PNK-007 is an investigational immunotherapy being developed by Celgene to treat acute myeloid leukemia (AML) and multiple myeloma (MM).
How PNK-007 works
PNK-007 is a type of immunotherapy, a treatment that gives the immune system a boost to attack and remove cancer from the body.
There are several types of immune cells that are capable of identifying and attacking abnormal cells, such as tumor cells. One type, called natural killer (NK) cells, are innately capable of targeting cancer cells without requiring specific stimulation beforehand. PNK-007 takes advantage of this by delivering a dose of NK cells to the patient. It is hoped that once inside the body of the patient, these NK cells will expand and attack the tumor.
The NK cells in PNK-007 are derived from stem cells taken from the umbilical cord blood of healthy full-term babies. These cells are matured in the presence of several immune proteins, or cytokines, and expanded in the laboratory to produce a population of NK cells capable of killing cancer cells.
PNK-007 in clinical trials
Celgene is currently recruiting participants for a Phase 1 safety trial of PNK-007 (NCT02781467) in patients with AML. The trial aims to enroll 28 patients at multiple sites in the U.S. The primary goal of the trial is to determine the maximum safe dose of PNK-007 and look for adverse events that may arise due to the treatment.
The secondary objective is to gain a preliminary estimate of the potential anti-tumor activity of the treatment after 42 days by monitoring how many patients achieve complete remission.
Patients on the trial will initially receive chemotherapy with cyclophosphamide and fludarabine. PNK-007 will then be administered through an injection into a vein, followed by up to six injections of recombinant human interleukin-2 (rhIL2), a protein that leads to the proliferation of T-cells and regulates the immune response.
The chemotherapy and rh-IL2 will act to create an environment for PNK-007 to expand and act within the body. The trial is estimated to be completed in December 2019.
A second Phase 1 trial (NCT02955550), investigating the safety, efficacy, and maximum tolerated dose of PNK-007 in people with multiple myeloma, is currently recruiting participants at multiple sites across the U.S. The patients will receive autologous stem cell transplant therapy (ASCT) 14 days before they receive PNK-007 through an injection into the bloodstream. This will be followed by up to six injections of rhIL2. The trial is estimated to be completed at the end of November 2018.
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