Ruishun Bio: The first allogeneic DNT cell drug in China to treat relapsed acute myeloid leukemia has been approved clinically

The breakthrough achievement of immunotherapy in curing advanced tumors has completely changed the rules of the game of clinical tumor therapy.
previous small molecule drugs (including targeted drugs), large molecule antibody drugs, etc. are targeted at tumor cells, consider how to kill tumors.
And the role of immunotherapy drugs is to restore the normal function of the patient's immune cells as the core, through the "normalized" body immune system to kill cancer cells in the blood and tissues, inhibit tumor growth, enhance the body's immunity, in tumor treatment has shown great therapeutic potential.
with the FDA's approval of two CAR-T cell therapy drugs in 2017, cell therapy has become a hot topic of research.
cell immunotherapy can be divided into two categories: autoimmune cell therapy and allogeneic immune cell therapy according to its cell source.
the current international has become a drug cell products are autologic cell products, that is, to extract the patient's own immune cells, after in-body processing and then back to the patient.
this autoimmune product has a long preparation time (generally 2-3 weeks), the preparation process is difficult to regulate, high cost, many patients due to their cell quality is poor, can not successfully prepare and other defects.
, the development of allogeneic immune cell products has become a hot spot in the international development.
DNT cells belong to a type of step cell immunotherapy.
And autoimmune cell products, DNT cell preparation raw materials from healthy donors peri-week blood, preparation process mature and controllable, large amount of insular amplification cells, can be prepared in advance after storage in -196 degrees C liquid nitrogen, patients can be used when needed.
completed non-registered clinical trial results show that allogeneic DNT cells are clinically safe and effective, and the number of DNT cells in patients more than 100 days after DNT cell infusion is still higher than the pre-reseeding level.
Ruishun Bio focuses on the development of DNT cells as the core technology platform of non-gene editing spot universal immune cell product line, the company is currently around the treatment of blood and solid tumors, layout of 8 product pipelines, in the research products are not listed at home and abroad Class I new drugs.
, the company developed an allogeneic DNT cell product RC1012 injection in November 2020 has been China's State Drug Administration Drug Review Center clinical trial implied license, to develop adaptive disorders for the recurrence of recurring acute myeloid leukemia.
the product, which comes from healthy donors and does not require HLA (human leukocyte antigen) form, is expected to be the first innovative global heteroenmmune cell drug to treat relapsed acute myeloid leukemia.
DNT cells with anti-tumor, transplant-free anti-host disease and host anti-transplant triple advantage DNT cells refers to the normal presence of CD3-CD4-CD8-T cell sub-groups in extraterrestate blood, accounting for 1%-5% of the total number of T-cells.
DNT cell surface expression CD3 molecules and alpha beta-or gamma-T cell receptors (T Cell Receptor, TCR), of which more than 80% are gamma T cells, but do not express CD4 and CD8 molecules.
, founder and chairman of Ruishun Bio, is a postdoctoral student at the University of Toronto School of Medicine in Canada with 30 years of experience in immunology and is one of the core inventors of DNT cell technology.
more than 20 years of basic, clinical transformation and clinical studies, researchers have found that DNT cells have unique advantages in tumor therapy.
according to Dr. Yang, the advantages of DNT cell technology platform products are mainly reflected in four aspects: First, DNT cells extracted from health donors, low preparation costs, can establish standardized production processes, advance preparation, avoiding the use of self-sourced cells for cell therapy existing material extraction, large-scale process production, access and other limitations.
allogeneic DNT cell products are not recognized and rejected by the patient's immune cells and do not cause a host anti-transplant reaction.
second, DNT cells can be used in association with other small molecule drugs and immuno-testing point inhibitors, such as PD-1 antibodies, to play a "1-1>2" synergy.
The effective rate of treating non-small cell lung cancer with PD-1 alone is only about 20%, and it needs to be used continuously, while the effective rate of DNT cell combined PD-1 antibody therapy can reach more than 50%, which can effectively improve the efficacy of non-small cell lung cancer and reduce the cost of treatment.
is developing a treatment for DNT-PD-1 to improve the effectiveness of the treatment of non-small cell lung cancer.
3 is based on the DNT cell innocidally does not cause GvHD's universal characteristics, without the need to knock out the relevant genes, can directly introduce CAR gene fragments to achieve the development of universal CAR-DNT series products, greatly improve development efficiency and reduce costs.
's first CAR-DNT cell pipeline has been shown to have a powerful, rapid and persistent in vitro tumor killing effect on CD19-plus acute lymphoblastic leukemia and non-Hodgkin's lymphoma, and plans are under way to verify its safety and drug ability and pharmacodynamic characteristics in animals.
fourth is that DNT cells can be genetically edited to further enhance DNT cell tumor killing activity and enhance DNT cell immersion of solid tumors to remove tumor cells.
Based on the many advantages of DNT cells mentioned above, Ruishun Bio has laid out 8 research and development pipelines to explore the therapeutic potential of DNT cells in tumors such as blood tumors (recurrence of acute myeloid leukemia, non-Hodgkin's lymphoma) and solid tumors (non-small cell lung cancer, liver cancer, stomach cancer, colorectal cancer, cervical cancer and ovarian cancer).
is expected to become the world's first treatment r/r AML isomer immunocellular drug RC1012 injection is the core product of Ruishun Bio, the product has been in November 2020 by china's State Drug Administration Drug Review Center clinical trial implied license, to develop adaptive diseases for recurring acute myeloid leukemia, is currently the first approved to carry out registered clinical trials of allogeneic immune cell products.
chemotherapy and bone marrow transplantation are the main means of treating relapsed acute myeloid leukemia (AML), but both methods have fatal defects such as high toxicity and easy recurrence.
70% of patients will relapse two years after chemotherapy, which will require a bone marrow transplant.
but bone marrow transplants have high physical condition and age requirements for patients and make it difficult to find suitable providers.
even if the bone marrow is successfully transplanted, patients will need to use immunosuppressants for life, leading to a decline in overall immune function and a risk of secondary infections and tumors.
RC1012 injection is the first allogeneic immunocellular therapy drug in China that does not require HLA dosing and comes from healthy donors.
The product has in vitro and in vivo tumor-killing activity on the original cells of patients with recurring and difficult-to-treat acute myeloid leukemia, and multiple back-transmission enhances tumor-killing activity, and does not trigger the anti-host disease of the graft and the host anti-transplant reaction.
clinical trial results show that RC1012 injection has good safety and effectiveness.
11 patients with acute myeloid leukemia who relapsed after receiving a hematopoietic stem cell transplant were treated with RC1012 injection, all patients had no severe toxic side effects and a full remission rate of 54.4% (6/11), of which three patients had a full remission time of more than 12 months, the longest of which was more than 17 months.
Yang said that the approval of RC1012 injection clinically is an important milestone in the development of DNT cell products.
" means we've reached the end of the dark tunnel and seen a ray of sunshine, believing that The Reshun creature can walk out of a kangzhuang road on the DNT cell track.
" next, Ruishun Bio will rapidly advance clinical trials of RC1012 injections to further verify the safety and effectiveness of the product in the registered clinical trials for the treatment of relapsed acute myeloid leukemia.
based on the currently known tumor-killing mechanism of DNT cells, DNT cells have therapeutic effects on about 90% of human tumors.
with the increasing life expectancy of human beings and the increasing incidence of tumors, the development potential of DNT cell technology platform is unlimited.
, Ruishun Bio will continue to expand its adaptive disorders with DNT cells as a platform for the benefit of more patients.
zhao Songguo, general manager of Ruishun Bio, said that the company's vision is based on universal immune cells, to build a domestic-based, global market-oriented innovative spot universal immune cell research and development and production enterprises.
is expected to make its world debut in the Chinese market by 2023, becoming the world's first allogeneic immunocytocytotherapy product to treat relapsed acute myeloid leukemia.
addition, it is hoped that in 2023 there will be two other products into Phase II clinical, three products approved clinical, further consolidate the company's core competitiveness in the immunocellular market.
Jiao Yanli Source: Arterial Network Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Original" are owned by Metz Medical and may not be reproduced by any media, website or individual without authorization, and shall be reproduced with the words "Source: Mets Medicine".
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