oNKord®
Glycostem invents novel treatment options for hematological indications and solid tumors with the company's first-generation Natural Killer (NK) cell-based immunotherapy product: oNKord®.
NK cells play an important role in control and even cure of both solid and hematological malignancies, like acute myeloid leukemia (AML) and multiple myeloma (MM). In allogeneic stem cell transplantation, NK cells have been shown to mediate graft-versus-leukemia immunity towards recipient tumor cells without attacking normal tissues, preventing graft-versus-host disease that is one of the risks when undergoing CAR-T treatment. In contrast to T cells, NK cells also have a natural killing mechanism recognizing MHC class I-negative targets, which are of great importance for inducing tumor rejection and which are tolerated by T cells.
NK cells can be used as a standalone and add-on therapy allowing multiple treatment options. oNKord® received an orphan drug designation for AML from both the EMA (2014) and FDA (2016).
Development
In collaboration with the Department of Hematology of the Radboud Medical Centre in Nijmegen (the Netherlands) a first-in-humans study has been conducted using oNKord®. This HOVON-associated study was designed for elderly acute myeloid leukemia (AML) patients who were not eligible for allogeneic stem cell transplantation. Ten elderly AML patients were treated in a phase I setting with excellent safety profile and strong indication of clinical efficacy. Year 1 survival data showed 80% compared to population data showing 35% for the group with no intervention.
Glycostem believes that oNKord® does not only have the potential to successfully treat AML patients but offers a platform to develop new NK-cell-based therapies in other disease areas such as: multiple myeloma and other hematological cancers as well as solid tumors (e.g. colorectal cancer, head and neck cancers, lung cancer and breast cancer).
Inaleucel as INN for oNKord®
Inaleucel has been added to the WHO recommended list as the international non-proprietary name (INN) oNKord®.
This enables Glycostem to use inaleucel as the single identical INN worldwide, in pharmacopoeias, labelling, publications, drug regulation, advertising, and other promotional materials. This is a significant step forward for scalable, allogeneic, off-the-shelf cell therapies, as they can now become a reality.
Serial killing of cancer cells by oNKord®
A recording under the microscope, showing the serial killing of cancer cells by oNKord® NK cells in vitro.
The experiment was conducted by Cellply. For more information please refer to the application note via the button after the video.