SOUTH SAN FRANCISCO, Calif., Dec. 09, 2023 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced a poster presentation at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition featuring follow-up data from its Phase 1 clinical trial that evaluates NKX101 in patients with relapsed or refractory acute myeloid leukemia (r/r AML). NKX101 is an allogeneic, off-the-shelf NK cell therapy candidate derived from healthy donors and engineered to target NKG2D ligands.
As reported in June 2023, of those patients who received NKX101 after a disease-specific lymphodepletion (LD) regimen comprising fludarabine and cytarabine (Flu/Ara-C), four of six achieved CR/CRi. In the follow up presented today, three of those four patients remained in CR/CRi at 4 months from treatment with NKX101. No cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD) of any grade were observed in these patients.
“While this data set is small, we’re encouraged to see responses and early durability in patients with high-risk features, including those who have relapsed after stem cell transplantation. Recent progress in therapy for r/r AML has been limited to targeted therapies, which only help a minority of patients. This all-comers study seeks to help patients without targetable mutations as well as those for whom these treatments are ineffective,” noted David R. Shook, MD, Chief Medical Officer of Nkarta. “We continue to evaluate NKX101 following Flu/Ara-C in this high-need patient population.”
Nkarta plans to provide an update from the NKX101 Flu/Ara-C LD cohort in the first half of 2024 that includes preliminary safety and response data from 12 to 20 additional patients.
Nkarta’s 2023 ASH poster will be available for download shortly after its scheduled presentation at http://www.nkartatx.com/publications/.
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with a membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support.
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com.
Cautionary Note on Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta’s expectations regarding any or all of the following: Nkarta’s position, plans, strategies, and timelines for the continued and future clinical development and commercial potential of NK cell therapies, including NKX101; the therapeutic potential, accessibility, tolerability and safety profile of NK cell therapies, including NKX101 for the treatment of AML; and Nkarta’s plans and timelines for the future availability and disclosure of NKX101 clinical trial data. Interim clinical data for NKX101 included in this press release are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more data on existing patients become available.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta’s limited operating history and historical losses; Nkarta’s lack of any products approved for sale and its ability to achieve profitability; the risk that the results of preclinical studies and early-stage clinical trials may not be predictive of future results; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the clinical success of its two lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta’s ability to obtain, maintain and protect its intellectual property; Nkarta’s dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; the availability of components and supplies necessary for the conduct of our clinical trials; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.
These and other risks and uncertainties are described more fully in Nkarta’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of Nkarta’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 9, 2023, and Nkarta’s other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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