Just - Evotec Biologics Expands Development and Manufacturing Agreement with ABL for Broadly Neutralising Antibodies Against HIV
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Insights
The collaboration between Just - Evotec Biologics and Advanced BioScience Laboratories to develop and manufacture broadly neutralising antibodies (bNAbs) against HIV is a significant stride in the biotech industry. This partnership leverages Just - Evotec Biologics' advanced biomanufacturing platform, which could potentially streamline the production process and reduce costs. The focus on bNAbs is pivotal, as they have been identified as a promising avenue for HIV treatment and prevention, capable of targeting multiple strains of the virus.
From an industry perspective, the use of continuous bioprocessing infrastructure, as mentioned by Dr. Linda Zuckerman, is a modern approach that could offer benefits such as increased productivity and scalability. The ability to support large-scale cGMP (current Good Manufacturing Practice) manufacturing campaigns is crucial for meeting regulatory standards and ensuring the quality and safety of pharmaceutical products. For stakeholders, this could mean a more efficient path to market for these bNAbs, potentially leading to a quicker return on investment.
The impact of developing a third bNAb against HIV cannot be understated in the context of global health. With over 38 million individuals living with HIV, according to the WHO, the need for effective treatments is urgent. The unique characteristic of bNAbs to target multiple HIV strains could revolutionize treatment paradigms and prevention strategies. This is especially important given the viral diversity and the tendency for resistance against current therapies.
Phase I clinical trials are critical for assessing safety, tolerability and pharmacokinetics of new therapies. The involvement of Just - Evotec Biologics in this early-stage clinical manufacturing denotes a commitment to accelerating the development pipeline. However, it is important to note that the journey from Phase I to market approval is lengthy and fraught with potential setbacks, including efficacy results and regulatory hurdles.
The absence of financial details in the announcement leaves some uncertainty for investors, as the economic impact of the agreement on Evotec's financials remains unclear. However, the fact that this contract is funded entirely by federal funds under an IDIQ contract suggests a stable and potentially significant revenue stream for Just - Evotec Biologics, contingent on the successful delivery of the agreed services.
For the stock market, this news could be perceived positively, as it demonstrates Evotec's continued expansion in the biologics space and its ability to secure governmental contracts. The long-term potential for Evotec could include not only revenue from this contract but also future opportunities arising from a successful bNAb development, such as partnerships, licensing deals, or even acquisition interest from larger pharmaceutical companies.
- JUST - EVOTEC BIOLOGICS TO PROVIDE DEVELOPMENT AND PHASE I CLINICAL MANUFACTURING OF BROADLY NEUTRALISING ANTIBODY AGAINST HIV
- AGREEMENT BUILDS ON PREVIOUS NIAID-FUNDED COLLABORATION TO DEVELOP A BROADLY NEUTRALISING ANTIBODY AGAINST HIV
HAMBURG, GERMANY / ACCESSWIRE / February 7, 2024 / Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ:EVO) today announced that its Seattle-based subsidiary Just - Evotec Biologics, Inc. has expanded its relationship with Advanced BioScience Laboratories, Inc. ("ABL"), a global contract development and manufacturing organisation ("CDMO") serving the US Government and biopharmaceutical industry. The expansion is under a new contract funded entirely by Federal funds under an indefinite delivery/indefinite quantity ("IDIQ") contract awarded to ABL from National Institute of Allergy and Infectious Disease ("NIAID"), National Institutes of Health ("NIH"), Department of Health and Human Services, ("DHHS") under Contract No. HHSN272201700010I/ 75N93023F00001.
The new agreement builds on previous collaborations between Just - Evotec Biologics and ABL to design highly efficient manufacturing processes for broadly neutralising antibodies ("bNAbs") against HIV. Under the expanded relationship, Just - Evotec Biologics will develop a third bNAb and perform large-scale cGMP manufacturing campaigns for both this bNAb and a previously developed bNAb against HIV for a Phase I clinical study. Just - Evotec Biologics will also provide release and stability testing services.
Dr Matthias Evers, Chief Business Officer of Evotec, commented: "We are excited to expand our long-standing partnership with ABL to include the development of a third bNAb. By leveraging Just - Evotec Biologics' next-generation biomanufacturing platform we provide an integrated development and manufacturing solution for our partner to support the delivery of new therapeutic options targeting HIV together."
Lauren Hudacik, President and Chief Executive Officer at ABL, added: "ABL has a long history of supporting the U.S. government's mission to develop effective prevention and therapeutic products against HIV. This expansion of partnership with Just - Evotec Biologics strengthens that tradition."
Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just - Evotec Biologics stated: "Building from the long-standing collaboration in the development of broadly-neutralising antibodies against HIV, we are excited to leverage Just - Evotec Biologics' intensified continuous bioprocessing infrastructure to drive ABL's towards clinical validation."
According to the WHO, there are over 38 million individuals living with HIV worldwide. The development of safe and efficacious HIV-1 treatments and prevention strategies remains one of the highest priorities of the NIAID. This programme aims to supply clinical material to continue vital ongoing clinical trials worldwide.
No financial details of the agreement between Just - Evotec Biologics and ABL were disclosed.
ABOUT ADVANCED BIOSCIENCE LABORATORIES, INC.
A leading CDMO harnessing decades of pioneering science and manufacturing expertise to drive the development of innovative therapies and vaccines. ABL has over 60 years of experience working with diverse organizations-including industry, government, and academic entities-to support their quest in improving vaccines, public health ABL maintains GMP facilities meeting U.S. regulatory standards, providing GMP manufacture of virus-based oncolytic therapies, gene therapies, vaccines, and protein-based immunotherapeutic products. ABL's CDMO services include bulk drug substance, fill/finish of drug product, process and assay development, and bioanalytical testing. ABL is part of the French bioindustrial group Institut Mérieux, which fights against infectious diseases and cancers, through the complementary approaches of its companies in the fields of diagnosis, immunotherapy, food safety and nutrition.
For more information visit www.ablinc.com or contact us at info@ablinc.com
ABOUT JUST - EVOTEC BIOLOGICS
Just - Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform company that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just - Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.
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 5,000 highly qualified people. The Company's 17 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 X/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 Evotec's expectations for revenues, Group EBITDA and unpartnered R&D expenses. 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, Gabriele.Hansen@evotec.com
Hinnerk Rohwedder, Director of Global Corporate Communications, Hinnerk.Rohwedder@evotec.com
IR Contact Evotec SE:
Volker Braun, EVP Head of Global Investor Relations & ESG, Volker.Braun@evotec.com
SOURCE: Evotec SE
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