• Agreement covers manu­fac­tur­ing of clin­i­cal supply for Cellectis’ UCART pipe­line
• Manufacturing to take place at Lonza’s GMP site in Geleen, Netherlands

Basel, Switzerland and New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on allo­geneic gene-edited CAR T-cells (UCART), and Lonza (SWX: LONN), an­nounced to­day that the com­pa­nies have entered into a manu­fac­tur­ing service agree­ment covering clin­i­cal manu­fac­tur­ing of Cellectis’ allo­geneic UCART prod­uct can­di­dates targeting hema­to­logical malig­nan­cies. Lonza is in charge of implementing Cellectis’ manu­fac­tur­ing processes as per current Good Manufacturing Practices (cGMP) in a way that meets the highest quality …

Silver Spring, MD (Approval & Safety Notification) – On Sep­tem­ber 26, 2019, the Food and Drug Admin­istra­tion approved dara­tu­mu­mab (DARZALEX, Janssen) for adult patients with multiple myeloma in com­bi­na­tion with bor­tez­o­mib, thalido­mide, and dexa­meth­a­sone in newly diag­nosed patients who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

Efficacy was in­ves­ti­gated in CASSIOPEIA (NCT02541383), an open-label, ran­dom­ized, active-controlled phase 3 study com­par­ing induction and con­sol­i­da­tion treat­ment with dara­tu­mu­mab 16 mg/kg in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (DVTd) to treat­ment with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) in patients with newly diag­nosed multiple myeloma eli­gible for …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with bor­tez­o­mib, thalido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone as treat­ment for patients newly diag­nosed with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant
• Approval based on Phase III CASSIOPEIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Application (sBLA) for this indi­ca­tion was sub­mitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen) in March 2019. The U.S. FDA sub­se­quently granted priority review to the sBLA, …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounced to­day that the last patient has been in­cluded in the OP-106 HORIZON pivotal phase 2 clin­i­cal study eval­u­ating mel­flu­fen with dexa­meth­a­sone in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM). Oncopeptides has pre­vi­ously com­mu­ni­cated a target en­roll­ment of 150 patients in the study be­fore the end of Sep­tem­ber, which now has been achieved.

Oncopeptides is engaged in preparations for submitting a New Drug Appli­ca­tion (NDA) to the U.S. Food & Drug Admin­istra­tion (FDA) for ac­cel­er­ated mar­ket ap­­prov­al in the United States based on …

Florham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day an­nounced that the Euro­pean Com­mis­sion has awarded CLR 131 orphan desig­na­tion for the treat­ment of mul­ti­ple myeloma.

Orphan desig­na­tion is given to medicinal prod­ucts that rep­re­sent a sig­nif­i­cant benefit over existing treat­ments; are in­tended for the treat­ment, prevention or diag­nosis of a dis­ease that is life-threatening or chronically debilitating; and where prev­a­lence of the con­di­tion in the EU is less than 5 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 …

GBR 1342 to be devel­oped by Glenmark Pharma­ceu­ticals' spinoff inno­va­tion com­pany

Mahwah, NJ (Press Release) – Glenmark Pharma­ceu­ticals (Glenmark), a research-led, integrated global pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Orphan Drug Desig­na­tion to its bispecific anti­body can­di­date GBR 1342 for the treat­ment of patients with multiple myeloma who have received prior ther­a­pies. Derived from the com­pany's pro­pri­e­tary BEAT® (Bispecific Engagement by Antibodies based on the T cell re­cep­tor) tech­nology, GBR 1342 is being in­ves­ti­gated for the treat­ment of multiple myeloma. The can­di­date is one of five clin­i­cal-stage assets in the pipe­line of Glenmark's new inno­va­tion …