Human Immunology Biosciences (HI-Bio), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), announced its launch with $120 million in financing. \n\n\n\nHI-Bio was incubated by ARCH Venture Partners and Monograph Capital, joined by Jeito Capital and unnamed institutional investors and family offices.\n\n\n\nFew targeted therapies exist for the autoimmune, allergic and inflammatory diseases that can together be referred to as IMDs. As much as 4% of the world’s population may have one of these diseases, representing an enormous health burden. \n\n\n\nConventional therapies are generally broad acting, and do not address the root causes of disease. As a result, many patients with IMDs experience limited relief from their symptoms and may experience unnecessary side effects. More than half of people treated with currently available therapies are not in remission. With such large unmet medical needs remaining, the global therapeutic market for these diseases could reach $150 billion by 2025.\n\n\n\n“We know the power of precision medicine to achieve better results for patients, and HI-Bio is the first company to combine that approach with a focus on the latest in genetics and immunology for immune-mediated diseases,” said Paul Berns, HI-Bio chairman and managing director at ARCH Venture Partners. \n\n\n\n“HI-Bio is uniquely positioned to lead the transformation in clinical immunology away from one-size-treats-all medicines and to improve the lives of patients through the development of novel, targeted therapies for immune-mediated diseases.”\n\n\n\nCell dysfunction\n\n\n\nMany IMDs stem from the dysfunction of cells that make up the immune system, including plasma cells, neutrophils, mast cells and more. These cells are responsible for critical functions and processes, including, for example, the secretion of antibodies, signaling mediators, tissue repair and allergic responses. \n\n\n\nHI-Bio’s programs apply a precision medicine approach to target, modulate or deplete these cellular drivers of disease with therapeutics. \n\n\n\n“We at HI-Bio are an embodiment of the urgent need to develop precision therapies that are more targeted for patients suffering from immune-mediated diseases,” said Travis Murdoch, CEO of HI-Bio. \n\n\n\n“Immune-mediated diseases represent a landscape where the scale of unmet need and potential patient benefit is truly enormous. We are grateful to investors like ARCH, Monograph and Jeito, who share our vision for HI-Bio. They see that we have an enormous opportunity to bring an unprecedented degree of precision and creativity to clinical immunology, with all the potential safety and efficacy enhancements that come with our approach.”\n\n\n\nClinical-stage assets\n\n\n\nHI-Bio’s clinical-stage assets include felzartamab, an anti-CD38 antibody, and HIB210, an anti-C5aR1 antibody. \n\n\n\nFelzartamab targets a protein expressed on the surface of mature plasma cells whose dysfunction is thought to drive several IMDs. When applied, felzartamab is believed to deplete plasmablasts and plasma cells, resulting in the removal of cells that produce disease-causing autoantibodies. HI-Bio is testing felzartamab for membranous nephropathy (MN) and IgA nephropathy (IgAN), with the potential to be the best-in-class therapy for autoantibody diseases. HIB210 is currently in ongoing phase 1 safety testing, with anticipated studies in IMDs currently being planned.\n\n\n\nFelzartamab and HIB210 were in-licensed through a transaction with MorphoSys in June 2022. HI-Bio holds exclusive worldwide rights for felzartamab, with the exception of Greater China, and exclusive worldwide rights except Greater China and South Korea for HIB210. \n\n\n\nTerms included a 15% equity stake in HI-Bio, milestone payments and single-to low-double-digit royalties on net sales. Both programs are believed to hold potential for expansion in multiple other indications in the IMD landscape. In addition to these programs, HI-Bio is advancing discovery programs targeting the dysfunction of mast cells implicated in several undisclosed indications. \n\n\n\nUnderlying HI-Bio's clinical pipeline is a toolkit that encompasses human genetics, human immunophenotyping, data sciences and therapeutic engineering. This discovery toolkit leverages emerging insights from research and development efforts to profile the immune phenotypes that drive IMDs. The toolkit will allow HI-Bio to rapidly advance its programs from early discovery through clinical development and can be applied to virtually all areas of the immune landscape.