Articles tagged with: BCMA Targeted Therapies

Press Releases»

[ by | Oct 5, 2020 6:30 am | Comments Off ]

Fifth in­dus­try col­lab­o­ration to eval­u­ate niro­gace­stat as a BCMA po­ten­ti­ator across modalities

SpringWorks Therapeutics Announces Clinical Collaboration With Pfizer Inc. To Evaluate Nirogacestat In Combination With PF‐06863135 In Patients With Relapsed Or Refractory Multiple Myeloma Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and can­cer, to­day an­nounced that the com­pany has entered into a clin­i­cal trial col­lab­o­ration agree­ment with Pfizer Inc. (NYSE: PFE) to eval­u­ate Spring­Works Thera­peutics’ inves­ti­ga­tional gamma se­cre­tase in­hib­i­tor (GSI), niro­gace­stat, in com­bi­na­tion with Pfizer’s anti-B-cell maturation an­ti­gen (BCMA) CD3 bispecific anti­body, PF‐06863135, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Gamma se­cre­tase in­hib­ition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In pre­clin­i­cal …

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[ by | Sep 22, 2020 6:59 am | Comments Off ]
  • FDA set a target action date of March 27, 2021
  • Ide-cel is the first CAR T cell ther­apy ac­cepted for regu­la­tory re­view for mul­ti­ple myeloma

U.S. Food And Drug Administration (FDA) Accepts For Priority Review Bristol Myers Squibb And Bluebird Bio Application For Anti-BCMA CAR T-Cell Therapy Idecabtagene Vicleucel (Ide-Cel, bb2121) Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and blue­bird bio, Inc. (Nasdaq: BLUE) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for Priority Review their Biologics License Appli­ca­tion (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and …

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[ by | Sep 21, 2020 7:00 am | Comments Off ]

Increasing BCMA Surface Expression and Reduced Soluble BCMA Levels with Gamma Secretase Inhibitor Niro­gace­stat May Enhance Clinical Benefit in Com­bi­na­tion with PBCAR269A, an Allogeneic BCMA-Targeted CAR T Cell Product

Precision BioSciences And SpringWorks Therapeutics Announce Clinical Collaboration To Evaluate PBCAR269A In Combination With Nirogacestat In Patients With Relapsed Or Refractory Multiple Myeloma Durham, NC and Stamford, CT (Press Release) – Pre­ci­sion BioSciences, Inc. (Nasdaq: DTIL), a clin­i­cal stage bio­technol­ogy devel­op­ing allo­geneic CAR T and in vivo gene correction ther­a­pies with its ARCUS® genome edit­ing plat­form, and Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and can­cer, to­day an­nounced they have entered into a clin­i­cal trial col­lab­o­ration agree­ment. Per the agree­ment, PBCAR269A, Pre­ci­sion BioSciences’ wholly-owned inves­ti­ga­tional allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date targeting B-cell maturation an­ti­gen (BCMA), will be eval­u­ated in com­bi­na­tion …

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[ by | Sep 14, 2020 6:30 am | Comments Off ]

Third col­lab­o­ration to eval­u­ate niro­gace­stat in com­bi­na­tion with BCMA ther­a­pies across modalities

SpringWorks Therapeutics Announces Clinical Collaboration With Janssen To Evaluate Nirogacestat In Combination With Teclistamab In Patients With Relapsed Or Refractory Multiple Myeloma Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and can­cer, to­day an­nounced that the com­pany has entered into a clin­i­cal col­lab­o­ration and supply agree­ment with Janssen Bio­tech, Inc. (Janssen) to eval­u­ate Spring­Works Thera­peutics’ inves­ti­ga­tional gamma se­cre­tase in­hib­i­tor (GSI), niro­gace­stat, in com­bi­na­tion with Janssen’s bispecific anti­body targeting B-cell maturation an­ti­gen (BCMA) and CD3, teclistamab, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Gamma se­cre­tase in­hib­ition prevents the cleavage and shedding of BCMA from the surface of myeloma …

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[ by | Sep 9, 2020 7:00 am | Comments Off ]
Precision BioSciences Receives Fast Track Designation From U.S. Food And Drug Administration For PBCAR269A, An Investigational Allogeneic CAR T Therapy For Relapsed / Refractory Multiple Myeloma

Durham, NC (Press Release) – Pre­ci­sion BioSciences, Inc. (Nasdaq: DTIL), a clin­i­cal stage bio­technol­ogy com­pany ded­i­cated to im­prov­ing life with its novel and pro­pri­e­tary ARCUS® genome edit­ing plat­form, to­day an­nounced the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track Desig­na­tion to PBCAR269A for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma. This is the com­pany’s sec­ond allo­geneic chi­meric an­ti­gen re­cep­tor (CAR T) cell ther­apy to re­ceive Fast Tack Desig­na­tion for which the FDA pre­vi­ously granted Orphan Drug Desig­na­tion.

“Fast Track Desig­na­tion will help us expedite our allo­geneic CAR T cell ther­apy pro­gram …

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[ by | Aug 26, 2020 2:06 pm | Comments Off ]
  • BLENREP is the first anti-BCMA (B-cell maturation an­ti­gen) ther­apy ap­prov­ed in the Euro­pean Union
  • Marketing autho­ri­sa­tion follows the recent US ap­prov­al of BLEN­REP

European Commission Approves Blenrep (Belantamab Mafodotin) For The Treatment Of Patients With Relapsed And Refractory Multiple Myeloma London, United Kingdom (Press Release) – GlaxoSmithKline plc to­day an­nounced the Euro­pean Com­mis­sion has granted con­di­tional mar­ket­ing autho­ri­sa­tion for BLEN­REP (belantamab mafo­dotin) as mono­therapy for the treat­ment of mul­ti­ple myeloma in adult patients who have re­ceived at least four prior ther­a­pies and whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent, and an anti-CD38 mono­clonal anti­body, and who have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. BLEN­REP is a first-in-class humanised anti-BCMA (B-cell maturation an­ti­gen) treat­ment for these patients whose …

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[ by | Aug 5, 2020 9:08 pm | Comments Off ]
  • BLENREP is a first-in-class anti-BCMA (B-cell maturation an­ti­gen) ther­apy for patients whose dis­ease has progressed de­spite prior treat­ment with an immuno­modu­la­tory agent, pro­te­a­some in­hib­i­tor and anti-CD38 anti­body
  • BLENREP is the fifth major med­i­cine ap­prov­al for GSK in 2020

FDA Approves GSK’s Blenrep (Belantamab Mafodotin-blmf) For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) an­nounced the US Food and Drug Admin­istra­tion (FDA) has approved BLEN­REP (belantamab mafo­dotin-blmf) as a mono­therapy treat­ment for adult patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an anti-CD38 mono­clonal anti­body, a pro­te­a­some in­hib­i­tor and an immuno­modu­la­tory agent. This in­di­ca­tion is approved under ac­cel­er­ated ap­prov­al based on re­sponse rate. Continued ap­prov­al for this in­di­ca­tion may be con­tin­gent upon veri­fi­ca­tion and description of clin­i­cal ben­e­fit in …

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