Latest news with #Immunology
Yahoo
22-07-2025
- Business
- Yahoo
Bispecific Antibodies Market Set to Surge to $163.15 Billion by 2032, Driven by a Robust 40.1% CAGR
Bispecific T‑cell engagers now dominate oncology pipelines, with global trial activity up 256% since 2019. FDA has approved more than 15 such drugs, and U.S. spending is projected to hit $12.2billion by 2025, rising to over $50 billion by 2032. San Francisco, USA, July 22, 2025 (GLOBE NEWSWIRE) -- The global is witnessing a transformative surge, projected to grow at an impressive compound annual growth rate (CAGR) of 40.10%, reaching a valuation of approximately USD 163,149.35 million by 2032. This extraordinary growth is propelled by the increasing adoption of bispecific antibody therapies in oncology and immunology, groundbreaking clinical outcomes, and robust R&D investments aimed at next-generation biologics. Bispecific antibodies are bioengineered molecules designed to simultaneously recognize and bind to two different antigens or epitopes. Unlike monoclonal antibodies that target a single antigen, bispecific antibodies can link a disease-related antigen (such as one found on cancer cells) to another molecule—often a T-cell—thus redirecting immune cells to attack malignant tissues with heightened precision. This dual-binding capability is unlocking new therapeutic possibilities in cancer, autoimmune diseases, and infectious diseases. As of 2024, over 300 bispecific antibodies are in global clinical development, with 14 already approved by the U.S. FDA, reflecting the sector's rapid growth and clinical validation. Download Free Sample Report PDF @ Global Bispecific Antibodies Market Key Players- Detailed Competitive Insights Amgen Genentech Akeso, Inc. Taisho Pharmaceutical Janssen Immunocore Adimab, Innovent Biologics, Inc. AstraZeneca Affimed GmbH Xencor F. Hoffmann-La Roche Ltd. Sanofi Regeneron Pharmaceuticals Inc. Pieris Pharmaceuticals, Inc. Eli Lilly Mereo BioPharma Group plc Merus MacroGenics, Inc. Sobi, TG Therapeutics Inc. Genmab A/S Alteogen Emergent BioSolutions Inc. Novartis AG Astellas Pharma Inc. Celgene Corporation Others Market Drivers 1. Increasing Cancer Prevalence Globally Cancer remains a global health crisis, with the World Health Organization (WHO) estimating around 19.3 million new cancer cases and nearly 10 million deaths in 2023 alone. Traditional therapies are often limited by poor specificity and severe side effects, which have shifted the focus toward more targeted modalities, such as bispecific antibodies. Their unique mechanism allows precise tumor targeting while preserving healthy tissues, making them a preferred choice for next-gen cancer therapies. 2. Regulatory Approvals and Accelerated Development Pathways The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have actively supported innovative antibody therapeutics. Between 2022 and 2024, the FDA approved six bispecific antibodies, a testament to their growing clinical value. Regulatory agencies are also introducing expedited pathways for breakthrough therapies, speeding up market entry for promising candidates. 3. Rising Investments in Immunotherapy and Biologics Governments and private players are significantly boosting funding for immunotherapy research. For instance, the U.S. National Cancer Institute (NCI) allocated over USD 15 billion toward cancer research in 2023, a portion of which is directed toward the development of targeted therapies, including bispecific antibodies. This capital influx is catalyzing clinical trials, molecule discovery, and scalable manufacturing solutions. Market Challenges Despite the optimistic trajectory, the bispecific antibodies market faces notable challenges: Complex Manufacturing: Producing bispecific antibodies involves intricate processes, such as protein folding and stability optimization, which increase production time and cost. High Development Costs: The R&D cycle for bispecific therapies is long and resource-intensive, often requiring large-scale trials and advanced biotechnological platforms. Immunogenicity Risks: Some bispecific formats can trigger unwanted immune responses, complicating their clinical profiles. Nonetheless, advances in antibody engineering, such as the development of Fc-engineered antibodies and T-cell engaging bispecifics (BiTEs), are helping overcome these limitations. Regional Insights North America is poised to maintain a dominant position in the global bispecific antibodies market. Its leadership is driven by: A well-established biotech and pharma industry. Substantial government and private R&D investments. Early and streamlined regulatory approvals. In 2023 alone, the U.S. government dedicated nearly USD 7.9 billion toward cancer research, a portion of which supports novel antibody-based treatments. Moreover, the presence of major biopharmaceutical companies and academic research centers ensures rapid clinical development. Asia-Pacific, on the other hand, is anticipated to experience the fastest growth rate. Countries such as China, India, and South Korea are: Increasing healthcare expenditures. Encouraging local biotech innovation. Expanding access to clinical trials and biologic therapies. China, for example, is investing heavily in biologics manufacturing capabilities and has introduced supportive regulations for fast-track drug approval, which will likely make the region a future hub for bispecific antibody development. TABLE OF CONTENT 1. Bispecific Antibodies Market Overview 1.1. Study Scope 1.2. Market Estimation Years 2. Executive Summary 2.1. Market Snippet 2.1.1. Bispecific Antibodies Market Snippet by Drug Type 2.1.2. Bispecific Antibodies Market Snippet by Indication 2.1.3. Bispecific Antibodies Market Snippet by Distribution Channel 2.1.4. Bispecific Antibodies Market Snippet by Country 2.1.5. Bispecific Antibodies Market Snippet by Region 2.2. Competitive Insights 3. Bispecific Antibodies Key Market Trends 3.1. Bispecific Antibodies Market Drivers 3.1.1. Impact Analysis of Market Drivers 3.2. Bispecific Antibodies Market Restraints 3.2.1. Impact Analysis of Market Restraints 3.3. Bispecific Antibodies Market Opportunities 3.4. Bispecific Antibodies Market Future Trends…… Get a detailed analysis on regions, market segments, customer landscape, and companies@ Market Segmentation by Indication The bispecific antibodies market is segmented by application into: Cancer Autoimmune and Inflammatory Disorders Others Among these, the oncology segment is forecasted to command the largest share throughout the forecast period. As of March 2025, over 650 bispecific antibodies are in clinical development globally—nearly all focused on oncology applications, and nine of the 11 bispecifics approved since 2021 target cancer, representing over 80% of recent regulatory approvals. Competitive Landscape & Innovation Strategies The bispecific antibody space is rapidly evolving with heightened competition among biotech giants and emerging players. Leading companies are prioritizing: Next-generation platforms for greater safety, flexibility, and efficacy. Strategic collaborations and licensing deals to expand pipeline access. Geographic expansion into emerging economies with rising healthcare demands. Biotech firms are utilizing AI-driven drug discovery, cell-line optimization, and novel bispecific formats (like dual-variable domain antibodies and knob-into-hole technologies) to advance their products. Some players are also entering into co-development agreements to reduce costs and accelerate regulatory milestones. Future Outlook The bispecific antibodies market is positioned at the forefront of immunotherapeutic innovation. With strong clinical potential, increasing funding, and a favorable regulatory climate, the sector is expected to witness substantial growth through 2032. As manufacturing bottlenecks are resolved and newer formats with improved safety emerge, bispecific antibodies will likely become standard components of combination therapies in oncology and immune-related disorders. In conclusion, the bispecific antibodies market offers immense opportunities for stakeholders across biotechnology, healthcare, and investment sectors. Its rapid evolution signals a paradigm shift in how complex diseases are treated, ushering in a new era of precision medicine. Browse more Reports from AnalystView Market Insights:CONTACT: U.S. Office: 11923 NE Sumner St STE 750924 Portland, Oregon, 97220, USA Phone: +1 615-326-5253 (U.S. Toll Free) Email: mayank@ Email: inquiry@ Website: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-07-2025
- Business
- Yahoo
Efficiently Identify Immunology Deal Structures and Terms - Upfront, Milestone, Royalties
Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered and rights transferred - contract documents provide this insight where press releases and databases do not. Dublin, July 21, 2025 (GLOBE NEWSWIRE) -- The "Immunology Collaboration and Licensing Deals 2016-2025" report has been added to offering. Fully revised and updated, the report provides details of 909 immunology deals from 2016 to Collaboration and Licensing Deals provides a comprehensive understanding and unprecedented access to the immunology deals entered into by the worlds leading biopharma companies. The report provides access to deal payment terms as announced between the parties. This data provides useful insight into the payment and other deal report contains a comprehensive listing of collaboration and licensing deals announced since 2016 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual licensing contract documents as submitted to the Securities Exchange Commission by companies and their initial chapters of this report provide an orientation of immunology dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in immunology 3 covers the financial deal terms for deals signed in the immunology field with stage of development announced. Deals are listed and sectioned by headline value, upfront payment, milestone payment and royalty 4 provides a review of the top 25 most active biopharma companies in immunology dealmaking. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances 5 provides a comprehensive and detailed review of immunology deals signed and announced since 2016 where a contract document is available. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on 6 provides a comprehensive directory of immunology deals listed by therapeutic report also includes numerous table and figures that illustrate the trends and activities in immunology deal making since 2016. In addition, a comprehensive deal directory is provided organized by company A-Z and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on Collaboration and Licensing Deals provides the reader with the following key benefits: Understand deal trends since 2016 Browse immunology collaboration and licensing deals Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, therapy focus and technology type Leading deals by value Most active dealmakers Identify assets and deal terms for each transaction Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Immunology Collaboration and Licensing Deals includes: Trends in immunology dealmaking in the biopharma industry Overview of collaboration and licensing deal structure Directory of immunology deal records covering pharmaceutical and biotechnology The leading immunology deals by value Most active immunology licensing dealmakers Analyzing contract agreements allows due diligence of: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Chapter 1 - IntroductionChapter 2 - Trends in immunology dealmaking2.1. Introduction2.2. Immunology partnering over the years2.3. Immunology partnering by deal type2.4. Immunology partnering by industry sector2.5. Immunology partnering by stage of development2.6. Immunology partnering by technology type2.7. Immunology partnering by therapeutic indicationChapter 3 - Financial deal terms for immunology partnering3.1. Introduction3.2. Disclosed financials terms for immunology partnering3.3. Immunology partnering headline values3.4. Immunology deal upfront payments3.5. Immunology deal milestone payments3.6. Immunology royalty ratesChapter 4 - Leading immunology deals and dealmakers4.1. Introduction4.2. Most active in immunology partnering4.3. List of most active dealmakers in immunology4.4. Top immunology deals by valueChapter 5 - Immunology contract document directory5.1. Introduction5.2. Immunology partnering deals where contract document availableChapter 6 - Immunology dealmaking by therapeutic target6.1. Introduction6.2. Deals by immunology therapeutic targetDeal directoryDeal directory - Immunology deals by company A-Z 2016 to 2025Deal directory - Immunology deals by technology type 2016 to 2025Deal type definitions For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
25-06-2025
- Business
- Yahoo
Press Release: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant recipients Riliprubart was also designated orphan drug for the investigational use in chronic inflammatory demyelinating polyneuropathy in the US and EU Paris, June 25, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi's commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US. Global Therapeutic Area Development Head, Immunology and Inflammation, Sanofi"Orphan drug designation for riliprubart marks an important milestone in our mission to address critical challenges in transplant medicine leveraging our expertise in immunology. Antibody mediated rejection represents a serious threat to transplanted organs and patient survival. Through riliprubart's innovative mechanism of action, we hope to bring forward a treatment option that could significantly improve outcomes for kidney transplant recipients." Riliprubart is currently being explored in multiple clinical studies across different indications in transplant and neurology. A phase 2 clinical study is currently ongoing, exploring its potential in kidney transplant recipients (NCT05156710). The study includes two patient cohorts: those at risk of developing rejection and those with active forms of antibody-mediated rejection. In addition, Sanofi is conducting two phase 3 studies exploring riliprubart in chronic inflammatory demyelinating polyneuropathy (CIPD), a rare neurological disorder, specifically in patients refractory to standard of care (MOBILIZE, clinical study identifier: NCT06290128), and in IVIg-treated patients (VITALIZE, clinical study identifier: NCT06290141). The broad clinical development program for riliprubart emphasizes Sanofi's commitment to exploring riliprubart's potential across multiple immune-mediated conditions with high unmet medical needs. About Riliprubart SAR445088 (riliprubart) is a potential first-in-class, IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit About AMRAntibody-mediated rejection is a serious complication that may arise after solid organ transplantation, occurring when the recipient's immune system produces antibodies that attack the transplanted organ. Sensitized recipients, who have pre-existing antibodies that target foreign antigens including those found on transplanted organs, face a high risk of developing antibody-mediated rejection. Subsequent immune response can lead to inflammation, organ damage, and organ failure if left untreated. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Léo Le Bourhis | +33 6 75 06 43 81 | Victor Rouault | +33 6 70 93 71 40 | Timothy Gilbert | +1 516 521 2929 | Léa Ubaldi | +33 6 30 19 66 46 | Investor RelationsThomas Kudsk Larsen | +44 7545 513 693 | Alizé Kaisserian | +33 6 47 04 12 11 | Felix Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Nathalie Pham | +33 7 85 93 30 17 | Tarik Elgoutni | +1 617 710 3587 | Thibaud Châtelet | +33 6 80 80 89 90 | Yun Li | +33 6 84 00 90 72 | Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press Release
Yahoo
25-06-2025
- Business
- Yahoo
Press Release: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant recipients Riliprubart was also designated orphan drug for the investigational use in chronic inflammatory demyelinating polyneuropathy in the US and EU Paris, June 25, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi's commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US. Global Therapeutic Area Development Head, Immunology and Inflammation, Sanofi"Orphan drug designation for riliprubart marks an important milestone in our mission to address critical challenges in transplant medicine leveraging our expertise in immunology. Antibody mediated rejection represents a serious threat to transplanted organs and patient survival. Through riliprubart's innovative mechanism of action, we hope to bring forward a treatment option that could significantly improve outcomes for kidney transplant recipients." Riliprubart is currently being explored in multiple clinical studies across different indications in transplant and neurology. A phase 2 clinical study is currently ongoing, exploring its potential in kidney transplant recipients (NCT05156710). The study includes two patient cohorts: those at risk of developing rejection and those with active forms of antibody-mediated rejection. In addition, Sanofi is conducting two phase 3 studies exploring riliprubart in chronic inflammatory demyelinating polyneuropathy (CIPD), a rare neurological disorder, specifically in patients refractory to standard of care (MOBILIZE, clinical study identifier: NCT06290128), and in IVIg-treated patients (VITALIZE, clinical study identifier: NCT06290141). The broad clinical development program for riliprubart emphasizes Sanofi's commitment to exploring riliprubart's potential across multiple immune-mediated conditions with high unmet medical needs. About Riliprubart SAR445088 (riliprubart) is a potential first-in-class, IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit About AMRAntibody-mediated rejection is a serious complication that may arise after solid organ transplantation, occurring when the recipient's immune system produces antibodies that attack the transplanted organ. Sensitized recipients, who have pre-existing antibodies that target foreign antigens including those found on transplanted organs, face a high risk of developing antibody-mediated rejection. Subsequent immune response can lead to inflammation, organ damage, and organ failure if left untreated. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Léo Le Bourhis | +33 6 75 06 43 81 | Victor Rouault | +33 6 70 93 71 40 | Timothy Gilbert | +1 516 521 2929 | Léa Ubaldi | +33 6 30 19 66 46 | Investor RelationsThomas Kudsk Larsen | +44 7545 513 693 | Alizé Kaisserian | +33 6 47 04 12 11 | Felix Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Nathalie Pham | +33 7 85 93 30 17 | Tarik Elgoutni | +1 617 710 3587 | Thibaud Châtelet | +33 6 80 80 89 90 | Yun Li | +33 6 84 00 90 72 | Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press ReleaseSign in to access your portfolio
Associated Press
03-06-2025
- Business
- Associated Press
Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector
ASCO: new Sarclisa data support subcutaneous administration with on-body injector Paris, June 3, 2025. New data from two clinical studies of the investigational use of Sarclisa administered subcutaneously (SC) via an on-body injector (OBI) (also referred to as an on-body delivery system) in relapsed or refractory multiple myeloma (R/R MM) support the potential use of this innovative delivery method to advance patient care, while upholding Sarclisa's efficacy and safety profile. The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and include full data from the IRAKLIA phase 3 study, the first to incorporate the use of an OBI in the treatment of MM, and demonstrate non-inferior efficacy and pharmacokinetics compared to Sarclisa intravenous (IV) infusion. Alyssa Johnsen, MD, PhD Global Therapeutic Area Head, Immunology and Oncology Development 'Our subcutaneous clinical program is rooted in our mission to address patient needs and reduce treatment burden in multiple myeloma. We believe the novel on-body injector represents a significant innovation thatcouldimprove and streamline the treatment process for both patients and providers. We are pleased to share thesedata, the first to evaluate an on-body injector with a multiple myeloma treatment, and look forwardtopotentiallybringing this formulation and administrationoptionto the multiple myeloma community.' The OBI offers the potential to improve the overall patient experience in MM treatment. Recent studies and surveys suggest the use of an OBI may be associated with greater convenience, flexibility, and patient satisfaction compared to IV or manual SC administration methods.1 In addition, an OBI may also streamline the administration process for providers, potentially reducing the physical burden on nurses and enabling them to possibly move freely through the use of a hands-free device while monitoring the patient during injection. The IRAKLIA phase 3 study and the IZALCO phase 2 study presented at ASCO were conducted using Enable Injections' enFuse® hands-free OBI, an automated injector designed to subcutaneously administer high-volume medicines beginning with the click of a button, to administer the hyaluronidase-free SC formulation of Sarclisa. The enFuse device uses a 30 gauge, hidden, and retractable needle that is smaller compared to some of the commonly used large-volume SC injection needles, which may support patient comfort. The safety and efficacy of Sarclisa SC administered with the OBI or manual administration are investigational and have not been approved for use by any regulatory authority. IRAKLIA phase 3 study IRAKLIA is a global, randomized, open-label, pivotal phase 3 non-inferiority study comparing Sarclisa SC administered via an OBI and Sarclisa IV, both in combination with pomalidomide and dexamethasone (Pd) in adult patients with R/R MM who have received at least one prior line of treatment. At the data cut-off of November 6, 2024, and a median follow-up of 12 months, the study demonstrated: Primary endpoints Secondary endpoints The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd, but with a notably lower rate of systemic IRs. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) associated with SC administration that occurred with a low incidence (0.4%, n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2. Xavier Leleu, MD, PhD Head of the Department of Hematology and Myeloma Clinic at the Hôpital La Mileterie and study investigator 'Results from the IRAKLIA phase 3 study represent a potentially transformational advancement in the administration of multiple myeloma treatment. These data not only establish non-inferiority between Sarclisa administered both subcutaneously and intravenously across several key endpoints but reinforce the positive impact that this on-body injector could have on the patient treatment experience, as demonstrated by patient satisfaction scores.' In addition to the oral presentation at ASCO, the full data were simultaneously published in the Journal of Clinical Oncology. IZALCO phase 2 study In addition to the IRAKLIA phase 3 study, Sanofi also presented new data from the randomized, sequential, open-label, IZALCO phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via manual push or an OBI, in combination with carfilzomib and dexamethasone (Kd) in adult patients with R/R MM who have received one to three prior lines of therapy. At a median follow-up of 10.1 months, the study demonstrated: The overall safety profile of Sarclisa SC-Kd observed in this study was consistent with the established safety profile of Sarclisa IV-Kd, with no new safety concerns observed. Advancing patient and provider-centric innovation in MM While SC administration is currently available for certain MM treatment regimens through a manual injection, administering large-volume medicines manually can present significant challenges, including a labor-intensive process for nurses, risk of strain and needlestick injuries, and potential need for larger needles that may compromise patient comfort and increase anxiety. Mehul Desai, PharmD, MBA Vice President, Medical Affairs, Enable Injections 'We believe multiple myeloma patients deserve a more convenient and comfortable treatment experience and recognize the crucial role providers play in delivering that care. Through our collaboration with Sanofi, we've aspired to advance an on-body injector that could transform the treatment experience for patients and providers alike. The results from the IRAKLIA and IZALCO studies represent a significant step toward our ambition and validate the potential of the on-body injector to deliver the same high standard of efficacy established with intravenous Sarclisa.' In addition to IRAKLIA and IZALCO, Sanofi is also evaluating Sarclisa SC administration via an OBI in the front-line treatment setting. The ISASOCUT phase 2 study conducted by the University of Poitiers, is evaluating Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) in adult patients with newly diagnosed MM (NDMM) not eligible for autologous stem-cell transplant (ASCT), while the German-speaking Myeloma Multicenter Group (GMMG)-HD8 phase 3 study, conducted in collaboration with the GMMG and the German Multiple Myeloma Study Group Consortium (DSMM), is evaluating Sarclisa SC-VRd induction in NDMM patients who are eligible for ASCT. In addition, results from the IZALCO, IRAKLIA and ISASOCUT studies will be presented at the European Hematology Association Congress later this month. The IRAKLIA abstract was also hand-selected to be included in the 2025 Best of ASCO program, held later in the summer of 2025, following the ASCO Annual Meeting. The data from these studies, collectively, will form the basis for global regulatory submissions. Sarclisa administered subcutaneously via the on-body injector or manual administration is investigational and has not been approved for any use by any regulatory authority. The safety and efficacy of this formulation and delivery method have not been established. About the IRAKLIA and IZALCO studies IRAKLIA is a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC formulation administered at a fixed dose SC via an OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes being assessed are ORR, defined as the proportion of patients with stringent CR, CR, VGPR, and partial response (PR) according to the 2016 IMWG criteria assessed by Independent Review Committee (IRC), and observed C trough at steady state (pre-dose at C6D1), defined as observed Sarclisa plasma concentrations. IZALCO is a two-part, randomized, sequential, open-label, phase 2 study evaluating the efficacy and safety of Sarclisa SC formulation administered SC via manual push or an OBI in adult patients with R/R MM who have received one to three prior lines of therapy. The primary objective is ORR, as assessed by IRC. The secondary objective is patient preference for the OBI versus manual administration of Sarclisa SC. About Enable Injections Based in the US (Cincinnati, OH), Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse. enFuse is an innovative wearable drug delivery platform that is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit About Sarclisa Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | +33 6 25 09 14 25 | [email protected] Evan Berland | +1 215 432 0234 | [email protected] Léo Le Bourhis | +33 6 75 06 43 81 | [email protected] Victor Rouault | +33 6 70 93 71 40 | [email protected] Timothy Gilbert | +1 516 521 2929 | [email protected] Investor Relations Thomas Kudsk Larsen |+44 7545 513 693 | [email protected] Alizé Kaisserian | +33 6 47 04 12 11 | [email protected] Felix Lauscher | +1 908 612 7239 | [email protected] Keita Browne | +1 781 249 1766 | [email protected] Nathalie Pham | +33 7 85 93 30 17 | [email protected] Tarik Elgoutni | +1 617 710 3587 | [email protected] Thibaud Châtelet | +33 6 80 80 89 90 | [email protected] Yun Li | +33 6 84 00 90 72 | [email protected] Sanofi forward-looking statements All trademarks mentioned in this press release are the property of the Sanofi group with the exception of enFuse. Attachment
