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HI Bio Reaches For The Lead With Phase II Primary Membranous Nephropathy Data

 
• By Joseph Haas

While Roche is in Phase III with Gazyva, HI-Bio thinks its autoantibody-depleting mechanism may be the best approach in PMN.

Autoantibody
HI-Bio takes an antiautobody-targeted approach to rare diseases • Source: Shutterstock

Human Immunology Biosciences, Inc. (HI-Bio) reported data from a pair of Phase II trials on 11 April that appear to position its anti-CD38 agent as a strong competitor in primary membranous nephropathy (PMN), where Roche Holding AG has its anti-CD20 cancer drug Gazyva in Phase III. HI-Bio’s felzartamab demonstrated dose-dependent reductions of pathogenic antibodies in the M-PLACE and NewPLACE studies, and the company will start talking to regulators about a pivotal trial in the rare kidney disease.

After coming out of stealth last November, HI-Bio licensed both felzartamab and HIB210, a preclinical anti-C5aR1 agent for an undisclosed immune-mediated disease, from MorphoSys AG to seed its pipeline. (Also see "As Its Debut Cancer Drug Struggles, MorphoSys Continues Refocus With $1bn Licensing Deal" - Scrip, 15 June, 2022

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