HI-Bio Launches with $120M and Two MorphoSys Assets in Immune-Mediated Space - Updated

Financing Concept

With $120 million in backing, Human Immunology Biosciences (HI-Bio) launched two assets licensed from MorphoSys AG aimed at severe immune-mediated diseases.

Felzartamab, an anti-CD38 antibody, targets a protein expressed on the surface of mature plasma cells whose dysfunction drives multiple immune-modulated diseases. 

It is believed that felzartamab can deplete plasmablasts and plasma cells, which will remove cells that produce disease-causing autoantibodies, the company noted. HI-Bio plans to evaluate felzartamab for two kidney diseases, antibody-positive membranous nephropathy ( aMN) and IgA nephropathy (IgAN).

Prior to the licensing deal, MorphoSys had already conducted early clinical work. Interim data from a Phase IIa study announced last year showed felzartamab has the potential to rapidly and substantially reduce anti-PLA2R auto-antibody titers, which are serological markers for aMN. 

The other asset, HIB210, is an anti-C5aR1 antibody. HI-Bio is running HIB210 in a Phase I program assessing the drug candidate's safety. The company intends to evaluate the drug in multiple programs for immune-mediated diseases.

HI-Bio holds exclusive worldwide rights for felzartamab, except for China, and exclusive worldwide rights, except for China and South Korea, for HIB210.

Beyond MN and IgAN, HI-Bio did not specifically identify any diseases within the space it was targeting.

The company noted that many of these diseases are caused by cellular dysfunction, particularly within plasma cells, neutrophils, mast cells and other cells responsible for the secretion of antibodies, signaling mediators, tissue repair and allergic responses.

HI-Bio expects its drug programs to target, modulate or deplete these cellular drivers of disease with therapeutics.

Travis Murdoch, chief executive officer of HI-Bio, said immune-mediated diseases "represent a landscape where the scale of unmet need and potential patient benefit is truly enormous."

As much as 4% of the world's population may have one of these immune-mediated diseases, HI-Bio noted in its announcement.

Murdoch told BioSpace the company aims to lead clinical immunology into its next chapter. He said they believe there have been significant developmental advancements that will allow them to “precizonize” the field in a way that hasn’t yet happened but is now possible.

“Given the advances in genetics and immunology and the ability to engineer more potent and specific drugs we believe we can create greater clinical impact for patients through a more targeted clinical impact,” he said.

He said the company intends to share some data from the ongoing clinical development programs for felzartamab later this week at the American Society of Nephrology meeting. Felzartamab and HIB210 are expected to offer an impactful approach to treating those rare kidney diseases. But those are just a starting point, Murdoch said.

Part of HI-Bio’s approach will be to look for new indications where they can find proof of concept for the two assets. Murdoch noted that Janssen’s Darzalex, which is also an anti-CD38 antibody, could provide new inspiration for what is possible for felzartamab. 

The company claimed that few targeted therapies are available for autoimmune, allergic and inflammatory diseases that can be referred to as immune-mediated diseases.

Many of the therapies that are available for these patients are considered broad-acting and do not address the root causes of the disease. HI-Bio estimates the unmet medical need of this community of patients could be valued at $150 billion by 2025. 

Beyond the two assets licensed from MorphoSys, HI-Bio's developmental programs are backed by a technology that incorporates human genetics, human immunophenotyping, data sciences and therapeutic engineering. 

The toolkit harnesses insights from R&D efforts to profile the immune phenotypes that drive IMDs, according to the company. 

Beyond Murdoch, the HI-BIO executive team includes Matthew Albert, chief translational officer, Ariella Kelman, senior vice president of development and Jaideep Dudani, head of portfolio development.  

As part of the deal, MorphoSys has taken a 15% stake in HI-Bo. 

The financing was backed by ARCH Ventures, Jeito Capital, Monograph Capital and other unnamed investors. 

For France-based Jeito Capital, the investment in HI-Bio is the firm's first in the United States and the eleventh to date. 

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