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SpringWorks and GSK will expand their previously established governance structures to add a new Joint Steering Committee and Joint Commercialization . Alternately, nirogacestat is described by SpringWorks as an investigational, orally-administered small molecule gamma-secretase inhibitor. In preclinical models of human multiple myeloma, nirogacestat has shown the ability to meaningfully enhance the activity of BCMA-targeted therapies. 09-09-2022. Popular . By blocking gamma secretase, nirogacestat is expected to increase the amount of BCMA on the surface of cancer cells, and boost the effectiveness of BCMA-targeted therapies. SpringWorks and GSK expand multiple myeloma collaboration. 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 Gamma secretase inhibition helps prevent the cleavage and shedding of BCMA from the surface of myeloma cells. 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. Outside of multiple myeloma, SpringWorks is evaluating nirogacestat for the treatment of desmoid tumors. 2145- 10.17.2022). Nirogacestat (PF-03084014) is a selective gamma secretase inhibitor developed by SpringWorks Therapeutics that has potential anti-tumor activity. 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 . 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. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. The researchers will test different doses of belantamab mafodotinto find the safest dose to give with nirogacestat. It was granted FDA breakthrough drug designation in September 2019 for adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. nirogacestat's ability to enhance the activity of bcma-directed therapies has been observed in preclinical models of multiple myeloma. There are no items. The new agreement expands the original collaboration to include the potential for continued development and . SpringWorks is pursuing a combination therapy approach to evaluate nirogacestat as a BCMA potentiator across modalities by collaborating with industry leaders. phase 1 (4) phase 1/phase 2 (2) phase 2 (2) Sponsor New. Multiple myeloma (MM) is a plasma cell disorder that is on the rise throughout the world, especially in the US, Australia, and Western Europe. 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. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. Incidence has risen by 126% globally and over 40% in the US since 1990, while global mortality has risen by 94% and US . "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. 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's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. - 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 - -. Nine percent of patients had grade 3/4 CRS, with 25% having neurotoxicity of any grade. To date, SpringWorks has entered into two clinical collaborations to evaluate nirogacestat in . Allogene Therapeutics . 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 []. Recruiting (6) Not yet recruiting (2) Phase. 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 . 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. Multiple myeloma (MM) is a hematologic malignancy characterized by excessive clonal proliferation of plasma cells. During the 2022 ASCO Annual Meeting, the investigators presented the preliminary results from 10 patients in the dose-escalation cohort. 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. 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. There are approximately 130,000 patients in the U.S. living with multiple myeloma. Serum Concentrations of Nirogacestat [ Time Frame: Up to 2 year and 5 months ] . In addition, a Phase 3 clinical trial, DeFi, is currently in progress for nirogacestat for adults with desmoid tumors and aggressive fibromatosis. Adding nirogacestat, a -secretase inhibitor, might allow for similar efficacy with lower doses of belantamab mafodotin. "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 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 . In addition, three trials are presently recruiting patients that include nirogacestat with other anticancer therapies in multiple myeloma , including the UNIVERSAL study for nirogacestat with the allogeneic CAR-T therapy ALLO-715 . 1 Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. We are currently studying nirogacestat in multiple myeloma patients through clinical collaborations with eight industry-leading developers of BCMA therapies. In agreement, preclinical data showed that myeloma cell death increased by 3,000 times when nirogacestat was added to GlaxoSmithKline 's Blenrep. The ORR was 60% (6 of 10 patients) and 20% (2 patients) achieved VGPR. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. Current filters: nirogacestat Biotechnology. SpringWorks is pursuing a combination therapy approach to evaluate nirogacestat as a BCMA potentiator across modalities by collaborating with industry leaders. 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. Current filters: nirogacestat Licensing Hematology. The new agreement expands the original collaboration to include the potential for continued development and commercialization of the combination of nirogacestat and Blenrep in earlier lines of treatment, including newly diagnosed multiple myeloma. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks Therapeutics' investigational gamma secretase inhibitor nirogacestat (PF-03084014) is slated to be evaluated in combination with Janssen Biotech, Inc's BCMA- and CD3-targeted. 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. 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. Partnership Features: Collaborative Development, No Shared Cost; Co-Development, Shared Dev . In preclinical models, nirogacestat has been shown to increase levels of. Nirogacestat + BLENREP Nirogacestat is currently in Phase 2 clinical trials . Researchers believe that inhibiting gamma-secretase stops BCMA from shedding from myeloma cell surfaces. Nirogacestat (PF-03084014), was found to significantly improve progression-free survival (PFS) over placebo when used in the treatment of adult patients with progressing desmoid tumors, meeting. The Real Story of Good Health ~ in 120 Seconds or Less. 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 " 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." Deal Structure: Development and Commercial License. SpringWorks is pursuing a combination therapy approach to evaluate nirogacestat as a BCMA potentiator across modalities by collaborating with industry leaders. 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. 1,2 SpringWorks is evaluating nirogacestat as a BCMA . Overall Status. 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 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. US clinical-stage biotech SpringWorks Therapeutics yesterday announced positive data from the Phase III DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors, during the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2022. Nirogacestat Nirogacestat ( PF-03084014) is a selective gamma secretase inhibitor [1] developed by SpringWorks Therapeutics that has potential anti-tumor activity. 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. Composition Of Matter Patent To Polymorphic Form Of Nirogacestat, Extending Patent Protection Into . [2] Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. To date, SpringWorks has entered into two clinical collaborations to evaluate nirogacestat in . 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 . In the US, MM accounts for almost 2% of cancer diagnoses and over 2% of cancer deaths (more than double the global proportion). Filter. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. 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. In a 44-patients study, JCARH125 achieved an ORR of 82% and very good partial response (VGPR) or better rate of 48%. Given that MM is the second most common blood cancer with a . Filter . 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. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. . This trial is testing the safety and efficacy of two drugs, belantamab mafodotin and nirogacestat, for people with relapsed or refractory multiple myeloma. 1,2 springworks is evaluating nirogacestat as a bcma potentiator and has seven collaborations with industry-leading bcma developers to evaluate nirogacestat in combinations across modalities, including with an "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 . AFLDS.org with Dr. Peterson Pierre presents Daily Dose: 'Title IX: What Parents Need to Know?' (Ep.
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