Nkarta, Inc. (Nasdaq: NKTX) is shifting its focus to advancing NKX019 for multiple autoimmune diseases and will discontinue its development in non-Hodgkin lymphoma. This strategic decision follows a review of clinical data from a cohort of patients with large B-cell lymphoma (LBCL) and the evolving treatment landscape. The company believes NKX019 has the potential to transform patient care in autoimmune diseases.
Clinical Progress in Autoimmune Disease
Nkarta has made significant strides in the clinical development of NKX019 for autoimmune diseases:
- The first patient was dosed in Ntrust-1, a clinical trial evaluating NKX019 for the treatment of lupus nephritis. The first patient entered screening in June 2024.
- The first patient was dosed in the investigator-sponsored trial (IST) of NKX019 in systemic lupus erythematosus at Columbia University Irving Medical Center (CUIMC). The CUIMC IST was initiated in July 2024.
- Enrollment is ongoing in both studies.
Anticipated Milestones
Nkarta anticipates several milestones in its autoimmune disease program:
- Patient enrollment in Ntrust-2, a clinical trial of NKX019 for systemic sclerosis, myositis, and vasculitis, is expected to begin by the end of 2024. The Investigational New Drug (IND) Application for Ntrust-2 was cleared in June 2024.
- Preliminary clinical data from the Ntrust-1 and Ntrust-2 clinical trials are expected in 2025.
NKX019 in Non-Hodgkin Lymphoma
Nkarta provided an update on the NKX019 program in non-Hodgkin lymphoma (NHL):
- A cohort of seven patients with heavily pretreated large B-cell lymphoma (LBCL), whose disease progressed following treatment with a CD19 CAR T-cell therapy, received NKX019 on Days 0, 3, and 7 following lymphodepletion.
- There were no cases of Grade >2 cytokine release syndrome (CRS) and no cases of immune effector cell-associated neurotoxicity (ICANS).
- Five patients achieved a partial response after a first cycle of treatment. One of these five patients achieved a complete response with >6 months durability after receiving a second cycle of treatment.
- Nkarta aims to report final data from the LBCL cohort at a future medical conference.
- Nkarta will forgo further development in NHL and prioritize development efforts on autoimmune diseases.
Financial Highlights
As of September 30, 2024, Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities totaling $405.3 million. The company expects these funds to be sufficient to fund its current operating plan into late 2027.
Research and development (R&D) expenses for the third quarter of 2024 were $25.3 million, including $1.8 million in non-cash stock-based compensation expense.
General and administrative (G&A) expenses for the third quarter of 2024 were $8.5 million, including $2.3 million in non-cash stock-based compensation expense.
The net loss for the third quarter of 2024 was $28.3 million, or $0.39 per basic and diluted share. This net loss includes non-cash charges of $5.8 million, primarily consisting of share-based compensation and depreciation expenses.
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies.
About Ntrust Clinical Trials in Autoimmune Disease
Ntrust-1 and Ntrust-2 are multi-center, open-label, dose-escalation clinical trials that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable long-term remissions via a “reset” of the immune system through the elimination of pathogenic B cells. Patients receive three-dose cycles of NKX019 at 1 billion or 1.5 billion cells per dose following single-agent lymphodepletion with cyclophosphamide. No patients in either trial will receive supplemental cytokines or antibody-based therapeutics.
