Nanjing, China (Press Release) – IASO Biotherapeutics (IASO BIO), a clin­i­cal stage bio­technology com­pany ad­vanc­ing the devel­op­ment of inno­va­tive ther­a­pies for cancer, and Innovent Biologics, Inc. (Innovent) (HKEX:01801), a world-class bio­pharma­ceu­tical com­pany that de­vel­ops and com­mer­cial­izes high quality med­i­cines, an­nounced to­day that IASO BIO has re­ceived National Medical Products Admin­istra­tion (NMPA) ap­prov­al for an Inves­ti­ga­tional New Drug Appli­ca­tion (IND) for CT103A – an inno­va­tive ther­apy for the treat­ment of re­lapsed re­frac­tory mul­ti­ple myeloma (rr/mm) patients. IASO Bio and Innovent will start a Phase Ib/II study to con­firm the R2PD and move to phase II …

• Agreement covers manu­fac­tur­ing of clin­i­cal supply for Cellectis’ UCART pipe­line
• Manufacturing to take place at Lonza’s GMP site in Geleen, Netherlands

Basel, Switzerland and New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on allo­geneic gene-edited CAR T-cells (UCART), and Lonza (SWX: LONN), an­nounced to­day that the com­pa­nies have entered into a manu­fac­tur­ing service agree­ment covering clin­i­cal manu­fac­tur­ing of Cellectis’ allo­geneic UCART prod­uct can­di­dates targeting hema­to­logical malig­nan­cies. Lonza is in charge of implementing Cellectis’ manu­fac­tur­ing processes as per current Good Manufacturing Practices (cGMP) in a way that meets the highest quality …

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 …

Shanghai, China (Press Release) – CARsgen Thera­peutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany, today announced the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) eligibility to its inves­ti­ga­tional CAR-T cell ther­apy fully human anti-BCMA (B Cell Maturation Antigen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T Cells (ct053) for the treat­ment of re­lapsed or refractory multiple myeloma.

PRIME eligibility was based on clin­i­cal data from an ongoing CT053 BCMA CAR-T phase 1 study in China. The results from the trial were presented at an oral presentation on Sep­tem­ber 14, 2019 in Boston at the 17th …

Shanghai, China (Press Release) – CARsgen Thera­peutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany, today announced the United States Food and Drug Admin­istra­tion (FDA) has granted orphan drug desig­na­tion to its inves­ti­ga­tional CAR T-cell ther­apy fully human anti-BCMA (B Cell Maturation Antigen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T Cells (CT053) for the treat­ment of multiple myeloma.

"FDA orphan desig­na­tion is an im­por­tant regu­la­tory mile­stone in the con­tinued devel­op­ment and com­mer­cial­iza­tion of CT053 anti-BCMA CAR-T cells," said Dr. Zonghai Li, Founder, CEO and CSO of CARsgen. "CT053 has dem­onstrated outstanding potency in an exploratory phase 1 …

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 …