Technology
Why NK Cell Therapy?
We believe the next generation of cellular immunotherapies includes technologies to adapt and enhance the natural killing ability of natural killer (NK) cells from the innate immune system.
NK cells are the body’s first line of defense against tumor or other pathogenic cells, utilizing a complex system of receptors to recognize self from non-self and detect stress antigens on the surface of target cells. Unlike T-cells, NK cells are not activated through the MHC pathway and have a reduced risk for alloreactivity and graft-versus-host disease (GVHD). Upon activation, NK cells release perforins and granzymes to kill the target cells and secrete cytokines to recruit and engage other immune cell’s activity. NK cells are also the mechanistic mediators of antibody-dependent cellular cytotoxicity (ADCC). Monoclonal antibody or NK-engager protein therapies interact with CD16 on the surface of NK cells, activating them to kill targeted cells.
Artiva’s Cell Therapy Manufacturing Platform
Artiva’s platform generates allogeneic natural killer (NK) cells from healthy donor umbilical cord blood (UCB) units selected for key characteristics. Our Manufacturing-First approach has created a highly scaled process capable of producing enough pure and consistently active NK cells from each UCB to treat hundreds to thousands of patients, with the opportunity for repeat dosing in the outpatient setting. Our NK cells are cryopreserved and ready for off-the-shelf therapeutic use, without the requirement for complex manipulation at the clinical site.
Artiva’s proprietary cell therapy manufacturing platform utilizes cell expansion and activation technology developed and enhanced for over a decade by our corporate partner, GC Cell. Umbilical cord blood (UCB) units with preferred characteristics, including the high affinity variant of CD16 (158 V/V) and the B-KIR haplotype, are selected from U.S. cord blood banks. Each UCB unit is used to derive an NK cell master cell bank, followed by a bioreactor-based large-scale NK cell expansion and activation process to produce pure NK cells. The scale of production has the potential to enable hundreds to thousands of patients to be treated from a single donor UCB unit and with a cost of production that we believe will support wider adoption of a cell therapy product. Optimized cryopreservation of the NK cells in infusion-ready media and demonstrated long-term stability, practical logistics, and ease of handling at the clinical site enable repeat dosing in the outpatient setting.
Artiva Biotherapeutics is advancing a pipeline of highly scaled, cryopreserved, off-the-shelf, allogeneic NK cell therapies for treating cancers and immune disorders. Our two-fold product strategy aims to harness the innate biology of NK cells with the intent of maximizing their therapeutic potential.
AlloNK® Non-Genetically Modified ADCC Enhancer
AlloNK® (also known as AB-101) is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting.
Targeted CAR-NK Platform
Artiva’s NK cells engineered to express chimeric antigen receptors, or CARs, have the potential to enhance the targeting and activity of the NK cells against either hematologic or solid tumors. Artiva utilizes a proprietary CAR platform optimized for use in NK cells to enhance their therapeutic activity and tumor targeting capability. Additionally, all CAR-NK products are manufactured via Artiva’s cell therapy manufacturing platform and maintain high expression of CD16, enabling dual targeting therapeutic approaches via monoclonal antibody combinations.
Artiva’s State-of-the-Art Manufacturing Infrastructure
Artiva’s San Diego corporate headquarters and R&D labs are based in a 52,000-square-foot facility that includes a multi-suite, custom-built current Good Manufacturing Practices (cGMP) cell production center, to support NK and CAR-NK cell production for Artiva’s pipeline development and clinical trial supply. The GC family of companies has invested significantly in state-of-the-art research and GMP manufacturing for the development of cell therapies. Artiva and GC Cell have established an exclusive partnership to further realize the clinical application of NK cell therapy.
Artiva has a purpose-built research, process development, and multi-suite NK manufacturing center in San Diego, California.
Artiva has an exclusive partnership with GC Cell and access to state-of-the-art cell therapy research and cGMP manufacturing in Seoul, Korea.
