Application is based on pos­i­tive data from the Phase 3 CANDOR study, which were pre­sented at the 2019 American Society of Hematology Annual Meeting

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for re­lapsed / re­frac­tory multiple myeloma. The sBLA is sup­ported by results from the Phase 3 CANDOR study, which com­pared treat­ment with DKd to car­filz­o­mib and dexa­meth­a­sone (Kd) in patients with multiple myeloma who re­lapsed after one to three prior lines of ther­apy.

"While we con­tinue to …

• Be­lan­ta­mab mafo­dotin ac­cepted for ac­cel­er­ated assess­ment by the EMA's Com­mit­tee for Human Medicinal Products (CHMP)
• Submission based on data from the pivotal DREAMM-2 study of immuno­con­ju­gate targeting B-cell maturation an­ti­gen (BCMA) recently pub­lished in The Lancet Oncology

London, United Kingom (Press Release) – GlaxoSmithKline plc to­day an­nounced that the Euro­pean Medicines Agency (EMA) val­i­dated the mar­ket­ing authori­sa­tion appli­ca­tion (MAA) for be­lan­ta­mab mafo­dotin for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma whose prior ther­apy in­cluded an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. Be­lan­ta­mab mafo­dotin was ac­cepted for ac­cel­er­ated assess­ment by the EMA's Com­mit­tee for Human Medicinal Products (CHMP).

Accelerated assess­ment is granted if the CHMP de­ter­mines the treat­ment is of major interest from a pub­lic health per­spec­tive …

• Biologics License Appli­ca­tion based on re­­sults from the pivotal DREAMM-2 study of immuno­con­jugate targeting B-cell maturation an­ti­gen (BCMA) in heavily pre-treated patient pop­u­la­tion who was re­frac­tory to an immuno­modu­la­tory drug and a pro­te­a­some in­hib­i­tor, and re­frac­tory or intolerant to an anti-CD38 anti­body
• Belantamab mafo­dotin has poten­tial to be the first anti-BCMA treat­ment avail­able to patients

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) an­nounced the US Food and Drug Admin­istra­tion (FDA) granted a priority re­view for the com­pany's Biologics License Appli­ca­tion (BLA) seek­ing ap­prov­al of be­lan­ta­mab mafo­dotin (GSK2857916) for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma whose prior ther­apy in­cluded an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body.

The BLA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, recently pub­lished in The Lancet Oncology, …

Increasing BCMA Surface Expression with Gamma Secretase Inhibitor Niro­gace­stat May Enable Deep and Durable Responses to ALLO-715, an Inves­ti­ga­tional Anti-BCMA Allogeneic CAR T Therapy

South San Francisco, CA and Stamford, CA (Press Release) – Allogene Thera­peutics, Inc. (Nasdaq: ALLO), a clin­i­cal-stage bio­technol­ogy com­pany pioneering the de­vel­op­ment of allo­geneic chi­meric an­ti­gen re­cep­tor T cell (AlloCAR T™) ther­a­pies for cancer 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 that they have entered into a clin­i­cal trial col­lab­o­ration agree­ment. This agree­ment will eval­u­ate ALLO-715, Allogene’s inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) AlloCAR T ther­apy in com­bi­na­tion with Spring­Works’ inves­ti­ga­tional gamma secretase in­hib­i­tor (GSI), niro­gace­stat, …

Shanghai, China (Press Release) – I-Mab Bio­pharma­ ("I-Mab"), a global bio­pharma­ceu­tical com­pany based in China and the United States and focused on the discovery and devel­op­ment of novel or highly dif­fer­en­ti­ated biologics in immuno-oncology and auto­immune dis­eases today announced the dosing of the first patient in mainland China in its reg­is­tra­tional study eval­u­ating its human CD38 anti­body (TJ202/MOR202) in patients with re­lapsed or re­frac­tory multiple myeloma (MM).

I-Mab ini­ti­ated two reg­is­tra­tional trials with TJ202 / MOR202 in re­lapsed or re­frac­tory MM in Taiwan in early 2019 and ex­panded these trials into mainland China in …

• IND clear­ance enables com­mence­ment of clin­i­cal trial to eval­u­ate NEXI-002 in multiple myeloma patients who have failed >3 pre­vi­ous lines of ther­apy
• FDA action rep­re­sents the Com­pany’s second IND clear­ance in 4Q2019 for its pipe­line of novel cellular ther­apy prod­ucts

Gaithersburg, MD (Press Release) – NexImmune, a clin­i­cal-stage bio­pharma­ceu­tical com­pany devel­op­ing novel immune-therapeutics based on a pro­pri­e­tary Artificial Immune Modulation (AIM) nanotechnology plat­form, has re­ceived IND clear­ance for the Com­pany’s second cellular ther­apy prod­uct. NEXI-002 is being devel­oped for the treat­ment of multiple myeloma patients that have failed at least three prior lines of ther­apy.

Scott P. Carmer, NexImmune’s Pres­i­dent and CEO, commented, “FDA clear­ance of our second IND this quarter marks another sig­nif­i­cant mile­stone for NexImmune and dem­onstrates our team’s focus and com­mitment to …

• Overall re­sponse­ rate (ORR) of 31% with 2.5 mg/kg regi­men and no new safety signals in heavily pre-treated patient pop­u­la­tion who were re­frac­tory to an immuno­modu­la­tory drug and a pro­te­a­some in­hib­i­tor, and were re­frac­tory or intolerant to an anti-CD38 anti­body
• Data pub­lished in The Lancet Oncology highlight the poten­tial of be­lan­ta­mab mafo­dotin for patients with mul­ti­ple myeloma whose dis­ease has progressed
• GSK con­firms sub­mission of a Biologics License Appli­ca­tion to the US Food and Drug Admin­istra­tion

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) today an­nounced treat­ment with the inves­ti­ga­tional single-agent be­lan­ta­mab mafo­dotin re­­sulted in a clin­i­cally meaningful 31% over­all re­sponse­ rate (ORR) with the 2.5 mg/kg regi­men in patients with heavily pre-treated mul­ti­ple myeloma. Patients in the trial re­ceived a median of seven prior lines of treat­ment, were re­frac­tory to an immuno­modu­la­tory drug and a pro­te­a­some in­hib­i­tor and were re­frac­tory and/or intolerant to an anti-CD38 anti­body. The median duration of re­sponse­ has not been reached at six …