Phase 1 trial in re­lapsed and re­frac­tory mul­ti­ple myeloma con­tinues to en­roll patients

Gaithersburg, MD (Press Release) – Arcellx, a clin­i­cal-stage bio­pharma­ceu­tical com­pany devoted to devel­op­ing immune cell ther­a­pies for cancer and other dis­eases, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Orphan Drug Desig­na­tion to CART-ddBCMA, its engi­neered T cell ther­apy uti­liz­ing a novel binding domain, for the treat­ment of patients with mul­ti­ple myeloma. Arcellx con­tinues to en­roll patients in its Phase 1 trial of CART-ddBCMA ther­apy for the treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma, the first in a series of clin­i­cal trials planned for the stepwise devel­op­ment of …

• Phase 1 trial is de­signed to val­i­date novel binding domain; first step in eval­u­ating Arcellx T cell ther­apy plat­form in the clinic
• Future trials will use Arcellx plat­form to direct T cell ac­­tiv­ity and target mul­ti­ple tumor an­ti­gens
• Therapy granted Fast Track Desig­na­tion for treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma

Gaithersburg, MD (Press Release) – Arcellx to­day an­nounced that the first patient has been dosed with its engi­neered T cell ther­apy uti­liz­ing a novel deimmunized syn­thet­ic binding domain in the treat­ment of patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. This first-in-human Phase 1 trial is the first in a series of clin­i­cal trials planned for efficient, stepwise devel­op­ment of the Arcellx ARC-T + sparX cell ther­apy plat­form, with BCMA as an initial target.

“Validating this novel binding domain facilitates sub­se­quent …

• 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, …

• Phase 1 clin­i­cal trial of off-the-shelf (allogeneic) anti-BCMA CAR T ther­apy can­di­date for patients with re­lapsed / re­frac­tory mul­ti­ple myeloma ex­pec­ted to begin dosing patients in 2020
• PBCAR269A has re­ceived Orphan Drug Desig­na­tion from the FDA for the treat­ment of mul­ti­ple myeloma
• First pro­gram for which clin­i­cal trial ma­teri­al will be gen­er­ated fully in-house at Precision’s Manu­factur­ing Center for Advanced Thera­­peutics (MCAT) in Durham, N.C.

Durham, NC (Press Release) – Precision BioSciences, Inc. (Nasdaq: DTIL), a genome edit­ing com­pany ded­i­cated to im­prov­ing life through the appli­ca­tion of its pioneering, pro­pri­e­tary ARCUS® plat­form, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted its Inves­ti­ga­tional New Drug (IND) appli­ca­tion for PBCAR269A, the Com­pany’s third allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date. The FDA has also granted Orphan Drug Desig­na­tion to PBCAR269A for the treat­ment of mul­ti­ple myeloma. Wholly-owned by Precision, PBCAR269A is an allo­geneic CAR …

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, …

• 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 …