Healthcare professionals
Glycostem is focused on developing innovative off-the-shelf cell therapies for cancer patients. Our therapies are based on allogeneic Natural Killer (NK) cells generated ex vivo from umbilical cord blood. Our development program includes first and next generation NK cell therapy for patients in urgent need when no approved alternative option is otherwise available but palliative therapy. We are committed to supporting healthcare professionals who care for patients with cancer and share a common goal of improving clinical outcomes.
Our clinical products
oNKord® is an off-the-shelf clinical grade preparation of NK cells for infusion manufactured by Glycostem. oNKord® is expanded and activated ex vivo for the treatment of patients with hematologic malignancies like acute myeloid leukemia or multiple myeloma and also for the treatment of patients with solid tumors.
Genetic engineering of NK cells with Chimeric Antigen Receptor (CAR) or T cell Receptors (TCR) targeting specific molecular biomarkers and cancer cells is an option to enhance the safety and efficacy of NK cell therapy. Glycostem has started the pre-clinical development of next generation drug-candidates based on CAR-NK cell and TCR-NK cell products.
Clinical studies of combination therapies of NK cells with novel checkpoint inhibitors or with targeted therapy and chemotherapy of cancer can start within the framework of pharmaceutical partnerships.
Overview of current trials
oNKord®clinical development is designed to address areas of significant medical need. Currently the phase I/IIa (pivotal) trial is on-going to evaluate the safety and efficacy of oNKord® in patients with Acute Myeloid Leukemia (AML) in November 2020. The WiNK trial will enroll 33 AML patients at eight clinical sites based in five European countries. Read more about ongoing clinical trials of these therapies here. For more information or questions, please contact us.
oNKord® is an investigational therapy; oNKord® safety and efficacy have not been evaluated by the EMA, the FDA or any other health authority. oNKord® clinical evaluation is ongoing in European clinical trials and an Investigative New Drug Application (IND) in AML is pending in the USA.
Clinical Experience
In a phase I dose ranging study, a good safety profile for single infusion was demonstrated in 10 elderly and frail patients with acute myeloid leukemia (AML) not eligible for hematopoietic stem cell transplantation. Interestingly, year 1 survival data showed promising efficacy outcome (80%) compared to historical cohort data (35%.) Clinical development of oNKord® in hematologic malignancies with repeat infusion 4 days apart starts from 2020 onwards, based on the recommended phase II dose.
oNKord® has been granted the Orphan Drug Designation (ODD) in AML both by the European Medicines Agency (EMA) and by the US Food and Drug Administration (FDA). ODD in MM is pending at EMA and FDA.
Our platform technology
Glycostem has developed a platform technology for the ex-vivo expansion and differentiation of allogeneic hematopoietic stem and progenitor cells derived from umbilical cord blood (UCB). UCB is a safe and widely available biomaterial for medicinal product manufacturing.
The proprietary technology involves a cell culture process for the expansion of CD34+ hematopoietic stem and progenitor cells and further differentiation into fully functional Natural Killer (NK) cells, a key component of innate immunity. The technology enables highest potential for cell expansion without feeder layer (compared to peripheral blood derived NK cells), and highest cytotoxicity (compared to peripheral blood derived NK cells), and great placidity as well; which is optimal for genetic manipulation and design of next generation NK cell therapy based on CAR-NK or TCR-NK.
The platform is based on the use of closed bioreactor systems in combination with a proprietary synthetic cell culture medium (GBGM – Glycostem Basal Growth Medium) and a patented combination of growth factors. Glycostem’s manufacturing facilities in the Netherlands have been GMP licensed in 2019. The closed system technology enables the manufacture of clinical grade cryopreserved off the shelf products without any logistical challenge. As from 2020, these products can be shipped to various clinical sites involved in clinical trials of hematologic malignancies (acute myeloid leukemia, multiple myeloma) and solid tumors.