Fate Therapeutics Reports Positive Interim Clinical Data from Programs for Patients with Relapsed / Refractory B-cell Lymphoma
Aug 20, 2021 By MarketDepth
Fate Therapeutics, Inc. (NASDAQ: FATE) a clinical-stage biopharmaceutical company which develops programmed cellular immunotherapies for cancer and immune disorders worldwide, reported on Friday positive interim clinical data from the Company’s FT516 and FT596 programs for patients with relapsed / refractory B-cell lymphoma. FT516 is the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.
“We are very pleased with the interim safety, response rates, and durability of responses observed in our ongoing clinical studies”Scott Wolchko, President and Chief Executive Offer of Fate Therapeutics
“We are very pleased with the interim safety, response rates, and durability of responses observed in our ongoing clinical studies of FT516 and FT596 for the treatment of patients with relapsed / refractory B-cell lymphomas. These data continue to demonstrate that our off-the-shelf, iPSC-derived NK cell product candidates can uniquely deliver substantial therapeutic benefit and expand patient access to cell-based cancer immunotherapies,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “At this time, we are initiating multiple indication-specific, dose-expansion cohorts to broadly assess FT516 in combination with CD20-targeted monoclonal antibody regimens, including in patients that have experienced disease progression following autologous CD19-targeted CAR T-cell therapy. In addition, early clinical data with the single-dose FT596 treatment schedule have shown robust 30-day response rates and we look forward to further assessing both single-dose and multi-dose treatment regimens to validate its potential best-in-class therapeutic profile.”
The FT596 Program is an ongoing clinical trial in relapsed / refractory B-cell lymphoma is assessing a single dose of FT596 as monotherapy (Monotherapy Arm) and in combination with a single dose of rituximab (375 mg/m2) (Combination Arm) following three days of conditioning chemotherapy (500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine).
The FT516 Program is a clinical trial in relapsed / refractory B-cell lymphoma is assessing FT516 in an off-the-shelf treatment regimen of up to two cycles, with each cycle consisting of three days of conditioning chemotherapy (500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine), a single dose of rituximab (375 mg/m2), and three weekly doses of FT516 each with IL-2 cytokine support.
In addition, The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs).