Eureka Therapeutics Announces Positive Preliminary Results of ET190L1-ARTEMISTM T-cell China Proof-of-Concept Human Clinical Study in Relapsed and Refractory (r/r) B-cell Lymphoma at ASCO Annual Meeting
- Category: DNA RNA and Cells
- Published on Monday, 04 June 2018 19:56
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No Cytokine Release Syndrome observed to date
EMERYVILLE, CA, USA I June 04, 2018 I Eureka Therapeutics, Inc., a clinical stage biopharmaceutical company with the goal of curing cancer by developing novel T-cell therapies that harness the evolutionary power of the immune system, today announced the publication of preliminary results of its lead product candidate, ET190L1-ARTEMIS, in relapsed and refractory (r/r) B-cell lymphoma patients in a proof-of-concept clinical study being conducted at Beijing Cancer Hospital in China. ET190L1-ARTEMIS utilizes Eureka’s proprietary ARTEMISTM T-cell receptor platform and proprietary human anti-CD19 antibody to target CD19-positive malignancies. In preclinical studies, ET190L1-ARTEMIS matched the cancer killing potency of current CAR-T therapies but with a dramatic reduction in the levels of inflammatory cytokines released. The preliminary results from the clinical study have been published during the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting Poster Session.
- As of May 30, 2018, 21 adult patients with CD19-positive (CD19+) r/r B-cell lymphoma, have received autologous ET190L1-ARTEMIS T-cells, and 17 subjects have completed the 1 month safety and efficacy assessment.
- The overall response rate was 65% (11/17), including 7 patients with complete metabolic response (CMR), 3 patients with partial response (PR) and 1 patient with stable disease (SD).
- ET190L1-ARTEMIS T-cell therapy appeared well tolerated with no observed cytokine release syndrome (CRS) or neurotoxicity.
- In all subjects who achieved complete metabolic response (CMR) at Month 1 continued to exhibit CMR at Month 3.
- Phase I clinical trial in the United States for CD19+ r/r NHL was initiated at Duke University in April 2018.
- Phase I clinical trial in the United States for r/r pediatric and young adult B-cell acute lymphocytic leukemia is expected to be initiated in 2018.
The findings from this ongoing clinical study funded by Eureka demonstrated a favorable safety profile of ET190L1-ARTEMIS T-cell therapy with no observed CRS or neurotoxicity and sustained response in r/r B-cell lymphoma patients. As of May 30, 2018, 21 adult patients received a single infusion of autologous ET190L1-ARTEMIS T-cells, 3 in the 1×106 cells/kg cohort, 13 in the 3×106 cells/kg cohort, and 5 in the 6×106 cells/kg cohort. 17 subjects have completed the one-month safety and efficacy assessment. Expansion of ET190L1-ARTEMIS T-cells after infusion was observed in all patients. Post-infusion plasma levels of IL-2, 4, 6, 8, 10, IFNγ, TNFα, and GM-CSF were below detection at most time points. Vital signs were normal except for 13 patients who had transient fever (37.5-39°C) from day 2 to day 4 post-infusion. These patients either spontaneously recovered or were re-hydrated with saline infusion. One patient from the 1 × 106 cells/kg cohort developed a transient skin rash and required no treatment.
"We’re excited to present these data as the results of our first-in-human proof-of-concept clinical study, ET190L1-ARTEMIS in r/r B-cell lymphoma patients, are very encouraging,” said Cheng Liu, Ph.D, President and Chief Executive Officer of Eureka Therapeutics. “The anti-tumor activities coupled with the favorable safety profile with no cytokine release syndrome and neurotoxicities observed, demonstrate a significant milestone for Eureka as we continue to execute on our goal of developing the next evolution of T-cell immunotherapies that are widely accessible to cancer patients. As we enter into the remainder of 2018, we are excited to continue on this momentum with the anticipated dosing in the second half of 2018 of our first patient in the United States in our concurrent Phase 1 clinical trial of ET190L1-ARTEMIS in CD19+ r/r NHL, which we initiated in April 2018 pursuant to an effective IND."
About Eureka Therapeutics, Inc.
Eureka Therapeutics is a privately held, clinical stage biopharmaceutical company with the goal of curing cancer by developing novel T-cell therapies that harness the evolutionary power of the immune system. Eureka Therapeutics is based in Emeryville, CA. ARTEMIS is a trademark owned by Eureka Therapeutics, Inc. For more information on Eureka Therapeutics, please visit www.eurekatherapeutics.com.