SOUTH SAN FRANCISCO, Calif., – May 25, 2023 –&nbsp;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 U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for felzartamab, the company’s investigational agent that is in development for the treatment of primary membranous nephropathy (PMN). Felzartamab is an investigational monoclonal antibody designed to deplete CD38+ plasma cells, which are believed to drive PMN through the production of pathogenic autoantibodies. The company intends to advance felzartamab into late-stage studies. “The FDA’s orphan drug designation for felzartamab is an acknowledgment of the critical and ongoing unmet need in PMN and the potential for felzartamab to be an important new therapeutic option to improve the lives of patients with PMN who currently have very limited treatment options,” said&nbsp;Uptal Patel, M.D., Chief Medical Officer at HI-Bio. “We are excited to advance our clinical development program to make progress on our goal of transforming PMN into a well-managed condition.”PMN is a rare IMD affecting the kidneys, impacting more than 36,000 people in the United States. There are currently no approved therapies for PMN. Standard of care comprises off-label use of a variety of agents, including immunosuppressive therapies like cyclophosphamide, and CD20-targeted B-cell depleting agents. Even with these strategies, half of patients with PMN continue to have nephrotic syndrome and nearly one third progress to kidney failure.&nbsp;As recently <a href="https://hibio.com/news/hi-bio-announces-positive-phase-2-data-on-felzartamab-for-the-treatment-of-primary-membranous-nephropathy">announced</a>, positive data was achieved for felzartamab in patients with PMN across two Phase 2 studies. Beyond PMN, felzartamab is currently in development for IgA Nephropathy and Antibody Mediated Rejection of kidney transplants. The company intends to explore developing felzartamab in additional IMDs where patients have serious unmet needs.&nbsp;The FDA’s Orphan Drug Designation program is designed to advance the development of drugs and biologics intended to treat a rare disease or condition that affects fewer than 200,000 people in the United States. Orphan drug designation qualifies HI-Bio for certain development incentives, including tax credits for qualified clinical trials, exemption of FDA application fees and up to seven-year market exclusivity upon regulatory approval.About Primary Membranous Nephropathy (PMN)PMN is a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome (NS) in adults worldwide. Disease onset and diagnosis typically occurs between 40 and 50 years of age, with 80% of patients presenting with Nephrotic Syndrome (i.e., edema, &gt;3.5 g/day proteinuria, hypoalbuminemia). PMN is characterized by a thickening of the glomerular basement membrane (GBM) due to the formation and deposition of immune complexes in this space between podocytes and the glomerular endothelium of the kidney.&nbsp;Approximately 80% of PMN cases arise due to autoantibodies that recognize the phospholipase A2 receptor (PLA2R) antigen expressed on podocytes. Anti-PLA2R is both a diagnostic and prognostic biomarker, and total aPLA2R antibody level has been shown to be a biomarker for prognosis of outcome in patients with PMN. Other autoantibodies have been identified in patients with PMN including anti-THSD7A, NELL-1 and Sema3B, further supporting the role of antibody-secreting plasma cells in the pathophysiology of PMN. CD38+ long lived plasma cells and plasmablasts are a main source of autoantibodies.&nbsp;There are no approved therapies for PMN. The current standard of care comprises off-label use of supportive care measures (e.g., angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, statins, and diuretics), conventional immunosuppressive treatments (ISTs) (e.g. cyclophosphamide combined with steroids and calcineurin inhibitors) or B-cell depleting agents (e.g. anti-CD20 antibodies). However, these treatments are not effective in all patients, with a significant proportion of patients not achieving remission or relapsing. In addition, conventional immunosuppressive treatments are associated with a high risk of toxicity.About FelzartamabFelzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. In PMN, CD38+long-lived plasma cells drive pathogenic antibody production, contributing to functional damage to the glomeruli in the kidney. By targeting CD38, felzartamab has the potential to deplete CD38+ plasma cells while leaving other functionally important plasma cells intact, which may ultimately improve clinical outcomes in a broad range of autoantibody driven diseases.HI-Bio is currently evaluating the safety and efficacy of investigational felzartamab for patients with aPLA2R antibody-positive membranous nephropathy (in the M-PLACE and NewPLACE trials) and Immunoglobulin A Nephropathy (IGNAZ trial). Felzartamab is also being evaluated in investigator-initiated studies for PMN in patients who have had inadequate response to anti-CD20 and for antibody mediated rejection (AMR) of renal allograft transplants. HI-Bio in-licensed felzartamab from MorphoSys in June 2022, and holds executive worldwide rights for felzartamab with the exception of Greater China.&nbsp;In 2017, MorphoSys entered into an exclusive regional licensing agreement with I-Mab Biopharma to develop and commercialize felzartamab in Greater China which encompasses Mainland China, Hong Kong, Macau and Taiwan. I-Mab is evaluating felzartamab in relapsed/refractory multiple myeloma.&nbsp;Felzartamab is an investigational drug that has not yet been approved by any regulatory authorities.

HI-Bio Receives FDA Orphan Drug Designation for Felzartamab for the Treatment of Membranous Nephropathy

SOUTH SAN FRANCISCO, Calif. – April 18, 2023 – Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced the appointment of Uptal Patel, M.D., as Chief Medical Officer. The company also announced that Sunil Agarwal, M.D., has been appointed to the Company’s Board of Directors.&nbsp;“Uptal is an accomplished drug developer and scientist with deep experience in clinical strategy and leading novel development programs,” said Travis Murdoch, M.D., CEO of HI-Bio. “In particular, his deep experience in nephrology will help us accelerate our clinical programs in Primary Membranous Nephropathy, and across the immune-mediated disease landscape.&nbsp;We look forward to working with him to further our mission.”Dr. Patel joins HI-Bio from AstraZeneca where he served as the Head of Clinical Renal and Executive Group Director in Early Cardiovascular, Renal and Metabolism (CVRM).&nbsp;In these roles, Dr. Patel led early clinical strategy and development for a wide range of therapies that address several kidney diseases, including ways to advance precision medicine approaches. Prior to joining AstraZeneca, he was Executive Director of Clinical Research at Gilead Sciences, leading global clinical development of novel therapies for kidney diseases that address inflammatory pathways.&nbsp;Previously, Dr. Patel was faculty in the adult and pediatric nephrology divisions at Duke University, a member of the Duke Clinical Research Institute and a transplant nephrologist who took care of patients of all ages. There, he led several multidisciplinary translational research efforts and a broad-based research program focused on improving the detection and management of kidney disease.&nbsp;He obtained his B.S. in Chemistry and Biochemistry from the University of California San Diego and earned his M.D. from the University of California San Francisco.&nbsp;Dr. Patel completed his residency and fellowship training at the University of Michigan."This is a very exciting time to join HI-Bio, following the recent positive results from two studies of felzartamab,” said Uptal Patel, M.D., Chief Medical Officer at HI-Bio. “As I got to know the team, its aim and programs, HI-Bio stood out to me as a company with great potential to positively impact the lives of patients with immune-mediated diseases thanks to its focus on targeting or modulating cellular drivers of disease. Many nonspecific therapies have incomplete efficacy with disabling side effects, highlighting the urgent need for more specific and individualized therapies. I look forward to working with the team to lead clinical immunology into its next chapter.”The company today also announced the addition of Sunil Agarwal, M.D., to its Board of Directors.&nbsp;Agarwal was most recently Executive Vice President, Head of Development and Chief Medical Officer at Sana Biotechnology. Prior to Sana, he was President of Research and Development at Juno Therapeutics and a Partner at Sofinnova, a Menlo Park, California-based biotech-focused investment firm. He is also a former Executive Vice President and Chief Medical Officer of Ultragenyx and served in various leadership roles at Genentech for more than a decade, leading the approval of multiple therapies including RITUXAN®, ACTEMRA®, LUCENTIS® and XOLAIR®.&nbsp;Agarwal completed his residency at Children’s National Medical Center (CNMC), Washington, D.C., and practiced in the CNMC Pediatric Emergency Department. He obtained his B.S. in neurobiology from Cornell University and earned his M.D. from Tufts University School of Medicine.“We are thrilled to have someone of Sunil’s caliber join HI-Bio’s Board of Directors,” said Paul Berns, HI-Bio Chairman and Managing Director at ARCH Venture Partners. “Sunil’s deep experience in clinical development and his impressive track record of shepherding new drugs through approval will be highly relevant to advancing our pipeline. We are delighted to welcome Sunil to the Board.”

HI-Bio Appoints Industry Veterans Uptal Patel, M.D., as Chief Medical Officer and Sunil Agarwal, M.D., as Board Member

Felzartamab showed dose-dependent reduction in pathogenic antibody levels across two clinical studiesProteinuria remission observed across patient groups, including those starting with high aPLA2R titers or refractory to prior immunosuppressive therapiesCompany intends to advance felzartamab into late-stage development in Primary Membranous Nephropathy and other autoantibody-driven immune-mediated diseasesPrimary Membranous Nephropathy is a rare, high burden, immune-mediated kidney disease with no approved therapiesSOUTH SAN FRANCISCO, Calif.&nbsp;– April 11, 2023 –&nbsp;Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced positive data from two Phase 2 studies of felzartamab, M-PLACE and NewPLACE. Felzartamab is an investigational monoclonal antibody designed to deplete CD38+ plasma cells, which are believed to drive Primary Membranous Nephropathy (PMN) through the production of anti-PLA2R (aPLA2R) autoantibodies. The company intends to advance felzartamab into late-stage studies.PMN is a rare IMD affecting kidney function that impacts more than 36,000 patients in the United States. There are currently no approved therapies for PMN. Standard of care comprises off-label use of&nbsp;a variety of agents, including immunosuppressive cyclophosphamide and CD20-targeted B-cell depleting agents. Even with these strategies, half of PMN patients continue to have nephrotic syndrome and nearly one third progress to end-stage renal disease (ESRD). aPLA2R autoantibodies are thought to be drivers of disease in as much as 80% of PMN cases. Persistent elevated aPLA2R levels are associated with worse response to immunosuppressive therapy, longer time to remission and high risk of progression to kidney failure.M-PLACE was a Phase 1b/2a proof-of-concept, open-label, multinational study to assess safety and efficacy in adults with aPLA2R-positive PMN using a five-month (nine-dose) course. The study enrolled 31 patients who were newly diagnosed and relapsed or refractory to immunotherapies.&nbsp;NewPLACE is a two-arm, multi-center, open-label, parallel-group Phase 2 trial that enrolled 24 patients to assess the efficacy, safety, pharmacokinetics and pharmacodynamics of alternative two- and five-dose courses, over two weeks and two months respectively, and retreatment of felzartamab in patients with aPLA2R-positive PMN indicated for immunosuppressive therapy. The studied dose level across both studies and all arms was consistent with the target dose for felzartamab at 16 mg/kg.The most durable reductions in aPLA2R levels were observed in the nine-dose arm as studied in M-PLACE, as compared to the two- and five-dose regimens studied in NewPLACE. Together, these studies enrolled a population of patients with the highest median aPLA2R serum titers&nbsp;as measured with an FDA-cleared immunoassay&nbsp;in a therapeutic clinical study to date (median [IQR]: 197 RU/mL [83-298 RU/mL]).&nbsp;In the final analysis of M-PLACE, early and substantial reductions in aPLA2R titers were observed in most patients as early as one week (median reduction of 45%), with deep responses (&gt;50% reduction) in most patients at six months at end-of-treatment. A deepening or maintenance of response in the majority of responders after end-of-treatment through month 12 was observed. Robust reduction of autoantibody levels was measured regardless of initial aPLA2R titer including in patients with high baseline titers, who typically have increased risk of disease severity and progression, and lower expected response to standard of care therapies.&nbsp;In M-PLACE, improvements in proteinuria and serum albumin levels were observed with administration of felzartamab, highlighting potential renal recovery. Proteinuria remissions included patients previously found to be refractory to anti-CD20 therapies (e.g., rituximab) and cyclophosphamide.&nbsp;Across both studies, felzartamab was found to be generally well tolerated. The majority of treatment emergent adverse events (TEAEs) reported were mild to moderate and consistent with the known mechanism of action of felzartamab in the PMN population. The most common TEAE was infusion-related reactions on the first infusion that were mostly mild to moderate in intensity. In all, four of 55 patients (7.3%) had a TEAE leading to treatment discontinuation that was deemed related to study drug. Further, <a href="https://pubmed.ncbi.nlm.nih.gov/35702397/">as published</a> in Kidney International Reports in 2022, humoral response to immunization with SARS-CoV-2 vaccines was preserved with felzartamab use.&nbsp;“PMN is one of the most common causes of nephrotic syndrome, resulting in severe proteinuria, edema, fatigue, progression to ESRD and increased risk of thromboembolism and infection,” said Dr. Brad Rovin, M.D., Director of the Division of Nephrology at Ohio State University. “We need to advance clinical immunology to a point where diseases like PMN can be turned into manageable conditions with deep and durable remissions. I am excited to continue studying felzartamab in that context, to further evaluate its potential to help PMN patients who are at high risk of serious complications and currently have very limited treatment options.”The company intends to present further data on the M-PLACE and NewPLACE studies at an upcoming medical meeting.&nbsp;“These data are very encouraging, demonstrating robust responses with proteinuria remissions in high-risk treatment naïve and refractory patients,” said Travis Murdoch, M.D., CEO of HI-Bio. “These results, the tolerability profile observed, and the fact that PMN is a high burden disease with no approved therapies all support our intention to advance felzartamab into late-stage&nbsp;development and discuss the path forward with regulators. We&nbsp;are focused on developing felzartamab in PMN and other autoantibody driven IMDs where patients have serious unmet needs.”About Primary Membranous Nephropathy (PMN)PMN is a&nbsp;rare&nbsp;autoantibody-mediated&nbsp;autoimmune&nbsp;kidney disease and a leading cause of nephrotic syndrome (NS) in adults worldwide.&nbsp;Disease onset and diagnosis typically occurs between 40 and 50 years of age, with 80% of patients presenting with Nephrotic Syndrome (i.e., edema, &gt;3.5 g/day proteinuria, hypoalbuminemia). PMN is characterized by a thickening of the glomerular basement membrane (GBM) due to the formation and deposition of immune complexes in this space between podocytes and the glomerular endothelium of the kidney.&nbsp;Approximately 80% of PMN cases arise due to autoantibodies that recognize the phospholipase A2 receptor (PLA2R) antigen expressed on podocytes. Anti-PLA2R is both a diagnostic and prognostic biomarker, and total aPLA2R antibody level has been shown to be a biomarker for prognosis of outcome in patients with PMN. Other autoantibodies have been identified in patients with PMN including anti-THSD7A, NELL-1 and Sema3B, further supporting the role of antibody-secreting plasma cells in the pathophysiology of PMN.&nbsp;CD38+ long lived plasma cells and plasmablasts are a main source of autoantibodies.&nbsp;There are no approved therapies for PMN. The current standard of care comprises off-label use of&nbsp;supportive care measures (e.g., angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, statins, and diuretics), conventional immunosuppressive treatments (ISTs) (e.g. cyclophosphamide combined with steroids and calcineurin inhibitors)&nbsp;or B-cell depleting agents (e.g. anti-CD20 antibodies). However, these treatments are not effective in all patients, with a significant proportion of patients not achieving remission or relapsing. In addition, conventional immunosuppressive treatments are associated with a high risk of toxicity.About FelzartamabFelzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. In PMN, CD38+long-lived plasma cells drive pathogenic antibody production, contributing to functional damage to the glomeruli in the kidney. By targeting CD38, felzartamab has the potential to deplete CD38+ plasma cells while leaving other functionally important plasma cells intact, which may ultimately improve clinical outcomes in a broad range of autoantibody driven diseases.HI-Bio is currently evaluating the safety and efficacy of investigational felzartamab for patients with aPLA2R antibody-positive membranous nephropathy (in the M-PLACE and NewPLACE trials) and Immunoglobulin A Nephropathy (IGNAZ trial). Felzartamab is also being evaluated in investigator-initiated studies for PMN in patients who have had inadequate response to anti-CD20 and for antibody mediated rejection (AMR) of renal allograft transplants. HI-Bio in-licensed felzartamab from MorphoSys in June 2022, and holds executive worldwide rights for felzartamab with the exception of Greater China.&nbsp;In 2017, MorphoSys entered into an exclusive regional licensing agreement with I-Mab Biopharma to develop and commercialize felzartamab in Greater China which encompasses Mainland China, Hong Kong, Macau and Taiwan. I-Mab is evaluating felzartamab in relapsed/refractory multiple myeloma.&nbsp;Felzartamab is an investigational drug that has not yet been approved by any regulatory authorities.

HI-Bio Announces Positive Phase 2 Data on Felzartamab for the Treatment of Primary Membranous Nephropathy

Fierce Biotech: HI-Bio's expectations elevated after pair of phase 2 readouts bolster autoimmune ambitions

BioPharma Dive: Armed with $120M, HI-Bio joins race to develop better autoimmune disease drugs

Fierce Biotech: Arch-backed HI-Bio launches with 2 clinical-stage therapies from MorphoSys and $120M in cash

HI-Bio is developing precision therapies&nbsp;for patients with immune-mediated diseasesCompany launches with multiple clinical-stage programs and a robust translational toolkit with potential to address multiple diseases with high unmet medical needsCompany funded by ARCH Venture Partners, Monograph Capital, Jeito Capital and othersSOUTH SAN FRANCISCO, Calif., November 1, 2022 – Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced its launch with $120 million in financing. The company was incubated by ARCH Venture Partners and Monograph Capital, joined by Jeito Capital and unnamed institutional investors and family offices.Few targeted therapies exist for the autoimmune, allergic and inflammatory diseases that can together be referred to as IMDs. As much as 4 percent of the world’s population may have one of these diseases, representing an enormous health burden. Conventional 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.“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. “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.”Many 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. HI-Bio’s programs apply a precision medicine approach to target, modulate or deplete these cellular drivers of disease with therapeutics.&nbsp;“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, M.D., CEO of HI-Bio. “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.”HI-Bio’s clinical-stage assets include felzartamab, an anti-CD38 antibody, and HIB210, an anti-C5aR1 antibody. Felzartamab 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.Felzartamab and HIB210 were in-licensed through a <a href="https://www.morphosys.com/en/news/morphosys-and-hibio-enter-equity-participation-and-license-agreements-felzartamab-and-mor210">transaction with MorphoSys</a> 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. Terms included a 15 percent 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.&nbsp;Underlying 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.HI-Bio’s leadership includes:<ul><li>Travis Murdoch, M.D., as Chief Executive Officer;</li><li>Matthew Albert, M.D., Ph.D., as Chief Translational Officer;</li><li>Christina Carlson, J.D., as General Counsel;</li><li>Carl Enell as Chief Business Officer;&nbsp;</li><li>Ariella Kelman, M.D., as Senior Vice President of Development;</li><li>Jaideep Dudani, Ph.D., as Head of Portfolio Development;</li><li>Joyce Liaw as Vice President, Finance; and</li><li>Lorna Dean as Vice President, Clinical Operations</li></ul>HI-Bio’s Board of Directors includes:<ul><li>Chairman Paul Berns, Managing Director at ARCH Venture Partners;&nbsp;</li><li>Fred Cohen, M.D., D.Phil., Co-Founder and Chairman at Monograph Capital Partners;</li><li>Barbara Krebs-Pohl, Ph.D., Chief Business Officer at MorphoSys;</li><li>Rachel Mears, J.D., Partner at Jeito Capital;</li><li>Mark Murcko, Ph.D., Founding Chief Scientific Officer at Dewpoint Therapeutics and Relay Therapeutics; and</li><li>Carol Suh, Partner at ARCH Venture Partners</li></ul>In addition to HI-Bio's executive team and Board, the company will benefit from the expertise of several accomplished scientific advisors. The company’s Scientific Advisory Board includes Mark Daly, Ph.D., Founding Chief of the Analytic and Translational Genetics Unit at Massachusetts General Hospital; John Davis, M.D., M.P.H., M.S., former Senior Vice President, Head of Early Clinical Development at Pfizer; Chris Goodnow, Ph.D., Executive Director of the Garvan Institute of Medical Research; Stefan Härtle, Ph.D., Head of Clinical Pharmacology at MorphoSys; Kristin Hogquist, Ph.D., Associate Director of the Center for Immunology at the University of Minnesota; Brian Kotzin, M.D., Senior Vice President, Clinical Development and Head of Immunology at Nektar Therapeutics; John Lowe, M.D., former Senior Director of Pathology at Genentech; Andrew Luster, M.D., Ph.D., Chief of the Division of Rheumatology, Allergy and Immunology at Massachusetts General Hospital; and Gregg Silverman, M.D., Mamdouha S. Bobst Professor of Internal Medicine, Department of Medicine at NYU Langone Health.About HI-BioHuman 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 with more targeted therapies that target cellular drivers of disease. To learn more about HI-Bio, visit us at <a href="https://www.hibio.com">www.hibio.com</a> or follow us on <a href="https://www.linkedin.com/company/hibio">LinkedIn</a> and <a href="https://twitter.com/HIBiosciences">Twitter</a>.

Human Immunology Biosciences Launches to Lead Clinical Immunology into Its Next Chapter with $120 Million Financing

Human Immunology Biosciences (HIBio) is a biotechnology company focused on developing precision medicines for autoimmune and inflammatory diseases, backed by ARCH Venture Partners and Monograph CapitalHIBio obtains exclusive worldwide rights, with the exception of Greater China for felzartamab and Greater China and South Korea for MOR210MorphoSys will receive a 15% equity stake in HIBio and up to $1 billion in milestone payments across programs, plus single- to low double-digit royalties on net salesAgreements allow MorphoSys to focus its resources on progressing its potential best-in-class, late- and mid-stage oncology pipelineJune 14, 2022PLANEGG/MUNICH, Germany &amp; SOUTH SAN FRANCISCO, Calif.--(<a href="https://www.businesswire.com/">BUSINESS WIRE</a>)--MorphoSys AG (FSE: MOR; NASDAQ: MOR) and Human Immunology Biosciences, Inc. (HIBio), a South San Francisco-based biotechnology company focused on discovering and developing precision medicines for autoimmune and inflammatory diseases, announced today that the companies entered into an equity participation agreement and license agreements to allow HIBio to develop and commercialize MorphoSys’ felzartamab, an anti-CD38 antibody, and MOR210, an anti-C5aR1 antibody.“Under the leadership of experienced drug developers, HIBio is backed by two world-class venture capital firms with demonstrated track records of building successful companies. Its management, coupled with deep scientific expertise in autoimmune diseases, makes HIBio exceptionally well positioned to successfully advance felzartamab and MOR210 into new medicines for patients in need of better treatment options,” said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “At MorphoSys, we will continue to focus our resources on driving our late- and mid-stage oncology pipeline forward. This includes pelabresib, our potential best-in-class BET inhibitor, and tafasitamab, our CD19 targeting immunotherapy – two medicines that have the potential to enhance the standard and quality of care in difficult-to-treat and debilitating types of blood cancers.”“At HIBio, we are discovering and developing transformative precision therapies for patients with autoimmune and inflammatory diseases. We are excited that we’ve reached this deal with MorphoSys, which will allow us to realize the potential of felzartamab and MOR210 across multiple autoimmune diseases,” said Travis Murdoch, M.D., CEO of HIBio. “These programs are foundational to our broader strategy of developing targeted therapies for patients with autoimmune diseases, where unmet need remains high.”“We recognize there is a tremendous unmet need and opportunity to develop more precise and effective therapies for patients with autoimmune and inflammatory diseases,” said Paul Berns, Managing Director at ARCH Venture Partners and HIBio Chairman, “HIBio is poised to become a leader in precision immunology, and we are pleased to add these potential best-in-class programs to our portfolio.”Under the terms of the agreements, HIBio will obtain exclusive rights to develop and commercialize felzartamab and MOR210 across all indications worldwide, with the exception of Greater China for felzartamab and Greater China and South Korea for MOR210. As part of the agreements, MorphoSys will receive a 15% equity stake in HIBio, along with certain equity earn-in provisions and standard investment rights. MorphoSys will also be represented as a member of HIBio’s Board of Directors. On achievement of development, regulatory and commercial milestones, MorphoSys will be eligible to receive payments from HIBio of up to $1 billion across both programs, in addition to tiered, single- to low double-digit royalties on net sales of felzartamab and MOR210 and will be compensated for ongoing program expenses. HIBio will assume full responsibility for future development and commercialization expenses. Upon signing, MorphoSys also receives an upfront payment of $15 million for MOR210.Felzartamab, a novel therapeutic human monoclonal antibody derived from MorphoSys' HuCAL antibody library and directed against CD38, is being evaluated as a potential treatment for two kidney diseases, anti-PLA2R antibody-positive Membranous Nephropathy (aMN), and Immunoglobulin A Nephropathy (IgAN), where limited treatment options are available. There are two Phase 2 trials in aMN fully enrolled and underway, M-PLACE and NewPLACE, and a Phase 2 trial being conducted in IgAN, IGNAZ. First interim data from the M-PLACE study, presented in November 2021, demonstrated that felzartamab has the potential to rapidly and substantially reduce anti-PLA2R auto-antibody titers (a serological marker for aMN) in difficult to treat patients with aMN. MOR210 is a novel human antibody directed against C5aR1, the receptor of the complement factor C5a.BofA Securities acted as the financial advisor to HIBio, and Goodwin Procter is serving as legal counsel to HIBio for this agreement.About FelzartamabFelzartamab (MOR202) is a therapeutic human monoclonal antibody derived from MorphoSys’ HuCAL antibody library and directed against CD38. In Membranous Nephropathy, long-lived plasma cells drive pathogenic antibody production, contributing to functional damage to the glomeruli in the kidney. By targeting CD38, felzartamab has the potential to deplete the CD38 positive plasma cells, which may ultimately improve clinical outcomes in a broad range of autoantibody driven diseases.MorphoSys is currently evaluating the safety and efficacy of investigational felzartamab for patients with anti-PLA2R antibody-positive membranous nephropathy (M-PLACE and NewPLACE trial) and Immunoglobulin A Nephropathy (IGNAZ trial).In 2017, MorphoSys entered into an exclusive regional licensing agreement with I-Mab Biopharma to develop and commercialize felzartamab in Greater China which encompasses Mainland China, Hong Kong, Macau, and Taiwan. I-Mab is evaluating felzartamab in relapsed/refractory multiple myeloma and Systemic Lupus Erythematosus.Felzartamab is an investigational drug that has not yet been approved by any regulatory authorities.About MOR210MOR210 is a novel human antibody directed against C5aR1 derived from MorphoSys's HuCAL technology. C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of autoimmune diseases and immuno-oncology. MOR210 has also been sublicensed to I-Mab Biopharma in Greater China and South Korea. I-Mab is investigating MOR210 as a treatment for relapsed or refractory advanced solid tumors. MOR210 is an investigational drug that has not yet been approved by any regulatory authorities.About PelabresibPelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been evaluated or approved by any regulatory authorities.About TafasitamabTafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).In Europe, Minjuvi® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi® monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).Tafasitamab is being clinically investigated as an immunotherapeutic option in B-cell malignancies in several ongoing combination trials.Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S. and marketed by Incyte under the brand name Minjuvi® in Europe, the UK and Canada.XmAb® is a registered trademark of Xencor, Inc.About MorphoSys:At MorphoSys, we are driven by our mission: More life for people with cancer. As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.morphosys.com&amp;esheet=52749597&amp;newsitemid=20220614005859&amp;lan=en-US&amp;anchor=www.morphosys.com&amp;index=1&amp;md5=1eae84ac8b2ad5daa5a8f25ab67d77ee">www.morphosys.com</a> and follow us on <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Fmorphosys&amp;esheet=52749597&amp;newsitemid=20220614005859&amp;lan=en-US&amp;anchor=Twitter&amp;index=2&amp;md5=6d36672e2546d8ad67cbb656831610d1">Twitter</a> and <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fmorphosys%2F&amp;esheet=52749597&amp;newsitemid=20220614005859&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=3&amp;md5=ad205a4b4cc5ba061a5e077a94f0baff">LinkedIn</a>.About HIBio:Human Immunology Biosciences, Inc. (HIBio) is a biotechnology company focused on discovering and developing precision medicines for people suffering from autoimmune and inflammatory diseases. HIBio was incubated with ARCH Venture Partners, one of the largest early-stage technology venture firms in the United States, and Monograph Capital, a San Francisco and London based life sciences investment firm. To learn more about HIBio, visit us at <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.hibio.com&amp;esheet=52749597&amp;newsitemid=20220614005859&amp;lan=en-US&amp;anchor=www.hibio.com&amp;index=4&amp;md5=2e10811f4ca146e6e5e264e17c64e6b1">www.hibio.com</a>.MorphoSys Forward Looking StatementsThis communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

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