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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
The Sun
30-05-2025
- Health
- The Sun
New threat to plummeting male fertility rates identified as common but ‘silent' parasite that ‘DECAPITATES sperm'
FERTILITY rates appear to have been declining in both men and women globally - and now scientists have found a common single-celled parasite may be a contributor. Male fertility rates in particular have been plummeting over the past half-century, with an analysis from 1992 showing a steady decrease in sperm counts and quality since the 1940s. 3 3 And a more recent study found male infertility rates increased nearly 80 per cent from 1990 to 2019. Declining fertility rates have been attributed to a combination of factors, including rising costs associated with raising children. But now accumulating evidence suggests parasitic infections could also be a threat. A study published in April this year showed for the first time "human sperm lose their heads upon direct contact" with a parasite called Toxoplasma gondii. Toxoplasma gondii causes toxoplasmosis - an often harmless infection but can cause serious problems in individuals with weakened immune systems, pregnant women, and newborns. The parasite is found in the faeces of infected cats and in undercooked meat. Writing for The Conversation, Bill Sullivan, Professor of Microbiology and Immunology, Indiana University, said how the "new study bolsters emerging findings that underscore the importance of preventing this parasitic infection". Foodbourne transmission and animal to human transmission are the top ways people can get toxoplasmosis. Eating raw or undercooked meat, particularly lamb, pork, and venison, is a primary source of infection. And eating unwashed fruits and vegetables that have been contaminated with cat faeces or soil can also lead to infection. Major health advice for couples as HSE offers new resources for anyone struggling with fertility Ingesting the parasite through contact with cat faeces (poop) or soil contaminated with cat faeces is a common way to get toxoplasmosis. Cleaning cat litter boxes without proper hygiene can also expose people to the parasite. While toxoplasmosis is generally harmless for most people with healthy immune systems, often causing no symptoms or mild, flu-like symptoms that resolve on their own, Sullivan said toxoplasma remains in the body for life as dormant cysts in brain, heart and muscle tissue. And these cysts can reactive and cause additional episode of severe illness that damage critical organ system. He explains: "Between 30 per cent and 50 per cent of the world's population is permanently infected with toxoplasma due to the many ways the parasite can spread. "Upon infection, toxoplasma spreads to virtually every organ and skeletal muscle. Evidence that toxoplasma can also target human male reproductive organs first surfaced during the height of the AIDS pandemic in the 1980s, when some patients presented with the parasitic infection in their testes. 3 "While immunocompromised patients are most at risk for testicular toxoplasmosis, it can also occur in otherwise healthy individuals. "Imaging studies of infected mice confirm that toxoplasma parasites quickly travel to the testes in addition to the brain and eyes within days of infection." Evidence in past studies suggesting toxoplasma can reside in male reproductive organs has prompted analysis of fertility in infected men. In the April 2025 study, researchyers from Germany, Uraguay and Chile observed that toxoplasma can reach the testes and epididymis - the tube where sperm mature and are stored - two days after infection in mice. Looking at what happens when the parasite comes into direct contact with human sperm in a test tube, they observed that after only five minutes, 22.4 per cent of sperm cells were beheaded. The number of decapitated sperm also increased the longer they interacted with the parasites. Sperm cells that maintained their head were often twisted and misshapen, and sperm cells had hole sin their head, suggesting the parasites were trying to invade them as it would any other type of cell. Sullivan added: "The evidence that toxoplasma can infiltrate male reproductive organs in animals is compelling, but whether this produces health issues in people remains unclear. "Testicular toxoplasmosis shows that parasites can invade human testes, but symptomatic disease is very rare. "Studies to date that show defects in the sperm of infected men are too small to draw firm conclusions at this time. "Additionally, some reports suggest that rates of toxoplasmosis in high-income countries have not been increasing over the past few decades while male infertility was rising, so it's likely to only be one part of the puzzle." Could you have toxoplasmosis? Toxoplasmosis is a common infection that you can catch from the poo of infected cats, or infected meat. It's usually harmless but can cause serious problems in some people. Most people who become infected with the toxoplasma gondii parasite don't show any signs of infection. The parasite can reside in the body for life without causing issues. However, if you do have symptoms, they can be mild and flu-like, such as fever, swollen lymph nodes, and muscle aches. According to the NHS, some people may have more serious symptoms including: confusion blurred vision slurred speech unsteady walking Your GP may do blood tests to see if you've been infected with toxoplasmosis. They can also prescribe medicines to treat the infection if necessary. Most people who get toxoplasmosis get better without treatment. However, you'll usually be given medicines, including antibiotics, if you: are pregnant have a weakened immune system, for example, you're taking immunosuppressant medicines or you have HIV have symptoms affecting your eyes To avoid toxoplasmosis: wear gloves while gardening, and wash your hands thoroughly afterwards wash your hands before preparing food and eating wash hands, knives and chopping boards thoroughly after preparing raw meat wash fruit and vegetables thoroughly to get rid of any traces of soil thoroughly cook meat, especially lamb, pork and venison avoid cat poo in cat litter and soil if you can, wearing gloves if you need to empty cat litter trays and washing your hands afterwards Don't: eat raw or undercooked meat, or cured meats like salami or parma ham have unpasteurised goats' milk or any products made from it touch pregnant sheep or lambs do not feed cats raw or undercooked meat
