Marizomib is a novel brain-penetrant pro­te­a­some inhibitor in devel­op­ment for patients with glioblastoma and re­lapsed and/or refractory multiple myeloma.

Toronto, ON and San Diego, CA (Press Release) – Triphase Accelerator Corpo­ra­tion, a private drug de­vel­op­ment com­pany dedicated to ad­vanc­ing novel com­­pounds through Phase 2 proof-of-concept, today an­nounced that Celgene Corpo­ra­tion, through an affiliate, has acquired the com­pany’s assets related to its pro­te­a­some inhibitor, marizomib (MRZ), which is in devel­op­ment for glioblastoma and re­lapsed and/or re­frac­tory multiple myeloma.

Under the terms of the agree­ment, Celgene will make an upfront payment plus addi­tional …

Horsham, PA (Press Release) – Janssen Biotech, Inc. today announced that the com­pany has entered into a master clin­i­cal trial col­lab­o­ration and supply agree­ment with Onyx Pharma­ceu­ticals, Inc., a wholly-owned sub­sid­i­ary of Amgen, Inc., to eval­u­ate the efficacy and safety of the first-in-class CD38-directed immuno­ther­apy dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with a pro­te­a­some inhibitor (PI) car­filz­o­mib (KYPROLIS®) and dexa­meth­a­sone. The agree­ment covers all poten­tial oppor­tu­ni­ties for combining dara­tu­mu­mab and car­filz­o­mib for the treat­ment of patients with cancer. Janssen licensed dara­tu­mu­mab from Genmab A/S and is responsible for all global devel­op­ment, mar­ket­ing and manu­fac­tur­ing.¹ …

Initial Phase 3 Registrational Study Planned in Relapsed or Refractory Multiple Myeloma Patients

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced a col­lab­o­ration with Janssen Biotech, Inc. to eval­u­ate the com­bi­na­tion of Amgen's KYPROLIS® (car­filz­o­mib) and Janssen's DARZALEX® (dara­tu­mu­mab) in multiple clin­i­cal studies in patients with multiple myeloma. Under the terms of the agree­ment, the com­pa­nies may elect to supply drug only or supply drug and share devel­op­ment costs on a study-by-study basis.

The first study ini­ti­ated as part of this agree­ment is a Phase 3 registrational trial eval­u­ating KYPROLIS in com­bi­na­tion with DARZALEX and dexa­meth­a­sone com­pared to KYPROLIS and dexa­meth­a­sone …

• New Phase III study combining dara­tu­mu­mab, car­filz­o­mib and dexa­metha­sone in re­lapsed / refractory multiple myeloma – dosing ex­pec­ted in 2017
• First study under Clinical Trial Collaboration and Supply Agreement be­tween Janssen and Amgen
• Agreement covers all poten­tial oppor­tu­ni­ties combining dara­tu­mu­mab and car­filz­o­mib to treat cancer

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that dara­tu­mu­mab (DARZALEX®) will be in­ves­ti­gated in a Phase III clin­i­cal study in com­bi­na­tion with car­filz­o­mib (KYPROLIS®) and dexa­meth­a­sone in patients with re­lapsed/refractory multiple myeloma. The study will be conducted under a master clin­i­cal trial col­lab­o­ration and supply agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Onyx Pharma­ceu­ticals, Inc., a wholly-owned sub­sid­i­ary of Amgen, Inc. The agree­ment covers all poten­tial oppor­tu­ni­ties for combining dara­tu­mu­mab and …

Lund, Sweden (Press Release) – BioInvent Inter­na­tional (STO:BINV) has received verbal notice from the U.S. Food and Drug Admin­istra­tion (FDA) that a full clin­i­cal hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clin­i­cal Phase II study with the anti­body BI-505 in patients with multiple myeloma. BioInvent has not yet received written notice of the clin­i­cal hold from the FDA, how­ever, based on verbal communications, the FDA informed BioInvent that the clin­i­cal hold is due to an adverse cardio­pul­mo­nary event in the clin­i­cal study.

The clin­i­cal study is …

Madrid, Spain (Press Release) – PharmaMar (MSE: PHM) has announced today that the European Med­i­cines Agency (EMA) has accepted to assess the Marketing Authorization Application (MAA) for Aplidin® (pliti­depsin) in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of re­lapsed / refractory multiple myeloma (MM).

PharmaMar submitted the above mentioned appli­ca­tion for the antitumor drug of marine origin, Aplidin®, in com­bi­na­tion with dexa­meth­a­sone given the positive results obtained from the ADMYRE study. Plitidepsin could be a thera­peutic alter­na­tive for patients suffering from re­lapsed and/or refractory multiple myeloma.

After this acceptance, the EMA is going to …

Philadelphia, PA and Oxford, United Kingdom (Press Release) – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in T-cell ther­apy to treat cancer, today announced that it has entered into a clin­i­cal trial col­lab­o­ration agree­ment with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), for the assess­ment of Adaptimmune’s NY-ESO SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell ther­apy in com­bi­na­tion with MSD’s anti-programmed death-1 (PD-1) inhibitor, KEYTRUDA® (pem­bro­lizu­mab), in patients with multiple myeloma. The study will eval­u­ate the safety, phar­ma­co­ki­netics, pharmacodynamics, and pre­lim­i­nary efficacy of the …