Latest news with #ASCT
Yahoo
14-04-2025
- Business
- Yahoo
Exicure, Inc. (Nasdaq: XCUR) Nears Completion of Phase 2 Study of GPC-100 in Multiple Myeloma
REDWOOD CITY, Calif., April 14, 2025--(BUSINESS WIRE)--Exicure, Inc. (Nasdaq: XCUR) today announced that GPCR Therapeutics USA, a subsidiary of Exicure Inc., has dosed the 19th patient in its ongoing Phase 2 clinical trial evaluating GPC-100 (burixafor), a small molecule CXCR4 inhibitor, for the mobilization of stem cells in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT) (NCT05561751). The study is an open-label, multi-center trial evaluating the safety and efficacy of GPC-100 and propranolol in combination with G-CSF. Data from an interim analysis of 10 patients were previously presented at the 2024 American Society of Hematology (ASH) Annual Meeting. Preliminary results are encouraging, with 100% of patients achieving the primary endpoint of successful CD34+ stem cell mobilization, including patients previously treated with daratumumab. Notably, GPC-100 enabled same-day administration of the mobilizing agent and leukapheresis, offering faster kinetics compared to FDA-approved agents such as plerixafor and motixafortide, which require overnight pre-treatment. Median times to neutrophil and platelet engraftment were 11 and 14 days, respectively, which is consistent with standard of care. This trial is expected to finish patient recruitment at the end of April. About Exicure, Inc. Exicure, Inc. has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. Following its restructuring and suspension of clinical and development activities, the Company is exploring strategic alternatives to maximize stockholder value. For further information, see View source version on Contacts Media Contact: Sarah Ellinwood, PhDKendall Investor Relationssellinwood@ Sign in to access your portfolio
Yahoo
13-04-2025
- Business
- Yahoo
EC approves extension of indication for Janssen-Cilag's Darzalex
The European Commission (EC) has approved the extension of indication for Janssen-Cilag International's Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024's indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy's SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd's overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: 'Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. 'This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.' J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J's Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab. "EC approves extension of indication for Janssen-Cilag's Darzalex" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
13-04-2025
- Business
- Yahoo
EC approves extension of indication for Janssen-Cilag's Darzalex
The European Commission (EC) has approved the extension of indication for Janssen-Cilag International's Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024's indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy's SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd's overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: 'Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. 'This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.' J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J's Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab. "EC approves extension of indication for Janssen-Cilag's Darzalex" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
29-03-2025
- Automotive
- Yahoo
Major traffic signal improvements coming to Murfreesboro
MURFREESBORO, Tenn. (WKRN) — Fourteen signalized intersections in Murfreesboro will receive high-tech improvements in order to help the flow of traffic in a highly traveled area. On Thursday, March 27, the Murfreesboro City Council approved a $5.35 million construction contract to start the Rutherford Adaptive Signal Control Technology (ASCT) Project. According to officials, the technology monitors traffic in real-time and will automatically adjust signal timings to reduce congestion and keep motorists moving. The project will cover Rutherford Boulevard (Southeast Broad Street to New Laccases Highway) and East Northfield Boulevard (New Lascassas Highway to Highland Avenue). 'We'll develop timing plans and algorithms within the software package. It will monitor that and run in the background and make recommendations on specific timing patterns in specific events,' said Jim Kerr, Murfreesboro's transportation director. City of Murfreesboro breaks ground on much-anticipated Veterans Park Murfreesboro said the ASCT project is funded by a $4.86 million grant from the Tennessee Department of Transportation and $536,127 in local matching funds through the City CIP budget and reallocated FY22 CIP funds. Per Thursday's press release from Murfreesboro, the city will take the following actions using the ASCT Project funding: Upgrade each of the signalized intersections with new signal control cabinets and internal control equipment Install fiber optic communication cable and hardware along the entire corridor Install corridor and system vehicle detection infrastructure and communications Install 12 CCTV cameras Install pedestrian signals at selected signalized intersections Develop and implement new traffic signal timing for each intersection and system as a whole READ MORE | Latest headlines from Murfreesboro and Rutherford County The project is also going to expand Murfreesboro CCTV system by adding 10 new cameras, bringing the total number of cameras up to 63. Officials said this will give them strategic visual coverage of important locations in the city, as well as help them monitor and evaluate traffic progression. In addition, TDOT said the ASCT Project will help reduce emissions and improve state air quality. As Murfreesboro continues to see rapid growth and development, city officials believe these new signals will help keep cars moving instead of wasting time at stoplights. Leaders also hope the project will future-proof the city. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
31-01-2025
- Business
- Yahoo
Press Release: Sarclisa is the first anti-CD38 treatment approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant
Sarclisa is the first anti-CD38 treatment approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant Approval based on positive results from the IMROZ phase 3 study that demonstrated Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free survival, compared to VRd alone in transplant-ineligible newly diagnosed multiple myeloma Second approval in China in three weeks following the R/R MM indication announced on January 13, 2025 Paris, January 31, 2025. The National Medical Products Administration (NMPA) in China has approved Sarclisa, in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT) based on data from the IMROZ phase 3 study. Global Head, Oncology'When Sanofi entered China more than four decades ago, we did so with the intention of bringing potentially transformative therapies to Chinese patients. This approval, occurring just weeks after Sarclisa's first in the country, represents tremendous progress towards advancing this mission. Now, patients with multiple myeloma and their providers have access to two new Sarclisa-based regimens that have the potential to improve outcomes across lines of therapy.' This approval closely follows the decision from the NMPA earlier in January 2025, approving Sarclisa in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Beyond China, in the Asia-Pacific region, a regulatory submission for Sarclisa in NDMM patients not eligible for hematopoietic stem cell transplantation (HSCT) is currently under review in Japan. About SarclisaSarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa. In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US Food and Drug Administration. Currently, Sarclisa is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple indications. 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; 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, 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. Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous (SC) administration method for Sarclisa in clinical studies. In January 2024, Sanofi reported positive results from the IRAKLIA phase 3 study evaluating Sarclisa SC formulation administered via an on-body delivery system (OBDS) in combination with Pd compared to intravenous (IV) Sarclisa in patients with R/R MM. In December 2024, additional positive results from the program, including the GMMG-HD7 phase 3 study evaluating Sarclisa-RVd induction therapy in transplant-eligible NDMM patients, were also presented at the 66th American Society of Hematology Annual Meeting and Exposition. The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery. In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as well as gastroenteropancreatic neuroendocrine tumors and other gastrointestinal and lung cancers. For more information on Sarclisa clinical studies, please visit About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center 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 | Nicolas Obrist | +33 6 77 21 27 55 | Léo Le Bourhis | +33 6 75 06 43 81 | Victor Rouault | +33 6 70 93 71 40 | Gilbert | +1 516 521 2929 | 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 | Châtelet | +33 6 80 80 89 90 | 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 pandemics or other 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, 2023. 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
