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

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 …

• 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

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 …

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

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 …

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

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 …

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 …

• 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

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 …

• 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

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 …