Glycostem announces new data presentation at EHA 2022 Congress highlighting early safety and clinical course of oNKord® in patients with Acute Myeloid Leukemia

OSS, Netherlands, May 13, 2022 /PRNewswire/ -- Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic allogeneic off-the-shelf Natural Killer (NK) cells, today announced that an abstract on further findings of patients treated in its phase I/IIa WiNK trial have been accepted and will be presented at the European Hematology Association (EHA) 2022 Congress, which will take place 9^th – 12^th June 2022 in Vienna, Austria. oNKord^® is the company's first-generation off-the-shelf allogeneic NK cell therapy under clinical development. Glycostem is furthermore developing a range of CAR-NK, combination therapy and TCR-NK products in-house.

"Achieving measurable residual disease (MRD) negativity is associated with longer-term survival in patients with AML. Our initial clinical data shows that all patients in the first dose cohort reached some level of MRD negativity with an excellent safety profile thus far," said Dr. Kai Pinkernell, CMO of Glycostem. "We are looking forward to the results on the following, increased dose levels, which we expect to further support the safety and activity of oNKord^® as shown in the early follow up."

The EHA abstract is now available at https://ehaweb.org/ as EHA-3555 with the title:

EARLY SAFETY AND CLINICAL COURSE OF PATIENTS WITH ACUTE MYELOID LEUKEMIA AND MEASURABLERESIDUAL DISEASE RECEIVING GTA002, AN OFF-THE-SHELF, EX VIVO-CULTURED ALLOGENEIC NK CELL PREPARATION

Glycostem will present the poster on Friday, 10^th June 2022 at 16:30 - 17:45 CEST.

About Glycostem

Netherlands-based Glycostem Therapeutics B.V., a clinical stage biotech company, developing allogeneic cellular immunotherapies to treat several types of cancer, by harnessing the power of stem cell-derived Natural Killer (NK) cells. NK cells have been shown to mediate graft-versus-leukemia (GVL) immunity towards recipient tumor cells without attacking recipients' normal tissues, which would otherwise lead to graft-versus-host disease (GVHD).

Glycostem's lead product, oNKord^®, is manufactured from allogeneic raw material and is available off-the-shelf, cryopreserved. Thanks to its nine patent families, longstanding technical expertise and resources, as well as orphan drug designation, Glycostem has secured a leadership position in the global NK-cell market with off-the-shelf products.

Beside of oNKord^®, Glycostem is developing a range of CAR-NK and TCR-NK products in-house and in cooperation with global partners.

About oNKord^®

oNKord^® is the company's first-generation Natural Killer (NK) cell-based immunotherapy product in clinical development. It gets produced in a closed system (uNiK^TM) in Glycostem's state-of-the-art and GMP (Good Manufacturing Practice) licensed production facility in the Netherlands, from which it can be distributed globally. The production technology includes ex vivo generation of high numbers of NK-cells derived feeder cell free from umbilical cord blood, with a high degree of purity for clinical applications.

About the WiNK clinical trial

The WiNK trial (NCT04632316) is a phase I/II clinical trial Glycostem to evaluate the safety and efficacy of oNKord^® in patients in completed remission, who have AML and MRD and are not undergoing hematopoietic stem cell transplantation. The clinical trial intends to enrol 33 AML patients at eight clinical sites based in five European countries. oNKord^® successfully passed a phase I clinical trial (elderly AML patients), providing safety data and first signs of clinical activity, including responses on MRD.

oNKord^® is a registered trademark of Glycostem in the US and Europe. viveNK^TM and uNiK™ are pending trademarks of Glycostem.

SOURCE Glycostem Therapeutics B.V.