By Vycellix –
– Single-step CD45-engager technology shows robust immune evasion with functional persistence in pre-clinical models
– Phase 1 study to evaluate ‘off-the-shelf’ natural killer cell cancer immunotherapy in the treatment of multiple myeloma
BOCA RATON, FLORIDA & STOCKHOLM, SWEDEN – December 3, 2025 – Vycellix, Inc., a biotechnology company developing next-generation allogeneic cell therapies designed to overcome the risk of immune rejection, today announced the successful completion of pre-clinical development for its universal cell engineering platform (VY-UC) with rigorous studies across many donor cell types proving robust immune evasion with functional persistence. The Company is now preparing for first-in-human clinical validation by seeking regulatory approval in Sweden to initiate a Phase 1 study for its lead VY-UC product candidate, a novel, off-the-shelf natural killer (NK) cell therapy (VNK-101) for patients with relapsed or refractory multiple myeloma. VY-UC is a single-step CD45 engager strategy intended to address a central barrier to donor-derived cell therapies, the host immune system’s rapid elimination of allogeneic cells. In pre-clinical studies, VY-UC expression enabled engineered donor cells to evade host cellular immune attack while retaining function, supporting the case for enhanced persistence and reduced need for immunosuppressive conditioning. The simplicity and modularity of this approach positions VY-UC as a highly capital efficient and capable alternative to gene editing dependent allogeneic platforms and enables broad applicability across multiple cell types and therapeutic programs. Vycellix evaluated the expression and function of VY-UC across multiple donor cell types, hematological and non-hematological, with results showing that the CD45 engager:
%2F2023%2F06%2F17%2Fimage%2Fjpeg%2FLSPbytnMRmOsLsXMMbnpUmcGhxrDLir4qS5SXWsc.jpg&w=1920&q=75 "New universal donor stem cell therapy to treat degenerative brain diseases")