SOUTH SAN FRANCISCO, Calif. – July 11, 2023 – Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that the first participants have been dosed in a Phase 1 healthy volunteer study of HIB210, an investigational monoclonal antibody targeting C5aR1. 

HIB210 follows felzartamab as the company’s second clinical-stage program and advances the company’s strategy of targeting and modulating the cellular drivers of IMDs. C5aR1, a downstream receptor of C5a, is believed to be implicated in neutrophil activation and chemotaxis.

“Targeting C5aR1 has the potential to transform the treatment paradigm in several high burden IMDs,” said Travis Murdoch, M.D., Chief Executive Officer at HI-Bio. “C5aR1 is a validated target for several IMDs. Our preclinical characterization of HIB210 highlights its potential as a highly potent therapy. We look forward to evaluating HIB210 for patients with IMDs.”

The Phase 1 healthy volunteer study is a double-blind, placebo-controlled, multiple ascending dose clinical trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of HIB210 in healthy volunteers (NCT05928585). Pharmacodynamic biomarkers of target engagement will be evaluated to provide proof-of-mechanism data. 

“We are excited that dosing of HIB210 comes on the heels of positive Phase 2 data and orphan drug designation for felzartamab, HI-Bio’s investigational agent for the treatment of primary membranous nephropathy,” said Murdoch. “As our second clinical-stage program, today’s HIB210 milestone is an important step forward in our mission to transform clinical immunology away from one-size-treats-all therapies and towards approaches that address the specific cellular drivers of immune-mediated diseases.”

About HIB210

HIB210 is an investigational therapeutic human monoclonal antibody directed against complement factor C5a receptor 1 (C5aR1). C5aR1 is responsible for guiding and activating myeloid cells and is highly expressed on neutrophils, monocytes and macrophages. HIB210 is intended to block the interaction between the ligand C5a and its receptor C5aR1 in effort to mitigate myeloid cell activation and neutrophil migration at sites of uncontrolled inflammation. Targeting downstream complement receptor C5aR1 has potential advantages, including maintaining the ability to form the C5b-dependent membrane attack complex, believed to be an important mechanism to defend against infection. Directly targeting C5aR1 also has the potential benefit of maintaining C5a engagement of C5aR2 signaling, which has been shown to play a beneficial anti-inflammatory role in some conditions. Elevated C5a levels and clear neutrophil involvement have been linked to numerous IMDs, suggesting potential broad application of HIB210. HI-Bio in-licensed HIB210 (previously known as MOR210) from MorphoSys in June 2022, and holds exclusive worldwide rights for HIB210 outside of Greater China and South Korea. 

In 2018, MorphoSys entered into an exclusive strategic collaboration and regional licensing agreement with I-Mab Biopharma to develop and commercialize HIB210 (TJ210) in South Korea and Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.

HIB210 is an investigational drug that has not yet been approved by any regulatory authorities. 

About HI-Bio 

Human Immunology Biosciences, Inc. (HI-Bio™) is a clinical-stage biotechnology company focused on discovering and developing precision medicines for people suffering from immune-mediated diseases (IMDs). HI-Bio is leading clinical immunology into its next chapter by targeting cellular drivers of disease. To learn more about HI-Bio, visit us at www.hibio.com or follow us on LinkedIn and Twitter.