Latest news with #MM
Yahoo
5 hours ago
- Business
- Yahoo
Press Release: Sanofi's SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma
Sanofi's SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma Designation granted for IgG1-based GPRC5D monoclonal antibody for the potential treatment of patients with relapsed or refractory multiple myeloma Paris, July 30, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to SAR446523, an IgG1-based Antibody-Dependent Cellular Cytotoxicity-enhanced (ADCC) monoclonal antibody (mAb) targeting G-protein coupled receptor family C group 5 member D (GPRC5D) for the potential treatment of patients with relapsed or refractory multiple myeloma (R/R MM). GPRC5D is highly expressed on plasma cells in MM patients, with low expression in healthy tissues. 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. 'The orphan drug designation is a significant milestone in our ongoing efforts to develop innovative treatments in multiple myeloma,' said , Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi. 'This underscores our commitment to multiple myeloma, a disease for which we have acquired strong expertise with the development of another widely used and approved immunotherapy treatment.' The safety and efficacy of SAR446523 has not been evaluated by any regulatory authority and is still under investigation. About SAR446523SAR446523 is an investigational IgG1-based mAb designed to target GPRC5D, which is highly expressed on plasma cells, with an engineered fragment crystallizable domain to enhance antibody dependent cell-mediated cytotoxicity. This innovative approach aims to improve the efficacy of treatment for MM, a rare and challenging cancer of plasma cells. Subcutaneous SAR446523 is currently being evaluated in an ongoing phase 1, first-in-human study in patients with R/R MM (clinical study identifier: NCT06630806). SAR4465523 originates from Sanofi Research in Vitry-sur-Seine, France. About multiple myelomaMultiple myeloma is considered a rare disease, yet MM is the second most common hematologic malignancy with more than 180,000 people diagnosed with MM each year, globally. Despite available treatments, MM remains an incurable malignancy with an estimated 62% five-year survival rate for newly diagnosed patients. There is a need for new frontline therapeutic options for all patients, especially for those who are transplant ineligible, due to high attrition rates in subsequent lines of therapy. Since MM does not have a cure, most patients will relapse and stop responding to therapies they have received. 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 MM clinical studies, please visit 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 | 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 | Ubaldi | +33 6 30 19 66 46 | Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | Alizé Kaisserian | +33 6 47 04 12 11 | Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Pham | +33 7 85 93 30 17 | 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 Press Release
Yahoo
5 hours ago
- Business
- Yahoo
Press Release: Sanofi's SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma
Sanofi's SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma Designation granted for IgG1-based GPRC5D monoclonal antibody for the potential treatment of patients with relapsed or refractory multiple myeloma Paris, July 30, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to SAR446523, an IgG1-based Antibody-Dependent Cellular Cytotoxicity-enhanced (ADCC) monoclonal antibody (mAb) targeting G-protein coupled receptor family C group 5 member D (GPRC5D) for the potential treatment of patients with relapsed or refractory multiple myeloma (R/R MM). GPRC5D is highly expressed on plasma cells in MM patients, with low expression in healthy tissues. 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. 'The orphan drug designation is a significant milestone in our ongoing efforts to develop innovative treatments in multiple myeloma,' said , Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi. 'This underscores our commitment to multiple myeloma, a disease for which we have acquired strong expertise with the development of another widely used and approved immunotherapy treatment.' The safety and efficacy of SAR446523 has not been evaluated by any regulatory authority and is still under investigation. About SAR446523SAR446523 is an investigational IgG1-based mAb designed to target GPRC5D, which is highly expressed on plasma cells, with an engineered fragment crystallizable domain to enhance antibody dependent cell-mediated cytotoxicity. This innovative approach aims to improve the efficacy of treatment for MM, a rare and challenging cancer of plasma cells. Subcutaneous SAR446523 is currently being evaluated in an ongoing phase 1, first-in-human study in patients with R/R MM (clinical study identifier: NCT06630806). SAR4465523 originates from Sanofi Research in Vitry-sur-Seine, France. About multiple myelomaMultiple myeloma is considered a rare disease, yet MM is the second most common hematologic malignancy with more than 180,000 people diagnosed with MM each year, globally. Despite available treatments, MM remains an incurable malignancy with an estimated 62% five-year survival rate for newly diagnosed patients. There is a need for new frontline therapeutic options for all patients, especially for those who are transplant ineligible, due to high attrition rates in subsequent lines of therapy. Since MM does not have a cure, most patients will relapse and stop responding to therapies they have received. 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 MM clinical studies, please visit 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 | 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 | Ubaldi | +33 6 30 19 66 46 | Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | Alizé Kaisserian | +33 6 47 04 12 11 | Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Pham | +33 7 85 93 30 17 | 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 Press Release
Korea Herald
2 days ago
- Business
- Korea Herald
Antengene Announces XPOVIO® Approved in China for the Second-Line Treatment of Multiple Myeloma, Marking the Third Approved Indication of the Drug
SHANGHAI and HONG KONG, July 28, 2025 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that the China National Medical Products Administration (NMPA) has approved XPOVIO ® (selinexor) in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy, a new indication of XPOVIO ®. This approval for XPOVIO ® is based on the data of the BENCH trial, a randomized, controlled, open-label, multicenter Phase III bridging study which compared the safety and efficacy of XVd and Vd regimens in 154 Chinese patients with R/R MM who have received one to three prior lines of therapy. The efficacy and safety data of the BENCH study are generally consistent with those from the global, multicenter, Phase III BOSTON study and met the objectives of the bridging study which showed: Clear superiority of the XVd regimen: compared to the Vd regimen, the XVd regimen demonstrated better clinical efficacy, longer PFS and DOR, a higher ORR, a higher rate of very good partial response (VGPR) or deeper responses and minimal residual disease (MRD) negativity, as well as a trend of prolonged OS. Notable clinical benefits for elderly patients: the study observed particularly notable efficacy in the cohort of elderly patients aged ≥65, validating XPOVIO ® as a better treatment option for this patient population. Prof. Jin Lu, principal investigator of the BENCH study from Peking University People ' s Hospital, said, "MM is the second most common hematologic malignancy. The clinical application of autologous hematopoietic stem cell transplantation (ASCT) and novel agents in the first-line setting have resulted in longer overall survival for patients. However, the condition remains incurable with most patients end up relapsing. As a novel inhibitor of the nuclear export protein that adopts a novel mechanism of action, selinexor was proven by the BENCH study to be significantly efficacious in Chinese patients with MM. This approval for XPOVIO ® is a great news for patients with R/R MM, especially those relapsing for the first time." Prof. Jian Hou, principal investigator of the BENCH study from Shanghai Jiaotong University School of Medicine Affiliated Renji Hospital, commented, "The incidence of MM has been steadily rising year after year. According to the Globocan statistics for 2022, there were 30,300 new cases of MM and 18,662 MM related deaths in China, a figure that highlights an urgent unmet clinical need. Selinexor in combination with bortezomib and dexamethasone incorporates a unique mechanism of action and demonstrated significant efficacy. Moreover, XPOVIO ® does not require intravenous administration, therefore provides clinicians a new treatment strategy that can effectively reduce burden on patients." With a novel mechanism of action, XPOVIO ® is the world's first approved orally-available, selective XPO1 inhibitor, which has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea). While bringing XPOVIO ® to more APAC markets, Antengene is also striving to expand the indications of XPOVIO ®. Leveraging the drug's novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO ® for the treatment of various indications including myelofibrosis (MF) and endometrial cancer. About Antengene Antengene Corporation Limited ("Antengene", SEHK: is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets, with the NDA for XPOVIO ® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact:
Economic Times
5 days ago
- Automotive
- Economic Times
Indian auto industry faces subdued FY26 growth amidst weak demand: Report
The Indian auto industry is expected to experience subdued growth in FY26, with most segments anticipating low to mid-single-digit growth, as revealed in a recent report by Motilal Oswal. Motilal Oswal report believes that the Indian Automobile industry is likely to witness just 6-7 per cent of growth rate for FY26. The report further reveals that a key challenge lies in the two-wheeler segment, where the current growth estimates carry a downside risk if demand doesn't pick up momentum in the near present, the key auto segments are facing weakness in demand, which has led to passenger vehicles posting a decline of 1.4 per cent, while two-wheeler ICE registered a decline of 8 per cent in volumes. Additionally, the commercial vehicle segment also booked marginal declines. Specifically, in the two-wheeler segment, motorcycle sales recorded a 9 per cent YoY decline, scooter ICE sales recorded a 5 per cent decline, and mopeds recorded an 11 per cent YoY decline. Additionally, the report also reveals that the car segment posted an 11 per cent YoY decline in Q1, with all players witnessing a decline in volumes. Precisely, the small car segment saw a significant decline in volumes: Alto (-36 per cent), Spresso (-38 per cent), and Celerio (-43 per cent).However, Nalinikant Gollagunta, CEO Automotive Division, MM, believes that "confident of mid to high teens growth in SUVs, strong double digit growth in exports and will stick to guidance of high single digit growth for LCVs for FY26."According to the report, in the CV segment, while MHCV (Medium and Heavy Commercial Vehicles) goods declined 4.5 per cent, LCV (Light Commercial Vehicle) goods marginally declined 0.5 per cent for Q1FY26. Bus continued to witness steady demand, with MHCV buses growing 7.6 per cent and LCV buses growing 8.8 per cent. In the commercial vehicle segment, Tata Motors Limited underperformed in all four CV segments, while VECV VE Commercial Vehicles Limited outperformed in most of the CV segments in Q1. (ANI)
Daily Mirror
6 days ago
- Health
- Daily Mirror
DWP issues update as 630,000 households owed up to £12,000 after PIP error
PIP is a benefit that is awarded to people who may need extra help with day-to-day activities due to an illness, disability or mental health condition Personal Independence Payment (PIP) benefit claimants could still be owed cash from the Department for Work and Pensions (DWP) following a major payment error. PIP is a benefit that is awarded to people who may need extra help with day-to-day activities due to an illness, disability or mental health condition. It comes in two parts - the daily living rate, and the mobility rate - and you can be entitled to both or just one of these, depending on how your condition affects your life. Most people must undertake a health assessment where a point system is used to determine how much PIP you are eligible for. However, a Supreme Court ruling in July 2019 - known as the MM judgement - changed the way the DWP defines "social support" in relation to one of the daily living questions. Following the ruling, the DWP had to change how it assesses the need for social support when engaging with other people face to face, as part of the PIP assessment. It means hundreds of thousands of PIP claimants were due additional points for this activity. The DWP launched an administrative exercise back in 2021 - but in a new update, it has been revealed that hundreds of thousands of cases still need to be reviewed. An estimated 633,338 households receiving PIP are thought to have been affected. Of this figure, the DWP has reviewed 527,745 cases and paid out £250million. This means there are still 105,593 cases waiting to be reviewed. The average payout is £5,285 each - however, some payments will be higher, and some lower. One claimant was entitled to a £12,000 back payment. There are other PIP errors also being corrected by the DWP. This includes PIP claimants who did not have their claim processed because they didn't have a National Insurance – despite an NI number not being needed for a claim. Some 455 cases of this were reviewed in the last year with £500,000 paid out. The DWP has also paid out £13million to Scottish PIP claimants who mistakenly saw a "loss of entitlement" when they tried moving over to the Adult Disability Payment (ADP). Almost 4,700 records of this have been reviewed, with another 176 cases still to be looked at. The daily living rate of PIP is worth £73.90 a week if you're awarded the lower rate, or £110.40 a week for the higher rate. The mobility rate is worth £29.20 a week for the lower rate, or £77.05 a week for the higher rate. PIP is paid every four weeks, so if you're awarded the maximum rates for both the daily living and mobility elements, then you would get £749.80 every four weeks.
