• 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 …

40% over­all re­sponse rate (ORR) with a total admin­istered dose of 60 mCi or greater

Forham Park, NJ (Press Release) – Cellectar Bio­sciences, Inc. (NASDAQ: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the dis­cov­ery, de­vel­op­ment and com­mer­cial­i­za­tion of drugs for the treat­ment of can­cer, to­day an­nounced that a clin­i­cally meaningful 40% over­all re­sponse rate (ORR) was ob­served in the subset of re­frac­tory mul­ti­ple myeloma patients deemed triple class re­frac­tory who re­ceived a total admin­istered dose of 60 mCi or greater. Triple class re­frac­tory is defined as patients re­frac­tory to immuno­modu­la­tory, pro­te­a­some in­hib­i­tors and anti-CD38 anti­body drug classes.

The 40% ORR (6/15 patients) rep­re­sents triple class re­frac­tory …

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 …

• TTI-622 (SIRPa-IgG4 Fc) com­pleted 8 mg/kg safety assess­ment in the on­go­ing dose escalation study in re­lapsed / re­frac­tory lym­phoma; now es­ca­lat­ing to 12 mg/kg dose level.
• TTI-622 mono­therapy shows 6/18 (33%) objective re­sponses at 0.8 to 8 mg/kg dose levels, in­clud­ing 3/6 (50%) objective re­sponses at 8 mg/kg.
• TTI-621 (SIRPa-IgG1 Fc) well tol­er­ated at 1.4 mg/kg; con­tinues to show mono­therapy signal and dose-depen­dent im­prove­ment in skin dis­ease scores in the on­go­ing dose escalation study in re­lapsed / re­frac­tory CTCL.
• Trillium to host conference call at 5:30 p.m. ET to­day

Cambridge, MA (Press Release) – Trillium Thera­peutics Inc. (“Trillium” or the “Company”) (NASDAQ/TSX: TRIL), a clin­i­cal stage immuno-oncology com­pany devel­op­ing inno­va­tive ther­a­pies for the treat­ment of can­cer, to­day an­nounced up­dated data from its on­go­ing TTI-622 and TTI-621 dose escalation stud­ies.

“We are exceedingly en­cour­aged by the evolving profile of TTI-622, our SIRPa-IgG4 Fc fusion pro­tein, as dem­onstrated in the on­go­ing dose escalation study in re­lapsed and re­frac­tory lym­phomas,” said Jan Skvarka, Trillium’s Pres­i­dent and Chief Exec­u­tive Of­fi­cer. “TTI-622 is showing sub­stan­tial …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the last patient has been suc­cess­fully en­rolled in the pivotal phase 3 study OCEAN in re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM). The original en­roll­ment target of 450 patients was reached in May 2020, but an analysis in­di­cated that patients were staying longer on treat­ment than ini­tially esti­mated. Thus, a de­ci­sion was made to leave recruitment open to ensure that the num­ber of dis­ease pro­gres­sion events needed to com­plete the study would be reached within a reason­able time­frame. An addi­tional 45 …