Fate Therapeutics has had a third investigational new drug (IND) cleared for their first-in-class adaptive memory natural killer (NK) cell product, FATE-NK100. This latest nod from the FDA clears the product for trialing in women n women with ovarian cancer resistant to, or recurrent on, platinum-based treatment.
FATE-NK100 is NK cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells, expressing the maturation marker CD57 and the memory-like activating receptor NKG2C. FATE-NK100 is produced through a feeder-free, seven-day manufacturing process during which NK cells sourced from a healthy donor are activated ex vivo with pharmacologic modulators.
The latest IND is expected to initiate a ten person maximum dose trial in which subjects will be administered intraperitoneally with a single infusion of FATE-NK100. A second, dose escalation study is intended to test up to three dose levels of FATE-NK100 with one subject enrolled per dose level.
“Our ability to successfully and reproducibly manufacture FATE-NK100 enables, for the first time, the administration of therapeutic quantities of mature, highly cytotoxic NK cells to patients for the treatment of cancer. Multiple studies point to a distinct role for CD57+ NK cells in cancer immune-surveillance, where the acquisition of CD57 on NK cells is associated with a profound shift towards enhanced effector function and potency,” said Scott Wolchko, CEO. He continued, “We look forward to initiating a third clinical trial of FATE-NK100 in advanced malignancies, and are excited to see early clinical results from each of these studies in the coming months.”
Source: Fate Therapeutics Announces Publication of Preclinical Data in Cancer Research and FDA Clearance of Third IND for FATE-NK100 Press Release