Guojian-Sanno bioCAR-NK cell therapy is declared clinical in China

On February 9th, the website of the Drug Review Center (CDE) of the State Drug Administration of China announced that a clinical trial application for a new class 1 drug, "Targeted mesothytin-inlay antigen-infused antigen-cell injection", had been accepted.
the clinical trial is aimed at advanced endoped ovarian cancer.
note that CAR-NK therapy has been listed by Nature Medicine as one of the ten notable advances in biomedical fields in 2020.
: CDE official website CAR-T cell therapy is one of the major breakthroughs in the field of cancer treatment in recent years, in the treatment of blood cancer has achieved significant results.
However, CAR-T cell therapy also faces many challenges, such as not being able to isolate enough T-cells in quantity and quality in some patients, the transformation and amplification of T-cells usually takes several weeks, during which the patient's condition may worsen, the presence of cytokine storms (CRS) and neurotoxic side effects, and so on.
NK cells (natural killer cells) are important immune cells in the human body, involved in anti-tumor, antiviral infection and immunomodulation and other physiological processes.
unlike T cells, NK cells belong to the congenital immune system, which does not express antigens that are rearmed by sorocyte cells and can target a variety of pathogenic antigens with stronger cytotoxicity.
NK cells also have a wide range of sources, do not need to rely on the patient's own specific immune cells, can reduce the probability of cytokine storms and other advantages.
because of these characteristics, NK cell-based immunotherapy in recent years has been widely concerned by enterprises, Guojian-Sanno biological is one of them. according to
public information, Guojian-Sino Bio was established in 2019 as a joint venture between Sinono Medical and National Life Sciences, focusing on the development of a variety of tumor cell therapies, including solid tumors, based on CAR-NK technology, to provide patients with large-scale spot anti-tumor drugs.
CDE this time is a "targeted mesothionin chisellular antigen-receiving NK cell injection."
, this is the first CAR-NK therapy to be declared clinically available for solid tumor therapy in China.
the study plans to evaluate the safety, toerability and initial efficacy of this CAR-NK cell injection in patients with advanced endocular cancer.
according to the official website of Theo Medicine, CAR-NK cell therapy has the following advantages: 1, CAR-NK therapy may have better safety.
is considered to be the most critical cause of cytokine storms, while CAR-NK therapy does not produce lecarin 6 during application.
addition, NK cell life is short, which means that CAR-NK stays in the blood circulation for a relatively short period of time without worrying about the long-term safety of the CAR structure on the body.
2, NK cells are easier to obtain, easier to manipulate, and immunogenicity is low, in some cases, the expression of CAR structure NK cells can also be used between foreign bodies.
preclinical studies of Sereno Medicine showed that CAR-NK had the same lethal effect on cancer cells as CAR-T therapy.
fact, there are many companies and research institutions around the world that are developing CAR-NK therapies.
the potential benefits of CAR-NK therapy have also been initially validated in clinical studies.
study published in the New England Journal of Medicine (NEJM) in 2020 found that 11 cancer patients received a CAR-NK therapy that targeted CD19 without the toxic effects common to CAR-T therapy.
It's worth noting that the study found that CAR, which targets tumor antigens, can be expressed not only in T-cells and NK cells, but also in macrophages, making macrophages a weapon against solid tumors, a treatment called CAR-M.
2020, a study published by scientists at the University of Pennsylvania showed that CAR-M therapy successfully reduced tumors in animals and extended their lifespan in mouse models treating HER2-positive metastatic ovarian cancer.
2020, nature-medicine, an authoritative academic journal, has listed CAR-NK therapy and CAR-M therapy as one of the ten notable advances in biomedical fields in 2020.
advances mean "a new era for cancer treatment with all kinds of CAR cells," he said in a commentary in Nature Medicine.
that as research progresses, these new CAR cell therapies can make more breakthroughs and provide a new weapon in the fight against cancer in humans! Follow Medicinal Mingkangde on WeChat Public No