Nkarta Presents NKX019 Trial in Progress Poster at the 2021 ASH Annual Meeting and Exposition
Nkarta, Inc. (NASDAQ: NKTX) presented a trial in progress poster for NKX019, an investigational therapy targeting relapsed and refractory B-cell malignancies, at the 63rd ASH Annual Meeting. NKX019 utilizes allogeneic NK cells engineered to express a CAR targeting CD19. The Phase 1 clinical trial is evaluating safety and anti-tumor activity. Initial data is expected in 2022. The treatment aims to overcome limitations of existing therapies. B-cell cancers remain a significant health challenge, with over half a million new non-Hodgkin lymphoma cases diagnosed yearly.
- NKX019 is designed as an allogeneic, off-the-shelf therapy, potentially offering enhanced accessibility.
- The clinical trial is progressing in both Australia and the US, indicating broad interest and applicability.
- The company has yet to demonstrate commercial viability, with no approved products for sale.
- Nkarta faces significant risks including competition and dependence on clinical trial success.
SOUTH SAN FRANCISCO, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today presented a trial in progress poster on NKX019 for the treatment of relapsed and refractory B-cell malignancies at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH).
NKX019 is an allogeneic and off-the-shelf investigational NK cell therapy candidate that builds on the innate anti-cancer biology of NK cells and their positive safety profile. Using NK cells selected from healthy donors, NKX019 is engineered to express a chimeric antigen receptor (CAR) targeting the B-cell antigen CD19 and membrane-bound IL-15 to augment the activity of the NK cells.
“Nkarta is pleased to share the details of the ongoing NKX019 Phase 1 clinical trial and its innovative multi-dose and multi-cycle treatment regimen with the clinical community,” said Kanya Rajangam, MD, PhD, Chief Medical Officer of Nkarta. “Our vision is to establish new standards in cell therapy, integrating the power of innate immunology and the unique benefits of an engineered, off-the-shelf product to transform cancer treatment. The NKX019 clinical trial continues to advance at sites in Australia and the US, and we look forward to reporting initial data in 2022.”
The poster outlines the design of a Phase 1 clinical trial (NCT05020678) evaluating the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy in patients with B-cell malignancies that express CD19, a well-validated B-cell cancer target. The presentation also includes preclinical data that demonstrate NKX019 retains its anti-tumor activity against cancer cell lines that express very low levels of CD19.
Poster Title: A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects with B-Cell Malignancies
Presenter: Michael Dickinson, MBBS, DMed Sci, FRACP, FRCPA, Peter MacCallum Cancer Centre and Royal Melbourne Hospital
Session: 704. Cellular Immunotherapies: Clinical: Poster III
Date and Time: December 13, 2021, 6:00pm – 8:00pm ET
Publication Number: 3868
The poster is available on the ASH website and on the Nkarta website here. Additional information about the clinical trial is available on ClinicalTrials.gov.
About B-Cell Cancers
B-cell lineage cancers are a worldwide healthcare burden. Over 500,000 new cases of non-Hodgkin lymphoma (NHL) and 50,000 new cases of acute lymphoblastic leukemia (ALL) are diagnosed worldwide each year (seer.cancer.gov, Smith 2015, Solomon 2017). Despite progress in treatment, many patients diagnosed with this heterogeneous group of cancers still succumb to their diseases. Autologous chimeric antigen receptor (CAR) T cells specific for CD19 have altered the treatment landscape for some patients with relapsed or refractory (r/r) B-cell malignancies, though significant toxicities associated with T-cell expansion and the necessity for bespoke manufacturing have limited their use.
About the NKX019-101 Clinical Trial
The NKX019-101 clinical trial is a Phase 1, multi-center, open-label, dose-finding and dose-expansion study to evaluate the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy. Patients with CAR T naïve relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B-cell acute lymphoblastic leukemia (B-ALL) will be enrolled in the dose-finding portion of the study. Following the selection of a recommended Phase 2 dose, patients with r/r aggressive or indolent NHL, B-ALL, or CLL, including patients whose disease progressed despite treatment with a CD19 CAR-T cell therapy, will be enrolled in the dose-expansion portion of the trial. To learn more about the clinical trial of NKX019 in advanced B cell malignancies, please visit ClinicalTrials.gov.
About NKX019
NKX019 is an investigational, allogeneic, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor 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 and malignant B cells, and it is a validated target for B cell cancer therapies.
About Nkarta
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. 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 anti-tumor 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 plans for its NKX019 clinical trial; Nkarta’s ability to establish new standards in cell therapy and transform cancer treatment; the safety, anti-tumor activity, success, and accessibility of Nkarta’s NK cell therapy candidates, including NKX019 for the treatment of B-cell malignancies; the timing of initial NKX019 clinical trial data; and Nkarta’s ability to build and advance a pipeline of cell therapies. 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; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the success of its co-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; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.
These and other risks 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, 2021, filed with the SEC on November 10, 2021, 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.
Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
gmann@nkartatx.com
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