Glycostem and medac enter into license, manufacturing, supply and commercialization agreement for Glycostem's lead product - oNKord®

OSS, Netherlands, Aug. 1, 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, and medac GmbH, an international pharmaceutical company based in Germany, will partner to commercialize Glycostem's lead product, oNKord^®. oNKord^® is currently in a phase I/II clinical trial across 10 hospitals in 5 European countries.

Under the terms of the agreement, medac receives an exclusive license to commercialize oNKord^® in the EU, the UK and further European countries for acute myeloid leukemia (AML) and multiple myeloma (MM) patients. Glycostem will receive an undisclosed upfront payment and through the manufacturing of oNKord^® a part of future revenues. Glycostem will also be eligible for payments upon achievement of certain development and sales milestones.

"This is our 2^nd commercialization agreement following the deal with inno.N for Korea and Japan. AML and MM patients desperately need new, safe and effective treatments, all over the world. This collaboration is of great importance as little is currently available for AML and MM patients and we are pleased to have been able to attract a partner in the caliber of medac," said Troels Jordansen, CEO.

"Like Glycostem, medac is committed to developing novel therapies, especially in areas of unmet medical need such as AML and MM. We believe in the high potential of oNKord^® and look forward to providing patients in need with this new and innovative treatment," said medac CBDO Heiner Will.

About Glycostem

Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company, develops allogeneic cellular immunotherapy to treat several types of cancer. By harnessing the power of stem cell-derived Natural Killer (NK) cells, Glycostem's products are a safe alternative to CAR-T-cells. Glycostem's lead product, oNKord^®, is manufactured from allogeneic raw material and is available off-the shelf. 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.

oNKord^® is produced in a closed system (uNiK^TM) in Glycostem's state-of-the-art and GMP (Good Manufacturing Practice) certified and 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 with a high degree of purity for clinical applications. oNKord^® successfully passed phase I clinical trial (elderly and frail AML - Acute Myeloid Leukemia - patients), providing solid safety data and strong indication of clinical activity, including response on MRD (Minimal Residual Disease). A I/IIa (pivotal) clinical trial is on-going to evaluate the safety and efficacy of oNKord^® in patients with Acute Myeloid Leukemia (AML). Glycostem is furthermore developing a range of CAR-NK and TCR-NK products in-house and in cooperation with global partners.

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

About medac GmbH

medac GmbH is a privately held, global pharmaceutical company with a growing pharmaceutical and diagnostics business. Since its foundation in Germany in 1970, medac has been specializing in the treatment of diseases within the indication areas oncology, hematology, urology and autoimmune disorders. medac is committed to the refinement of existing and the development of new therapeutic products – always with the focus on improving patients' quality of life. medac has become known for developing innovative products also in less common indications. This dedication has resulted in a comprehensive portfolio of pharmaceutical products that help make a difference in the lives of patients. medac continually invests in its product development and manufacturing as well as logistic capacities to meet both patients' needs and the demands of healthcare professionals. For more information visit https://international.medac.de/home/

SOURCE Glycostem Therapeutics B.V.