NK Cell Therapies
Artiva's NK Cell Therapy Pipeline for Cancer
| Program | Target | Indication | Preclinical | Phase 1 | Phase 2 | Partner |
ADCC Enhancer, Non-Genetically Modified NK |
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| AB-101 | + CD20 mAb | B-Cell Malignancies | ||||
| AB-101 | + AFM13 CD30 NKE | Hodgkin’s Lymphoma/ T-Cell Lymphoma |
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| AB-101 | + CD38 mAb | Multiple Myeloma | ||||
Targeted CAR-NK |
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| AB-201 | HER2 | HER2+ Cancers | ||||
| AB-203 | BCMA (+CD38 mAb) | Multiple Myeloma | ||||
| AB-205 | CD5 | T-Cell Lymphoma |
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| AB-MK-001 | Not Disclosed | Solid Tumor |
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| AB-MK-002 | Not Disclosed | Solid Tumor |
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Non-Genetically Modified ADCC-Enhancer NK Cells
AB-101: Non-Genetically Modified ADCC-Enhancer NK Cells
AB-101 is a cord blood-derived, allogeneic, non-genetically engineered, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. We select cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced product activity. Our AlloNKTM platform can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining high and consistent expression of CD16 without the need for engineering, making AB-101 an optimal adjunct therapy to targeted, ADCC-mechanistic biologics.
AB-101 + Anti-CD20 Monoclonal Antibodies
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-101 + CD30 NK Engager AFM-13
Artiva and Affimed have entered into a strategic collaboration to jointly develop, manufacture, and commercialize a combination therapy comprised of Artiva’s, AB-101, and Affimed’s Innate Cell Engager (ICE®) AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.
AB-101 + Anti-CD38 Monoclonal Antibodies
Our preclinical assessment of combinations of AB-101 with anti-CD38 mAbs in relapsed and refractory multiple myeloma models was recently presented at ASH 2022. AB-101 has very low expression of CD38 without the requirement for engineering and can be combined with CD38 mAbs daratumumab and isatuximab without significant fratricide. We intend to clinically explore the potential of high AB-101 NK cell doses and frequent administrations to enhance anti-CD38 mAb therapeutic activity.
Genetically Modified CAR-NK Cells
AB-201: HER2 CAR-NK
AB-201 is our clinical-stage CAR-NK cell therapy candidate targeting HER2-positive solid tumors. We are initiating the clinical evaluation of AB-201 at multiple centers in the US and Republic of Korea. The studies will assess AB-201 safety and efficacy in HER2+ breast and gastric/GEJ carcinomas. Patients in the study can potentially be treated with up to three repeat administrations of AB-201 in the outpatient setting. AB-201 HER2 CAR-NK uses a novel, high affinity HER2-directed antibody converted to Artiva’s proprietary CAR structure and expression of IL-15 for improved cellular persistence. Utilizing Artiva’s AlloNKTM platform, AB-201 cell products maintain high expression of CD16, as well as other activating innate cell tumor engaging receptors, enabling the potential for dual targeting therapeutic approaches via monoclonal antibody combinations. The resulting CAR-NK is manufactured at large scale and cryopreserved in infusion-ready media to enable repeat clinical administrations in the outpatient setting.
AB-203: BCMA CAR-NK
Our preclinical CAR-NK targeting B-cell maturation antigen (BCMA) is being developed for potential clinical use in combination with anti-CD38 mAb therapies in the treatment of multiple myeloma. Artiva has developed anti-BCMA-CAR constructs from a de novo antibody screen. BCMA-directed CAR-T and bispecific therapies have been extremely efficacious in the relapsed/refractory multiple myeloma setting, but access to CAR-T therapies is limited and both of these modalities have the potential for significant cytokine release syndrome. NK cells have the potential to be safer, efficacious therapies in a variety of clinical settings. They also have the potential to be used in the community oncology setting as allogeneic, off-the-shelf, outpatient administration therapies. In preclinical studies, AB-203 has demonstrated the same low CD38 and high CD16 expression seen with AB-101, providing the potential for dual tumor targeting without complex engineering beyond the addition of the CAR construct.
AB-205 CD5-Directed CAR-NK
AB-205 has been developed preclinically by Artiva’s strategic partner, GC Cell, for the treatment of CD5+ lymphomas of T-cell origin. AB-205 is currently in IND-enablement studies. Artiva intends to clinically develop AB-205 in the US and GC Cell will lead development in Korea.
Partnered Programs
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 AlloNKTM platform and proprietary CAR-NK technology. The collaboration includes two CAR-NK programs. 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 jointly develop, manufacture, and commercialize a combination therapy comprised of Artiva’s AB-101 and Affimed’s Innate Cell Engager (ICE®) AFM13. The clinical agreement follows the parties’ previous two-year preclinical collaboration to assess combining elements of the companies’ respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies. As part of the collaboration, the companies evaluated the combination of AFM13 and AB101 in various preclinical models and generated data that supports development of a co-administered combination therapy.
Expanded Access Policy
immediately life-threatening condition or serious disease to gain access to an investigational drug for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
We are focused on enrolling and conducting the clinical trials necessary to bring innovative, safe, and effective products to patients as quickly as possible. Participation in one of our clinical trials is the only way to access Artiva’s investigational products at this time. We encourage patients and healthcare providers interested in our investigational products to learn more about our ongoing studies by visiting Artiva Clinical Studies. For more information, please contact us at info@artivabio.com.