HI-Bio Announces Positive Phase 2 Data on Felzartamab for - BioSpace You are now leaving the MorphoSys.com website. Felzartamab is an investigational drug that has not yet been approved by any regulatory authorities. B-cell counts were not markedly changed from baseline. Under the terms of the agreements, HIBio will obtain exclusive Felzartamab (MOR202/TJ202) is a therapeutic human monoclonal antibody derived from MorphoSys' HuCAL antibody library and directed against CD38. 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. MorphoSys and Human Immunology Biosciences, Inc. (HIBio), a biotechnology company focused on developing precision medicines for autoimmune and inflammatory diseases, backed by ARCH Venture Partners and Monograph Capital, announced that the companies have entered into an equity participation agreement and license agreements to allow HIBio to develop and commercialize MorphoSys felzartamab, an CD38 antibody, and TJ210, an C5aR1 antibody, outside of Greater China. NOV-8 (CMK389) is being investigated by Novartis for the treatment of pulmonary sarcoidosis (Phase 2) and severe atopic dermatitis (also Phase 2). Jun. 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). Tafasitamab is being clinically investigated as an immunotherapeutic option in B-cell malignancies in several ongoing combination trials. 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. Upon signing, MorphoSys also receives an upfront payment of $15 million for MOR210. You'll now be able to see real-time price and activity for your symbols on the My Quotes of Nasdaq.com. We are excited and look forward to working together with MorphoSys and HIBio to advance clinical development and commercialization of felzartamab and TJ210, said Dr. Andrew Zhu, President of I-Mab. Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. In Membranous Nephropathy, long-lived plasma cells drive pathogenic antibody production, contributing to functional damage to the glomeruli in the kidney. Media ReleasePlanegg/Munich, Germany, South San Francisco, United States, June 14, 2022, MorphoSys and HIBio Enter Into Equity Participation and License Agreements for Felzartamab and MOR210, 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 Capital, HIBio obtains exclusive worldwide rights, with the exception of Greater China for felzartamab and Greater China and South Korea for MOR210 MorphoSys 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 sales, Agreements allow MorphoSys to focus its resources on progressing its potential best-in-class, late- and mid-stage oncology pipeline. 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. Global Anti-Cd38 Antibody Pipeline Insight Report 2021 Featuring participation agreement and license deal to allow US biotech C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. HIBio To Develop, Commercialize MorphoSys' Felzartamab, And TJ210 Felzartamab (MOR202/TJ202) is a therapeutic human monoclonal antibody derived from MorphoSys' HuCAL antibody library and directed against CD38. "We have made significant progress in the development of felzartamab towards registration in China and we have brought TJ210 to the clinic in the United States. To learn more about HIBio, visit us at www.hibio.com. Bimagrumab is currently being investigated by Versanis Bio in Phase 2b study as a novel treatment for obesity. Tel. MorphoSys and Human Immunology Biosciences, Inc. (HIBio), a biotechnology company focused on developing precision medicines for autoimmune and inflammatory diseases, backed by ARCH Venture Partners and Monograph Capital, announced that the companies have entered into an equity participation agreement and license agreements to allow HIBio to develop and commercialize MorphoSys' felzartamab, an CD38 antibody, and TJ210, an C5aR1 antibody, outside of Greater China. PLANEGG/MUNICH, Germany & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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. Tulmimetostat is a second-generation EZH2 inhibitor that has been designed to achieve comprehensive target coverage through extended on-target residence time. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. MOR210 is a novel human antibody directed against C5aR1 derived from MorphoSys's HuCAL technology. MorphoSys and HIBio Enter Into Equity Participation and License 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. Pelabresib (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. 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). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Among other things, the business outlook and quotations in this press release, as well as the statements regarding data from the felzartamab (TJ202/MOR202) and TJ210/MOR210 clinical trials, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of felzartamab (TJ202/MOR202) and TJ210/MOR210, contain forward-looking statements. In Membranous Nephropathy, long-lived plasma cells drive pathogenic antibody production, contributing to functional damage to the glomeruli in the kidney. (RTTNews) - MorphoSys AG (MOR) and Human Immunology Biosciences Inc. or HIBio reached an equity participation agreement and license agreements to allow HIBio to develop and commercialize. Germany's MorphoSys (FSE: MOR) has entered into an equity participation agreement and license deal to allow US biotech Human Immunology Biosciences (HIBio) to develop and commercialize MorphoSys' felzartamab, an anti-CD38 antibody, and MOR210, an anti-C5aR1 antibody. RTTNews->. This communication contains certain forward-looking statements concerning the MorphoSys group of companies. : +49 (0)89 / 89927 26079 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. MorphoSys will receive a 15% equity stake in HIBio and up to $1 billion in milestone payments across programs, plus . MorphoSys Presents Interim Results from M-PLACE Study with Felzartamab 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 . This brings us one step further in providing these innovative investigational medicines to China and other countries as soon as possible to benefit more patients.. Mit Ihrer Anmeldung erklren Sie sich damit einverstanden, Inhalte von uns zu erhalten. This link will take you to a different website. 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 Capital, HIBio obtains exclusive worldwide rights, with the exception of Greater China for felzartamab and Greater China and South Korea for MOR210, MorphoSys 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 sales, Agreements allow MorphoSys to focus its resources on progressing its potential best-in-class, late- and mid-stage oncology pipeline. HIBio will assume full responsibility for future development and commercialization expenses. Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. MorphoSys will also be represented as a member of HIBios Board of Directors. 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. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the SEC. 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. According to its suggested mode of action, the antibody recruits cells of the body's immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). MorphoSys presents interim results from M-PLACE study with felzartamab Felzartamab (MOR202/TJ202) is a therapeutic human monoclonal antibody derived from MorphoSys' HuCAL antibody library and directed against CD38. I-Mab is currently conducting Phase 1 clinical trial in U.S. for TJ210 in oncology indications. Felzartamab has the potential to rapidly and substantially reduce anti-PLA2R antibody titers in patients with anti-PLA2R-positive membranous nephropathy PLANEGG/MUNICH, GERMANY / ACCESSWIRE / November 4, 2021 / MorphoSys AG (FSE:MOR)(NASDAQ:MOR) presented interim results from the M-PLACE study with felzartamab at the 2021 Annual Meeting of the American Society of Nephrology (ASN) on November 4-7. 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. During a transition phase, MorphoSys is evaluating felzartamab for patients with two renal autoimmune diseases, anti-PLA2R antibody-positive membranous nephropathy (M-PLACE and NewPLACE trial) and Immunoglobulin A Nephropathy (IGNAZ trial) together with HI-Bio. 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. We are excited and look forward to working together with MorphoSys and HIBio to advance . To learn more about HIBio, visit us at www.hibio.com. When the symbol you want to add appears, add it to Watchlist by selecting it and pressing Enter/Return. You are now leaving the MorphoSys.com website. Felzartamab (MOR202) is a therapeutic human monoclonal antibody derived from MorphoSys HuCAL antibody library and directed against CD38. Ianalumab is also in Phase 2 clinical development in autoimmune hepatitis (AIH). At MorphoSys, we will continue to focus our resources on driving our late- and mid-stage oncology pipeline forward. thomas.biegi@morphosys.com Published: Apr 11, 2023 Felzartamab showed dose-dependent reduction in pathogenic antibody levels across two clinical studies Proteinuria remission observed across patient groups, including those starting with high aPLA2R titers or refractory to prior immunosuppressive therapies I-Mab (Nasdaq: IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology diseases. Felzartamab (TJ202/MOR202) is an investigational human monoclonal antibody derived from MorphoSys HuCAL antibody technology. I-Mab is evaluating felzartamab in relapsed/refractory multiple myeloma and Systemic Lupus Erythematosus. Currently I-Mab is developing and commercializing felzartamab in Greater China and TJ210 in Greater China and South Korea. DB16375. When the symbol you want to add appears, add it to My Quotes by selecting it and pressing Enter/Return. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao. 2021/ MorphoSys AG presented interim . , , , , , , Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, I-Mab Announces Publication of Claudin18.2 x 4-1BB Bispecific Antibody Givastomig in JITC, I-Mab Announces the Appointment of Raj Kannan as CEO. Human Immunology Biosciences, Inc. (HI-Bio) obtained exclusive rights to develop and commercialize felzartamab across all indications worldwide, with the exception of Greater China. Upon signing, MorphoSys also receives an upfront payment of $15 million for MOR210. Ianalumab (VAY736) is a fully human IgG1/k mAb with a dual mode of action targeting B-cell lysis and BAFF-R blockade that is being investigated by Novartis in several indications including Sjgren's, systemic lupus erythematosus (SLE), immune thrombocytopenia (1L and 2L ITP), and warm autoimmune hemolytic anemia (wAIHA). Copyright 2023 I-MAB Biopharma Co., Ltd. All Rights Reserved. I-Mab Announces China NMPA Approval for Phase 1b Trial of Felzartamab To ensure the most secure and best overall experience on our website, we recommend the latest versions of. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. Senior Director Ianalumab (VAY736) is a fully human IgG1/k mAb with a dual mode of action targeting B-cell lysis and BAFF-R blockade that is being investigated by Novartis in several indications including Sjgrens, systemic lupus erythematosus (SLE), immune thrombocytopenia (1L and 2L ITP), and warm autoimmune hemolytic anemia (wAIHA). FGS Global 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. According to its suggested mode of action, the antibody recruits cells of the bodys immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Type a symbol or company name. This drug entry is a stub and has not been fully annotated. An overview of the clinical studies on our own drug candidates and the most advanced clinical programs of our partners. 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. morgan.warners@fgsglobal.com Eamonn Nolan HI-Bio Launches with $120M and Two MorphoSys Assets in - BioSpace Are you a U.S. resident? Tafasitamab is being clinically investigated as an immunotherapeutic option in B-cell malignancies in several ongoing combination trials. Written by The scientific information may include data/information on investigational use(s) of compounds/drugs of which the efficacy and safety have not yet been established. HIBio Strikes Exclusive License with Morphosys to Felzartamab, an Anti MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. julia.neugebauer@morphosys.com . For inquiries, get in touch with our team. In Membranous Nephropathy, long-lived plasma. Statements that are not historical facts, including statements about I-Mabs beliefs and expectations, are forward-looking statements. MorphoSys presents interim results from M-PLACE study with felzartamab I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou, Guangzhou, Lishui and Hong Kong in China, and Maryland and San Diego in the United States. Richard Yeh Chief Operating Officer[emailprotected], Gigi FengChief Communications Officer[emailprotected], The Piacente Group, Inc.Emilie WuE-mail: [emailprotected] Office line: +86 21 6039 8363. Felzartamab (MOR202/TJ202) is a therapeutic human monoclonal antibody derived from MorphoSys' HuCAL antibody library and directed against CD38. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. DGAP-News: MorphoSys AG / Key word(s): AgreementMorphoSys and HIBio Enter Into Equity Participation and License Agreements for Felzartamab and MOR210 14.06.2022 / 22:01 The issuer is solely responsible for the content of this announcement. I-Mab is evaluating felzartamab in relapsed/refractory multiple myeloma and Systemic Lupus Erythematosus. MorphoSys: MorphoSys is providing the data presented at medical congresses as part of scientific exchange. Patients will be dosed with felzartamab or placebo for a period of 6 months. Felzartamab (TJ202/MOR202) is an investigational human monoclonal antibody derived from MorphoSys' HuCAL antibody technology. To learn more, visit us at www.morphosys.com and follow us on Twitter and LinkedIn. HIBio To Develop, Commercialize MorphoSys' Felzartamab, And - Nasdaq Pelabresib (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. Document - SEC.gov To learn more, visit us at www.morphosys.com and follow us on Twitter and LinkedIn. 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. Setrusumab (BPS804/UX143) is an antibody directed against sclerostin that is currently being investigated by Ultragenyx and Mereo BioPharma in a phase 2/3 clinical study for the treatment of osteogenesis imperfecta. 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. Founded in the late 1990s by Andrew Mariathasan in New York, with the goal of covering Wall Street for a new generation of investors, RTTNews has expanded steadily over the years to become a trusted provider of content for a wide array of subjects across several platforms. I-Mab's globally competitive pipeline of more than 20 clinical and preclinical-stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies. HuCAL Platinum is a registered trademark of MorphoSys AG. Media Contacts: 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). HIBio: Felzartamab was well tolerated. 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. 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. HIBio will assume full responsibility for future development and commercialization expenses. The scientific information may include data/information on investigational use(s) of compounds/drugs of which the efficacy and safety have not yet been established. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. 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. MorphoSys will also be represented as a member of HIBios Board of Directors. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of felzartamab in Greater China. I-Mab is investigating MOR210 as a treatment for relapsed or refractory advanced solid tumors. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been evaluated or approved by any regulatory authorities. Tafasitamab is being clinically investigated as an immunotherapeutic option in B-cell malignancies in several ongoing combination trials. Tel: +1 617-548-9271 TJ210/MOR210 is a novel human antibody directed against C5aR1 derived from MorphoSyss HuCAL Platinum technology. , . I-Mab is investigating MOR210 as a treatment for relapsed or refractory advanced solid tumors. I-Mab is currently conducting Phase 1 clinical trial in U.S. for TJ210 in oncology indications. The Company is progressing from a clinical-stage biotech company into an innovative global specialty biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility, and commercial capability. In Membranous Nephropathy, long-lived plasma cells drive pathogenic antibody production, contributing to functional damage to the glomeruli in the kidney. The Company is progressing from a clinical-stage biotech company into an innovative global specialty biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility, and commercial capability. Felzartamab (MOR202) is a therapeutic human monoclonal antibody derived from MorphoSys HuCAL antibody library and directed against CD38. HIBio will assume full responsibility for future development and commercialization expenses. Felzartamab. Background. I-Mab Partner MorphoSys Announces New License Agreements for Felzartamab and TJ210 (Bloomberg) - "'We have made significant progress in the development of felzartamab towards registration in China and we have brought TJ210 to the clinic in the United States. SHANGHAI and GAITHERSBURG, Md., June 15, 2022 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announced two assets the Company has licensed from partner MorphoSys AG (FSE: MOR;NASDAQ: MOR), felzartamab (also known as TJ202/MOR202) and TJ210 (also known as MOR210), are advancing globally through new license agreements. Conclusion. 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. 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.
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