On November 3, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that new data across its hematology pipeline will be highlighted in 17 presentations at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 10-13 in New Orleans, LA (Press release, Regeneron, NOV 3, 2022, View Source [SID1234622905]).
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"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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper) 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 View Source 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.
Odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Results from a prespecified analysis of the pivotal Phase II study ELM-2
Odronextamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) Grade 1–3a: Results from a prespecified analysis of the pivotal Phase II study ELM-2
Trial in Progress: Follicular lymphoma outcomes in relapsed/refractory patients treated with systemic therapy in a real-world assessment (FLORA)
Trial in Progress: Outcomes in patients with relapsed/refractory DLBCL treated with systemic therapy from real-world experience (ORCHID)
Selection of odronextamab pediatric dosing regimens for aggressive non-Hodgkin lymphoma via a modeling and simulation approach
Optimization of intravenous Odronextamab step-up dosing regimen for reducing the risk of high-grade cytokine release syndrome
#5245
Publication Number
Online publication
Modeling and simulation in support of odronextamab subcutaneous dose selection for adult patients with indolent or aggressive non-Hodgkin lymphoma
#5257
Publication Number
Online publication
Evaluate dynamics of IL-6 release during step-up dosing of subcutaneous administration of odronextamab via a quantitative systems pharmacology modelling approach
#5424
Publication Number
Online publication
A quantitative systems pharmacology modelling framework for evaluation of cytokine release syndrome mediated by intravenous odronextamab monotherapy in patients with B-cell non-Hodgkin lymphoma
#5433
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Online publication
Linvoseltamab (formerly REGN5458)
Updated safety and efficacy of REGN5458, a BCMAxCD3 bispecific antibody, treatment for relapsed/refractory multiple myeloma: A Phase 1/2 first-in-human study
Trial in Progress: REGN5458, a BCMAxCD3 bispecific antibody, in a Phase Ib multi-cohort study of combination regimens for patients with relapsed/refractory multiple myeloma
Trial in Progress: A Phase II window of opportunity study of the BCMAxCD3 bispecific antibody REGN5458 in previously untreated patients with symptomatic multiple myeloma
Real-world study of patients with triple-class exposed relapsed or refractory multiple myeloma: Analysis across a spectrum of advanced disease stage patients in the U.S.
Prevalence of ocular comorbidities in elderly patients with multiple myeloma in the U.S.: An Analysis of 100% Medicare sample data during 2007-2020
Incidence of second primary malignancies (SPMs) in patients in the U.S. with triple-class-exposed (TCE) relapsed or refractory multiple myeloma (RRMM)
A Phase 2, randomized trial evaluating the safety and efficacy of pozelimab and cemdisiran in patients with paroxysmal nocturnal hemoglobinuria
Patient-reported outcomes from a Phase 2, randomized trial evaluating the safety and efficacy of pozelimab and cemdisiran in patients with paroxysmal nocturnal hemoglobinuria
A Phase 2, open-label study evaluating the safety and efficacy of combination pozelimab and cemdisiran therapy in patients with paroxysmal nocturnal hemoglobinuria who switch from eculizumab
Blockade of common gamma chain cytokine signaling with REGN7257, an interleukin 2 receptor gamma (IL2RG) monoclonal antibody, protected mice from inflammatory and autoimmune diseases
Evaluation of common gamma chain cytokine signaling blockade with REGN7257, an interleukin 2 receptor gamma (IL2RG) monoclonal antibody, on immune cell populations in monkey and human
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 ([email protected] 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).