A mitochondrial glutamine transporter variant is a key regulator of glutamine metabolism and metabolic reprogramming in cancer cells, and targeting such transporters could be a new strategy for controlling tumor growth, Korean researchers reported online in the Dec. 19, 2019, edition of Cell Metabolism.
Nearly four years after its start, a phase III trial of Gamida Cell Ltd.'s ex vivo expanded cord blood candidate, omidubicel, for hematologic malignancies is fully enrolled, the company said.
The natural immune system has two lines of defense that complement each other. In response to an infection, a rapid but fairly unspecific and short-lived response by the innate immune system is followed by the precisely targeted attack of the B and T cells of the adaptive immune system, followed by immune memory that can last a lifetime
BEIJING – Chinese regulators granted the marketing nod to Beijing-based Beigene Ltd.‘s PD-1 antibody, tislelizumab, for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. To be sold under the Chinese trade name Baize’an, tislelizumab is Beigene’s first drug to win approval in China, following an FDA approval for its BTK inhibitor, Brukinsa (zanubrutinib), last month.
Astellas Pharma Inc.’s early 2018 buyout of Universal Cells Inc. (UC) may have laid the groundwork for longer-range steps in allogeneic CAR T-cell therapy, but Xyphos Biosciences Inc. CEO James Knighton told BioWorld that the buyout of his firm provides the Tokyo-based giant for now with “an incredibly elegant solution that has tremendous potential.”
Unveiled by Oxfordshire, U.K.-based Immunocore Ltd. at the November meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Md., were encouraging new findings from the phase I/II study with tebentafusp (also known as IMC-gp100), a bispecific protein in the pivotal works for metastatic uveal melanoma (MUM). The results showed a correlation between treatment-induced immune response and improvement in overall survival (OS) and tumor shrinkage in advanced uveal as well as cutaneous melanoma.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency. Daiichi's Enhertu (trastuzumab deruxtecan), the subject of a $6.9 billion deal with Astrazeneca, won accelerated approval for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eisai's Dayvigo (lemborexant) was approved to treat insomnia. Intra-Cellular's Caplyta (lumateperone) was approved to treat schizophrenia. Allergan’s Ubrelvy (ubrogepant) became the first of a relatively new class of drugs to be approved for the acute treatment of migraine.
BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
Though they made known their reservations about the patient sample size and queried front-line vs. second-line use of tazemetostat, members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-0 to recommend approval of the oral, first-in-class EZH2 inhibitor from Cambridge, Mass.-based Epizyme Inc.
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