A new generation of chimeric antigen receptor (CAR) T-cell therapies with advanced functions could hold the answer to improved safety and efficacy for these effective but potentially dangerous cancer therapies, shows research led by Boston University. The scientists showed it is possible to add ‘on’ or ‘off’ switches to CAR T cells, which can be activated using oral drugs with a known safety profile.
A new generation of chimeric antigen receptor (CAR) T-cell therapies with advanced functions could hold the answer to improved safety and efficacy for these effective but potentially dangerous cancer therapies, shows research led by Boston University. The scientists showed it is possible to add ‘on’ or ‘off’ switches to CAR T cells, which can be activated using oral drugs with a known safety profile.
Gilead Sciences Inc. said it is increasing manufacturing capacity to match an anticipated increase in demand for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), which gained FDA approval for a wider group of lymphoma patients late last week.
Allogene Therapeutics Inc. officials took many questions but had few answers during a conference call regarding the FDA’s clinical hold after the report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the phase I/II Alpha2 study.
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
Nearly a full month ahead of the PDUFA date, ADC Therapeutics SA said Friday the FDA has granted accelerated approval for Zynlonta (loncastuximab tesirine), a CD19-targeted antibody-drug conjugate for the single-agent treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indication includes the treatment of patients with diffuse large B-cell lymphoma not otherwise specified and those with DLBCL arising from low grade lymphoma and high grade B-cell lymphoma, which ADC's CEO Chris Martin said would be an important point of differentiation for the product.
Century Therapeutics Inc. raised $160 million in a series C round to progress its preclinical pipeline of allogeneic cell therapies for cancer, which are derived from induced pluripotent stem cells (iPSCs), and to expand its operational, laboratory and production facilities across several locations.
CAR T therapy developer JW Therapeutics Co. Ltd. launched a HK$2.325 billion (US$300 million) IPO in Hong Kong by issuing 97.7 million shares at HK$23.8 apiece on Nov 3. The listing is set to help the company’s march toward the goal of winning the first CAR T product approval in China.
Crispr Therapeutics AG's first stab at developing an allogeneic CAR T-cell therapy, CTX-110, looks promising, but the efficacy data were overshadowed by a death in the study.
Researchers at City of Hope have used a combination of oncolytic virus and CD19-targeting CAR T cells to first force expression of CD19 on tumor cells and then hunt down those cells, eradicating tumors in immunocompetent mouse models and endowing them with immunity to later re-administration of tumor cells.