The treatment of multiple myeloma presents a variety of unique challenges due to the complex molecular pathophysiology and incurable status of the disease at this time. Phase 1 Recruiting Has No Placebo Learn More Memorial Sloan Kettering Westchester (Limited Protocol Activities) (+6 Sites)Malin Hultcrantz, MD, PhD Phase-Based Progress Estimates 3 Effectiveness Abstract: P939 Type: Poster presentation Session title: Myeloma and other monoclonal gammopathies - Clinical Background Preclinical data demonstrate that nirogacestat, a gamma-secretase inhibitor, may increase cell-surface levels of a B-cell maturation antigen (BCMA) and reduce soluble BCMA levels, which could enhance anti-BCMA agent activity in multiple myeloma. . We are currently studying nirogacestat in multiple myeloma patients through clinical collaborations with eight industry-leading developers of BCMA therapies. Deal Structure: Development and Commercial License. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. Allogene Therapeutics . Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks and GSK will expand their previously established governance structures to add a new Joint Steering Committee and Joint Commercialization . Synergistic Effects of Low Dose Belantamab Mafodotin in Combination SpringWorks Therapeutics Highlights Nirogacestat Clinical Data at the SpringWorks Therapeutics Announces Clinical Collaboration Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is pursuing a combination therapy approach to evaluate nirogacestat as a BCMA potentiator across modalities by collaborating with industry leaders. Clinical Trial on Multiple Myeloma: Teclistamab, Daratumumab Small Business | L'Observateur The researchers will test different doses of belantamab mafodotinto find the safest dose to give with nirogacestat. SpringWorks Therapeutics Announces Global Clinical Collaboration With It was granted FDA breakthrough drug designation in September 2019 for adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. Pfizer teams up with SpringWorks to evaluate PF06863135 + nirogacestat Alternately, nirogacestat is described by SpringWorks as an investigational, orally-administered small molecule gamma-secretase inhibitor. It was granted FDA breakthrough drug designation in September 2019 for adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.. Medical uses []. AFLDS.org with Dr. Peterson Pierre presents Daily Dose: 'Title IX: What Parents Need to Know?' (Ep. During the 2022 ASCO Annual Meeting, the investigators presented the preliminary results from 10 patients in the dose-escalation cohort. A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma This information was retrieved directly from the website clinicaltrials.gov without any changes. The other anti-BCMA CAR T-cell therapies that have been tested in the largest studies to date are JCARH125, LCAR-B38M, and P-BCMA-101. "Belantamab mafodotin in combination with novel therapies, such as nirogacestat, could prove to be an impactful therapeutic option for patients with multiple myeloma, as these combination regimens may further optimize the benefit-risk profile of Blenrep, especially in earlier lines of therapy." Expanding the agreement SpringWorks Therapeutics Announces Clinical Collaboration With Pfizer Inc. To Evaluate Nirogacestat In Combination With PF06863135 In Patients With Relapsed Or Refractory Multiple Myeloma; SpringWorks Therapeutics Announces Issuance Of New U.S. Nirogacestat Significantly Improves PFS in Progressing - OncLive To date, SpringWorks has entered into two clinical collaborations to evaluate nirogacestat in . " Blenrep in combination with novel therapies, such as nirogacestat, could prove to be an impactful therapeutic option for patients with multiple myeloma, as these combination regimens may further optimize the benefit-risk profile of Blenrep, especially in earlier lines of therapy." Multiple myeloma (MM) is a hematologic malignancy characterized by excessive clonal proliferation of plasma cells. Blenrep-nirogacestat Combo Moves to Dose-testing Phase 2 of Trial DREAMM-5 Study: BLENREP Combined with Nirogacestat Presented at ASCO 2022 Partnership Features: Collaborative Development, No Shared Cost; Co-Development, Shared Dev . Belantamab Mafodotin to Treat Multiple Myeloma: A Comprehensive Review The purpose of this study is to find out whether combination treatment with the study drugsbelantamab mafodotin and nirogacestat is a safe treatment for people who have relapsed orrefractory multiple myeloma. Allogene Therapeutics and SpringWorks Therapeutics Announce - BioSpace SpringWorks is pursuing a combination therapy approach to evaluate nirogacestat as a BCMA potentiator across modalities by collaborating with industry leaders. Inclusion Criteria: - Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria - Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of . Popular . A Study of Teclistamab With Other Anticancer Therapies in Participants 1 Pfizer teams up with SpringWorks to evaluate PF06863135 + nirogacestat in multiple myeloma Oct. 05, 2020 6:51 AM ET Pfizer Inc. (PFE) , SWTX PFE , SWTX By: Mamta Mayani , SA News Editor 1 Comment The new agreement expands the original collaboration to include the potential for continued development and . SpringWorks Therapeutics Highlights Nirogacestat Clinical Data at the SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two . SpringWorks Announces Expansion of Global, Non-Exclusive Collaboration Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks Therapeutics Announces Clinical Collaboration with Seagen Nirogacestat - Wikipedia Researchers believe that inhibiting gamma-secretase stops BCMA from shedding from myeloma cell surfaces. "Blenrep in combination with novel therapies, such as nirogacestat, could prove to be an impactful therapeutic option for patients with multiple myeloma, as these combination regimens may . - Initial Data to be Presented from GSK-Sponsored Phase 1/2 Study Evaluating Nirogacestat in Combination with Low-Dose BLENREP in Patients with Relapsed or Refractory Multiple Myeloma - -. 09-09-2022. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. AACR Annual Meeting 2017 - nirogacestat, Biotechnology Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks Therapeutics Announces Clinical Collaboration with AbbVie "Gamma secretase inhibition has emerged as a clinically validated mechanism to potentiate BCMA therapies and we believe that nirogacestat has the potential to become a cornerstone of BCMA combination therapy for patients with multiple myeloma," said Saqib Islam, CEO of SpringWorks. FDA Grants Breakthrough Designation to Nirogacestat for Desmoid Tumors Allogene, SpringWorks Team Up for RRMM Trial Testing ALLO-715 Filter . 2145- 10.17.2022). In addition, a Phase 3 clinical trial, DeFi, is currently in progress for nirogacestat for adults with desmoid tumors and aggressive fibromatosis. AACR Annual Meeting 2017 - nirogacestat, Licensing, Hematology Springworks' Nirogacestat, an oral gamma-secretase inhibitor, in combination with GSK's Blenrep, an antibody-drug conjugate targeting B-cell maturation antigen for the treatment of multiple myeloma. Given that MM is the second most common blood cancer with a . SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two . Multiple Myeloma (3) Relapsed/Refractory Multiple Myeloma (3) Desmoid Fibromatosis (1) Ovarian Cancer (1) Ovarian Granulosa Cell Tumor (1) Ovarian Granulosa-Stromal Tumor (1) Recurrent Desmoid Fibromatosis (1) Unresectable Desmoid Fibromatosis (1) .more. 1,2 SpringWorks is evaluating nirogacestat as a BCMA . Outside of multiple myeloma, SpringWorks is evaluating nirogacestat for the treatment of desmoid tumors. In preclinical models, nirogacestat has been shown to increase levels of. Nirogacestat is an orally available small molecule that works by blocking gamma secretase, an enzyme that cleaves BCMA from the surface of myeloma cells, releasing it in a soluble form. In this collaboration, Applied BioMath is developing a model of SpringWorks' investigational oral selective small molecule gamma secretase inhibitor (GSI), nirogacestat, in combination with an agent that targets B-cell maturation antigen (BCMA) for the treatment of multiple myeloma. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. In a 44-patients study, JCARH125 achieved an ORR of 82% and very good partial response (VGPR) or better rate of 48%. SpringWorks Therapeutics shares were up 8% to $27.97 after the US biotech announced that it has entered into an expanded global, non-exclusive license and collaboration agreement with UK pharma major GSK. Nirogacestat - Wikipedia Clinical Trials on Relapsed/Refractory Multiple Myeloma - ICHGCP The FDA has granted nirogacestat (PF-03084014), an investigational gamma-secretase inhibitor, with a breakthrough therapy designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. SpringWorks Therapeutics Highlights Nirogacestat Clinical Adding nirogacestat, a -secretase inhibitor, might allow for similar efficacy with lower doses of belantamab mafodotin. Chemistry:Nirogacestat - HandWiki Nirogacestat Clinical Trials 2022 | Clincosm Nine percent of patients had grade 3/4 CRS, with 25% having neurotoxicity of any grade. Gamma secretase inhibition helps prevent the cleavage and shedding of BCMA from the surface of myeloma cells. Nirogacestat (PF-03084014) is a selective gamma secretase inhibitor developed by SpringWorks Therapeutics that has potential anti-tumor activity. SpringWorks and GSK first entered into a clinical trial collaboration and supply agreement in June 2019, later amended in October 2021, to cover the initial clinical development of nirogacestat in combination with Blenrep in patients with relapsed or refractory multiple myeloma. Who had the September 2022 Top Biopharma Deal | DealForma SpringWorks Announces Expansion of Global, Non-Exclusive Collaboration nirogacestat's ability to enhance the activity of bcma-directed therapies has been observed in preclinical models of multiple myeloma. In this collaboration, Applied BioMath is developing a model of SpringWorks' investigational oral selective small molecule gamma secretase inhibitor (GSI), nirogacestat, in combination with an agent that targets B-cell maturation antigen (BCMA) for the treatment of multiple myeloma. SpringWorks Therapeutics Announces Dosing of First Patient - BioSpace Small Business - The Clanton Advertiser | The Clanton Advertiser A Study of Belantamab Mafodotin and Nirogacestat in People With [2] Serum Concentrations of Nirogacestat [ Time Frame: Up to 2 year and 5 months ] . NIROGACESTAT - Drug Approvals International There are no items. Nirogacestat in multiple myeloma Multiple myeloma is the second most common hematologic malignancy in the U.S., accounting for approximately 10 percent of all hematologic cancers.
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