• 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, …

• 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 …

A major source of op­ti­mism in the myeloma com­munity these days is the large num­ber of poten­tially very ef­fec­tive treat­ments under devel­op­ment for the dis­ease.

Increasing the num­ber of ef­fec­tive treat­ment op­tions for the dis­ease could lead to a sizable jump in sur­vival for both newly diag­nosed and re­lapsed mul­ti­ple myeloma patients.

There is, how­ever, a common theme among many of the promising inves­ti­ga­tional ther­a­pies for mul­ti­ple myeloma that could limit their ability to make as large an im­pact on myeloma sur­vival as many hope. The common theme can be summarized in …

Belantamab mafo­dotin (GSK2857916) on track for regu­la­tory sub­mission by the end of 2019

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced pos­i­tive headline re­­sults from the pivotal DREAMM-2 open-label, ran­domised study of two doses of be­lan­ta­mab mafo­dotin (GSK2857916).

The 196 patients in the trial had re­lapsed mul­ti­ple myeloma, were re­frac­tory to an immuno­modu­la­tory drug, a pro­te­a­some in­hib­i­tor, and to treat­ment with an anti-CD38 anti­body. The two-arm study met its pri­mary objective and dem­onstrated a clin­i­cally meaningful over­all re­sponse rate with be­lan­ta­mab mafo­dotin in the patient pop­u­la­tion. The safety and tol­er­a­bil­ity profile was con­sis­tent with that ob­served in DREAMM-1, the first …

Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc., 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 GlaxoSmithKline to eval­u­ate Spring­Works Thera­peutics’ inves­ti­ga­tional gamma secretase in­hib­i­tor (GSI), niro­gace­stat, in com­bi­na­tion with GlaxoSmithKline’s inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) anti­body-drug con­ju­gate (ADC), be­lan­ta­mab mafo­dotin (formerly GSK2857916), in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Gamma secretase is an enzyme that cleaves mul­ti­ple transmembrane pro­teins, in­clud­ing BCMA. As evi­denced in pub­li­ca­tions and pre­clin­i­cal ex­per­i­ments, …

• TAK-169 Represents a Novel Mechanism of Action Targeting CD38
• Phase I Study to be Conducted in Relapsed/Refractory Multiple Myeloma Patients

Austin, TX (Press Release) – Molecular Templates, Inc., (Nasdaq: MTEM, “Molec­u­lar,” “Molec­u­lar Templates” or “MTEM”) a clin­i­cal stage bio­pharma­ceu­tical com­pany focused on the discovery and devel­op­ment of Engi­neered Toxin Bodies (ETBs), a new class of targeted biologic ther­a­pies that possess unique mech­a­nisms of action in on­col­ogy, announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted the Inves­ti­ga­tional New Drug (IND) appli­ca­tion for TAK-169, an ETB targeting CD38.

MTEM and partner Takeda Pharma­ceu­tical Company Limited (Takeda) are co-developing TAK-169 and plan to conduct an open …