Ruichuang Bio's Allogeneic Universal Immune Cell Therapy RC1012 Injection Receives IND Approval in China for Relapsed/Refractory Acute Myeloid Leukemia

On November 19, Ruichuang Biotech announced that its allogeneic immune cell therapy product, RC1012 injection, had received implied approval for clinical trials from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration. The intended indication is relapsed/refractory acute myeloid leukemia (r/r AML). According to the press release, RC1012 injection, an allogeneic immune cell product approved for registrational clinical trials, does not require HLA (human leukocyte antigen) matching and is derived from healthy donors.

Source: CDE Official Website

Ruichuang Biotech is a wholly-owned subsidiary of Zhejiang Ruishun Biotech, specializing in the research and development and clinical application of RC1012 injection, a universal (allogeneic) product targeting relapsed/refractory acute myeloid leukemia (AML). It is an innovative biopharmaceutical company dedicated to providing treatment or cure for leukemia patients.

According to the press release, RC1012 injection is a globally innovative allogeneic immune cell therapy independently developed by Ruichuang Biotechnology. This cell therapy is prepared through ex vivo expansion from the peripheral blood of healthy donors and is enriched with CD3+CD4-CD8- T (Double Negative T, DNT) cell subsets. Also known as double-negative T cells, DNT cells are a T-cell subtype in normal human peripheral blood that express the CD3 molecule but do not express CD4 and CD8 molecules. Compared with NK cells, DNT cells exhibit stronger specific activity in killing AML tumor cells and have a longer duration in vivo, representing a highly promising universal T-cell therapy for the treatment of various clinical tumors.

According to publicly available information from Ruichuang Bio, due to the high heterogeneity of AML tumor cells, no tumor antigens capable of specifically targeting AML cells have been identified to date, thus limiting the clinical application of CAR-T technology in AML. The ability of DNT cells to specifically kill AML cells through multiple targets precisely addresses this limitation.

Data from completed investigator-initiated clinical trials indicate that RC1012 injection demonstrates a favorable safety profile and promising efficacy in the treatment of patients with relapsed or refractory acute myeloid leukemia.

▲ Dr. Yang Liming, Chairman and Chief Scientific Officer of Ruichuang Biotechnology (Image source: official website of Rushun Biotechnology)

According to the press release, the purpose of this approval to conduct registration clinical trials is to further verify the safety and efficacy of the product in treating r/r AML in registration clinical trials, providing solid confirmatory clinical data to accelerate the standardized clinical development of the drug and expedite its market approval for use in treating patients with relapsed/refractory AML after chemotherapy or bone marrow transplantation.

References:

[1] Clinical trial of RC1012 injection, the first allogeneic immune cell therapy product developed by Ruichuang Biology in China, receives implicit approval from the National Medical Products Administration of China. Retrieved Nov 19, 2020, from https://mp.weixin.qq.com/s/iKi8HNtO_hXCGlpGM6werQ

[2] Ruichuang Bio's RC1012 Injection Receives NMPA Clinical Trial Acceptance. Retrieved Aug 27, 2020, from http://www.wyzebiotech.com/view.php?id=381

Source: Pharmaceutical Perspectives

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