A Phase 1/2 Study of REGN7257 (Anti-Interleukin 2 Receptor Subunit Gamma [IL2RG] Monoclonal Antibody) in Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy

This study is researching an experimental drug called REGN7257 (called "study drug"). The study is focused on patients who have severe aplastic anemia (SAA), a disease of the bone marrow resulting in an impairment of the production of blood cells.
The main purpose of this two-part study (Part A and Part B) is to test how safe and tolerable REGN7257 is in patients with SAA in which other Immunosuppressive therapies (ISTs) have not worked well.
The study is looking at several other research questions to better understand the following properties of REGN7257:
* Side effects that may be experienced by participants taking REGN7257
* How REGN7257 works in the body
* How much REGN7257 is present in blood after dosing
* If REGN7257 works to raise levels of certain blood counts after treatment
* How quickly REGN7257 works to raise levels of certain blood counts
* In patients for whom REGN7257 works to raise levels of certain blood counts after treatment, how many continue to show such a response throughout the study
* If REGN7257 works to lower the number of platelet and red blood cell transfusions needed
* How REGN7257 changes immune cell counts and composition
* How the body reacts to REGN7257 and if it produces proteins that bind to REGN7257 (this would be called the formation of anti-drug antibodies [ADA])

开始日期2021-01-13

申办/合作机构

Regeneron Pharmaceuticals, Inc.

100 项与 REGN-7257 相关的临床结果

登录后查看更多信息

100 项与 REGN-7257 相关的转化医学

登录后查看更多信息

100 项与 REGN-7257 相关的专利（医药）

登录后查看更多信息

项与 REGN-7257 相关的文献（医药）

2023-01-11·Science Translational Medicine1区 · 医学

Blocking common γ chain cytokine signaling ameliorates T cell–mediated pathogenesis in disease models

1区 · 医学

Article

作者: Pan, Hao ; Sleeman, Matthew A. ; Shah, Sweta ; Farrales, Pamela ; Gayvert, Kaitlyn ; Chatterjee, Ishita ; Kim, Jee H. ; Birchard, Dylan ; Ben, Li-Hong ; Romero Hernandez, Annabel ; Norton, Thomas ; Orengo, Jamie M. ; Murphy, Andrew J. ; Lim, Wei Keat ; Korgaonkar, Chandrashekhar K. ; Tay, Amanda ; Le Floc’h, Audrey ; Popke, Jon ; Kamat, Vishal ; Huang, Tammy ; Franklin, Matthew ; Nagashima, Kirsten ; Perlee, Lorah ; Yancopoulos, George D. ; Herbin, Olivier ; Scott, George ; Ajithdoss, Dharani ; Oyejide, Adelekan ; Olson, William

The common γ chain (γc; IL-2RG) is a subunit of the interleukin (IL) receptors for the γc cytokines IL-2, IL-4, IL-7, IL-9, IL-15, and IL-21. The lack of appropriate neutralizing antibodies recognizing IL-2RG has made it difficult to thoroughly interrogate the role of γc cytokines in inflammatory and autoimmune disease settings. Here, we generated a γc cytokine receptor antibody, REGN7257, to determine whether γc cytokines might be targeted for T cell–mediated disease prevention and treatment. Biochemical, structural, and in vitro analysis showed that REGN7257 binds with high affinity to IL-2RG and potently blocks signaling of all γc cytokines. In nonhuman primates, REGN7257 efficiently suppressed T cells without affecting granulocytes, platelets, or red blood cells. Using REGN7257, we showed that γc cytokines drive T cell–mediated disease in mouse models of graft-versus-host disease (GVHD) and multiple sclerosis by affecting multiple aspects of the pathogenic response. We found that our xenogeneic GVHD mouse model recapitulates hallmarks of acute and chronic GVHD, with T cell expansion/infiltration into tissues and liver fibrosis, as well as hallmarks of immune aplastic anemia, with bone marrow aplasia and peripheral cytopenia. Our findings indicate that γc cytokines contribute to GVHD and aplastic anemia pathology by promoting these characteristic features. By demonstrating that broad inhibition of γc cytokine signaling with REGN7257 protects from immune-mediated disorders, our data provide evidence of γc cytokines as key drivers of pathogenic T cell responses, offering a potential strategy for the management of T cell–mediated diseases.

项与 REGN-7257 相关的新闻（医药）

2023-11-03

·GlobeNewswire-Health Care

Regeneron to Highlight Scientific Advancements Across Diversified Pipeline in Difficult-to-Treat Blood Cancers and Disorders at ASH

Ten abstracts, including three oral presentations, spotlight the expanding body of evidence supporting odronextamab in follicular lymphoma and diffuse large B-cell lymphoma Additional presentations include the first review of primary endpoint results with longer follow-up from the pivotal trial for linvoseltamab in heavily pre-treated patients with multiple myeloma TARRYTOWN, N.Y., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that new and updated data from its hematology pipeline will be shared in 19 abstracts at the American Society of Hematology (ASH) Annual Meeting from December 9 to 12 in San Diego, CA. These include research across six investigational medicines that span eight difficult-to-treat blood cancers and disorders. Together, these presentations showcase the diversity of approaches Regeneron is advancing through its hematology pipeline and its dedication to leading-edge research. “We are fusing our legacy of innovation with our deep scientific expertise in hematology to advance research across multiple modalities as we aim to ultimately make a meaningful impact in patients’ lives. Our data at ASH are a testament to our progress towards this ambition,” said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Hematology at Regeneron. “In addition to new results from our pivotal trials evaluating odronextamab and linvoseltamab, we are presenting findings on our growing blood disorders pipeline. Further, our presentations span emerging measures of disease that contribute to a deeper understanding of these advanced conditions, which in the future could form the basis of response-directed treatment paradigms.” At ASH, 10 abstracts will feature updated data and analyses for Regeneron’s most advanced investigational blood cancer medicine, odronextamab (CD20xCD3 bispecific antibody), in relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL). Among them are three oral presentations from its pivotal trial (ELM-2), including: the final analysis in R/R DLBCL patients; a comprehensive analysis of minimal residual disease status and circulating tumor DNA profiling in R/R FL and DLBCL patients; and updated analyses and long-term follow-up of efficacy, safety and patient reported outcomes in R/R FL. Furthermore, the company will share long-term survival outcomes and a responder analysis for odronextamab from a Phase 1 trial (ELM-1) in R/R DLBCL patients who have progressed after CAR-T therapy, a patient population who have a particularly dismal prognosis and limited effective treatment options. Odronextamab is currently under regulatory review for the treatment of R/R FL and R/R DLBCL by the U.S. Food and Drug Administration, with a target action date of March 31, 2024, as well as by the European Medicines Agency. Five presentations will highlight data supporting linvoseltamab (BCMAxCD3 bispecific antibody), including the first presentation of primary endpoint results with longer follow-up from the pivotal Phase 2 trial (LINKER-MM1) in heavily pre-treated patients with multiple myeloma. Additionally, two presentations will review the latest results from three Phase 2 studies evaluating pozelimab (C5 antibody) in combination with Alnylam Pharmaceuticals, Inc.’s cemdisiran (siRNA C5 inhibitor) in patients with paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Regeneron presentations at ASH: Abstract title Abstract Presenting/Lead AuthorPresentationdate/time(PT)OdronextamabCirculating Tumor DNA Analysis Associates with Progression-Free Survival (PFS) with Odronextamab Monotherapy in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma (DLBCL): Identification of Minimal Residual Disease Status and High-Risk Subgroups from the Phase 2 ELM-2 Study#427 Oral PresentationJon E. ArnasonSunday,December 10,9:30 AM Final Analysis of the Phase 2 ELM-2 Study: Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)#436 Oral PresentationSabarish Ram AyyappanSunday,December 10,10:15 AM Maintenance of Moderate to High Levels of Functioning and Quality of Life with Odronextamab Monotherapy in Patients with Relapsed or Refractory Follicular Lymphoma#669 Oral PresentationBenoît TessoulinSunday,December 10,5:00 PM Odronextamab Monotherapy for the Treatment of Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma (DLBCL): Focus on Clinical Pharmacology and Pharmacometrics in the ELM-1 and ELM-2 Studies#1436 Poster PresentationMin ZhuSaturday,December 9,5:30-7:30 PM Results of a Second, Prespecified Analysis of the Phase 2 Study ELM-2 Confirm High Rates of Durable Complete Response with Odronextamab in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) with Extended Follow-Up#3041 Poster PresentationJose (J.C.) C. Villasboas BisnetoSunday,December 10,6:00-8:00 PM Trial in Progress: Phase 1 Trial Evaluating the Safety and Tolerability of Odronextamab in Combination with Cemiplimab in Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma#3100 Poster PresentationCecilia CarpioSunday,December 10,6:00-8:00 PM Odronextamab Demonstrates Durable Complete Responses in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing After CAR-T Therapy: Outcomes from the ELM-1 Study#4461 Poster PresentationJennifer L. CrombieMonday,December 11,6:00-8:00 PM Health-Related Quality of Life and Symptoms in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated with Odronextamab Monotherapy in the Phase 2 ELM-2 Study#4504 Poster PresentationElżbieta Iskierka-JażdżewskaMonday,December 11,6:00-8:00 PM Key prognostic factors in patients with relapsed/refractory follicular lymphoma: An evidence based systematic literature and medical review#7261 Online publicationAna Jimenéz-UbietoN/A Key prognostic factors in patients with relapsed/refractory diffuse large B-cell lymphoma: An evidence based systematic literature and medical review#7258 Online PublicationBastien von TresckowN/A LinvoseltamabIncidence of Second Primary Malignancies in Medicare-Insured Patients in the US with Triple-Class Exposed Relapsed/Refractory Multiple Myeloma#912 Oral PresentationSikander AilawadhiMonday,December 11,4:00 PM Health-Related Quality of Life (HRQoL) Among Patients with Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in LINKER-MM1: Interim Assessment Up to 36 Weeks of Treatment#3359 Poster PresentationJames E. HoffmanSunday,December 10,6:00-8:00 PM Trial In Progress: A Phase 2 Study of Linvoseltamab for the Treatment of High-Risk Smoldering Multiple Myeloma (LINKER-SMM1)#3393 Poster PresentationPaula Rodriguez-OteroSunday,December 10,6:00-8:00 PM Real-World Study of Patients with Triple-Class Exposed Relapsed/Refractory Multiple Myeloma: Analysis Across a Spectrum of Advanced Disease Stage Medicare Patients in the United States#3773 Poster PresentationQiufei MaSunday,December 10,6:00-8:00 PM Patterns of Response to 200 mg Linvoseltamab in Patients with Relapsed/Refractory Multiple Myeloma: Longer Follow-up of the LINKER-MM1 study#4746 Poster PresentationSundar JagannathMonday,December 11,6:00-8:00 PM Pozelimab + Cemdisiran*Psychometric Evaluation of the PNH Symptom Questionnaire (PNH-SQ) Among Patients With Paroxysmal Nocturnal Hemoglobinuria from Three Phase 2 Clinical Trials With Pozelimab Monotherapy or in Combination With Cemdisiran#3752 Poster PresentationChristopher HartfordSunday,December 10,6:00-8:00 PM 52-Week Open-Label Extension Data from A Phase 2 Study Evaluating the Safety and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Switched from Eculizumab#2716 Poster PresentationRichard J. KellySunday,December 10,6:00-8:00 PM REGN7999 (TMPRSS6 inhibitor)Single Ascending Doses of REGN7999, A Monoclonal Antibody Inhibitor of TMPRSS6, Increase Serum Hepcidin And Cause Deep, Sustained Reductions in Serum Iron in Healthy Human Volunteers#3841 Poster PresentationNikhil SinghMonday,December 11,6:00-8:00 PM REGN7257 (IL2RG antibody)Blockade of Common Gamma Chain Cytokine Signaling with REGN7257, an Interleukin 2 Receptor Gamma (IL2RG) Monoclonal Antibody, in Combination with Costimulatory Blockers Delayed Skin Graft Rejection in Mice#2550 Poster PresentationAudrey Le Floc’hSunday,December 10,6:00-8:00 PM REGV131-LNP1265 (in vivo CRISPR/Cas9-based Factor 9 gene insertion therapy)**Novel Approaches for Gene-Based Therapies: Targeted Gene Insertion of Factor 9 as a Durable Treatment for Hemophilia BInvited TalkLeah SabinSaturday,December 9,9:30-10:45 AM *In collaboration with Alnylam Pharmaceuticals, Inc.**In collaboration with Intellia Therapeutics, Inc. The potential uses of odronextamab, linvoseltamab, pozelimab, cemdisiran, REGN7999, REGN7257, and REGV131-LNP1265 described above are investigational, and their safety and efficacy have not been fully evaluated by any regulatory authority. About Regeneron in HematologyAt Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders. Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in combination with each other and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments. Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling. If you are interested in learning more about our clinical trials, please contact us (clinicaltrials@regeneron.com or 844-734-6643) or visit our clinical trials website. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Regeneron’s medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about Regeneron, please visit www.regeneron.com or follow Regeneron on LinkedIn. Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation odronextamab (CD20xCD3 bispecific antibody), linvoseltamab (BCMAxCD3 bispecific antibody), pozelimab (C5 antibody) in combination with Alnylam Pharmaceuticals, Inc.’s cemdisiran (siRNA C5 inhibitor), and other of Regeneron’s Product Candidates discussed or referenced in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including odronextamab for the treatment of relapsed/refractory (“R/R”) diffuse large B-cell lymphoma and R/R follicular lymphoma, linvoseltamab for the treatment of multiple myeloma, and pozelimab in combination with cemdisiran for the treatment of paroxysmal nocturnal hemoglobinuria; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as odronextamab, linvoseltamab, and pozelimab in combination with cemdisiran); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as odronextamab, linvoseltamab, and pozelimab in combination with cemdisiran) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) as well as Regeneron’s agreement with Alnylam Pharmaceuticals, Inc. as referenced in this press release, to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection and REGEN-COV® (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022 and its Form 10-Q for the quarterly period ended September 30, 2023. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Contacts: Media RelationsTammy Allen Tel: +1 914-306-2698tammy.allen@regeneron.comInvestor RelationsVesna TosicTel: +1 914-847-5443vesna.tosic@regeneron.com

临床2期临床结果临床1期ASH会议免疫疗法

2022-11-03

·BioSpace

Regeneron Presents New Data at ASH from Advancing Hematology Pipeline across Multiple Blood Cancers and Disorders

First Phase 2 data for odronextamab (CD20xCD3) in diffuse large B-cell lymphoma and follicular lymphoma to be presented in two oral sessions Additional presentations include new data on linvoseltamab (REGN5458; BCMAxCD3) in multiple myeloma Regeneron will host an investor webcast on Wednesday, December 14 at 8:30 AM ET to provide updates across its hematology portfolio TARRYTOWN, N.Y., Nov. 3, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that new data across its hematology pipeline will be highlighted in 17 presentations at the 2022 American Society of Hematology (ASH) Annual Meeting from December 10-13 in New Orleans, LA. "We've made significant strides toward developing a comprehensive hematology portfolio that has the potential to address diverse and difficult-to-treat blood cancers and blood disorders," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Hematology at Regeneron. "Our ASH presentations not only showcase some of the many modalities we're exploring – which includes monoclonal antibodies, bispecific antibodies, gene modifying technologies, and siRNA inhibition – but also the depth of research we're conducting in support of our pipeline." Notable Regeneron blood cancer presentations at ASH include the first interim data from the Phase 2 ELM-2 study of odronextamab (CD20xCD3) in relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), which will be shared in two oral sessions. Updated Phase 1/2 data will also be presented for linvoseltamab (REGN5458; BCMAxCD3 bispecific antibody) in patients with heavily pre-treated multiple myeloma. Based on these findings, a recommended dose was selected for the Phase 2 portion of the linvoseltamab trial. Additionally, first clinical data from two Phase 2 studies evaluating pozelimab (C5 antibody) in combination with Alnylam Pharmaceuticals, Inc.'s cemdisiran (siRNA C5 inhibitor) in patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, will be shared. Investor Webcast Information Regeneron will host a conference call and simultaneous webcast to share updates on the company's hematology portfolio on Wednesday, December 14 at 8:30 AM ET. A link to the webcast may be accessed from the 'Investors and Media' page of Regeneron's website at . To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the company's website for at least 30 days. Regeneron data at ASH: The potential uses of odronextamab, linvoseltamab, pozelimab, cemdisiran and REGN7257 described above are investigational, and their safety and efficacy have not been fully evaluated by any regulatory authority. About Regeneron in Hematology At Regeneron, we're applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders. Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in combination with each other and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments. Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling. If you are interested in learning more about our clinical trials, please contact us (clinicaltrials@regeneron.com or 844-734-6643) or visit our clinical trials website. About Regeneron's VelocImmune Technology Regeneron's VelocImmune® technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt. in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn). About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit or follow @Regeneron on Twitter. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation odronextamab (a CD20xCD3 bispecific antibody), linvoseltamab (a BCMAxCD3 bispecific antibody), and other of Regeneron's Product Candidates discussed or referenced in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products and Regeneron's Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as odronextamab for the treatment of diffuse large B-cell lymphoma and follicular lymphoma and linvoseltamab for the treatment of multiple myeloma; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates (such as odronextamab and linvoseltamab) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including those discussed or referenced in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials or therapeutic applications; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Praluent® (alirocumab), and REGEN-COV® (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended September 30, 2022. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( ) and its Twitter feed ( ). Company Codes: NASDAQ-NMS:REGN

抗体合作siRNA

2021-07-16

·GlobeNewswire

Aplastic Anemia Pipeline Insight 2021: Emerging Drugs, Key

Los Angeles, USA, July 15, 2021 (GLOBE NEWSWIRE) -- Aplastic Anemia Pipeline Insight 2021: Emerging Drugs, Key Companies, Clinical Trials Updates The rise in awareness of Aplastic Anemia has led to the increased Research & Development activities in the pharmaceutical sector and the development of pipeline products such as PF-06462700, REGN7257, Romiplostim, BL-8040, and others. DelveInsight’s “Aplastic Anemia Pipeline Insight” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in the Aplastic Anemia pipeline landscapes. It comprises Aplastic Anemia pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Aplastic Anemia therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Aplastic Anemia pipeline products. Some of the key takeaways from the Aplastic Anemia Pipeline Report Get an overview of pipeline landscape @ Aplastic Anemia Clinical Trials Analysis Aplastic Anemia is a rare, severe blood disorder due to failure of the bone marrow to produce blood cells. The disease can be moderate, painful, or very severe. Aplastic Anemia treatment is based on the severity. Treatment with immune system-suppressing therapy or a stem cell transplant is required for patients with severe Aplastic Anemia, whereas there is no standard of care for moderate Aplastic Anemia. Aplastic Anemia Emerging Drugs PF-06462700 is an immunosuppressant/immunosuppressive agent. PF-06462700 is being developed by Pfizer for Aplastic Anemia patients and is currently in the phase III stage of development. Regeneron Pharmaceuticals is developing REGN7257 for Aplastic Anemia treatment. It is currently in phase I/II stage of development. LB-001 acts as a modulator of Interleukin 2 and immunomodular. Romiplostim, a member of the thrombopoietin (TPO) mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor. Romiplostim is currently being evaluated in Phase II/III clinical trials to treat patients with Aplastic Anemia. BL-8040 (Motixafortide) targets CXCR4, a chemokine receptor and a well-validated therapeutic target that is over-expressed in many human cancers, including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis, therapeutic resistance, and CXCR4 overexpression correlated with poor prognosis. A Phase II clinical trial has been completed for BL-8040 for the treatment of Aplastic Anemia. For further information, refer to the detailed report @ Aplastic Anemia Pipeline Therapeutics Scope of Aplastic Anemia Pipeline Drug Insight · Aplastic Anemia Therapies Late-stage (Phase III) · Aplastic Anemia Therapies Mid-stage (Phase II)· Aplastic Anemia Therapies Early-stage (Phase I) · Aplastic Anemia Pre-clinical stage and Discovery candidates · Discontinued and Inactive candidates · Thrombopoietin receptor agonists· Anti-interleukin 2 receptor subunit gamma inhibitors· Cell replacements · Vaccines· Monoclonal Antibody· Peptides· Polymer· Small molecule · Infusion· Intradermal· Intramuscular· Intranasal· Oral· Parenteral· Subcutaneous· Topical · Monotherapy· Combination· Mono/Combination Key Questions regarding Current Aplastic Anemia Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customized pipeline report @ Aplastic Anemia Drugs Pipeline Report Related Reports DelveInsight's Aplastic Anemia - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's Aplastic Anemia - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Aplastic Anemia in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Aplastic Anemia - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2020 " report by DelveInsight offers comprehensive insights on marketed and Phase III products for Aplastic Anemia. DelveInsight's Anemia In Chronic Kidney Disease Market Insights, Epidemiology and Market Forecast - 2030 report proffers a detailed overview of the disease and understanding of historical and forecasted epidemiology. DelveInsight's Anemia in CKD patients - Market Insights, Epidemiology, and Market Forecast - 2030 report provides a detailed overview of the disease and an in-depth understanding of historical and forecasted epidemiology. DelveInsight's Chemotherapy Induced Anemia - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. Browse Blog Posts About DelveInsightDelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

小分子药物抗体疫苗

100 项与 REGN-7257 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
再生障碍性贫血	临床2期	韩国	Regeneron Pharmaceuticals, Inc.	2021-01-13
再生障碍性贫血	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2021-01-13
再生障碍性贫血	临床2期	英国	Regeneron Pharmaceuticals, Inc.	2021-01-13
再生障碍性贫血	临床2期	法国	Regeneron Pharmaceuticals, Inc.	2021-01-13
难治性重度再生障碍性贫血	临床2期	韩国	Regeneron Pharmaceuticals, Inc.	2021-01-13
难治性重度再生障碍性贫血	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2021-01-13
难治性重度再生障碍性贫血	临床2期	英国	Regeneron Pharmaceuticals, Inc.	2021-01-13
难治性重度再生障碍性贫血	临床2期	法国	Regeneron Pharmaceuticals, Inc.	2021-01-13