Oral and late-breaking oral presentations will highlight data from Phase 2 IGNAZ study in IgA nephropathy and Phase 2 data in antibody-mediated&nbsp;rejectionSOUTH SAN FRANCISCO, Calif. – March 29, 2024 – Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that two abstracts have been accepted for oral presentation at the 61st European Renal Association (ERA) Congress, taking place May 23-26, 2024, in Stockholm and in a virtual format. Presentations will include data from the Phase 2 IGNAZ trial of felzartamab in patients with IgA nephropathy (IgAN) and a late-breaking oral presentation of complete Phase 2 data from the investigator-sponsored study of felzartamab in antibody-mediated rejection (AMR) in kidney transplant recipients. The presentations reflect the first clinical data from felzartamab in these indications, and the first clinical data from HI-Bio development programs with felzartamab beyond primary membranous nephropathy (PMN).&nbsp;Oral Presentations&nbsp;&nbsp;Abstract Title:&nbsp;Felzartamab (anti-CD38) in Patients with IgA Nephropathy - Interim Results from the IGNAZ StudySession Topic: Glomerular, tubulo-Interstitial diseases &amp; general nephrologySubtopic:&nbsp;B4 - Prevention, Treatment and Clinical TrialsDate and Time:&nbsp; May 24, 2024, 12:54&nbsp;– 13:03&nbsp;CEST (Moderated Orals 1.2, Room T5)Presenter:&nbsp;Jürgen Floege, M.D., RWTH Aachen University&nbsp;Abstract Title:&nbsp;Randomized Phase 2 Trial of Felzartamab in Humoral Transplant RejectionSession Topic: InstitutionalSubtopic:&nbsp;E3&nbsp;- Treatment &amp; Clinical TrialsDate and Time: May 25, 2024, 12:30 – 12:45 CEST (Late Breaking Clinical Trials II, Victoria Hall)Presenter: Katharina A. Mayer, M.D., Medical University of ViennaFor more information, please visit the&nbsp;<a href="https://www.era-online.org/events/stockholm-2024/">61st ERA Congress website</a>.&nbsp;About FelzartamabFelzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies.HI-Bio is focused on developing felzartamab in a number of immune-mediated diseases, including antibody-mediated rejection (AMR), IgA nephropathy (IgAN), lupus nephritis (LN) and primary membranous nephropathy (PMN). Felzartamab has received Breakthrough Therapy designation and Orphan Drug Designation from the FDA for development in the treatment of PMN, and Orphan Drug Designation in the treatment of AMR in kidney transplant recipients.HI-Bio in-licensed felzartamab from MorphoSys in 2022 and holds exclusive worldwide rights for felzartamab with the exception of Greater China.&nbsp;Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority.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">X</a>.

HI-Bio to Present at the 61st European Renal Association (ERA) Congress

SOUTH SAN FRANCISCO, Calif., – March 21, 2024 – 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 for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.“Following the FDA’s granting of Breakthrough Therapy Designation for felzartamab in primary membranous nephropathy, we are encouraged to receive Orphan Drug Designation for felzartamab for antibody-mediated rejection,” said Uptal Patel, M.D., Chief Medical Officer at HI-Bio. “Along with our academic collaborators, we look forward to submitting clinical data from the ongoing study of felzartamab in antibody-mediated rejection to a medical conference this year. We are confident in the clinical progress of our anti-CD38 cellular depletion strategy, which to date, has resulted in proof-of-concept data in multiple severe immune-mediated diseases including antibody-mediated rejection, IgA nephropathy and primary membranous nephropathy.”&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 Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients&nbsp;Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure, with late AMR affecting approximately 23,000 patients total in the U.S. There is no effective treatment for AMR and patient options are highly limited. Donor-specific antibody (DSA) production by plasma cells, and tissue infiltration of Natural Killer (NK) cells presumed to be involved in DSA-dependent microvascular inflammation,&nbsp;are both linked to AMR. Observations that both plasma cells and NK cells express high levels of CD38 have motivated the approach of targeting CD38 to deplete these cell populations to address AMR.&nbsp;About FelzartamabFelzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies.HI-Bio is focused on developing felzartamab in a number of immune-mediated diseases, including antibody-mediated rejection (AMR), IgA nephropathy (IgAN), lupus nephritis (LN) and primary membranous nephropathy (PMN). Felzartamab has received Breakthrough Therapy designation and Orphan Drug Designation from the FDA for development in the treatment of PMN, and Orphan Drug Designation in the treatment of AMR in kidney transplant recipients.HI-Bio in-licensed felzartamab from MorphoSys in 2022 and holds exclusive worldwide rights for felzartamab with the exception of Greater China.&nbsp;Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority.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">X</a>.

HI-Bio Receives FDA Orphan Drug Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients

Funding allows advancement of diverse programs through multiple clinical data readouts, including multiple indications for lead candidate felzartamabSOUTH SAN FRANCISCO, Calif. – Jan. 4, 2024 – Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced the closing of a $95 million Series B financing led by new investor Alpha Wave Global. Viking Global Investors and Arkin Bio Capital participated in the financing, as well as existing investors Jeito Capital and ARCH Venture Partners.“These funds allow us to advance felzartamab, our clinically differentiated lead therapeutic candidate, through clinical readouts in multiple indications and preparation for registrational studies,” said Travis Murdoch, M.D., CEO of HI-Bio. “We are encouraged by promising clinical data to date for felzartamab and its anti-CD38 cell depletion approach, and we look forward to new data, including Phase 2 results from an investigator-initiated trial for antibody-mediated rejection in kidney transplant patients.”&nbsp;Since the company’s launch, HI-Bio has advanced felzartamab, a monoclonal antibody targeting CD38 and in-licensed from MorphoSys, across indications including antibody-mediated rejection (AMR), IgA nephropathy (IgAN), lupus nephritis (LN) and primary membranous nephropathy (PMN). Felzartamab has received Breakthrough Therapy Designation and Orphan Drug Designation from the U.S. Food and Drug Administration in PMN. HI-Bio has also initiated a clinical study of HIB210, an anti-C5aR1 candidate targeting neutrophil activation and chemotaxis.&nbsp;“Immune-mediated diseases contribute to an immense disease burden which drives the need for novel targeted treatments to improve on existing therapies,” said&nbsp;Chris Dimitropoulos, Managing Director of Healthcare Investments at Alpha Wave Global. “HI-Bio is generating compelling clinical data demonstrating the differentiated potential of felzartamab; we look forward to continued progress for felzartamab across multiple indications with high unmet need.”Funding from the Series B will be used to advance clinical development of felzartamab, to evaluate the clinical properties of HIB210 in healthy volunteers and to advance a discovery-stage program targeting mast cell dysfunction toward IND-enabling studies.&nbsp;In conjunction with the financing, the company announced that Chris Dimitropoulos, Managing Director of Healthcare Investments at Alpha Wave Global, has been appointed to the HI-Bio Board of Directors.About HI-Bio&nbsp; Human Immunology Biosciences, Inc. (HI-Bio™) is a clinical-stage biotechnology company&nbsp;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="http://www.hibio.com/">www.hibio.com&nbsp;</a>or follow us on&nbsp;<a href="https://www.linkedin.com/company/hibio">LinkedIn</a> and&nbsp;<a href="https://twitter.com/HIBiosciences">Twitter</a>.&nbsp;

HI-Bio Announces $95 Million Series B Financing to Advance Targeted Therapies for Immune-Mediated Diseases

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>.

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