UN Ocean Conference sets sail off France on World Oceans Day

NICE, France (AP) — Dozens of research and exploration vessels from around the world set sail just off the French coastal city of Nice on Sunday to kick off the third U.N. Ocean Conference and pay tribute to World Oceans Day.
The event, themed 'Ocean Wonders,' saw the vessels sail across Nice's Baie des Anges, or Bay of Angels, to spotlight the beauty and importance of the ocean while urging world leaders not to lose sight of its value as they make decisions about the planet's future.
Thousands of delegates, including heads of state, scientists, and environmental advocates, are expected in Nice this week to confront growing threats to the ocean, and the need to transform pledges into protection.
The United Nations has called the threats a global emergency facing the world's oceans as they confront rising temperatures, plastic pollution choking marine life, and relentless overexploitation of fish and other resources.
Just 2.7% of the global ocean is effectively protected from destructive activities like industrial fishing and deep-sea mining — far below the global goal of 30% by 2030.
Participating boats included the Energy Observer, a solar-panel covered catamaran that was the first vessel to circumnavigate the globe using renewable energy alone. It produces hydrogen fuel on board via seawater electrolysis, offering a vision of zero-emissions maritime travel.
Other standout vessels included France's Alfred Merlin, dedicated to underwater archaeology; the OceanXplorer, a high-tech billionaire-owned research yacht; and the WWF's Blue Panda, which is working to map and protect the last remaining seagrass meadows in the Mediterranean Sea.
At the heart of the conference is the push to ratify the High Seas Treaty, adopted in 2023. If it takes effect, the treaty would for the first time allow countries to establish marine protected areas in international waters, which cover nearly two-thirds of the ocean and remain largely ungoverned.
'The High Seas Treaty is critical to ensuring we can protect biodiversity in the ocean,' said Rebecca Hubbard, director of the High Seas Alliance. 'We're in the middle of a biodiversity and climate crisis. We absolutely have to protect the ocean to address those crises.'
But even in waters already designated as protected, enforcement often falls short. Many countries, France included, face criticism from environmental groups over weak regulation and continued industrial activity within their marine protected areas.
'The ambition is not there, the speed is not there, and the scale has not been there,' said Sílvia Tavares, project manager at Oceano Azul Foundation. 'Moments like UNOC are key to changing that.'
Several countries are expected to announce new marine protected areas, or MPAs, during the conference, along with bans on bottom trawling and other destructive activities within their existing MPA networks.
The 'Ocean Wonders' fleet will remain docked in Nice and open to the public until the conference concludes on June 13.
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Follow Annika Hammerschlag on Instagram @ahammergram.
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The Associated Press receives support from the Walton Family Foundation for coverage of water and environmental policy. The AP is solely responsible for all content. For all of AP's environmental coverage, visit https://apnews.com/hub/climate-and-environment
Annika Hammerschlag, The Associated Press

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AB Science - New peer-reviewed data provide strong evidence supporting masitinib potential for the treatment of Alzheimer's disease

PRESS RELEASE NEW PEER-REVIEWED DATA PROVIDE STRONG EVIDENCE SUPPORTING MASITINIB'S POTENTIAL FOR THE TREATMENT OF ALZHEIMER'S DISEASE THROUGH A DUAL MECHANISM OF COGNITIVE ENHANCEMENT AND NEUROPROTECTION THIS PUBLICATION CORROBORATES NEW ANALYSIS FROM THE CLINICAL PHASE 2B/3 STUDY SHOWING COGNITIVE IMPROVEMENT UNDER MASITINIB TREATMENT PHASE 3 CLINICAL STUDY WITH MASITINIB AS A DISEASE-MODIFYING THERAPY FOR ALZHEIMER'S DISEASE HAS BEEN AUTHORIZED BY THE FDA AND KEY EU COUNTRIES Paris, June 23, 2025, 8am CET AB Science SA (Euronext - FR0010557264 - AB) today announced that a new peer-reviewed study from an independent research team based in China (Guangdong Pharmaceutical University and Sun Yat-sen University) presents new evidence showing that masitinib offers a promising new approach to treating Alzheimer's disease, specifically the most common form, sporadic Alzheimer's disease (sAD), which accounts for over 95% of all cases. Masitinib is a highly innovative drug for Alzheimer's disease because unlike the majority of drug development research in this indication, masitinib targets the brain's innate immune system, including mast cells and microglia. The positioning of masitinib as a treatment of Alzheimer's disease is also different from other drugs. New evidence from peer-reviewed study This new publication is accessible online from the Neuroscience Letters journal website at: [1] In the study, researchers used a well-established mouse model that mimics the cognitive and behavioral symptoms of human sAD. When treated with masitinib, the mice showed marked improvements in memory, learning, sense of smell, and anxiety-like behaviors, all of which are early indicators of Alzheimer's progression. The research also revealed that masitinib: • Reduced toxic brain proteins such as hyperphosphorylated Tau. • Alleviated synaptic dysfunction and morphological damage, i.e., it protected synapses, which are essential for brain cell communication. • Suppressed microglial activation, which in turn inhibited the NF-κB/NLRP3/caspase-1 signaling axis, a key inflammatory signaling cascade linked to Alzheimer's disease, thereby suppressing inflammation in the brain of sAD mice. The authors emphasized that this is the first study to demonstrate that masitinib attenuates sporadic Alzheimer's disease pathology through dual mechanisms of cognitive enhancement and neuroprotection. Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France said, 'These new, independent findings provide strong evidence supporting masitinib as a promising disease-modifying therapy for sporadic Alzheimer's disease and perfectly compliment previously published clinical and preclinical data for masitinib in this indication.' New data from phase 2B/3 study in patients with mild Alzheimer's disease It has previously been shown that masitinib enhances cognitive function and synaptic integrity in a familial Alzheimer's disease mouse model [2]. Moreover, randomized, placebo-controlled, phase 2 and phase 2B/3 studies demonstrated that masitinib (4.5 mg/kg/day) can effectively delay or mitigate the progression of dementia [3,4]. Clinical and preclinical study findings have also been summarized in a review article [5], with the authors concluding that 'all research studies revealed positive effects concerning the cognitive functions in Alzheimer's disease and generally with good safety and tolerability'. New analysis from the completed phase 2B/3 study (AB09004), shows that masitinib treatment may not only slow down worsening of cognition in patients with mild Alzheimer's disease, but actually improves it over the treatment period of 24 weeks. Indeed, study AB09004 included patient with both mild and moderate AD (MMSE [12 - 25]). In the overall study population, which included patient with both mild and moderate AD (MMSE [12 - 25]), masitinib 4.5 mg/kg/day plus standard of care (memantine and anticholinesterase) demonstrated a significant reduction in cognitive impairment (ADAS-Cog LS Mean Diff = -2.15; p=0.0003) compared with standard of care alone. However, the clinical benefit on ADAS-Cog was greater in patients with mild impairment (LS Mean Diff = -2.89 ; p=0.0008) than in patients with moderate impairment (LS Mean Diff = -1.74; p=0.0284). Notably, there was a meaningful improvement in cognitive function between baseline and week 24 in the mild AD subgroup under masitinib treatment (LS Mean = -2.47), while it remained stable in the control arm (LS Mean = -0.42), as presented in the table below. ADAS-COG Change from Baseline to Week 24 N LS Mean LS Mean Diff.(97.51% CI) p-value Mild and moderate AD patients Masitinib 4.5 mg/kg/day + SoC 182 -1.45 -2.15(-3.48, -0.81) 0.0003 Placebo + SoC 176 0.69 ADAS-COG Change from Baseline to Week 24 N LS Mean LS Mean Diff.(97.51% CI) p-value Mild patients [MMSE (21-25)] Masitinib 4.5 mg/kg/day + SoC 63 -2.47 -2.89(-4.80, -0.99) 0.0008 Placebo + SoC 61 0.42 Moderate patients [MMSE (12-20)] Masitinib 4.5 mg/kg/day + SoC 119 -1.04 -1.74(-3.52, 0.04) 0.0284 Placebo + SoC 115 0.70 SoC = Standard of care = memantine and anticholinesteraseNote : Negative change in LS Mean of ADAS-COG means an improvement of cognition. Positive change in LS Mean of ADAS-COG means a worsening of cognition. Authorized phase 3 to support New Drug Application in case of success AB Science previously received an Investigational New Drug (IND) approval letter from the FDA and similar authorizations from several European countries to initiate Phase III study (AB21004) in patients with Alzheimer's disease. Study AB21004 is a randomized, double-blind phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild Alzheimer's disease, as an add-on therapy to standard of care, cholinesterase inhibitors and/or memantine. The study will enroll 600 patients. The objective of study AB21004 is to confirm results from the first phase 2B/3 study, AB09004, which showed that masitinib administered at 4.5 mg/kg/day significantly slowed cognitive deterioration relative to placebo and also reduced loss of functional ability in activities of daily living in the targeted AD population. Study AB21004 will evaluate the effect of masitinib on absolute change from baseline in cognition (ADAS-Cog-11) as primary endpoint and integrated AD rating scale (iADRS) and daily living (ADCS-ADL) as secondary endpoints. Expected patent protection until 2041 Based on the results from AB09004 study, AB Science filed a patent application relating to methods of treating Alzheimer's disease (i.e. a medical use patent) with its lead compound masitinib (WO2022129410A1). If granted, this patent will provide intellectual property protection for masitinib in this indication until 2041. A similar strategy was successfully applied in Amyotrophic Lateral Sclerosis, with medical use patent for masitinib in ALS being granted worldwide (press release dated June 1st 2023). References : Jia K, Shen Q, Zhang Z, et al. Masitinib attenuates neuropathological changes in acrolein-induced sAD mouse model via NF-κB/NLRP3/Caspase-1 signaling pathway. Neurosci Lett. Volume 862, 27 July 2025, 138300. Published online June 10, 2025. Li T, Martin E, Abada YS, et al. Effects of Chronic Masitinib Treatment in APPswe/PSEN1dE9 Transgenic Mice Modeling Alzheimer's Disease. J Alzheimers Dis. 2020;76(4):1339-1345. doi:10.3233/JAD-200466 Dubois B, López-Arrieta J, Lipschitz S, et al. Masitinib for mild-to-moderate Alzheimer's disease: results from a randomized, placebo-controlled, phase 3, clinical trial [published correction appears in Alzheimers Res Ther. 2023 Apr 22;15(1):85. doi: 10.1186/s13195-023-01230-9.]. Alzheimers Res Ther. 2023;15(1):39. Piette F, Belmin J, Vincent H, et al. Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial. Alzheimers Res Ther. 2011;3(2):16. Published 2011 Apr 19. doi:10.1186/alzrt75 Ettcheto M, Cano A, Sanchez-López E, et al. Masitinib for the treatment of Alzheimer's disease. Neurodegener Dis Manag. 2021;11(4):263-276. doi:10.2217/nmt-2021-0019 About AB ScienceFounded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment. AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB). Further information is available on AB Science's website: Forward-looking Statements - AB ScienceThis press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance. These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB ScienceFinancial Communication & Media Relations investors@ Attachment Alz sAD Model PreClin vENG VFError 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

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Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma

Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone If approved, it would represent the fourth indication in the EU and second in the front-line setting globally Paris, June 23, 2025. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months. Global Head, Oncology'The CHMP's recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions. If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.' The positive CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study (clinical study identifier: NCT03617731), presented at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the Journal of Clinical Oncology. GMMG-HD7 is the first phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in transplant-eligible (TE) NDMM patients, with a higher proportion of patients with minimal residual disease (MRD) negativity benefit post-induction, alongside a significant progression-free survival (PFS) benefit from first randomization, regardless of maintenance therapy and without consolidation. Additionally, the data showed the highest post-induction and post-transplant MRD negativity rates of any CD38 monoclonal antibody using VRd as a backbone in TE NDMM. The results are part of the growing body of clinical evidence supporting the use of Sarclisa in the front-line setting and reinforce the potential of Sarclisa-VRd when used prior to transplant. Sarclisa is currently approved in three indications in the EU, across different lines of therapy in adult patients with relapsed and/or refractory (R/R) MM and with NDMM who are not eligible for transplant. About the GMMG-HD7 studyGMMG-HD7 is an investigational pivotal, randomized, open-label, multicenter, two-part phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in TE NDMM patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients. The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period. The GMMG-HD7 protocol defined two primary endpoints: MRD negativity following induction therapy in the first part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available at a later time. The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety. MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10-5) after induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization. About SarclisaSarclisa (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 pomalidomide and dexamethasone 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 the German-speaking Myeloma Multicenter Group GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany. The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10). 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 is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Le Bourhis | +33 6 75 06 43 81 | 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 | 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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, 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 Press_Release

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Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma

Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone If approved, it would represent the fourth indication in the EU and second in the front-line setting globally Paris, June 23, 2025. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months. Global Head, Oncology'The CHMP's recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions. If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.' The positive CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study (clinical study identifier: NCT03617731), presented at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the Journal of Clinical Oncology. GMMG-HD7 is the first phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in transplant-eligible (TE) NDMM patients, with a higher proportion of patients with minimal residual disease (MRD) negativity benefit post-induction, alongside a significant progression-free survival (PFS) benefit from first randomization, regardless of maintenance therapy and without consolidation. Additionally, the data showed the highest post-induction and post-transplant MRD negativity rates of any CD38 monoclonal antibody using VRd as a backbone in TE NDMM. The results are part of the growing body of clinical evidence supporting the use of Sarclisa in the front-line setting and reinforce the potential of Sarclisa-VRd when used prior to transplant. Sarclisa is currently approved in three indications in the EU, across different lines of therapy in adult patients with relapsed and/or refractory (R/R) MM and with NDMM who are not eligible for transplant. About the GMMG-HD7 studyGMMG-HD7 is an investigational pivotal, randomized, open-label, multicenter, two-part phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in TE NDMM patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients. The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period. The GMMG-HD7 protocol defined two primary endpoints: MRD negativity following induction therapy in the first part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available at a later time. The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety. MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10-5) after induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization. About SarclisaSarclisa (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 pomalidomide and dexamethasone 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 the German-speaking Myeloma Multicenter Group GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany. The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10). 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 is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Le Bourhis | +33 6 75 06 43 81 | 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 | 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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, 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 Press_ReleaseSign in to access your portfolio