobank will provide a strategic resource for fundamental and translational research. In addition to the samples of plasma, serum, urine, DNA and tissue that will be stored, the repository will also have the considerable advantage of containing associated linked clinical data, through the UK Renal Registry.

Running over a five-year period, the samples will be obtained through 14 NHS Trusts, with patients followed up at specific intervals. From mid-2018, all researchers will be able to apply for access to samples stored in the biobank for future studies.

The biobank is funded by AbbVie Inc, Evotec, UCB Celltech Biopharma and Kidney Research UK. Experts from the University of Bristol and the University of Nottingham form the core academic team overseeing all operational delivery. Biomarker analysis will take place at the University of Geneva and histopathological (tissue) analysis at the University of Birmingham. More information is available here: nurturebiobank 

NEPLEX

In November 2017, Evotec announced a strategic collaboration on microfluidics technology including induced pluripotent stem cell ("iPSC") differentiation with leading academic institutions in the UK and Italy to accelerate the discovery of novel drugs to treat kidney diseases. The collaboration will combine key technologies from Evotec and the academic institutions to develop a novel drug discovery device ("Nephron-on-a-Chip"). It will merge state-of-the-art microfluidics technology established at the Cambridge University with world-class expertise in iPSC technology and kidney disease from the University of Bristol, the Mario Negri Institute in Bergamo and from Evotec.

The goal of the NEPLEX ("NEPHRON-ON-A-CHIP WITH CELLULAR AND EXTRACELLULAR MATRIX COMPLEXITY") consortium is to develop a functional Nephron-on-a-Chip that reflects both the filtration area as well as the resorption area of a human kidney. The functional nephrons will be based on fully characterised human cell lines and iPSC-derived human kidney cells. Prof. Moin Saleem and his group from the University of Bristol will contribute human kidney cell lines focusing on the resorption unit, Dr Yan Yan Shery Huang and her lab from the University of Cambridge will develop the glomerular part of the chip, Dr Christodoulos Xinaris and his colleagues from the Mario Negri Institute will provide human iPSC lines and expertise. Evotec will add its state-of-the-art iPSC and kidney disease platforms. The device will allow testing of drug candidates in a fully human nephron already in the pre-clinic and thereby improve and accelerate drug discovery in the field of kidney diseases.

Oncology

Indivumed/ Non-Small Cell Lung Cancer

In January 2020, Evotec and Indivumed announced a new research collaboration to discover and develop first-in-class therapeutics for the treatment of non-small cell lung cancer (“NSCLC”). The collaboration will combine Evotec’s proprietary bioinformatics analysis platform EVOpanHunter as well as its small molecule and antibody discovery platforms with the NSCLC cohort of Indivumed’s true multi-omics cancer database “IndivuType”.The alliance aims to deliver highly effective treatments for NSCLC patients.

Mark Foundation/ TargetAlloMod

In March 2019, Evotec and and The Mark Foundation for Cancer Research announced that they have entered into a research collaboration to discover and develop first-in-class therapeutics in oncology. The collaboration, for an initial period of two years, is based on Evotec’s new proprietary drug discovery platform TargetAlloMod, which is focused on disrupting cell signalling via a novel mechanism of action. This approach is expected to deliver highly potent and more durable treatments for both clinically validated and novel immuno-oncology targets.

Yale/ TargetDBR

In December 2013, Evotec entered into a research collaboration, TargetDBR (DNA Break Repair), with the laboratories of Prof. Peter Glazer and Prof. Ranjit Bindra at Yale School of Medicine. The objective of this collaboration is to identify novel mechanisms, targets and compounds that have the potential to interfere with DNA repair. DNA repair mechanisms allow cancer cells to cope with extensive genome rearrangements as well as to escape conventional radio- and chemotherapy and thus have potential applications in many cancer indications. This is the first collaboration to be announced as part of Evotec's open innovation alliance with Yale University.
In July 2019, based on the TargetDBR research, Evotec announced the formation of Breakpoint Therapeutics, a spin-off company focusing on the development of Evotec`s DNA damage response portfolio.

About the open innovation alliance with Yale

In January 2013, Evotec and Yale University entered into a strategic partnership. Under the agreement, Evotec and Yale intend to leverage first rate science performed at Yale University together with Evotec‘s drug discovery infrastructure and expertise into highly innovative discovery approaches in diseases of high unmet medical need. Initially, Evotec and Yale have defined a wide range of scientific fields including metabolic diseases, CNS, immunological diseases and cancer where they will jointly assess and potentially pursue novel assays, screens and models but in particular exploratory drug targets and compounds. The intention is to seamlessly integrate Evotec’s drug discovery infrastructure with highly innovative biology at Yale to mature individual projects to a stage where they can be commercialised.

Rare diseases

CENTOGENE/ Gaucher disease

In August 2020, Evotec and CENTOGENE N.V., a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, announced that the companies have expanded their existing drug discovery partnership related to the protein target glucocerebrosidase (“GBA”) with a focus on Gaucher disease, a genetic and relatively common lysosomal storage disorder. The parties intend to develop a treatment option for the majority of patients whereas currently available treatments are individualised for each patient depending on the type of Gaucher disease, focusing on symptomatic relief.

Women`s health

Bill & Melinda Gates Foundation

In December 2021, Evotec as received a $ 18 m grant from the Bill & Melinda Gates Foundation for the integrated discovery and development of a novel, first-in-class programme to accelerate progress in the area of women’s health and contraceptive technology, leveraging Evotec’s integrated R&D platform.

The project makes use of Evotec’s fully-integrated drug discovery and development platforms as well as therapeutic area expertise to take an idea from concept to nomination of a pre-clinical development candidate. To efficiently deliver safe and efficacious pre-clinical drug candidates, Evotec will use its extensive toolbox of computational tools, structural biology, therapeutic area knowledge, translational biology models, safety assessment and deep talent across the full R&D continuum.

Antisense Oligonucleotides

In August 2020, Evotec and the leading independent European antisense drug discovery company, Secarna Pharmaceuticals GmbH & Co. KG, announced a strategic partnership in the field of antisense oligonucleotide (“ASO”)-based therapeutics. Antisense therapy is an innovative, clinically and commercially validated, highly-targeted pharmacological approach which interferes with gene expression in the cells of interest to specifically inhibit the production of proteins which promote development and progression of diseases.

Secarna is the next generation antisense drug discovery company, combining its proprietary LNAplus™ platform with cutting edge third generation LNA-chemistry to generate molecules with significantly improved potency and a comprehensive safety profile against targets that are difficult to regulate or currently not druggable with alternative approaches. Using state-of-the-art bioinformatics (Oligofyer™), Secarna’s antisense molecules are precisely engineered to specifically bind to the targeted RNA of the gene of interest. Additionally, they are pre-screened and selected because of their high potential for activity. As a result, there is little to no need for lead optimisation which significantly speeds up the discovery and development process compared to conventional therapeutic approaches.

With their framework agreement, Evotec and Secarna have laid the foundation for a long-term platform collaboration spanning across a number of targets and indications. The first programme has been identified and the companies are now progressing towards the establishment of a pipeline of co-owned antisense oligonucleotide therapies. This comprehensive partnership creates a unique opportunity for biotech and pharmaceutical companies to enter the rapidly growing field of antisense therapeutics by partnering with Evotec and Secarna and to gain access to the companies’ co-owned pipeline through a variety of individual deal structures.