Nkarta Announces Initiation of Investigator-Sponsored Clinical Trial Evaluating NKX019 for Systemic Lupus Erythematosus
Nkarta, Inc. (Nasdaq: NKTX) has announced the initiation of an investigator-sponsored trial (IST) of NKX019, their allogeneic, CD19-directed CAR NK-cell therapy, for patients with systemic lupus erythematosus (SLE). The trial, led by Dr. Anca D. Askanase at Columbia University Irving Medical Center, will enroll up to 6 SLE patients, regardless of renal involvement. This IST complements Nkarta's ongoing Phase 1 Ntrust-1 trial of NKX019 in lupus nephritis patients.
The single-center, open-label Phase 1 IST will evaluate safety, clinical outcomes, and include translational and biomarker studies. Patients will receive NKX019 on Days 0, 7, and 14 following lymphodepletion with cyclophosphamide. Nkarta believes NKX019's reduced-toxicity regimen could potentially benefit a broader patient population, including those with less advanced disease.
Nkarta, Inc. (Nasdaq: NKTX) ha annunciato l'inizio di uno studio sponsorizzato da un investigatore (IST) su NKX019, la loro terapia CAR NK-cell allogenica diretta contro il CD19, per pazienti affetti da lupus eritematoso sistemico (LES). Lo studio, guidato dalla Dr.ssa Anca D. Askanase presso il Columbia University Irving Medical Center, arruolerà fino a 6 pazienti con LES, indipendentemente dal coinvolgimento renale. Questo IST completa il trial di Fase 1 Ntrust-1 in corso di Nkarta su pazienti con nefriti lupica.
Lo studio IST di Fase 1, condotto in un unico centro e a etichetta aperta, valuterà la sicurezza, gli esiti clinici e includerà studi traslazionali e sui biomarcatori. I pazienti riceveranno NKX019 nei Giorni 0, 7 e 14 dopo linfodeplezione con ciclofosfamide. Nkarta crede che il regime a bassa tossicità di NKX019 possa potenzialmente beneficiare una popolazione di pazienti più ampia, inclusi quelli con malattia meno avanzata.
Nkarta, Inc. (Nasdaq: NKTX) ha anunciado el inicio de un estudio patrocinado por investigadores (IST) de NKX019, su terapia CAR de células NK alogénicas dirigida contra CD19, para pacientes con lupus eritematoso sistémico (LES). El estudio, dirigido por la Dra. Anca D. Askanase en el Columbia University Irving Medical Center, inscribirá hasta 6 pacientes con LES, sin importar la implicación renal. Este IST complementa el ensayo Ntrust-1 en fase 1 de Nkarta en pacientes con nefritis lúpica.
El IST de fase 1, de un solo centro y abierto, evaluará la seguridad, los resultados clínicos, e incluirá estudios traslacionales y de biomarcadores. Los pacientes recibirán NKX019 en los Días 0, 7 y 14 tras la linfodepleción con ciclofosfamida. Nkarta cree que el régimen de baja toxicidad de NKX019 podría beneficiar potencialmente a una población de pacientes más amplia, incluyendo aquellos con enfermedad menos avanzada.
Nkarta, Inc. (Nasdaq: NKTX)는 시스템성 홍반 루푸스(SLE) 환자를 위한 그들의 동종 CD19 표적 CAR NK세포 요법인 NKX019에 대한 연구자 주도 임상 시험(IST)의 시작을 발표했습니다. 이 시험은 Columbia University Irving Medical Center의 Anca D. Askanase 박사가 이끌며, 신장 관련 여부와 관계없이 최대 6명의 SLE 환자를 등록할 예정입니다. 이 IST는 루푸스 신염 환자에 대한 Nkarta의 진행 중인 1상 Ntrust-1 시험을 보완합니다.
단일 센터, 개방형 1상 IST는 안전성, 임상 결과를 평가하며 전이 연구 및 바이오마커 연구를 포함할 것입니다. 환자들은 사이클로포스파미드로 림프 감소 후 0, 7, 14일에 NKX019를 받게 됩니다. Nkarta는 NKX019의 저독성 요법이 상대적으로 병이 덜 진행된 환자들을 포함하여 더 넓은 환자 집단에 혜택을 줄 수 있다고 믿습니다.
Nkarta, Inc. (Nasdaq: NKTX) a annoncé le lancement d'un essai sponsorisé par un investigateur (IST) de NKX019, leur thérapie CAR à cellules NK allogènes dirigée contre CD19, pour des patients atteints de lupus érythémateux systémique (LES). L'essai, dirigé par la Dr Anca D. Askanase au Columbia University Irving Medical Center, recrutera jusqu'à 6 patients atteints de LES, quel que soit l'implication rénale. Cet IST complète l'essai de Phase 1 Ntrust-1 en cours de Nkarta sur des patients atteints de néphrite lupique.
L'IST à centre unique et ouvert de Phase 1 évaluera la sécurité, les résultats cliniques et comprendra des études translationnelles et des biomarqueurs. Les patients recevront NKX019 aux Jours 0, 7 et 14 après une lymphodéplétion avec cyclophosphamide. Nkarta pense que le régime à faible toxicité de NKX019 pourrait potentiellement bénéficier à une population de patients plus large, y compris ceux ayant une maladie moins avancée.
Nkarta, Inc. (Nasdaq: NKTX) hat den Beginn einer vom Investigator gesponserten Studie (IST) von NKX019, ihrer allogenen, CD19-gesteuerten CAR-NK-Zelltherapie für Patienten mit systemischem Lupus erythematodes (SLE), angekündigt. Die Studie, die von Dr. Anca D. Askanase am Columbia University Irving Medical Center geleitet wird, wird bis zu 6 SLE-Patienten einschließen, unabhängig von einer Nierenbeteiligung. Dieses IST ergänzt die laufende Phase-1-Studie Ntrust-1 von Nkarta bei Patienten mit Lupusnephritis.
Die einzentralisierte, offene Phase-1-IST wird die Sicherheit, klinische Ergebnisse sowie translational und biomarker-Studien bewerten. Die Patienten erhalten NKX019 an den Tagen 0, 7 und 14 nach einer Lymphodepletion mit Cyclophosphamid. Nkarta glaubt, dass das reduzierte Toxizitätsregime von NKX019 möglicherweise einer breiteren Patientenpopulation, einschließlich solcher mit weniger fortgeschrittener Erkrankung, zugutekommen könnte.
- Expansion of NKX019 clinical evaluation to include systemic lupus erythematosus (SLE) patients
- Collaboration with prestigious academic institution (Columbia University Irving Medical Center)
- Potential to reach a broader patient population with reduced-toxicity lymphodepletion regimen
- Small sample size of up to 6 patients in the investigator-sponsored trial
- Early-stage (Phase 1) trial with no guarantee of success or efficacy
Insights
The initiation of the investigator-sponsored clinical trial of NKX019 for systemic lupus erythematosus (SLE) marks a significant step in the treatment of autoimmune diseases. With this trial, Nkarta is expanding the therapeutic potential of its NK cell therapy beyond cancer. Understanding that traditional lupus treatments often involve toxic medications, this novel approach could represent a paradigm shift. Should NKX019 demonstrate safety and efficacy, it may open the door to new, less toxic treatment options, potentially driving Nkarta's stock upwards.
From a market perspective, the broadening of NKX019’s clinical applications to include SLE is a strategic move that diversifies Nkarta's pipeline. This expansion diminishes the company's reliance on any single indication and may attract a wider range of investors. If the trial shows positive results, it could significantly boost investor confidence and enhance Nkarta’s market valuation. However, the risks inherent in early-stage clinical trials should not be overlooked and any setbacks could have negative implications for the stock.
Investors should note that the financial implications of successful clinical trials can be substantial. Positive outcomes would likely result in increased funding opportunities and higher market capitalization for Nkarta. The collaboration with Columbia University Irving Medical Center also lends credibility and may reduce investor concerns regarding trial execution and integrity. However, given the early phase of this trial and the small sample size, it is important for investors to maintain a balanced view, keeping an eye on subsequent trial phases and broader financial health of the company.
SOUTH SAN FRANCISCO, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced that researchers at Columbia University Irving Medical Center (CUIMC) have initiated an investigator-sponsored trial (“IST”) of NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with systemic lupus erythematosus (SLE). The IST broadens the clinical evaluation of NKX019 in lupus. In June 2024, Nkarta announced the initiation of Ntrust-1, its Phase 1 clinical trial of NKX019 in patients with lupus nephritis (LN).
The single-center, single-arm, open-label Phase 1 IST is being led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at CUIMC and the Director of Rheumatology Clinical Trials.
“People with lupus face significant challenges, including years of exposure to toxic/partially effective medications,” said Dr. Askanase. “Cell therapy provides the hope of long-term, medication-free remission.”
The CUIMC IST is designed to enroll up to 6 patients with SLE, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are also planned. Patients receive NKX019 on Days 0, 7 and 14 following single-agent lymphodepletion with cyclophosphamide. Patient screening is underway.
Systemic lupus erythematosus (SLE) is an autoimmune disease that causes the body’s immune system to attack its own tissues. The dysregulated immune system produces antibodies that can affect various organs, including the skin, joints, kidneys, heart, and brain. Symptoms can include fatigue, joint pain, or severe life-threatening organ disease. SLE can cause lupus nephritis (LN), a severe complication that affects the kidneys.
“With its reduced-toxicity lymphodepletion regimen, enabled by cytokine engineering, we believe that NKX019 has potential to reach more patients, including those with less advanced disease,” said David R. Shook, M.D., Nkarta’s Chief Medical Officer and Head of R&D. “We’re eager to collaborate with our academic partners at Columbia and look forward to making a difference in the lives of people living with autoimmune diseases like lupus.”
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 Nkarta
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf, on-demand 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 (or the expectations of others) regarding any or all of the following: the therapeutic potential of cell therapies, including NKX019, for the treatment of autoimmune disease, including lupus; and the accessibility, tolerability, advantages, and safety profile of NKX019 and single-agent cyclophosphamide lymphodepletion.
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 NKX019; that Nkarta may be delayed in initiating, enrolling or completing its 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; and the complexity of the manufacturing process for CAR NK cell therapies.
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 March 31, 2024, filed with the SEC on May 9, 2024, 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.
FAQ
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