On April 25, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported data from the ANCHOR Phase 1 study of KUR-502 during an oral presentation by Carlos Ramos, M.D., professor, Center for Cell and Gene Therapy, Baylor College of Medicine, at the Tandem Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT), and the Center for International Blood & Marrow Transplant Research (CIBMTR), taking place April 23 to 26, in Salt Lake City, UT (Press release, Athenex, APR 25, 2022, View Source [SID1234612898]).
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"Encouraging data from the interim update of the ANCHOR study further support the promising efficacy and favorable safety profile of KUR-502 in heavily pretreated patients with hematological malignancies," said Dan Lang, M.D., President of Athenex Cell Therapy. "It is exciting to see the therapeutic benefit of our CAR-NKT cell therapy persists as the ANCHOR study matures, particularly in patients who have already progressed on autologous CAR-T therapy. We intend to collect additional patient data as we expand the study to include more sites and look forward to providing another update later this year."
Highlights from the interim update include response data from seven evaluable patients, including two additional patients who were previously too early to assess (1 NHL, 1 ALL):
One patient with NHL had stable disease (SD), and a second patient with ALL had progressive disease (PD) at the 4-week assessment
Two CRs persisted for more than 6 months with one at 34 weeks and still ongoing
Two responses (1 CR and 1 PR) were observed in patients who had relapsed after previous autologous CAR-T therapy
Excellent safety with no immune effector cell-associated neurotoxicity syndrome (ICANS) and no graft versus host disease (GvHD) attributable to CAR-NKT cells
Grade 1 cytokine release syndrome (CRS) in 2 ALL patients
NHL Patients
(n=5) ALL Patients
(n=2) Total
(n=7)
CR 2 40% 1* 50% 3 43%
PR 1 20% 0 - 1 14%
ORR 3 60% 1* 50% 4 57%
DCR 4 80% 1* 50% 5 71%
*Patient B1 from the ALL cohort had a complete response with incomplete hematologic recovery (CRi)
About the Phase I Study of KUR-502 (Allogeneic CD19 CAR-NKT Cells) in Patients with Relapsed or Refractory B-Cell Malignancies (ANCHOR)
The Phase 1 study is an open-label, dose-escalation trial. NKT cells were isolated from the leukapheresis product of one HLA-unmatched healthy individual, transduced with the CAR, expanded ex vivo for 14 days (99.8% NKT purity), and cryopreserved. Subjects were treated in an outpatient setting and received 107 (DL 1) or 3×107 (DL 2) CAR-NKT cells per square meter of body surface area following lymphodepleting conditioning with cyclophosphamide/fludarabine. Adverse events were evaluated per NCI criteria. When accessible, patients underwent core biopsies of an involved site at 2-5 weeks post-infusion. Response to therapy was assessed at 4 weeks per Lugano Criteria (for NHL) or NCCN guidelines (for ALL).
For further information about the study, visit ClinicalTrials.gov, identifier: NCT03774654. The abstract "Allogeneic NKT Cells Expressing a CD19-Specific CAR in Patients with Relapsed or Refractory B-Cell Malignancies" presented at the 2022 Transplantation & Cellular Tandem Meetings of ASTCT and CIBMTR can be viewed here.