Artiva Biotherapeutics' Cryopreserved, Off-the-Shelf NK Cell Therapy AB-101 Receives FDA Fast Track Designation for Lupus Nephritis
Artiva Biotherapeutics
Cancer Treatment Drug Developer
February 25, 2024
eMedClub News
Recently,Artiva BiotherapeuticsAnnouncementIts ready-made allogeneicNKCell TherapyAB-101ObtainFDAGranted Fast Track Designation (FTD), used in combination with rituximab or obinutuzumab for the treatment of lupus nephritis (LN）, which meansAB-101A milestone has been reached in the field of autoimmune diseases.
AB-101 is a cord blood-derived, allogeneic, cryopreserved, non-genetically modified, ADCC (antibody-dependent cell-mediated cytotoxicity)-enhanced NK cell therapeutic candidate that can be used in an outpatient setting in combination with monoclonal antibodies or innate cell engagers. Using rituximab alone may lead to incomplete B-cell depletion, while adding allogeneic NK cells as an ADCC-enhancing therapy can significantly enhance the ability of rituximab to drive deeper levels of B-cell depletion. Meanwhile, Artiva Biotherapeutics has established a manufacturing platform that supports the generation of thousands of doses of cryopreserved, infusion-ready AB-101 cells from a single cord blood unit, maintaining high CD16 expression.
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Currently, the candidate therapy is undergoing two clinical studies: one in combination with a CD20 antibody for the treatment of LN patients who are relapsed or unresponsive to prior standard-of-care therapies, and the other in combination with rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) patients. Previously, Artiva presented preliminary data from the first-in-human phase 1/2 clinical trial of AB-101 at the 2023 ASCO Annual Meeting.Among the 7 evaluable patients treated with AB-101 at a dose of 1 billion cells combined with rituximab, the ORR was 57.1%, including 3 CRs and 1 PR.In addition, in the outpatient setting, combination therapy successfully administered up to 16 doses of AB-101 (1 billion cells per dose) without observing ICANS or GvHD, while the monotherapy dose reached 4 billion cells.
Frequent Progress in Non-Gene-Modified NK Therapy in China
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NK Cells’ Killing of Target Cells Does Not Require Specific Activation; the Process Can Be Initiated Solely Through Recognition of the Target Cells. Currently, NK cells under research can be broadly categorized into unmodified NK cells and genetically engineered NK cells. The former leverages their inherent cytotoxic functions, such as CD56+/CD3- NK cells CYNK-001 expanded from CD34+ cells extracted from human placenta, and the aforementioned AB-101. The latter aims to enhance the activity and persistence of NK cells in targeting and killing tumors. In China, nearly 30 companies have ventured into NK/CAR-NK therapies, with CAR-NK therapies being the majority. However, non-genetically modified NK cell therapies have also made significant progress.
Enkaicell was established in 2020 and owns unique technologies in allogeneic peripheral blood NK cell expansion and cryopreservation, genetic modification, and clinical "off-the-shelf" grade ABCDE-NK.®Strategic platform, and through the technical chassis of logic gate gene circuits and other synthetic immunology strategies, achieve intelligent editing of NK cells, enabling them to precisely target cancer cells, accurately adapt to the tumor microenvironment, and precisely match the effector/target cells of donors and recipients.
The lead product of Enkaicell, NK010, is a non-gene-modified allogeneic peripheral blood-derived NK cell candidate., with advantages such as optimized receptor spectrum, diversified targets, high purity, and broad applicability, demonstrating high potential in cancer treatment for various types of tumors. Moreover, according to the official website, NK010 also has potential applications in expanding to non-cancer disease treatments and serves as the optimal base cell for a subsequent series of synthetic NK cell drugs (SynNK). In January this year, the IND application for NK010 was approved by the FDA.It is the first non-gene-modified allogeneic peripheral blood NK cell drug in China to receive FDA approval.。
Artiva Biotherapeutics focuses on the development and translation of gene engineering technology applications for cancer gene therapy, immune cell therapy, and vaccines. It has NK, DC-CIK, CAR-NK, and T-cell process development and production platforms, capable of achieving an NK cell ratio as high as 97%. Its self-developed autologous NK cell therapy, E10H, involves collecting the patient's own blood sample, screening, expanding, culturing, and then reinfusing it back into the patient’s body.Reportedly, this is the first autologous NK therapy in China to enter Phase 1 clinical trials, with indications for gastrointestinal tumors.。
In addition, Artiva Biotherapeutics has also developed several non-gene-modified CAR-raNK therapies. IBR822, one of its research and development products, is an antibody-NK cell conjugate drug. It consists of a full-length monoclonal antibody targeting the human Trop2 antigen chemically conjugated through a linker to NK cells derived from in vitro expanded allogeneic healthy donor peripheral blood. This results in a non-viral, non-genetically modified, Trop2 antigen-targeting antibody-NK conjugate drug (Trop2 CAR-raNK) with the ability to kill tumor cells. Its IND application was accepted by the CDE in January this year.
In December 2023, the IND for IBR733 from Yingbai Rui was approved by the CDE.This is the world's first CD33 and CLL1 dual-target antibody conjugated NK product approved for IND clinical research, and also an off-the-shelf universal NK cell product using non-viral vectors and no genetic modification.In addition, Artiva Biotherapeutics' IBR854 is the first non-gene-edited CAR-raNK cell therapy for solid tumors in China, and it is also an allogeneic, off-the-shelf product derived from peripheral blood. It has already entered clinical trials.
Summary
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NK Cell Therapy in the Treatment of Tumors, Neurological Diseases, Infectious Diseases, Anti-Aging, Autoimmune Diseases, and Many Other Disease Areas Has Already Been Researched and Has Achieved Preliminary Progress. It is Evident That the Future Application Fields of NK Cell Therapy Are Very Broad. Currently, Whether It is Non-Modified NK Cell Therapy or Modified NK Cell Therapy in China, Both Are Still in a Relatively Early Stage, But as the Saying Goes, "The Road, Though Far, Will Be Traveled."
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