Just – Evotec Biologics and Alpine Immune Sciences Expand Partnership for Commercial Process Development of ALPN-303

Rhea-AI Summary

Evotec SE and Alpine Immune Sciences have expanded their partnership to develop a commercial manufacturing process for ALPN-303, a dual BAFF/APRIL inhibitor. This collaboration builds on their ongoing first-in-human program initiated in 2020, with Evotec providing drug substance materials for clinical studies. The enhanced contract will utilize Evotec's J.DESIGN technology platform in Redmond, Washington, aiming to improve outcomes for patients with systemic lupus erythematosus and other autoimmune diseases.

Positive

• Expanded partnership with Evotec to develop ALPN-303's commercial process.
• Utilization of advanced J.DESIGN technology for efficient biologics development.
• Potential to address significant unmet medical needs in autoimmune diseases.

Negative

• None.

- Just – 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. (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 program 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 endeavor 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 Biologic’s J.DESIGN platform to bring this important therapeutic to late-stage clinical development.”

About ALPN-303

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.

About Alpine Immune Sciences

Alpine 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’ 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. Follow @AlpineImmuneSci on Twitter and LinkedIn.

About Just – Evotec Biologics

Just – 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

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 4,200 highly qualified people. The Company’s 15 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.

Evotec 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.

Alpine Forward-Looking Statements

This release contains forward-looking statements that are not based on historical fact and include statements regarding Alpine’s 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’s 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’s control, include, but are not limited to: the impact of the COVID-19 pandemic on Alpine’s business, including the impact on third parties who act for or on Alpine’s behalf, may be more severe and prolonged than currently anticipated; Alpine’s clinical programs may not result in approved products; as well as the other risks identified in Alpine’s 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.

The Alpine logo is a registered trademark or trademark of Alpine Immune Sciences, Inc. in various jurisdictions.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220809006095/en/

Investor Relations

Alex Sharif

Director, Investor Relations and Corporate Development

Alpine Immune Sciences, Inc

206-788-4545

ir@alpineimmunesciences.com

Media Relations

Kelli Perkins

Red House

kelli@redhousecomms.com

Source: Alpine Immune Sciences Inc.

FAQ

What is the significance of the expanded partnership between Evotec and Alpine for ALPN-303?

The partnership aims to streamline the development of a commercial manufacturing process for ALPN-303, enhancing its availability for clinical use.

What is ALPN-303 and its intended use?

ALPN-303 is a dual BAFF/APRIL inhibitor being developed to treat systemic lupus erythematosus and other B cell-mediated diseases.

When did the original partnership for ALPN-303 begin?

The first partnership began in 2020, focusing on the initial development phases of ALPN-303.

Where will the commercial manufacturing process for ALPN-303 take place?

The commercial manufacturing process will be developed at Evotec's J.POD biomanufacturing facility in Redmond, Washington.