SOUTH SAN FRANCISCO, Calif., – October 31, 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 U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for felzartamab in primary membranous nephropathy (PMN).“The FDA’s decision to grant felzartamab Breakthrough Therapy designation is recognition of the promising data we have collected to date, as well as an acknowledgement of the need for major advances over available therapies in the treatment of patients with PMN,” said Uptal Patel, M.D., Chief Medical Officer at HI-Bio. “We believe that the cellular depletion strategy with felzartamab in PMN is applicable to many more immune-mediated diseases driven by antibodies produced in CD38+ plasma cells. For that reason, we are currently developing felzartamab in multiple diseases including PMN, IgA nephropathy, antibody-mediated rejection and lupus nephritis.”&nbsp;The FDA selectively grants Breakthrough Therapy designation to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). The designation comes with eligibility for more frequent regulatory interactions to ensure collection of appropriate data needed to support drug approval, and the potential for accelerated approval, priority review, and rolling review of a Biologics License Application (BLA).The designation for felzartamab was based on clinical data submitted to the FDA, including results from M-PLACE, a Phase 1b/2a proof-of-concept, open-label, study. The final analysis of the M-PLACE study has been <a href="https://hibio.com/news/hi-bio-to-present-at-the-american-society-of-nephrology-kidney-week-2023-annual-meeting">accepted as an oral presentation</a> at the American Society of Nephrology (ASN) Kidney Week 2023 Annual Meeting (Abstract TH-OR27) by Brad Rovin, M.D., Director of the Division of Nephrology at Ohio State University.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. 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 focused on developing felzartamab in a number of autoantibody-driven immune-mediated diseases, including primary membranous nephropathy (PMN), IgA nephropathy (IgAN), antibody-mediated rejection (AMR) and lupus nephritis (LN). In May, felzartamab received Orphan Drug Designation (ODD) from the FDA for treatment of PMN. ODD was achieved following data from two Phase 2 studies of felzartamab in PMN showing dose-dependent reductions in pathogenic antibody levels.HI-Bio in-licensed felzartamab from MorphoSys in&nbsp;June 2022, and holds exclusive 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&nbsp;Greater China&nbsp;which encompasses Mainland China,&nbsp;Hong Kong, Macau and Taiwan. I-Mab is evaluating felzartamab in oncology and autoimmune diseases. &nbsp;Felzartamab is an investigational drug that has not yet been approved by any regulatory authorities.About HI-Bio&nbsp;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&nbsp;<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=2087756996&amp;u=http%3A%2F%2Fwww.hibio.com%2F&amp;a=www.hibio.com+">www.hibio.com&nbsp;</a>or follow us on&nbsp;<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1920414883&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhibio&amp;a=LinkedIn">LinkedIn</a>&nbsp;and&nbsp;<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1556751518&amp;u=https%3A%2F%2Ftwitter.com%2FHIBiosciences&amp;a=Twitter">Twitter</a>.

HI-Bio Announces Felzartamab Granted Breakthrough Therapy Designation by U.S. Food and Drug Administration for Primary Membranous Nephropathy (PMN)

Oral presentation will highlight final data from Phase 2 M-PLACE study of felzartamab in patients with Primary Membranous Nephropathy&nbsp;SOUTH SAN FRANCISCO, Calif. – October 13, 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 three abstracts will be presented at the upcoming American Society of Nephrology’s (ASN) Kidney Week 2023 Annual Meeting, taking place November 2-5, 2023 in Philadelphia, Pennsylvania. This will include an oral presentation of final data from the Phase 2 M-PLACE trial of felzartamab in patients with primary membranous nephropathy (PMN).&nbsp;Oral Presentation&nbsp;Abstract Title:&nbsp;Safety and Efficacy of Felzartamab in Primary Membranous Nephropathy (PMN): Final Analysis of the M-PLACE Study [#TH-OR27]Session Title:&nbsp;Glomerular Diseases: Clinical and Translational Studies [OR1402]Date and Time: November 2, 2023, 5:24 PM – 5:33 PM ETPresenter: Brad Rovin, M.D., Ohio State University&nbsp;Poster PresentationsAbstract Title:&nbsp;Felzartamab (anti-CD38 antibody) for the treatment of Lupus Nephritis – An Open Label Phase 1b Study (NCT06064929) [#INFO13-TH]Session Title:&nbsp;Informational Posters - IDate and Time:&nbsp;November 2, 2023, 10 AM – 12 PM ETPresenter: Brad Rovin, M.D., Ohio State University&nbsp;Abstract Title:&nbsp;Felzartamab reduces aPLA2R Ab by selectively depleting CD38+ plasma cells and plasmablasts, the main pathogenic cellular drivers of disease in Primary Membranous Nephropathy (PMN) [#SA-PO910]Session Title: Glomerular Diseases: Therapeutics [PO1402-1]Date and Time:&nbsp;November 4, 2023, 10 AM – 12 PM ETPresenter:&nbsp;Donna&nbsp;Flesher, Ph.D., HI-BioFor more information on these and other abstracts, please visit the&nbsp;<a href="https://www.asn-online.org/education/kidneyweek/">ASN Kidney Week 2023 website</a>.&nbsp;&nbsp;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 Lupus NephritisLupus nephritis (LN) is an organ-threatening manifestation of systemic lupus erythematosus (SLE) affecting nearly 135,000 U.S. patients, with only 30 to 40 percent of all patients achieving a complete renal response with current standard of care. Approximately 35 percent of those who do respond may relapse. A hallmark of lupus, including LN, is the production of high-titer, high affinity, isotype-switched autoantibodies produced by CD38+ plasma cells. In patients with LN, autoantibodies form immune complexes that directly induce disease pathogenesis in the kidney through activation of the complement cascade and initiate a feed-forward loop to further drive inflammation through the production of Type I interferons (IFN) and other pro-inflammatory cytokines.&nbsp;Plasmablasts and plasma cells express very high levels of CD38, making CD38 a compelling target for depletion of pathogenic autoantibody-producing cells in patients with SLE, including LN. In patients with SLE, CD38 expression is also induced on plasmacytoid Dendritic Cells (pDCs), the primary cellular source of Type I IFN production that perpetuates SLE pathogenesis.About FelzartamabFelzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. 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 focused on developing felzartamab in a number of autoantibody-driven immune-mediated diseases, including primary membranous nephropathy (PMN), IgA nephropathy (IgAN) and antibody mediated rejection (AMR). In May, felzartamab received Orphan Drug Designation from the FDA for treatment of PMN. ODD was achieved following data from two Phase 2 studies of felzartamab in PMN showing dose-dependent reductions in pathogenic antibody levels.&nbsp;HI-Bio in-licensed felzartamab from MorphoSys in June 2022, and holds exclusive 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.About HI-Bio&nbsp;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 <a href="http://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>.

HI-Bio to Present at the American Society of Nephrology Kidney Week 2023 Annual Meeting

SOUTH SAN FRANCISCO, Calif. –&nbsp;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&nbsp;healthy volunteer study of HIB210,&nbsp;an investigational monoclonal antibody targeting C5aR1.&nbsp;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&nbsp;Travis Murdoch, M.D., Chief&nbsp;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&nbsp;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.&nbsp;“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 HIB210HIB210 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.&nbsp;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.&nbsp;About HI-Bio&nbsp;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 <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=2087756996&amp;u=http%3A%2F%2Fwww.hibio.com%2F&amp;a=www.hibio.com+">www.hibio.com </a>or follow us on <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1920414883&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhibio&amp;a=LinkedIn">LinkedIn</a> and <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1556751518&amp;u=https%3A%2F%2Ftwitter.com%2FHIBiosciences&amp;a=Twitter">Twitter</a>.&nbsp;

HI-Bio Initiates Healthy Volunteer Study of HIB210 for Immune-Mediated Diseases

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.About HI-Bio&nbsp;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 <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=2087756996&amp;u=http%3A%2F%2Fwww.hibio.com%2F&amp;a=www.hibio.com+">www.hibio.com </a>or follow us on <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1920414883&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhibio&amp;a=LinkedIn">LinkedIn</a> and <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1556751518&amp;u=https%3A%2F%2Ftwitter.com%2FHIBiosciences&amp;a=Twitter">Twitter</a>.

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.”About HI-Bio&nbsp;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 <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=2087756996&amp;u=http%3A%2F%2Fwww.hibio.com%2F&amp;a=www.hibio.com+">www.hibio.com </a>or follow us on <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1920414883&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhibio&amp;a=LinkedIn">LinkedIn</a> and <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1556751518&amp;u=https%3A%2F%2Ftwitter.com%2FHIBiosciences&amp;a=Twitter">Twitter</a>.

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.About HI-Bio&nbsp;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 <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=2087756996&amp;u=http%3A%2F%2Fwww.hibio.com%2F&amp;a=www.hibio.com+">www.hibio.com </a>or follow us on <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1920414883&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhibio&amp;a=LinkedIn">LinkedIn</a> and <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=3915828-1&amp;h=1556751518&amp;u=https%3A%2F%2Ftwitter.com%2FHIBiosciences&amp;a=Twitter">Twitter</a>.&nbsp;

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