Agreement establishes a phased technology-transfer program for the RNK001/HSPC-NK platform and creates a framework for future CAR-NK development
SÃO PAULO, Brazil and NIJMEGEN, the Netherlands — September 2026 — Cryopraxis, BioNK and Radboud university medical center (Radboudumc) have entered into a collaboration agreement to transfer and establish in Brazil technology for the manufacture of allogeneic Natural Killer (NK) cells derived from umbilical cord blood hematopoietic stem and progenitor cells.
The initial focus of the collaboration is RNK001, an investigational, unmodified NK-cell product generated ex vivo from CD34+ hematopoietic stem and progenitor cells (HSPCs) obtained from umbilical cord blood. The program is intended to reproduce, document, qualify and compare the manufacturing process currently established in the Netherlands and progressively build the technical capabilities required for local production in Brazil.
RNK001 has already reached first-in-human clinical evaluation. The Phase 1 INTRO-01 study (NCT03539406), published in Gynecologic Oncology in 2026, evaluated the feasibility, safety and toxicity of RNK001 in patients with recurrent epithelial ovarian cancer. The study was designed as an early-stage safety and feasibility investigation and was not intended to establish clinical efficacy.
The technology developed at Radboudumc uses umbilical cord blood-derived CD34+ HSPCs as a starting population to generate large numbers of allogeneic NK cells. Radboudumc has described the manufacturing approach as a robust, reproducible and scalable platform and has also investigated its potential as a basis for genetic engineering of NK cells.
Under the collaboration, the initial technology-transfer program is expected to include transfer of manufacturing processes and analytical methods, technical documentation, personnel training, assessment of local infrastructure, engineering runs, qualification activities and a structured comparability program between the processes performed in the Netherlands and Brazil.
The objective of this first stage is not immediate commercial-scale manufacturing. Instead, the partners intend to establish evidence that critical process parameters and product quality attributes can be reproducibly controlled following transfer to a new manufacturing environment.
Prof. Dr. Harry Dolstra, Professor of Translational Immunohematology at Radboudumc, said:
“NK cells derived from CD34+ hematopoietic stem and progenitor cells represent a relevant platform for allogeneic cellular immunotherapy. For this technology to advance in another territory, it is essential to demonstrate that critical quality attributes — including identity, purity, viability, potency, microbiological safety and post-cryopreservation stability — can be consistently reproduced.”
For Luís Eduardo da Cruz, project lead in Brazil, the agreement represents an opportunity to establish advanced cell-manufacturing capabilities within the country rather than simply import a finished technology.
“The significance of this collaboration goes beyond transferring a manufacturing protocol. The objective is to create the local capability to reproduce, control, document and compare an advanced cellular process with the scientific discipline, quality systems, traceability and technical governance required for cell-therapy development,” Cruz said.
Valeria Povolotsky, Vice President of BioNK in the United States, said the collaboration provides a foundation for a broader regional development strategy.
“BioNK sees this collaboration as an opportunity to build an NK-cell development platform in Latin America based on quality, traceability and translational science. The initial priority is the responsible transfer and development of RNK001, while creating the scientific and manufacturing foundation that may support future CAR-NK programs.”
Building a platform for future engineered NK-cell programs
The agreement also establishes a framework under which the partners may evaluate future CAR-NK development programs.
Such programs would represent a separate stage of development and would require additional scientific, preclinical, process-development, manufacturing, analytical, safety and regulatory work before progression toward clinical evaluation.
Radboudumc’s HSPC-NK platform is particularly relevant to this longer-term strategy because the progenitor-based manufacturing system can potentially serve as a starting point for genetic modification designed to introduce tumor-targeting receptors or other functional characteristics into NK cells.
Any CAR-NK candidate arising from the collaboration would therefore remain distinct from RNK001, which is an unmodified NK-cell product.
A phased technology-transfer strategy
Cryopraxis is expected to provide the Brazilian manufacturing, cell-processing, cryopreservation, traceability, cold-chain and operational infrastructure required for the local development program, with specific responsibilities to be defined through development plans, quality agreements and technical documentation.
The program will be conducted in phases under joint scientific, manufacturing, quality, regulatory and intellectual-property governance.
Initial activities are expected to focus on process transfer, analytical transfer, training and engineering work, followed by qualification and comparability activities designed to determine whether the transferred process can consistently reproduce predefined product and process characteristics.
The collaboration combines Radboudumc’s scientific and translational expertise in HSPC-derived NK-cell technologies, BioNK’s development strategy for NK and CAR-NK programs, and Cryopraxis’ experience in cell processing, cryopreservation, traceability, cold-chain management and regulated cellular operations in Brazil.
Investigational status
RNK001 remains an investigational cell-therapy product and is not being presented as an approved commercial therapy under this collaboration.
Any future clinical development, manufacturing expansion or engineered CAR-NK program will remain subject to the scientific, ethical, manufacturing, biosafety and regulatory requirements applicable in the jurisdictions in which such activities are proposed.
The collaboration does not imply regulatory approval, marketing authorization or demonstrated clinical efficacy of RNK001 or of any future CAR-NK candidate.
Scientific Reference
Hoogstad-van Evert JS, de Jonge PKJD, Zusterzeel PLM, et al. Intraperitoneal infusion of stem cell-derived natural killer cells in recurrent epithelial ovarian cancer patients: Results of the phase 1 INTRO-01 trial. Gynecologic Oncology.2026;204:91–99. doi:10.1016/j.ygyno.2025.11.006. ClinicalTrials.gov identifier: NCT03539406.
About Radboudumc
Radboud university medical center (Radboudumc), based in Nijmegen, the Netherlands, is an academic medical center integrating patient care, scientific research and education. Its Translational Immunohematology research program develops and investigates cellular immunotherapies, including NK-cell approaches derived from hematopoietic stem and progenitor cells and genetically engineered immune-cell platforms.
About BioNK
BioNK is focused on the scientific, translational and strategic development of Natural Killer cell technologies. Its activities include unmodified NK-cell programs, CAR-NK development, CMC and manufacturing strategy, potency and comparability development, cryopreservation, clinical planning and regulatory preparation for investigational cellular therapies.
About Cryopraxis
Cryopraxis is a Brazilian organization specialized in cell processing, cryopreservation, traceability, cryogenic storage, cold-chain management and cellular process documentation. The company provides infrastructure and operational capabilities supporting the development and handling of cellular products in regulated environments.
Media Contacts
Cryopraxis / BioNK
Valeria Povolotsky
VP Business Development
povlera@gmail.com
+1(973)780-7988
Radboudumc
Paul van der Hoeven (PhD, RTTP)
Sr. Business Developer
Technology Transfer Office
M +31(0)654902391
paul.vanderhoeven@radboudumc.nl
