First inves­ti­ga­tional prod­uct being rec­om­mended for Break­­through Therapy Desig­na­tion in China

Somerset, NJ (Press Release) – Legend Bio­tech Corpo­ra­tion (NASDAQ:LEGN) an­nounced to­day that the China Center for Drug Evaluation, National Medical Products Admin­istra­tion (CDE, NMPA) has rec­om­mended Break­­through Therapy Desig­na­tion (BTD) for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells), an inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) targeted chi­meric an­ti­gen re­cep­tor (CAR) T-cell ther­apy being studied for the treat­ment of adults with re­lapsed or re­frac­tory mul­ti­ple myeloma (RRMM).

The BTD for cilta-cel (LCAR-B38M CAR-T cells) is based on the on­go­ing Phase 2 CARTIFAN-1 study being con­ducted in China (MMY2002, NCT03758417, CTR20181007), the on­go­ing Phase 1b/2 CARTITUDE-1 study …

• BLA sub­mission based on re­­sults from pivotal Phase 2 KarMMa study eval­u­ating ide-cel in heavily pre-treated patient pop­u­la­tion
• Companies are com­mit­ted to work­ing with the FDA to rapidly ad­vance ide-cel through the regu­la­tory re­­view process

Princeton, NJ and Cambridge, MA – Bristol Myers Squibb (NYSE: BMY) and blue­bird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the sub­mission of their Bio­logics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) 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 re­lapsed and re­frac­tory mul­ti­ple myeloma. This sub­mission provides fur­ther details on the Chemistry, Manu­fac­tur­ing and Con­trols (CMC) module to address the out­stand­ing …

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency (EMA) adopted a pos­i­tive opinion rec­om­mending the ap­prov­al of 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.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head …

• Recommendation based on re­view of DREAMM clin­i­cal trial pro­gramme, in­clud­ing the pivotal DREAMM-2 study
• If approved, be­lan­ta­mab mafo­dotin will be a first-in-class anti-BCMA ther­apy for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma

London, United Kingdom (Press Release) – GlaxoSmithKline to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) Oncologic Drugs Advisory Com­mit­tee (ODAC) voted 12-0 in favour of the dem­onstrated ben­e­fit of mono­therapy treat­ment with be­lan­ta­mab mafo­dotin outweighing the risks for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. Two com­mit­tee members could not par­tic­i­pate in the final vote.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of …

• Phase 1 clin­i­cal trial eval­u­ating the off-the-shelf anti-BCMA CAR T can­di­date CYAD-211 for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma (r/r MM) ex­pected to begin by year-end 2020
• CYAD-211 rep­re­sents the com­pany’s first allo­geneic CAR T clin­i­cal can­di­date using shRNA tech­nology

Mont-Sain-Guibert, Belgium (Press Release) – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clin­i­cal-stage bio­technol­ogy com­pany focused on the dis­cov­ery and de­vel­op­ment of chi­meric an­ti­gen re­cep­tor T cell (CAR T) ther­a­pies for cancer, to­day an­nounced that the com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for CYAD-211, the com­pany’s first-in-class short hairpin RNA (shRNA)-based allo­geneic CAR T can­di­date and sec­ond non-gene edited off-the-shelf pro­gram, is in effect with the U.S. Food and Drug Admin­istra­tion (FDA). The com­pany’s lead allo­geneic can­di­date from its next-gener­a­tion CYAD-200 series, CYAD-211 targets B-cell …

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 first patient has been dosed in a Phase 1b clin­i­cal trial eval­u­ating Spring­Works Thera­peutics’ inves­ti­ga­tional gamma secretase in­hib­i­tor, niro­gace­stat, in com­bi­na­tion with GlaxoSmithKline’s (GSK) inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) anti­body-drug con­ju­gate, be­lan­ta­mab mafo­dotin, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. The niro­gace­stat and be­lan­ta­mab mafo­dotin com­bi­na­tion is being eval­u­ated as a sub-study in GSK’s on­go­ing DREAMM-5 plat­form trial.

Gamma secretase in­hib­ition …

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) will convene a meeting of the Oncologic Drugs Advisory Com­mit­tee (ODAC) to re­view data sup­port­ing the com­pany’s Biologics License Appli­ca­tion (BLA) for be­lan­ta­mab mafo­dotin for the poten­tial treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. The ODAC will meet virtually on 14 July 2020.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of Oncology …