The new "revolution" of cell therapy, a number of giant companies in NK therapy have joined forces

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Celularity announced today that the FDA has granted orphan drug designation to its investigational natural killer (NK) cell therapy CYNK-101 for the treatment of gastric/gastroesophageal junction cancer

CYNK-101 is a placental hematopoietic stem cell-derived NK cell therapy genetically modified to express a high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity

In addition, Celularity has an NK cell therapy, CYNK-001

The rise of natural killer (NK) cell therapy

Natural killer (NK) cells are the third type of lymphocytes in the human body, and are also known as the core cells of innate immunity.

It is worth mentioning that compared with other anti-cancer immune cells, NK cells have stronger and more effective killing effects on tumor and virus-infected cells, and their activation does not depend on tumor cell surface antigens, nor does it need to be like T cells.

At present, immunotherapy based on NK cell development is in full swing, including monoclonal antibodies against NK cell inhibitory or activating receptors, immune factor-related therapy, and NK cell adoptive immunotherapy

NK cell adoptive immunotherapy mainly includes two categories: one is autologous or allogeneic NK cell infusion, and the other is CAR-NK cell therapy

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Several have entered clinical research

Currently, NK cell therapy is mostly in the early stages of research

SNK01 is an autologous NK cell therapy that harvests a small amount of NK immune cells from a patient, expands in vitro, and then infuses the activated NK cells back into the patient to fight cancer

FC21-NK is a haploid, FC21-expanded allogeneic NK cell therapy

FT500 is a clonal master-derived iPSC-derived allogeneic NK cell therapeutic immunotherapy that provides a large syngeneic NK cell population and clearly shows potent activity and the ability to synergize with T cells

FT516 is Fate Therapeutics' "ready-to-use" NK cell therapy differentiated from a clonal induced pluripotent stem cell (iPSC) line using an innovative high-affinity, non-cleavable CD16Fc receptor designed to maximize antibody-dependent cellular mediation induced cytotoxicity (ADCC)

FT536 is a multi-engineered, induced pluripotent stem cell (iPSC)-derived, ready-to-use CAR-NK cell therapy

CAT-248 is an allogeneic CD70-targeted CAR-NK cell therapy developed by Catamaran through its TAILWIND™ platform

CAR19-CYNK was produced by Celularity retrovirally transduced human placental CD34+ cells with an anti-CD19 CAR (CD19scFv-CD28CD3ζ from Sorrento Therapeutics) and cultured under cytokine conditions

The prospect is promising, and a number of pharmaceutical companies have jointly deployed

Baekje, Merck, Gilead.

Fate Therapeutics, Nkarta Therapeutics, Innate Pharma, Glycostem Therapeutics, NantKwest and other companies are the leading players in the field of NK cell therapy
.
Among them, Nkarta Therapeutics focuses on CAR-NK therapy, and Glycostem Therapeutics focuses on the development of stem cell-derived NK cell therapy
.
NantKwest focuses on the treatment of cancer and virus-induced infectious diseases through NK cell therapy.
Its main products include haNK cell products with high expression of high-affinity CD16 receptor, taNK cell products with high expression of specific CAR, and t cells that combine the advantages of both.
-Three series of haNK cell products
.

In recent years, more and more companies have attached importance to NK cell therapy and have joined forces with other companies to deploy this market:

In February 2022, Intellia Therapeutics and ONK Therapeutics reached a partnership of up to $920 million
.
Under the agreement, Intellia will grant ONK a non-exclusive patent license for its in vitro gene editing and LNP delivery technologies, as well as an exclusive patent license for certain gRNAs, for the development of five CRISPR gene-edited allogeneic NK cell therapies
.

In February 2022, Boya Biotech and Xing Yiang Biotechnology reached a cooperation, the two parties will be based on Boya Jiyin's high-throughput genome editing screening and Xing Yiang Biotechnology's induced pluripotent stem cells (iPSC) and natural killer cells (NK cells).
) technology and resource advantages in cell function and production process, research and development cooperation of a new generation of immune cell therapy
.

In June 2021, BeiGene announced a cooperation agreement with Shoreline Biosciences
.
BeiGene will pay $45 million upfront to introduce four-target allogeneic NK cell therapy developed by Shoreline technology
.
BeiGene has global commercialization rights, while Shoreline reserves the right to retain commercialization rights for up to two targets in the U.
S.
and Canada
.

In January 2021, Merck signed a global exclusive cooperation and license agreement with Artiva Biotherapeutics totaling over US$1.
8 billion, using Artiva's off-the-shelf allogeneic NK cell manufacturing platform and proprietary CAR-NK technology to develop solid tumor-related antigens of novel CAR-NK cell therapy
.

In April 2020, Gilead subsidiary Kite Pharma and biotech company oNKo-innate entered into a three-year cancer immunotherapy research collaboration to support the discovery and development of next-generation drugs and cell therapies focused on natural killer (NK) cells.
development
.

In December 2018, Fate Therapeutics entered into an agreement with the Max Delbrück Center (MDC) to obtain exclusive options for novel humanized antibody BCMA-CAR constructs for the development of iPSC-derived cell products, including iPSCs-derived CAR-NK cells and T cell products
.

In October 2018, Dragonfly Therapeutics and Merck signed a cooperation agreement of up to $695 million to jointly develop and market solid tumor cancer immunotherapy developed through TriNKET, Dragonfly's unique technology platform
.

Summarize

NK cells have been in clinical trials for more than ten years.
However, due to factors such as few sources, difficulties in expansion, large differences in transduction technology, and low transduction efficiency, NK cell therapy has developed slowly, and the future market prospects are still very bright
.
However, with the development of science and technology, many technical difficulties will be overcome.
Some institutions predict that the global NK cell therapy market sales will reach 350 million US dollars in 2021, and it is expected to reach 1 billion US dollars in 2028
.