- JUST – EVOTEC BIOLOGICS WILL APPLY ITS FULLY INTEGRATED TECHNOLOGY PLATFORM TO DEVELOP AN OPTIMISED COMMERCIAL PROCESS FOR ALPN-303, A DUAL BAFF/APRIL INHIBITOR FOR SYSTEMIC LUPUS ERYTHEMATOSUS AND OTHER AUTOIMMUNE AND INFLAMMATORY DISEASES
Hamburg & Seattle, 10 August 2022:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Alpine Immune Sciences, Inc. (NASDAQ: ALPN) today announced that Evotec’s Seattle-based subsidiary, Just – 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 – Evotec Biologics delivered drug substance materials using their J.DESIGN continuous manufacturing platform for Alpine’s ongoing Phase I study and anticipated Phase II studies of ALPN-303.
Under the expanded contract, Just – Evotec Biologics will leverage its data-driven technology platform to develop a commercial manufacturing process for ALPN-303. The programme includes upstream and downstream process, analytical method, and formulation development with a view to support commercial manufacturing of ALPN 303. Commercial process development activities will be performed at Just – Evotec Biologics’ state-of-the art J.POD® biomanufacturing facility located in Redmond, Washington.
J.DESIGN, Just – Evotec Biologics’ 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 – 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.
Dr Linda Zuckerman, Executive Vice President, Global Head Biotherapeutics at Just – Evotec Biologics, commented: “We 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.”
Dr Craig Johnstone, Chief Operating Officer at Evotec, added: “We are proud to support Alpine in its endeavour to further develop ALPN-303. The combination of flexible manufacturing capacity with smart, robust and high-yielding process development makes Just – Evotec Biologics’ J.DESIGN the ideal platform to bring ALPN-303 to patients with currently significant unmet medical needs.”
Dr Wayne Gombotz, Alpine’s Chief Technology Officer, commented: “ALPN-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 – Evotec Biologics’ J.DESIGN platform to bring this important therapeutic to late-stage clinical development.”
ALPN-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.