NK Cell Therapies
Artiva's NK Cell Therapy Pipeline for Cancer
Artiva Biotherapeutics is advancing a pipeline of highly scaled, cryopreserved, off-the-shelf, allogeneic NK cell therapies for treating hematologic cancers and solid tumors. Our twofold product strategy aims to harness the innate biology of NK cells with the intent of maximizing their therapeutic potential:
- ADCC Enhancers – NK cells that can enhance a patient’s ADCC, or antibody-dependent cellular cytotoxicity, response when undergoing monoclonal antibody therapy for either hematological or solid tumors.
- Targeted CAR-NK – NK cells engineered to express proprietary chimeric antigen receptors, or CARs, that have the potential to enhance the targeting and activity of the NK cells against either hematologic or solid tumors.
Our internal programs are currently focused on specific targeting of CD20 and CD19 in B-cell lymphomas and HER2 in solid tumors. Our ongoing research includes additional novel CAR-NK cell therapies and further optimization of our NK cell therapy’s activity and persistence through gene editing. We are also developing both ADCC-enhancer and CAR-NK programs in strategic partnerships. Our programs are being developed under our license and option agreements with GC Cell, with exclusive rights outside the Asia-Pacific region for existing Artiva programs and with exclusive worldwide rights for our programs under our collaboration with Merck.
AB-101: ADCC-Enhancer NK Cell Therapy
AB-101 is a highly active allogeneic NK cell therapy being developed for therapeutic use in combination with a variety of targeting modalities, including monoclonal antibody therapy and NK-engager bispecific technology. Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood sample. Drug product generated by our process is consistently active, with little donor-to-donor variability. Our ongoing Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT04673617) is assessing the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab. The study is enrolling patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy.
AB-201: HER2 CAR-NK Cell Therapy
AB-201 is our CAR-NK cell therapy candidate targeting HER2 positive solid tumors. The CAR construct has been optimized for activity within NK cells and utilizes a highly specific proprietary anti-HER2 extracellular domain. The background NK cells maintain all the preferred characteristics seen within the AB-101 product, including high expression of activating NK receptors and CD16, as well as the cryopreservation and infusion-ready formulation. Our first planned clinical studies with AB-201 are for an assessment of activity in several HER2+ solid tumor types.
AB-202: CD19 CAR-NK Cell Therapy
AB-202 is a our CAR-NK cell therapy candidate targeting CD19 positive B-cell malignancies. The CAR construct has been optimized for activity within NK cells and utilizes an anti-CD19 domain. The background NK cells demonstrate a high expression of activating NK receptors and CD16. AB-202 also takes advantage of our cryopreservation technology and our infusion-ready formulation. Our first planned clinical study of AB-202 will be designed to investigate monotherapy treatment and an assessment of dual tumor-antigen targeting via combination therapy with anti-CD20 monoclonal antibody therapy.
We are leveraging our established NK manufacturing platform to develop new CAR-NK cell therapies and NK-combination therapies to address unmet needs for patients with cancer. We are also evaluating specific gene editing techniques to further enhance the therapeutic activity of NK cells, including increasing activity in the tumor microenvironment and enhancing in vivo persistence in patients with the potential to reduce the need for lymphodepleting chemotherapy.
Artiva and Merck have entered into an exclusive worldwide research and development collaboration and license agreement to develop novel CAR-NK cell therapies for solid tumors. The collaboration leverages Artiva’s off-the-shelf allogeneic NK cell manufacturing platform and proprietary CAR-NK technology. The collaboration initially includes two CAR-NK programs with an option for a third. Under the agreement, Artiva is responsible for initial development through the first GMP manufacturing campaign and IND preparation, followed by transfer of the applicable program to Merck for clinical and commercial development.
Artiva and Affimed have entered into a strategic collaboration to assess the feasibility and preclinical activity of combinations of Artiva’s allogeneic NK cell product candidate, AB-101, and Affimed’s ICE molecules. Affimed’s ICE molecules specific for EGFR and other undisclosed targets are being combined with Artiva’s GMP-grade allogeneic NK cells during the cell manufacturing process. The process will include the loading of AB-101 with Affimed ICE molecules prior to cryopreservation, aimed at creating specifically targeted allogeneic cells without the requirement for viral transduction. The resulting cryopreserved, off-the-shelf, targeted allogeneic NK cell product candidates will be assessed for anti-tumor activity and development potential.