Initially Launching a Novel, High-Affinity BCMA CAR Targeting NK Cell De­vel­op­ment Candidate for Multiple Myeloma, with an Option for up to Five Additional CAR Targeting Sequences

San Diego, CA (Press Release) – NantKwest, Inc. (Nasdaq:NK), a leading clin­i­cal-stage Natural Killer (NK) cell based thera­peutics com­pany, and ProMab Biotech­nol­ogies to­day an­nounced the estab­lish­ment of a world­wide license to a B-Cell Maturation Antigen (BCMA) targeted anti­body sequence for mul­ti­ple myeloma along with an op­tion for up to five undisclosed targeting sequences for ex­clu­sive use in the devel­op­ment of chi­meric an­ti­gen re­cep­tor (CAR) based NK cell ther­a­pies.

“We are pleased to an­nounce this col­lab­o­ration with ProMab Biotech­nol­ogies, marking another mile­stone for NantKwest in the devel­op­ment of targeted, next gen­er­a­tion, NK cell thera­peutics …

Shanghai, China (Press Release) – CARsgen Therapeutics, a clin­i­cal-stage com­pany committed to devel­op­ing chi­meric an­ti­gen re­cep­tor T cell ther­a­pies for cancer, today announced that one of its leading drug can­di­dates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treat­ment of patients suffering from re­lapsed / refractory multiple myeloma (rrMM), has received Inves­ti­ga­tional New Drug (IND) clearance from the National Medical Products Admin­istra­tion (NMPA).

"At the American Society of Hematology meeting in December 2018, our col­lab­o­rator, Dr. Songfu Jiang presented en­cour­ag­ing safety and efficacy data in patients with rrMM who received CT053 …

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage phar­ma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) Onco­logic Drugs Advisory Committee (ODAC) met to discuss the New Drug Application (NDA) for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) com­­pound. The NDA, which is cur­rently under Priority Review by the FDA, is seeking accelerated approval for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with re­lapsed refractory multiple myeloma who have received at least three prior ther­a­pies and whose disease is refractory to …

Martinsried / Munich, Germany (Press Release) – Medigene AG (FSE: MDG1, Prime Standard, SDAX), a clin­i­cal stage immuno-oncology com­pany focusing on the devel­op­ment of T cell immuno­therapies, announced today that it has dosed the first patient in its first-in-human clin­i­cal trial with its TCR ther­apy can­di­date MDG1011. The Phase I/II trial in­ves­ti­gates the safety and feasibility of MDG1011 for the treat­ment of various types of blood cancer, in­­clud­ing acute myeloid leukemia (AML), myelo­dys­plastic syn­drome (MDS) and multiple myeloma (MM). MDG1011 is a novel immuno­therapy can­di­date using patient-derived, T cell re­cep­tor (TCR)-modified T cells targeting …

• Phase III COLUMBA study com­par­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab to the in­tra­venous for­mu­la­tion in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma met both co-primary end­points
• Results show that dara­tu­mu­mab admin­istered sub­cu­tane­ously was non-inferior in ef­fi­cacy and phar­ma­co­ki­netics as com­pared to dara­tu­mu­mab admin­istered in­tra­venously
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings in sup­port of bringing con­ve­nience of sub­cu­tane­ous dara­tu­mu­mab op­tion to patients

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) an­nounced to­day top­line re­­sults from the Phase III COLUMBA study (MMY3012) of sub­cu­tane­ous (SC) versus in­tra­venous (IV) dara­tu­mu­mab for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. The re­­sults showed that SC admin­istra­tion of dara­tu­mu­mab co-formulated with recombinant human hyal­uron­i­dase PH20 is non-inferior to IV admin­istra­tion of dara­tu­mu­mab with regard to the co-primary end points of over­all re­sponse rate (ORR) and Maximum Trough con­cen­tra­tion (C_trough) of dara­tu­mu­mab on day 1 of …

Key Patent Covers Manufacture of Thera­peutic Products Containing a High Percentage of T Stem Cell Memory Cells

San Diego, CA (Press Release) – Poseida Thera­peutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany leveraging pro­pri­e­tary non-viral gene engi­neer­ing tech­nolo­gies to create life-saving thera­peutics, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allow­ance for a patent pro­tecting the method of producing genetically modified T cells with a high per­cent­age of stem cell memory T cells (Tscm).

Tscm cells are long-lived, self-renewing and multipotent. These cells have the capacity to reconstitute the entire spectrum of effector and memory T cells subsets and usually sur­vive for decades and poten­tially …

Revised prod­uct label allows for new admin­istra­tion option

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved a split-dosing regi­men for DARZALEX® (dara­tu­mu­mab), providing health­care professionals and patients with multiple myeloma an option to split the first in­fusion over two consecutive days.¹ The U.S. FDA approval is based on data from the Phase 1b EQUULEUS (MMY1001) clin­i­cal study, which dem­onstrated DARZALEX phar­ma­co­ki­netic (PK) con­cen­tra­tions were com­parable at the end of weekly dosing, re­gard­less of whether the first dose was admin­istered as a split in­fusion …