Swiss researchers have published results of a small clin­i­cal trial testing whether nelfinavir, a drug originally used to treat AIDS, can overcome resistance to Revlimid in re­lapsed multiple myeloma patients.

The trial was motivated by pre­vi­ous research showing that nelfinavir can overcome resistance to Velcade, for a period of time, in many re­lapsed myeloma patients.

Unfortunately, the results of the more recent nelfinavir trial are not as en­cour­ag­ing as the pre­vi­ous research involving nelfinavir and Velcade. Less than a third of the patients in the more recent trial responded to the three-drug …

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 …

• Phase III CANDOR study of dara­tu­mu­mab in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prove­ment in pro­gres­sion free sur­vival
• Data to be discussed with health author­i­ties in preparation for regu­la­tory sub­missions

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day top­line re­­sults from the Phase III CANDOR study, sponsored by Amgen, of dara­tu­mu­mab in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone (Kd) versus Kd alone in patients with mul­ti­ple myeloma who have re­lapsed after one to three prior ther­a­pies. The study met the pri­mary end­point of im­prov­ing pro­gres­sion free sur­vival (PFS). The regi­men re­­sulted in a 37% re­duc­tion in the risk of pro­gres­sion or death in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma treated with …

First Phase 3 Study Combining KYPROLIS and DARZALEX, Two Critical Mechanisms of Action in Treatment of Multiple Myeloma

Thousand Oaks, CA (Press Release) -- Amgen (NASDAQ:AMGN) today announced the Phase 3 CANDOR study eval­u­ating KYPROLIS® (car­filz­o­mib) in com­bi­na­tion with dexa­meth­a­sone and DARZALEX® (dara­tu­mu­mab) (KdD) com­pared to KYPROLIS and dexa­meth­a­sone alone (Kd) met its pri­mary end­point of pro­gres­sion-free survival (PFS). The regi­men resulted in a 37% reduction in the risk of pro­gres­sion or death in patients with re­lapsed or refractory multiple myeloma treated with KdD (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014). The median PFS for patients treated with Kd alone was 15.8 months, while the median PFS for patients treated …

• CCS1477 is the first drug to be used in patients that specifically targets p300/CBP, offering a new route to treat specific drug-resistant cancers
• Trial in late stage prostate cancer well underway across multiple clin­i­cal centres, under the leadership of Johann de Bono of The Royal Marsden Hospital, The Institute of Cancer Research, London
• Dosing in patients with haematological malig­nan­cies has now begun, starting at the Christie Hospital, Manchester

Cambridge, United Kingdom (Press Release) – CellCentric has ex­panded the clin­i­cal devel­op­ment pro­gramme of its novel anti-cancer drug CCS1477, a highly potent and specific small molecule inhibitor of p300/CBP. Dosing has commenced in a new study involving patients with multiple myeloma and will in­clude those with acute myeloid leukaemia and cer­tain lym­phomas. Trials are already underway for patients with late stage drug resistant prostate cancer.

Dr Nigel Brooks, CellCentric’s Director of Translational Science, commented: “Inhibiting p300/CBP is of growing interest to researchers. …

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 …