{"id":47125,"date":"2022-08-10T08:01:53","date_gmt":"2022-08-10T06:01:53","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/just-evotec-biologics-and-alpine-immune-sciences-expand-partnership-for-commercial-process-development-of-alpn-303\/"},"modified":"2022-08-10T08:01:53","modified_gmt":"2022-08-10T06:01:53","slug":"just-evotec-biologics-and-alpine-immune-sciences-expand-partnership-for-commercial-process-development-of-alpn-303","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/just-evotec-biologics-and-alpine-immune-sciences-expand-partnership-for-commercial-process-development-of-alpn-303\/","title":{"rendered":"Just \u2013 Evotec Biologics and Alpine Immune Sciences Expand Partnership for Commercial Process Development of ALPN-303"},"content":{"rendered":"
\n

\n– Just \u2013 Evotec Biologics will apply its fully integrated technology platform to develop an optimized commercial process for ALPN-303, a Dual BAFF\/APRIL Inhibitor for Systemic Lupus Erythematosus and Other Autoimmune and Inflammatory Diseases –<\/i>\n<\/p>\n

HAMBURG, Germany & SEATTLE–(BUSINESS WIRE)–Evotec SE (Frankfurt Stock Exchange: EVT, MDAX\/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Alpine Immune Sciences, Inc. (NASDAQ: ALPN) today announced that Evotec\u2019s Seattle-based subsidiary, Just \u2013 Evotec Biologics, Inc., expanded a multi-year partnership with Alpine for the development of a commercial process for ALPN-303, an engineered TACI domain with significantly improved potency against the B cell cytokines BAFF and APRIL, being developed for the treatment of systemic lupus erythematosus and other B cell-mediated inflammatory and autoimmune diseases. The contract is a continuation of their first-in-human program initiated in 2020 in which Just \u2013 Evotec Biologics delivered drug substance materials using their J.DESIGN continuous manufacturing platform for Alpine\u2019s ongoing Phase I study and anticipated Phase II studies of ALPN-303.\n<\/p>\n

<\/a><\/p>\n

\nUnder the expanded contract, Just \u2013 Evotec Biologics will leverage its data-driven technology platform to develop a commercial manufacturing process for ALPN-303. The program includes upstream and downstream process, analytical method, and formulation development with a view to support commercial manufacturing of ALPN\u2011303. Commercial process development activities will be performed at Just \u2013 Evotec Biologics\u2019 state-of-the art J.POD\u00ae<\/sup> biomanufacturing facility located in Redmond, Washington.\n<\/p>\n

\nJ.DESIGN, Just \u2013 Evotec Biologics\u2019 data-driven, highly automated end-to-end biologics technology platform, employs a series of innovative technologies relying on the use of artificial intelligence, machine learning, intensified and continuous bioprocesses specifically designed for flexible and efficient biologics development, from discovery through to clinical and commercial manufacturing. The advanced Just \u2013 Evotec Biologics platform is specifically well suited for monoclonal antibodies and related protein modalities such as Fc fusion proteins. The J.POD facility was designed to support both clinical and commercial manufacturing processes while leveraging its expandable and highly flexible capacity.\n<\/p>\n

\nDr Linda Zuckerman, Executive Vice President, Global Head Biotherapeutics at Just \u2013 Evotec Biologics, commented: <\/b>\u201cWe are excited to continue our highly collaborative partnership with the innovative team at Alpine to support the development of a commercial process for ALPN-303 in our state-of-the-art J.POD site in Redmond, WA.\u201d\n<\/p>\n

\nDr Craig Johnstone, Chief Operating Officer at Evotec, added: <\/b>\u201cWe are proud to support Alpine in its endeavor to further develop ALPN-303. The combination of flexible manufacturing capacity with smart, robust and high-yielding process development makes Just \u2013 Evotec Biologics\u2019 J.DESIGN the ideal platform to bring ALPN-303 to patients with currently significant unmet medical needs.\u201d\n<\/p>\n

\nDr Wayne Gombotz, Alpine\u2019s Chief Technology Officer, commented: <\/b>\u201cALPN-303 is a highly differentiated and promising therapeutic candidate with the potential to treat challenging target diseases such as lupus and other B-cell related inflammatory diseases. We are excited to be leveraging Just \u2013 Evotec Biologic\u2019s J.DESIGN platform to bring this important therapeutic to late-stage clinical development.\u201d\n<\/p>\n

\nAbout ALPN-303<\/b>\n<\/p>\n

\nALPN-303 is a dual B cell cytokine antagonist being developed for multiple autoimmune and\/or inflammatory diseases. Engineered by directed evolution, ALPN-303 potently inhibits the pleiotropic B cell cytokines B cell activating factor\/B lymphocyte stimulator (BAFF, BLyS) and a proliferation inducing ligand (APRIL), which play key roles in B cell development, differentiation, and survival, and together contribute to the pathogenesis of multiple autoimmune diseases like systemic lupus erythematosus (SLE) and many other autoantibody-related inflammatory diseases. By simultaneously blocking these two cytokines, ALPN-303 has the potential to improve outcomes in patients suffering from severe autoimmune and\/or inflammatory diseases.\n<\/p>\n

\nAbout Alpine Immune Sciences<\/b>\n<\/p>\n

\nAlpine Immune Sciences is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients\u2019 lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit www.alpineimmunesciences.com<\/a>. Follow @AlpineImmuneSci on Twitter and LinkedIn.\n<\/p>\n

\nAbout Just \u2013 Evotec Biologics<\/b>\n<\/p>\n

\nJust \u2013 Evotec Biologics, wholly owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep expertise in the fields of artificial intelligence, machine learning, protein discovery, bioprocessing and manufacturing, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just-evotecbiologics.com<\/a>\n<\/p>\n

\nAbout Evotec SE<\/b>\n<\/p>\n

\nEvotec 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\u2019s 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 \u201cData-driven R&D Autobahn to Cures\u201d 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 4,200 highly qualified people. The Company\u2019s 15 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com<\/a> and follow us on Twitter @Evotec<\/a> and LinkedIn<\/a>.\n<\/p>\n

\nEvotec Forward-Looking Statements<\/b>\n<\/p>\n

\nThis announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec\u2019s securities. Words such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cmight,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwould\u201d and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec\u2019s 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\u2019s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.\n<\/p>\n

\nAlpine Forward-Looking Statements<\/b>\n<\/p>\n

\nThis release contains forward-looking statements that are not based on historical fact and include statements regarding Alpine\u2019s platform technology and potential therapies, the timing of and results from any potential clinical trials, clinical and regulatory objectives and the timing thereof, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of Alpine\u2019s product candidates. Forward-looking statements include statements that are predictive in nature and depend upon or refer to future events or conditions. Forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond Alpine\u2019s control, include, but are not limited to: the impact of the COVID-19 pandemic on Alpine\u2019s business, including the impact on third parties who act for or on Alpine\u2019s behalf, may be more severe and prolonged than currently anticipated; Alpine\u2019s clinical programs may not result in approved products; as well as the other risks identified in Alpine\u2019s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Alpine undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.\n<\/p>\n

\nThe Alpine logo is a registered trademark or trademark of Alpine Immune Sciences, Inc. in various jurisdictions.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nInvestor Relations<\/b>
Alex Sharif
\n
Director, Investor Relations and Corporate Development
\n
Alpine Immune Sciences, Inc
\n
206-788-4545
\n
ir@alpineimmunesciences.com<\/a>\n<\/p>\n

\nMedia Relations<\/b>
Kelli Perkins
\n
Red House
\n
kelli@redhousecomms.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

– Just \u2013 Evotec Biologics will apply its fully integrated technology platform to develop an optimized commercial process for ALPN-303, a Dual BAFF\/APRIL Inhibitor for Systemic Lupus Erythematosus and Other Autoimmune and Inflammatory Diseases – HAMBURG, Germany & SEATTLE–(BUSINESS WIRE)–Evotec SE (Frankfurt Stock Exchange: EVT, MDAX\/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Alpine Immune Sciences, Inc. … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47125","6":"format-standard","7":"category-industry"},"yoast_head":"\nJust \u2013 Evotec Biologics and Alpine Immune Sciences Expand Partnership for Commercial Process Development of ALPN-303 - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/just-evotec-biologics-and-alpine-immune-sciences-expand-partnership-for-commercial-process-development-of-alpn-303\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Just \u2013 Evotec Biologics and Alpine Immune Sciences Expand Partnership for Commercial Process Development of ALPN-303 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"– Just \u2013 Evotec Biologics will apply its fully integrated technology platform to develop an optimized commercial process for ALPN-303, a Dual BAFF\/APRIL Inhibitor for Systemic Lupus Erythematosus and Other Autoimmune and Inflammatory Diseases – HAMBURG, Germany & SEATTLE–(BUSINESS WIRE)–Evotec SE (Frankfurt Stock Exchange: EVT, MDAX\/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Alpine Immune Sciences, Inc. ... 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