On November 3, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that new and updated data from its hematology pipeline will be shared in 19 abstracts at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 9 to 12 in San Diego, CA (Press release, Regeneron, NOV 3, 2023, View Source [SID1234636898]). 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.

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"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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper), 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 (Free ASH Whitepaper):

Abstract title Abstract Presenting/Lead Author Presentation
date/time
(PT)
Odronextamab
Circulating 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 Presentation Jon E. Arnason Sunday,
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 Presentation Sabarish Ram Ayyappan Sunday,
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 Presentation Benoît Tessoulin Sunday,
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 Presentation Min Zhu Saturday,
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 Presentation Jose (J.C.) C. Villasboas Bisneto Sunday,
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 Presentation
Cecilia Carpio Sunday,
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 Presentation Jennifer L. Crombie Monday,
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 Presentation Elżbieta Iskierka-Jażdżewska Monday,
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 publication Ana Jimenéz-Ubieto N/A

Key prognostic factors in patients with relapsed/refractory diffuse large B-cell lymphoma: An evidence based systematic literature and medical review
#7258

Online Publication Bastien von Tresckow N/A

Linvoseltamab
Incidence of Second Primary Malignancies in Medicare-Insured Patients in the US with Triple-Class Exposed Relapsed/Refractory Multiple Myeloma
#912

Oral Presentation Sikander Ailawadhi Monday,
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 Presentation James E. Hoffman Sunday,
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 Presentation Paula Rodriguez-Otero Sunday,
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 Presentation Qiufei Ma Sunday,
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 Presentation Sundar Jagannath Monday,
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 Presentation Christopher Hartford Sunday,
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 Presentation Richard J. Kelly Sunday,
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 Presentation Nikhil Singh Monday,
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 Presentation Audrey Le Floc’h Sunday,
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 B
Invited Talk Leah Sabin Saturday,
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 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.