On December 13, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported 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) (Free ASH Whitepaper) (Press release, Nkarta, DEC 13, 2021, View Source [SID1234597017]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 (Free ASH Whitepaper) 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.