Zelluna & Glycostem Announce Development, License & Supply Agreement

Zelluna Immunotherapy and Glycostem Therapeutics BV recently announce they have entered into a development, license, and supply agreement. This collaboration will focus on the development and manufacture of allogeneic TCR guided NK-cell therapies (TCR-NK’s) for the treatment of patients with cancer.

“This partnership between Zelluna and Glycostem represents a critical milestone in Zelluna’s aim to transform cell therapy treatments by enabling more patients to be treated effectively, rapidly and safely. It is the industry’s first commercial development partnership of TCR-NK cells for treating cancer aiming at the rapid translation of our proprietary TCR-NK approach,” said Miguel Forte, CEO, Zelluna. “Zelluna selected Glycostem as a partner for the delivery of TCR-NK therapies for their expertise in NK-cell science, GMP manufacturing and clinical testing of NK-cell products. The development of TCR-NK programs will run in parallel to Zelluna’s autologous TCR-T development programs, including its lead autologous T-cell product entering the clinic next year. Zelluna’s vision of cell therapies continues to be autologous and allogeneic products delivering much needed patient benefit.”

Currently, NK-cell based therapies such as CAR-NK’s are receiving considerable interest from the wider cell therapy community. Through the partnership with Glycostem, Zelluna is enabling its proprietary TCR-NK approach with the potential to target a broader repertoire of tumor associated antigens by targeting NK-cells with TCRs for treatment of patients with solid cancers.

Zelluna will lead the development and commercialization of TCR-NK products with its TCRs and TCR development competence. Glycostem will contribute by manufacturing clinical grade umbilical cord derived NK-cells, NK-cell expertise, product process development, and clinical and commercial supply. Zelluna and Glycostem will be able to manufacture upfront a large number of patient doses to store and ship to clinical sites upon demand in an “off-the-shelf” manner.

“We are very proud to be collaborating with Zelluna, a transformative TCR cell therapy company to jointly develop allogeneic TCR-NK products for the benefit of hard to treat patients. This partnership will enable Glycostem’s NK-cells to deliver increased efficacy against solid tumors in a TCR-NK product using Zelluna’s TCR targeting mechanism,” said Troels Jordansen, CEO, Glycostem. “This is further confirmation of the significant interest in NK-cell products and an external validation of Glycostem’s abilities which supports our commercial and scientific ambitions; taking cellular immunotherapy to the next level.”

Zelluna Immunotherapy is a company developing transformative T cell receptor (TCR) based cellular immunotherapies for the treatment of solid cancers. The company is developing a unique portfolio of tumor specific TCR’s that target the MHC class II pathway to broadly engage the host immune system to provide a safe, efficient and durable clinical response. The company is developing therapies based on the effector functions of autologous T cells (TCR-T) and allogeneic NK cells (TCR-NK). Both of these platforms have their unique advantages and provides the opportunity to attack cancers from multiple angles and improve access to these advanced therapies to a large patient population. For more information, visit www.zelluna.com.

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(R), 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(R) is produced in a closed system 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 with a high degree of purity for clinical applications. oNKord(R) 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). Results indicate that oNKord(R) may be safely infused in AML patients. Glycostem is furthermore developing a range of CAR-NK products in-house and in cooperation with amongst other global partners MolMed SPA (BIT:MLM).