Shanghai, China (Press Release) – CARsgen Therapeutics, a clin­i­cal-stage com­pany committed to devel­op­ing Chimeric Antigen Receptor T cell ther­a­pies for cancer, today announced that one of its leading drug can­di­dates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treat­ment of patients suffering from re­lapsed / refractory multiple myeloma (rrMM), has received Inves­ti­ga­tional New Drug (IND) clearance from the United States Food and Drug Admin­istra­tion (FDA). CT053 has also received IND clearance from the National Medical Products Admin­istra­tion in China four months ago and is the subject of an ongoing phase I clin­i­cal …

• ALLO-715 Utilizes Gene-Editing of TRAC and CD52 Loci to Enable Allogeneic CAR T Therapy
• ALLO-715 will be Evaluated in Com­bi­na­tion with ALLO-647, Allogene’s Proprietary anti-CD52 Anti­body as Part of the Lymphodepletion Regimen
• Allogene Plans to Initiate the UNIVERSAL Study for ALLO-715 in Re­lapsed / Re­frac­tory Multiple Myeloma in the Second Half of 2019

South San Francisco, CA (Press Release) – Allogene Thera­peutics, Inc. (Nasdaq: ALLO), a clin­i­cal-stage bio­technology com­pany pioneering the devel­op­ment of allo­geneic CAR T (AlloCAR T™) ther­a­pies for cancer, to­day an­nounced that the U.S. Food & Drug Admin­istra­tion (FDA) has cleared Allogene’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for ALLO-715 in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma. The Phase 1 portion of the UNIVERSAL study, which will in­clude ALLO-647 as part of the lym­pho­de­ple­tion regi­men, is ex­pec­ted to be ini­ti­ated in the …

San Diego, CA (Press Release) – Poseida Therapeutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany leveraging pro­pri­e­tary non-viral gene engi­neer­ing tech­nolo­gies to create life-saving thera­peutics, today announced the United States Food and Drug Admin­istra­tion (FDA) has granted orphan drug desig­na­tion to P-BCMA-101 for the treat­ment of re­lapsed and/or refractory multiple myeloma. P-BCMA-101 is an au­tol­o­gous CAR-T ther­apy devel­oped using Poseida’s piggyBac® plat­form tech­nology. P-BCMA-101 is com­prised of a high per­cent­age of long-lived, self-renewing stem cell memory T cells targeting cancer cells expressing B-cell maturation an­ti­gen (BCMA).

“FDA orphan desig­na­tion is an im­por­tant regu­la­tory mile­stone in …

Newark, CA (Press Release) – Teneobio, Inc. and its affiliate TeneoOne, Inc. announced today that their inves­ti­ga­tional new drug appli­ca­tion (IND) for TNB-383B, a bispecific T-cell engaging anti­body for the treat­ment of multiple myeloma, was cleared for the initiation of Phase I clin­i­cal studies by the US Food and Drug Admin­istra­tion (FDA) on April 24th, 2019. The ongoing devel­op­ment of TNB-383B is being pursued in col­lab­o­ration with AbbVie, Inc.

TNB-383B is a fully human bispecific anti­body with two binding moieties for B-Cell Maturation Antigen (BCMA) on one arm and a unique anti-CD3 on …

PRIME (PRIority MEdicines) desig­na­tion based on clin­i­cal study re­­sults eval­u­ating safety and ef­fi­cacy of novel CAR-T ther­apy in the treat­ment of patients with ad­vanced re­lapsed or re­frac­tory mul­ti­ple myeloma

Beerse, Belgium (Press Release) - The Janssen Pharma­ceu­tical Com­panies of John­son & John­son to­day an­nounced that the Euro­pean Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) desig­na­tion for the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) ther­apy, JNJ-68284528 (JNJ-4528). PRIME offers en­hanced inter­action and early dialogue to optimise devel­op­ment plans and speed up evaluation of cutting-edge, scientific ad­vances that target a high unmet med­i­cal need.¹

“The PRIME desig­na­tion of this novel BCMA CAR-T ther­apy highlights the value of regu­la­tory inno­va­tion in the Euro­pean Union,” said Sjaak Bot, …

Initially Launching a Novel, High-Affinity BCMA CAR Targeting NK Cell De­vel­op­ment Candidate for Multiple Myeloma, with an Option for up to Five Additional CAR Targeting Sequences

San Diego, CA (Press Release) – NantKwest, Inc. (Nasdaq:NK), a leading clin­i­cal-stage Natural Killer (NK) cell based thera­peutics com­pany, and ProMab Biotech­nol­ogies to­day an­nounced the estab­lish­ment of a world­wide license to a B-Cell Maturation Antigen (BCMA) targeted anti­body sequence for mul­ti­ple myeloma along with an op­tion for up to five undisclosed targeting sequences for ex­clu­sive use in the devel­op­ment of chi­meric an­ti­gen re­cep­tor (CAR) based NK cell ther­a­pies.

“We are pleased to an­nounce this col­lab­o­ration with ProMab Biotech­nol­ogies, marking another mile­stone for NantKwest in the devel­op­ment of targeted, next gen­er­a­tion, NK cell thera­peutics …

Shanghai, China (Press Release) – CARsgen Therapeutics, a clin­i­cal-stage com­pany committed to devel­op­ing chi­meric an­ti­gen re­cep­tor T cell ther­a­pies for cancer, today announced that one of its leading drug can­di­dates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treat­ment of patients suffering from re­lapsed / refractory multiple myeloma (rrMM), has received Inves­ti­ga­tional New Drug (IND) clearance from the National Medical Products Admin­istra­tion (NMPA).

"At the American Society of Hematology meeting in December 2018, our col­lab­o­rator, Dr. Songfu Jiang presented en­cour­ag­ing safety and efficacy data in patients with rrMM who received CT053 …