New York, NY (Press Release) – SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the devel­op­ment of novel cancer immuno­therapies for a broad range of cancer indi­ca­tions, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has approved orphan medicinal prod­uct desig­na­tion (OMPD) for galinpepimut‑S (GPS), the Company’s lead prod­uct can­di­date, for the treat­ment of multiple myeloma (MM). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present …

• Efficacy and safety con­tinue to be a major ad­van­tage, with a very high response rate, no dose limiting toxicities and only a single in­ci­dence of sus­pected cytokine release syn­drome
• P-BCMA-101 clin­i­cal data as well as pre­clin­i­cal data from MUC1C and PSMA solid tumor pro­grams and BCMA allo­geneic pro­gram presented at the CAR-TCR Summit

San Diego, CA (Press Release) – Poseida Therapeutics Inc. (“Poseida”), a clin­i­cal-stage bio­tech­nology com­pany translating best-in-class gene engi­neer­ing tech­nolo­gies into lifesaving cell ther­a­pies, announced data results from the first eleven patients treated in its ongoing Phase 1 study of its P-BCMA-101 stem cell memory chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) prod­uct in re­lapsed / refractory multiple myeloma. All eleven patients remain on study with seven of ten patients evaluable by Inter­na­tional Myeloma Work­ing Group (IMWG) criteria achieving at least a partial response. The remaining patient also dem­onstrated …

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced that the European Com­mis­sion (EC) has granted mar­ket­ing authori­sa­tion for Darzalex^® (dara­tu­mu­mab) for use as frontline (initial) ther­apy. The approval is for the use of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP), for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

The approval is based on results from the ran­domised, open-label, multicentre Phase 3 ALCYONE (MMY3007) study, published in the New England Journal of Medicine …

• DARZALEX approved in Europe in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone in patients with newly diag­nosed multiple myeloma
• Approval follows pos­i­tive opinion by European Committee for Medicinal Products for Human Use (CHMP) in July
• Genmab to receive mile­stone pay­ment of USD 13 million from Janssen upon first sale of DARZALEX in the newly approved indi­ca­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for DARZALEX^® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP), for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The EC approval follows a pos­i­tive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in July 2018. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) …

Filing Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study

Thousand Oaks, CA (Press Release) - Amgen (NASDAQ : AMGN ) today announced the sub­mission of a supple­mental New Drug Application (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) to expand the Prescribing Information for KYPROLIS® (car­filz­o­mib) to in­clude a once-weekly dosing option in com­bi­na­tion with dexa­meth­a­sone (Kd) for patients with re­lapsed or refractory multiple myeloma. The sNDA is based on data from the Phase 3 A.R.R.O.W. trial, demonstrating KYPROLIS admin­istered once-weekly at 70 mg/m² with dexa­meth­a­sone (once-weekly Kd) achieved superior pro­gres­sion-free survival (PFS) and over­all response rates (ORR), with a com­parable safety profile versus …

Application based on re­­sults from Phase 2 ELOQUENT-3 study

Princeton, NJ (Press Release) - Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) ac­cepted its supple­mental Biologics License Appli­ca­tion (sBLA) for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. The FDA granted the appli­ca­tion priority review with an action date of De­cem­ber 27, 2018.

“This file ac­ceptance is an im­por­tant step in BMS’s on­go­ing efforts to ad­vance …

Berkeley, CA (Press Release) – Aduro Biotech, Inc. (NASDAQ: ADRO) today announced that the United States Patent and Trademark Office has issued a new composition of matter patent related to altered APRIL-binding anti­bodies, further enhancing the com­pany’s B-select intellectual property port­folio. Specifically, the granted claims cover BION-1301, Aduro’s first-in-class anti-APRIL anti­body being eval­u­ated in a Phase 1/2 dose escalation trial for the treat­ment of multiple myeloma.

“Blocking APRIL rep­re­sents a unique ap­proach to treating patients with multiple myeloma and we believe BION-1301 has poten­tial to treat a myriad of on­col­ogy indi­ca­tions as …