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Experimental lupus treatment aims to prevent inflammatory attacks

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Alpine, Evotec Expanding Production of ALPN-303, Potential Therapy

Experimental lupus treatment aims to prevent inflammatory attacks

by Marisa Wexler, MS | August 15, 2022

Alpine Immune Sciences and Evotec announced the expansion of an agreement to manufacture ALPN-303, an experimental anti-inflammatory therapy that Alpine is developing for systemic lupus erythematosus (SLE) and other diseases driven by immune B-cells.

Under the initial 2020 agreement, Evotec’s subsidiary Just-Evotec Biologics used its continuous manufacturing platform, called J.DESIGN, to produce ALPN-303 for use in ongoing Phase 1 and anticipated Phase 2 clinical testing. With the expansion, Just-Evotec will utilize its platform to develop a process allowing ALPN-303 to be made at a scale suitable for commercialization.

“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,” Linda Zuckerman, PhD, executive vice president and global head of biotherapeutics at Just-Evotec, said in a company press release.

ALPN-303 targets B-cell growth and activation

ALPN-303 is designed to inhibit the activity of B-cells, a type of immune cell that plays a key role in the autoimmune inflammatory attack that drives lupus.

It works by blocking the activity of two signaling molecules that promote B-cell growth and activation, called B-cell activating factor (BAFF or BLyS) and a proliferation inducing ligand (APRIL). The experimental therapy was created by modifying part of a protein receptor called TACI, which normally binds to these signaling molecules.

Alpine is sponsoring a Phase 1 trial (NCT05034484) evaluating the safety and pharmacological profile of ALPN-303 in healthy volunteers. The study is recruiting participants at locations in Brisbane and Melbourne, Australia. It is open to adults, ages 18–65, who are fully vaccinated against COVID-19, among other criteria.

“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,” said Wayne Gombotz, PhD, chief technology officer at Alpine.

Just-Evotec’s J.DESIGN platform uses artificial intelligence and machine learning, alongside other processes, to facilitate the development of biologics — medicines that require the use of living cells in the manufacturing process.

“We are excited to be leveraging Just – Evotec Biologics’ J.DESIGN platform to bring this important therapeutic to late-stage clinical development,” Gombotz said.

The company’s biomanufacturing facility is located in Redmond, Washington state.

“We are proud to support Alpine in its endeavour to further develop ALPN-303,” added Craig Johnstone, PhD, Evotec’s chief operating officer.

Marisa Wexler, MS Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.