Nkarta Inc. (NKTX) is scheduled to report updated clinical data from its ongoing clinical trial of NKX019, its CD19-directed CAR NK cell therapy candidate, today, December 5.
The company is developing allogeneic engineered natural killer (NK) cell therapies to treat cancer.
NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses NK cells derived from the peripheral blood of healthy donors and engineered with a chimeric antigen receptor (CAR) targeting the CD19 antigen and a membrane-bound form of IL15. CD19 antigen is a B cell marker and validated target for B cell cancer therapies.
A phase I study evaluating NKX019 as a multi-dose, multi-cycle monotherapy in patients with relapsed/refractory non-Hodgkin lymphoma (NHL), say, Large B cell lymphoma, Follicular lymphoma, Marginal zone lymphoma, Mantle cell lymphoma or B cell acute lymphoblastic leukemia, is underway. The trial is being conducted in two parts – dose finding and dose expansion.
Preliminary data from the dose finding portion of the phase I NKX019 trial were reported in April of this year. According to the data reported, 5 of 6 patients responded (83%) and 3 of 6 patients achieved complete response (50%) in NHL when receiving 3 doses of 1 billion cells of CAR NK cell dose.
The updated data from the trial to be presented today include safety and activity data from patients who received the 3-dose monotherapy treatment at the higher 1.5 billion CAR NK cell dose.
The company recently opened enrolment in the dose expansion portion of the phase I clinical trial of NKX019. This dose expansion will investigate for the first time NKX019 as combination therapy with approved biological cancer drug Rituximab in patients with r/r non-Hodgkin lymphoma, as well as NKX019 as monotherapy in patients with large B-cell lymphoma (LBCL) who previously received autologous CD19 CAR T therapy.
The other clinical investigational product of the company is NKX101, an NK cell cancer immunotherapy engineered to express a chimeric activating receptor (CAR) targeting NKG2D, a key activating receptor found on naturally occurring NK cells.
A phase I study to determine the safety and tolerability of NKX101 in patients with relapsed/refractory B-cell malignancies, say acute myeloid leukemia and higher-risk myelodysplastic syndrome, is underway.
Preliminary data from the phase I NKX101 trial, reported in April of this year, showed that three of five patients with heavily pre-treated AML treated at the two highest dose-level cohorts, i.e., 3 doses of 1 billion cells or 3 doses of 1.5 billion cells, achieved a complete response (60% CR) with hematologic recovery, with two of the three responses being MRD (measurable residual disease) negative.
MRD negativity is broadly viewed as an important quantitative measure of disease burden in AML and is associated with increased disease-free survival and decreased risk of recurrence, according to the company.
A clinical update on the NKX101 phase I trial is expected to be provided in the first half of 2023.
Nkarta ended September 30, 2022, with cash, cash equivalents, restricted cash, and short-term investments of $395.1 million.
The company made its debut on the Nasdaq Global Select Market on July 10, 2020, pricing its shares at $18 each.
NKTX has traded in a range of $7.55 to $20.35 in the last 1 year. The stock closed Friday’s trading at $8.59, up 2.63%.
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