Glycostem received GMP license for oNKord®
25th June 2019 - Glycostem Therapeutics BV today announced they have received GMP license for Glycostem’s proprietary closed production system used to manufacture their lead product, oNKord®, an off-the-shelf,allogeneic Natural Killer(NK) cell therapy.
Troels Jordansen, CEO said “This is a key milestone for Glycostem as it allows us to progress with our pivotal clinical trials in Acute Myeloid Leukemia (AML) to be followed by Multiple Myeloma (MM), two life-threatening hematologic malignancies with severe prognostic. But it is also a unique event in the cellular therapy sector as this is the first inspection leading to approval of a closed allogeneic cellular production systemin a class-C cleanroom. This major achievement allows for oNKord® production in class-C clean room which is more cost efficient than in class-A/B clean rooms; both in set-up and running costs.
“oNKord® is an off-the-shelf produc of NK-cells generated ex vivo from umbilical cord blood(UCB) and is an investigational product aiming at registration as Advanced Therapy Medicinal Product for use in immune oncotherapy. NK-cells are known for not inducing GvHD or cytokine storm, so a safe alternative to other cellular products. Multiple patients can currently be treated with a batch from one UCB donor, moreover planned automation steps and process improvements suggest to significantly reduce production costs and increase cell yields. This will drive down the production cost to a fraction of that of CAR-T-cell products. Glycostem expectsto start the above mentioned multicenter (8 sites) AML trial in 5 European countries in Q1 ‘20.