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 …

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 …

There cur­rently are more than 300 clin­i­cal trials ongoing around the world that are investigating treat­ments for multiple myeloma and looking for patient par­tic­i­pants. Most of these trials are exploring new myeloma ther­a­pies that have not yet been approved for use outside of clin­i­cal trials, and many of these “investigational” ther­a­pies, as they often are called, have the poten­tial to be extremely effective.

The number of new treat­ments under devel­op­ment for multiple myeloma is greater than it ever has been, and this creates tremendous hope in the myeloma com­munity. In just a …

Newark, CA (Press Release) – Teneobio, Inc. a clin­i­cal-stage bio­technology com­pany devel­op­ing engi­neered bispecific anti­bodies for the treat­ment of cancer announced today that the first patient has been dosed with TNB-383B in a Phase 1 clin­i­cal study to eval­u­ate the safety and tolerability of its dif­fer­en­ti­ated anti-BCMAxCD3, a bispecific anti­body that redirects T-cells to kill multiple myeloma cells with minimal cytokine release. Earlier this year, Teneobio’s affiliate TeneoOne, Inc. and AbbVie entered a strategic part­ner­ship, giving AbbVie the exclusive right to acquire TeneoOne post-Phase 1 studies and lead the sub­se­quent global devel­op­ment and …

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, …