Glycostem

Glycostem Therapeutics, a Dutch clinical-stage biotechnology company founded in 2007, is concentrated on developing allogeneic cell therapies for cancer. The company's core business revolves around harnessing the therapeutic potential of Natural Killer (NK) cells derived from umbilical cord blood stem cells to treat various hematological malignancies and solid tumors. Glycostem's technology originated at the German Cancer Institute and was later advanced at Radboud University Medical Centre under the scientific guidance of Dr. Jan Spanholtz.

The company's business model involves in-house research, development, and manufacturing of its cell therapy products, complemented by strategic partnerships for commercialization and further development. Glycostem serves the immuno-oncology market, providing potential treatments for critically ill cancer patients, such as those with Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM). Revenue streams are anticipated from product sales post-approval and through collaboration agreements with other pharmaceutical and biotech companies.

Glycostem's lead product is oNKord®, an off-the-shelf, allogeneic NK cell therapy. A key feature of oNKord® is that it is derived from allogeneic raw materials, making it readily available for patient treatment without the lengthy and costly process of harvesting a patient's own cells. The production process utilizes a proprietary, closed bioreactor system with a feeder cell-free culture medium, ensuring high purity and scalability. This method allows for the large-scale manufacturing of highly active NK cells. oNKord® has demonstrated a strong safety profile and indications of clinical efficacy in a Phase I trial for elderly AML patients. The therapy has received Orphan Drug Designation from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for AML and MM, which provides incentives and an accelerated path to market. The company initiated a pivotal Phase I/IIa trial for oNKord® in AML patients across Europe in late 2020. Beyond its lead product, Glycostem is advancing its pipeline with second-generation therapies, including Chimeric Antigen Receptor (CAR)-engineered NK cells (viveNKTM) and T-cell receptor (TCR)-engineered NK cells, to enhance tumor targeting and persistence.

The company's leadership includes Troels Jordansen, who became Chairman in 2014 and has served as CEO since July 2016. Jordansen brings extensive experience from a career spanning over two decades in the cellular therapy sector, having worked with companies like Genzyme, IsoTis, and as a co-founder of Azellon Ltd. His background covers sales, marketing, and general management, with a track record of raising significant capital for both private and public companies. This deep industry experience is pivotal in guiding Glycostem's clinical and corporate development strategy. Keywords: cellular immunotherapy, Natural Killer cells, NK cell therapy, allogeneic cell therapy, oNKord, cancer treatment, Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), immuno-oncology, GMP manufacturing, stem cell-derived NK cells, umbilical cord blood, off-the-shelf therapy, CAR-NK, TCR-NK, viveNK, clinical-stage biotech, hematological malignancies, solid tumors, biopharmaceutical, cancer research, cell-based immunotherapy, Jan Spanholtz, Troels Jordansen, orphan drug