Nkarta Inc. (NASDAQ: NKTX) is up 40% after announcing positive preliminary Phase 1 findings from its dose-finding trials of NKX101 and NKX019 in hematological malignancies. NKX101 and NKX019 are two leading chimeric antigen receptor natural killer cell therapies the company is developing for two different sets of hematologic malignancies.

NKX101 and NKX019 demonstrated positive single-agent activity in subjects

CEO and President Paul J. Hastings said:


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We’re excited to see our CAR NK co-lead candidates, NKX101 and NKX019, show such striking early single-agent activity in heavily pretreated patient populations, with an exceptional safety profile without the side effects associated with CAR T cell therapies.

In the first assessing NKX101 in r/r myelodysplastic syndrome and acute myeloid leukemia, three out of the five subjects with heavily pretreated AML that were given a high dose level in the three-dose treatment plan attained a complete response of 60% with hematologic recovery and two if the three responses were minimal residual disease (MRD) negative. It is vital to note that currently, this patient population doesn’t have an approved standard of care.

Three of six subjects treated at the higher dosages in the three-dose treatment plan in the second study, assessing NKX019 in r/r B cell malignancies, demonstrated a complete response (50% CR), with one subject with aggressive diffuse large B cell lymphoma (DLBCL) and another with mantle cell lymphoma (MCL). There weren’t any dose-limiting toxicities or CAR T-like adverse reactions of any severity in either trial.

Hastings added:

These encouraging data across multiple indications further validate Nkarta’s best-in-class NK cell platform, as we seek to transform cancer treatment by bringing together the safety advantages of NK cells with an off-the-shelf modality designed to make the benefits of cell therapy accessible in a community setting.

NKX101 is cancer immunotherapy targeting NKG2 ligands in cancer cells

The company is studying NKX101 as potential off-the-shelf oncology immunotherapy that uses NK cells to target NKG2D ligands in tumor cells. So far, the company has enrolled and doses 17 subjects with AML and 4 with MDS.

Study investigator Marcello Rotta said:

Relapsed/refractory acute myeloid leukemia (AML) is a historically hard-to-treat disease, and given the lack of effective treatments, people with cancer and those who treat them are faced with few options. Complete responses with corresponding MRD negativity in r/r AML using engineered NK cells, as seen in these preliminary findings, is encouraging.

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