December 15, 2016 – New York (N.Y.) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced the National Institute of Health's Recombinant DNA Advisory Committee (RAC)’s unanimous approval of two Phase 1 study protocols for Cellectis’ UCART123, the Company’s most advanced, wholly owned TALEN® gene edited product candidate in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
September 26, 2016 - Kite Pharma, Inc., (Nasdaq:KITE) today announced positive topline results from a pre-planned interim analysis of ZUMA-1 for its lead product candidate, KTE-C19, in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). KTE-C19 met the primary endpoint of objective response rate (ORR), p < 0.0001, with ORR of 76 percent, including 47 percent complete remissions (CR).
July 25, 2016 - In the ICT-107 phase 3 registrational trial, as of July 21, 2016, 109 patients have been screened in the US and Canada, with plans to randomize qualifying patients once they have completed standard of care and are re-screened (patients randomized in the trial are treated approximately 90 days following initial screening). In addition, clinical supplies (ICT-107 and placebo) for 12 patients have been manufactured.ImmunoCellular also reported that 56 clinical sites in the US and two sites in Canada have been activated, representing almost half the total number of the planned 120 sites for the trial.
June 30, 2016 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces that its lead product, ATIR101™, has been granted an expansion to its existing Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) to include treatment in a hematopoietic stem cell transplantation (HSCT).
June 20, 2016 - Kite Pharma, Inc. (NASDAQ:KITE) today announced that it has entered into a new Cooperative Research and Development Agreement (CRADA) with the Experimental Transplantation and Immunology Branch (ETIB) of the National Cancer Institute (NCI) for the research and clinical development of T-cell receptor (TCR) product candidates directed against human papillomavirus (HPV)-16 E6 and E7 oncoproteins for the treatment of HPV-associated cancers.
June 7, 2016 - ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today announced that the first patient has been treated in the phase 3 registrational trial of ICT-107, the Company's lead cancer immunotherapy product candidate, in newly diagnosed glioblastoma. ICT-107 is a patient-specific, dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. The phase 3 trial is designed as a randomized, double-blind, placebo-controlled study of 414 HLA-A2-positive subjects, which will be conducted at approximately 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival, which the FDA and EU regulators have identified as an appropriate endpoint for registrational clinical studies in glioblastoma. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups.
June 2, 2016 - Kite Pharma, Inc. (NASDAQ: KITE) ("Kite") and Cell Design Labs, Inc. today announced a research collaboration and license agreement to develop next generation, precision-controlled chimeric antigen receptor (CAR) product candidates that incorporate Cell Design Labs' molecular "on/off switch" technology.
May 6, 2016 - ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today announced that the Company has received approval from regulatory authorities in Canada, the United Kingdom and the Netherlands to initiate the ICT-107 Phase 3 registration trial in patients with newly diagnosed glioblastoma. Patient screening is anticipated to commence shortly and the first clinical supplies could be manufactured for qualifying patients in Canada and Europe in the third quarter of 2016. The Company also is near to completing interactions with regulatory authorities in six other European countries and currently expects approval of those clinical trial applications in June 2016, with patient screening to begin in the third quarter of 2016.
May 02, 2016 - Kite Pharma, Inc. (Nasdaq:KITE) ("Kite"), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designations to Kite's lead product candidate, KTE-C19, for the treatment of primary mediastinal B cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). Kite previously received orphan drug designation for KTE-C19 for the treatment of diffuse large B cell lymphoma (DLBCL) in both the U.S. and the EU, as well as orphan drug designations in the EU for PMBCL, MCL, FL, ALL, and CLL.
April 25, 2016 – TxCell SA, a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T cells (Treg) to treat severe chronic inflammatory and autoimmune diseases, and Ospedale San Raffaele (OSR), one of the most prestigious research institutions in Europe in the field of cell and gene therapy, today announce they have entered into a strategic R&D collaboration. The collaboration will include a development arm focused on Lupus Nephritis, as well as a research program dedicated to CAR-Treg biology.