Nkarta Presents NKX019 Clinical Data at the European Hematology Association 2023 Congress and 17th International Conference on Malignant Lymphoma
June 10 2023 - 9:47AM
Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing
engineered natural killer (NK) cell therapies, today announced
presentations highlighting preliminary data based on a November
2022 data cut-off from its Phase 1 dose escalation clinical trial
of NKX019 at two scientific conferences: the European Hematology
Association (EHA) 2023 Hybrid Congress and the 17th International
Conference on Malignant Lymphoma (17-ICML). NKX019 is an
allogeneic, off-the-shelf NK cell therapy candidate derived from
healthy donors and engineered to target CD19.
Seven of ten patients with relapsed/ refractory non-Hodgkin
lymphoma (NHL) treated at the higher dose levels showed a complete
response (70% CR), including two patients with aggressive large B
cell lymphoma (LBCL) as well as other difficult histologies,
including mantle cell lymphoma (MCL), high-risk follicular lymphoma
(FL) and marginal zone lymphoma (MZL). No dose limiting toxicity,
neurotoxicity / ICANS, graft versus host disease (GvHD), or
>Grade 3 cytokine release syndrome (CRS) were observed in the
study.
“Autologous CAR-T cell therapies set a standard for responses in
patients with relapsed/ refractory B-cell malignancies. However,
potential for toxicity and logistic challenges have limited access
to these therapies, and many patients could still benefit from a
safe, on-demand treatment,” said Michael Dickinson, M.D., Lead,
Aggressive Lymphoma disease group, Clinical Haematology, Peter
MacCallum Cancer Centre and Royal Melbourne Hospital, and
investigator in the NKX019 trial. “In this early evaluation of an
allogeneic CAR-NK cell therapy candidate, NKX019 had a manageable
safety profile with encouraging anti-tumor activity as well as the
option for retreatment after relapse. Based on these early data,
NKX019 merits further study as a potential outpatient cell therapy
approach.”
“These data highlight the encouraging safety profile and
clinical activity across different histologies in the dose
escalation portion of the NKX019 study,” said David R. Shook, M.D.,
Nkarta’s Chief Medical Officer. “We continue to explore the
potential of allogeneic CAR NK cells, leveraging their biology to
create a differentiated cellular therapy, and we look forward to
the next update on the NKX019 program later this year.”
Nkarta’s presentation materials from EHA and ICML will be
available for download on the Nkarta website
(https://www.nkartatx.com/publications/). The presentations will
ensure that the broader clinical and academic community has the
opportunity to assess the NKX019 clinical data in a peer-reviewed
format. All data were previously disclosed at a company event in
December 2022. Nkarta plans to provide an update from the NKX019
program, including data from dose expansion cohorts, in 2023.
About NKX019NKX019 is an allogeneic,
cryopreserved, off-the-shelf cancer 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 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. To learn more
about the NKX019 clinical trial in adults with advanced B cell
malignancies, please visit ClinicalTrials.gov.
About NkartaNkarta 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 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: the
timing of release of additional NKX019 clinical trial data and the
nature of the data to be released; the anti-tumor activity and
safety profile of NKX019; the potential for NKX019 to be a
differentiated, outpatient cellular therapy; and the ability of
redosing with NKX019 to restore responses post-relapse. Clinical
data referenced in this press release are as of the November 28,
2022 data cut-off date and 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.
Interim data from clinical trials 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. The clinical trial program is ongoing, and the
final results may be materially different from those reflected in
any interim data we report. Further, others, including regulatory
agencies, may not accept or agree with Nkarta’s assumptions,
estimates, calculations, conclusions or analyses or may interpret
or weigh the importance of data differently, which could impact the
value of the particular program, the approvability or
commercialization of the particular product candidate or product
and the value of the company in general. In addition, the
information Nkarta chooses to publicly disclose regarding a
particular study or clinical trial is typically a summary of
extensive information, and you or others may not agree with what
Nkarta determines is the material or otherwise appropriate
information to include in Nkarta’s disclosure, and any information
Nkarta determines not to disclose may ultimately be deemed
significant with respect to future decisions, conclusions, views,
activities or otherwise regarding a particular product, product
candidate or business.
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 March 31, 2023, filed with the
SEC on May 11, 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.
Nkarta Media/Investor Contact:Greg MannNkarta,
Inc.gmann@nkartatx.com
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