• First study of dara­tu­mu­mab in smoldering multiple myeloma
• Study expected to start in  2015

Copenhagen, Denmark (Press Release) - Genmab A/S (OMX: GEN) announced today that its col­lab­o­ra­tion partner, Janssen Biotech, Inc. (Janssen) plans to start a Phase II study of dara­tu­mu­mab in smol­der­ing multiple myeloma.  The study (SMM2001) will eval­u­ate three dif­fer­en­t dose schedules of dara­tu­mu­mab for the treat­ment of smol­der­ing multiple myeloma.  The study is ex­pec­ted to start enrolling patients in 2015.

"We are pleased to announce this study, which illustrates that the devel­op­ment plan for dara­tu­mu­mab encompasses all stages of multiple myeloma. …

• This Phase I trial will test the safety and tolerability of lirilumab (BMS-986015) in combination with elotuzumab (BMS-901608) in patients with multiple myeloma
• This new Phase I initiated by Bristol-Myers Squibb is the first combination trial of lirilumab in a hematological tumor type

Marseille, France (Press Release) - Innate Pharma SA (the "company" -  euronext paris:FR0010331421 - IPH), the innate immunity com­pany devel­op­ing first-in-class thera­peutic anti­bodies for cancer and in­flam­ma­tory dis­eases, to­day an­nounced that a new Phase I com­bi­na­tion trial with lirilumab, a …

• Results show statistically significant and clinically relevant increase in median progression-free survival with LBH589 plus bortezomib and dexamethasone[1]
• LBH589, a first-in-class treatment for patients with relapsed/refractory multiple myeloma if approved, helps extend benefit of standard-of-care therapy[1]
• First Phase III study to demonstrate superiority of a three-drug over two-drug combination in this patient population[1]
• Multiple myeloma, the second most common blood cancer, is incurable; most patients will relapse or become refractory so new treatments are needed[2],[3]

 …

Madison, WI (Press Release) - Cellectar Biosciences, Inc. (Nasdaq:CLRB), an­nounced to­day that the U.S. Food & Drug Admin­istra­tion (FDA) has ac­cepted the Com­pany's inves­ti­ga­tional new drug (IND) appli­ca­tion to begin clin­i­cal study of I-131-CLR1404, a highly-selective, cancer-targeting radiopharmaceutical, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma, an incurable cancer of plasma cells.

I-131-CLR1404 is radiotherapeutic com­prised of a pro­pri­e­tary phos­pho­lipid ether (PLE) analog, acting as a cancer-targeted de­livery and retention vehicle, covalently labeled with Iodine-131, a cytotoxic radioisotope that is already commonly used to treat thyroid and other cancer types. Because Cellectar's …

Burlingame, CA (Press Release) - Cleave Biosciences today announced that it has begun a Phase 1 clin­i­cal trial to eval­u­ate its lead drug can­di­date, CB-5083, in patients with re­lapsed and refractory multiple myeloma. CB-5083 is a first-in-class, oral inhibitor of p97, a critical enzyme that controls various aspects of protein homeo­stasis.

The open-label, Phase 1 dose escalation/dose expansion trial will eval­u­ate the safety, phar­ma­co­ki­netics, pharmacodynamics and anti-tumor activity of CB-5083 in multiple myeloma patients who have re­lapsed/​refractory or refractory disease after receiving two or more lines of ther­apy, in­­clud­ing an immuno­modu­la­tory agent …

Thousand Oaks, California and South San Francisco, California (Press Release) - Amgen (NASDAQ: AMGN) and its sub­sid­i­ary, Onyx Pharma­ceu­ticals, Inc., today announced that the Phase 3 clin­i­cal trial FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) did not meet its pri­mary end­point of im­prov­ing over­all survival (OS) (HR=0.975, 95 per­cent CI, 0.760, 1.249). The 315-patient, open-label study eval­u­ated single-agent Kyprolis® (car­filz­o­mib) for Injection compared to an active control regi­men of low-dose dexa­meth­a­sone, or equivalent corticosteroids, plus optional cyclo­phos­pha­mide in patients with re­lapsed and ad­vanced refractory multiple myeloma. Nearly all patients in …

Madison, Wisconsin (Press Release) - Cellectar Biosciences, Inc. (OTCQX:CLRB), an­nounced that it has sub­mitted an Inves­ti­ga­tional New Drug (IND) appli­ca­tion to the U.S. Food & Drug Admin­istra­tion (FDA) to begin clin­i­cal study of I-131-CLR1404, a highly-selective, cancer-targeting radio­phar­ma­ceut­i­cal, in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma, an incurable cancer of plasma cells.

"Despite the emergence of new treat­ment op­tions, no cure exists for mul­ti­ple myeloma and the lim­i­ta­tions of avail­able ther­a­pies are par­tic­u­larly evident in patients that have re­lapsed or be­come resistant to treat­ment creating a clear need for the devel­op­ment of addi­tional …