Linvoseltamab

Alladapt Immunotherapeutics, a well-financed biotech working in the food allergy field, shut down following talks with the FDA, according to a source familiar with the company. After claiming success in a Phase 1/2 trial in June 2023, Alladapt prepared for a Phase 3 of its experimental food allergy drug. Codenamed ADP101, the oral candidate had received the FDA fast track tag for mono- and multi-food allergies. But a late-stage trial proved too financially daunting. The “FDA guidance for the Phase 3 trial made it economically unviable,” according to the source, who confirmed the company closure to Endpoints News on the condition of anonymity. Investors got a “partial recovery on their investment,” the source added. The Menlo Park, CA-based startup was co-founded in 2018 by CEO Ashley Dombkowski and Kari Nadeau, a former Stanford allergist and now chair of the Department of Environmental Health at Harvard School of Public Health. Dombkowski didn’t respond to an Endpoints inquiry. Alladapt disclosed a $119 million funding round in June 2022 and a $50 million loan with Hercules Capital two months later. The biotech disclosed construction of a manufacturing facility on the outskirts of Philadelphia the year prior. The facility was expected to be completed in “late 2024,” according to architecture and engineering firm Genesis. The company’s investors included Patient Square Capital’s Enavate Sciences, Gurnet Point Capital, AllerFund, Red Tree Venture Capital, Novartis and others. Its equipment was listed for auction in July. Rock Creek Advisors, a firm that works on liquidations and restructurings, lists Alladapt as a client on its website. Some of its top executives left this year for posts at Eccogene and Navigator Medicines . The food allergy space has been through a series of ups and downs in recent years. Nestlé’s attempt to market a peanut allergy drug — known as Palforzia, from its $2.6 billion Aimmune acquisition — had failed commercially. There was a major win in February with the FDA approval of Novartis and Genentech’s Xolair for children and adults with one or more food allergies. Novartis had also axed a peanut allergy Phase 3 trial earlier this year, but said it expected to start a new study of the anti-inflammatory, dubbed ligelizumab, later in 2024. With its ADP101 candidate, Alladapt aimed to deliver small bits of protein from the “big nine” food allergies — milk, eggs, wheat, fish, shellfish, peanuts, tree nuts, soy and sesame — so that patients wouldn’t be as sensitized to the allergens. The startup also terminated an open-label extension study this year. Also in the food allergy space are Leaps by Bayer-backed Ukko and Regeneron, which is testing Dupixent combined with its hematology drug linvoseltamab in Phase 1 .

Oral presentation shares head-to-head results for investigational combination pozelimab plus cemdisiran vs. ravulizumab in paroxysmal nocturnal hemoglobinuria Initial results for odronextamab in first-line follicular lymphoma showcase compelling monotherapy potential and progress in the confirmatory trial Additional oral presentations explore odronextamab in areas of high unmet need, including the primary analysis in diffuse large B-cell lymphoma progressing after CAR-T therapy and first results in relapsed/refractory marginal zone lymphoma TARRYTOWN, N.Y., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data from its hematology pipeline will be shared across 23 abstracts at the American Society of Hematology (ASH) 2024 Annual Meeting, taking place from December 7-10 in San Diego, CA. The latest research advances demonstrate the potential of Regeneron’s diverse pipeline, which aims to address unmet needs in ten types of blood cancers and disorders. These innovative and differentiated approaches include CD3 bispecific antibodies, costimulatory bispecific antibodies, and a pioneering combination of a monoclonal antibody and small interfering RNA (siRNA). “Our presentations at ASH demonstrate the progress we are making toward transforming care for a range of blood cancers and disorders where advancements are desperately needed,” said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. “These include new head-to-head data exploring a novel combination that aims to maximize disease control in paroxysmal nocturnal hemoglobinuria compared to a standard-of-care treatment, as well as initial results from our confirmatory odronextamab trial in first-line follicular lymphoma. Together, our presentations underscore our commitment to work towards translating scientific breakthroughs to differentiated medicines for hematology patients.” At ASH, abstracts in blood disorders include an oral presentation from an exploratory cohort of a Phase 3 trial investigating a novel combination of pozelimab with cemdisiran compared to ravulizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH) who were naïve to complement inhibition at baseline. Notably, the presentation will detail interim results from patients who were initially randomized to ravulizumab but crossed over to the combination in an open label extension portion of the trial. Progress on the odronextamab development program will be featured in twelve abstracts. Among them are initial results in patients with previously untreated follicular lymphoma (FL) from Part 1 of the Phase 3 OLYMPIA-1 confirmatory trial, which consists of a non-randomized safety run-in (Part 1) followed by a randomized efficacy portion (Part 2) comparing odronextamab monotherapy to rituximab plus standard-of-care chemotherapies. Two oral presentations on the ELM-1 and pivotal ELM-2 trials will feature new analyses in settings with significant unmet needs: one in patients with diffuse large B-cell lymphoma (DLBCL) who progressed after CAR-T therapy and the other in relapsed/refractory (R/R) marginal zone lymphoma (MZL). Other notable abstracts include the latest linvoseltamab efficacy and safety results from the pivotal LINKER-MM1 study in R/R multiple myeloma (MM), preclinical data evaluating a CD38xCD28 costimulatory bispecific antibody in combination with linvoseltamab, and preclinical data on TMPRSS6 inhibition in beta-thalassemia. The full list of Regeneron presentations at ASH includes: Abstract TitleAbstractPresenterSession Date/Time (PT)Odronextamab Efficacy and Safety of Odronextamab Monotherapy in Patients (Pts) with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing after CAR T-Cell Therapy: Primary Analysis from the ELM-1 StudyAbstract #866Oral PresentationSessionMatthew MatasarMonday, December 9, at 2:45-4:15 pmMarriott Marquis San Diego Marina, Pacific Ballroom Salons 15-17Efficacy and Safety of Odronextamab in Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL): Data from the R/R MZL Cohort in the ELM-2 StudyAbstract #862Oral PresentationSessionTae Min KimMonday, December 9, at 2:45-4:15 pmMarriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13Odronextamab Monotherapy in Previously Untreated Patients with High-Risk Follicular Lymphoma (FL): Results of the Safety Lead-in of the Phase 3 OLYMPIA-1 StudyAbstract #4411Poster PresentationSessionElizabeth BremMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEfficacy and Safety of Odronextamab in Rare Subtypes of Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (B-NHL): Data from a Dedicated Cohort of Other B-NHLs in the ELM-2 StudyAbstract #4502Poster PresentationSessionEmmanuel BachyMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HTreatment Duration and Risk of Fatal Infections in Patients with B-Cell Non-Hodgkin Lymphoma Achieving Complete Response with OdronextamabAbstract #3080Poster PresentationGottfried von KeudelMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HDynamics of Complete Responses in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Treated with Odronextamab in the ELM-2 StudyAbstract #4486Poster PresentationSessionSabarish AyyappanMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HLong-Term Efficacy and Safety of Odronextamab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Pooled Analysis from ELM-1 and ELM-2 StudiesAbstract #3118Poster PresentationSessionJohn N. AllanSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEvaluation of CAR-HEMATOTOX Scoring as a Predictor of Infection Risk following Treatment with Odronextamab (a CD20×CD3 Bispecific Antibody) in Relapsed/Refractory Diffuse Large B-Cell LymphomaAbstract #3076Poster PresentationSessionMathew MatasarSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEvaluation of Baseline CAR-HEMATOTOX Scores to Predict Increased Severe Infection Risk in Patients with Relapsed/Refractory Follicular Lymphoma Treated with OdronextamabAbstract #1650Poster PresentationSessionMatthew MatasarSaturday, December 7, at 5:30-7:30 pmSan Diego Convention Center, Halls G-HDynamics of Complete Responses in Patients with Relapsed or Refractory Follicular Lymphoma Treated with Odronextamab in the ELM-2 StudyAbstract #1628Poster PresentationSessionStefano LuminariSaturday, December 7, at 5:30-7:30 pmSan Diego Convention Center, Halls G-HTrial in Progress: Odronextamab for the Treatment of Patients with Relapsed/Refractory Mantle Cell Lymphoma following Prior BTK Inhibitor Therapy - A Cohort of the ELM-2 StudyAbstract Publication OnlySrikanth AmbatiN/AMatching-Adjusted Indirect Comparisons (MAICs) of Odronextamab Versus Mosunetuzumab and Epcoritamab for the Treatment of Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) after Two or More Lines of Systemic TherapyAbstract Publication OnlyDeepa JagadeeshN/ALinvoseltamabLinvoseltamab in Patients with Relapsed/Refractory Multiple Myeloma: Longer Follow-Up and Selected High-Risk Subgroup Analyses of the LINKER-MM1 StudyAbstract #3369Poster PresentationMansi R. ShahSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HSoluble BCMA Dynamics in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in LINKER-MM1Abstract #3310Poster PresentationAnasuya HazraSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HCharacterization of Linvoseltamab’s BCMA Binding Epitope and Efficacy Against BCMA Mutations in Relapsed/Refractory Multiple MyelomaAbstract #3265Poster PresentationKen Lee & Yi ZhouSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HA CD38xCD28 Costimulatory Bispecific Antibody Demonstrates Potent Preclinical Combinatorial Activity with a BCMAxCD3 T Cell-EngagerAbstract #3283Poster PresentationKara Olson & David J. DiLilloSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HReducing Time Toxicity for Anti-B-Cell Maturation Antigen (BCMA) Bispecific Treatment: Evidence from Pivotal Single-Arm Trial Data on Teclistamab, Elranatamab, and Linvoseltamab for Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)Abstract #2271Poster Presentation SessionSikander AilawadhSaturday, December 7, at 5:30-7:30 pmSan Diego Convention, Halls G-HExposure-Response Analyses of Various Efficacy and Safety Endpoints in Support of Registrational Dose Selection of Linvoseltamab in Patients with Relapsed/Refractory Multiple MyelomaAbstract Publication OnlyOleg MilbergN/AComparative Effectiveness of Linvoseltamab Versus Current Real-World Standard-of-Care Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma Treated at IMWG SitesAbstract Publication OnlyShaji KumarN/AComparative Effectiveness of Linvoseltamab Versus Current Real-World (RW) Standard-of-Care (SOC) Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM): Key Subgroups AnalysisAbstract Publication OnlyShaji KumarN/AAdditional PresentationsEfficacy and Safety of Pozelimab Plus Cemdisiran vs Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria who are Naïve to Complement Inhibition* Abstract #306Oral Presentation SessionChristopher PatriquinSaturday, December 7, at 4 – 5:30 pmSan Diego Convention Center, Room 11TMPRSS6 Inhibition Rapidly Reverses Liver Iron Overload and Prevents an Increase of Splenic Pro-Inflammatory Macrophages in a Mouse Model of Beta-Thalassemia Abstract #2473Poster Presentation SessionHeinrich E. LobSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HThe Reality of Beta Thalassemia and Iron Chelation Therapy – A Qualitative Study Unveiling the Patient BurdenAbstract Publication OnlyChris Hartford *Agreement with Alnylam Pharmaceuticals, Inc. Linvoseltamab as well as the combination of pozelimab and cemdisiran are investigational, and the potential uses of odronextamab in R/R MZL and rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono™ to treat R/R FL or DLBCL after two or more lines of systemic therapy, but the safety and efficacy of odronextamab have not been fully evaluated by any other 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 various combinations 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. 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 a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo®, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). 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 by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most 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, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.  Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. 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 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 pozelimab in combination with cemdisiran, odronextamab, linvoseltamab, and the other programs 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, such as odronextamab for the treatment of follicular lymphoma in the United States, linvoseltamab for the treatment of relapsed/refractory multiple myeloma in the United States and/or European Union, and the other programs 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 (such as those referenced above) 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 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 those referenced above) 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 (including biosimilar versions of Regeneron’s Products); 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), 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), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), 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, 2023 and its Form 10-Q for the quarterly period ended September 30, 2024. 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 AllenTel: +1 914-306-2698tammy.allen@regeneron.comInvestor RelationsMark HudsonTel: +1 914-847-3482mark.hudson@regeneron.com