Opportunity in Cellular Immunotherapy with oNKord Unmodified Natural Killer Cells from Glycostem
Glycostem Therapeutics B.V. (“Glycostem” or the “Company”). Glycostem is a cell therapy company focused on developing stem cell-derived Natural Killer cells (NK cells) to treat cancer. Due to their tightly regulated “natural killing” of cancer cells, NK cells are the new star in the domain of cellular immunotherapy. They play an important role in treating hematological malignancies, like Acute Myeloid Leukemia (AML), Multiple Myeloma (MM) and possibly solid tumors.
The Sage Group represents Glycostem, a Netherlands-based company, in its efforts to establish a clinical development and commercialization partnership in the US for Glycostem’s first product, oNKord® (unmodified NK cells) which received Orphan Drug Designation from the FDA in 2016. oNKord® is derived from CD34+ cells from umbilical cord blood (UCB) and expanded, differentiated, and harvested using the Company’s proprietary manufacturing process, uNiK™, which received its GMP license in 2019 and was re-certified in November 2012.
Preclinical and Phase I data demonstrate the safety and efficacy of oNKord® in treating AML. These studies were conducted with oNKord® that were not cryopreserved and are designated GTA-001. The results were remarkable. Of the 10 subjects, after a single dose, 9 had a complete response (CR1) and one had a complete response (CR3) with an overall survival (OS) rate of 80% after one year and 50% after five years with a Progression Free Survival (PFS) rate of 60% and 40%, respectively. The Company has commenced a Phase I/IIa of oNKord® with cells manufactured by the uNiK™ process which are cryopreserved (off-the-shelf), feeder free and are designated GTA-002.
The Company has a strong IP position, with five (5) U.S. issued patents and 4 US. Patent applications. oNKord® has been out-licensed for Japan and Korea and a term sheet has been signed for the European market .
For a discussion with the management team or to ask further questions, please contact
Dr. Bill Mason & Wayne Pambianchi
Directors, The Sage Group
Tel +44 7785 950134