Kiadis Pharma have filed the first investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for K-NK002, the company’s natural killer cell (NK-cell) therapy product.
With plans to initiate Phase I/II studies, Kiadis Pharma have filed the first investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for K-NK002, the company’s natural killer cell (NK-cell) therapy product. Utilizing Kiadis Pharma’s proprietary PM21 technology, the goal is to enable high-dose, low-cost, scalable and industrial NK-cell therapy production, while negating the risk of residual tumor cells in the final product.1
K-NK002 is being developed as an additional therapy to the current haploidentical hematopoietic stem cell transplant (haploHSCT) standard of care, with the objective of reducing relapse rates. NK-REALM (haploidentical NK-cells to prevent post-transplant RElapse in AML and MDS), will assess K-NK002 as an adjunctive treatment for hematological oncology patients undergoing haploHSCT with the standard of care, post-transplant cyclophosphamide (PTCy). The Phase I/II study will enroll 63 patients at leading transplant centers in the U.S and be conducted alongside the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).1
HSCT represents one of the only curative treatment strategies for both acute myeloid leukemia and myelodysplastic syndromes.2-4 Considering this, the prevention of relapse in the post-transplant population is critical, with the majority of patients who relapse after allogeneic HSCT not achieving long-term survival.5
Arthur Lahr, CEO of Kiadis Pharma, commented:
“The filing of this IND is an important step forward for Kiadis in bringing K-NK cell therapy to patients in need. Under normal circumstances, the FDA would take 30 to 60 days to review an IND, but given the current environment it is difficult to project a date for IND approval. Once approved, we are ready to immediately initiate the trial with the BMT CTN, and ramp up production of clinical materials.”1
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Döhner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010;115:453–474.
Fey MF, Dreyling M. ESMO Guidelines Working Group. Acute myeloblastic leukaemias and myelodysplastic syndromes in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(Suppl5):v158–v161.
Scott BL, Deeg HJ. Myelodysplastic syndromes. Annu Rev Med. 2010;61:345–358.
Levine JE, Braun T, Penza SL, et al. Prospective trial of chemotherapy and donor leukocyte infusions for relapse of advanced myeloid malignancies after allogeneic stem-cell transplantation. J Clin Oncol. 2002;20:405–412.
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