- 7 of 10 r/r NHL patients achieved complete response (70% CR rate) following treatment with NKX019 monotherapy at 1 billion and 1.5 billion CAR NK cells per dose in the Phase 1 dose escalation study
- Data demonstrate potential for redosing of allogeneic CD19 CAR NK to deepen response or restore response post-relapse
- Majority of patients achieved CR after a single cycle of NKX019
- Early safety data support potential of allogeneic CD19 CAR NK to be administered on outpatient basis
- No neurotoxicity / ICANS, graft versus host disease (GvHD), or > Gr3 cytokine release syndrome (CRS)
- 40% of eligible patients received NKX019 in the outpatient setting after first cycle
SOUTH SAN FRANCISCO, CA, USA I June 10, 2023 I 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 NKX019
NKX019 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 Nkarta
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 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.
SOURCE: Nkarta
Post Views: 405
- 7 of 10 r/r NHL patients achieved complete response (70% CR rate) following treatment with NKX019 monotherapy at 1 billion and 1.5 billion CAR NK cells per dose in the Phase 1 dose escalation study
- Data demonstrate potential for redosing of allogeneic CD19 CAR NK to deepen response or restore response post-relapse
- Majority of patients achieved CR after a single cycle of NKX019
- Early safety data support potential of allogeneic CD19 CAR NK to be administered on outpatient basis
- No neurotoxicity / ICANS, graft versus host disease (GvHD), or > Gr3 cytokine release syndrome (CRS)
- 40% of eligible patients received NKX019 in the outpatient setting after first cycle
SOUTH SAN FRANCISCO, CA, USA I June 10, 2023 I 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 NKX019
NKX019 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 Nkarta
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 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.
SOURCE: Nkarta
Post Views: 405
