Indapta Therapeutics has commenced the Phase I clinical trial of natural killer (NK) cell therapy IDP-023, treating the first patients with multiple myeloma and non-Hodgkin’s lymphoma.
The initial treatments were administered at the University of Texas MD Anderson Cancer Center and NEXT Oncology in Virginia, US.
The first patient in the trial received one dose of IDP-023, while the second subject has begun a regimen of three planned doses.
Future cohorts will receive three doses of the cell therapy, with some receiving it in combination with interleukin-2.
On validating the safety of this therapy regimen, the trial will progress to combining IDP-023 with monoclonal antibodies, rituximab and daratumumab, for patients with lymphoma and multiple myeloma patients, respectively.
Indapta has also confirmed the successful production of adequate quantities of the cell therapy to supply the Phase I clinical trial until the second half of this year.
The company's universal, allogeneic NK cell therapy platform utilises a subset of naturally occurring NK cells, known as g-NK cells. It significantly enhances the cancer-killing properties of monoclonal antibody therapy without needing genetic modification.
These g-NK cells, which emerge due to epigenetic changes from exposure to cytomegalovirus, are preferentially expanded from healthy donors having a high count of g-NK cells to create IDP-023.
Unlike other NK cell therapies, Indapta's off-the-shelf g-NK cell therapy is a cryopreserved asset characterised by reduced variability.
In preclinical studies, IDP-023 has shown increased potency and lasting antitumor activity when used in conjunction with cancer-targeting monoclonal antibodies versus standard NK cells.
Indapta CEO Dr Mark Frohlich said: “Based on the encouraging clinical activity of NK cells demonstrated by others and the superior activity of IDP-023 compared to conventional NK cells in preclinical models, we are looking forward to evaluating the safety and clinical activity of IDP-023 in this Phase I trial.
“We are very pleased with the high yields we are achieving in our GMP production runs.
“The recent improvements in our manufacturing process together with additional planned process changes should position us well for a competitive cost of goods by the time of product launch.”
