- 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

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:

• Disrupted immune synapse formation and abrogated immune rejection
• Demonstrated specificity with no off-target interactions detected across more than 6,500 human membrane and secreted proteins
• Enabled durable engraftment and maintained effector function in humanized models

Vycellix plans to submit its findings for peer-reviewed publication and present the data at upcoming international meetings, providing external validation.

According to Vycellix’s founding Chairman, Evren Alici, M.D., Ph.D., “Our mission is to deliver therapies that outperform the increasingly complex therapeutic landscape by focusing on scalability, persistence and simplicity. VY-UC represents a new engineering approach that allows donor-derived cells to function longer and more consistently in patients with the potential manufacturing cost profile optimized for broad commercial deployment.” Dr. Alici serves as the head of the Cell & Gene Therapy Group at Karolinska Institutet (KI), Sweden.

The Company’s foundational science was developed at KI and Vycellix is a partner in ‘NextGenNK’, Sweden’s Innovation Agency’s Competence Center focused on the development of next-generation NK cell therapies.

To view VY-UC mechanism-of-action video, please visit:

https://vycellix.com/universal-cells-2026/

About VY-UC:

VY-UC is a universal cell engineering technology designed to impart immune-evasive properties to donor cells, irrespective of cell type, through a single engineering step using a proprietary CD45 engager. The simplicity and scalability of VY-UC make it a potential foundation for multiple therapeutic franchises including oncology, transplantation and autoimmunity.

About VNK-101 Clinical Trial:

Vycellix is preparing for regulatory interactions with the Swedish Medical Products Agency (MPA) to initiate a Phase 1 clinical trial of VNK-101, allogeneic NK cell therapy engineered with VY-UC. The study will focus on relapsed or refractory multiple myeloma, a high burden market segment in which rapid delivery and the possibility of reduced conditioning could create competitive advantages for off-the-shelf therapies.

About Vycellix, Inc.

Headquartered in Florida with scientific operations in Sweden, Vycellix is a biotechnology company with the mission to deliver superior outcomes for patients through the delivery of highly innovative allogeneic medicines that eliminate the risk of immune rejection.

Beyond VY-UC, the Company’s cell engineering platforms represent ideal solutions to enhance and optimize multi-antigen engagement (VY-GAGE), gene delivery (VY-OZ), cell expansion (VY-M), and cell potency (VY-X).

For more information, please visit: www.Vycellix.com

Forward Looking Statements:

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the pre-clinical, regulatory, clinical and/or commercial development and all anticipated uses of VY-OZ, VY-X, VY-M, VY-UC and VY-GAGE, and the Company’s plans for seeking out-licensing opportunities for these assets. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with immuno-discovery product development, including risks associated with advancing products to human clinical trials and/or ultimately regulatory and commercial success which is subject to the uncertainty of regulatory approval, market adoption and other risks and uncertainties affecting Vycellix and its development programs. Other risks and uncertainties of which Vycellix is not currently aware may also affect Vycellix’s forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. Vycellix undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251203373099/en/

Vycellix's universal cell platform (VY-UC) represents a breakthrough solution to overcoming the central barrier to donor derived-therapies, preventing the host immune system's rapid elimination of allogeneic cells.