Ruichuang Biologics was approved for IND for the new indication of universal DNT cell therapy

January 8, 2023 / eMedClub News / -- January 6, 2023, Guangdong Ruishun Biotech Co.
, Ltd.
(hereinafter referred to as "Wyze Biotech CO.
, Ltd.
"), a biopharmaceutical company focusing on the R&D and commercialization of global innovative immunotherapy cell drugs based on off-the-shelf universal DNT cells as a technology platform, announced that its wholly-owned subsidiary, Ruichuang Biotechnology Co.
, Ltd.
(hereinafter referred to as "Ruichuang Biotechnology" The application for IND for the indication of RC1012 injection "Prevention of recurrence after allogeneic hematopoietic stem cell transplantation of acute myeloid leukemia" was officially approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (acceptance number: CXSL2200539, approval number: 2023LP00042).

At present, maintenance therapy after allogeneic hematopoietic stem cell transplantation mainly includes demethylating drugs, immunomodulators and FLT3 inhibitors, etc.
, although certain effects have been achieved, there are still serious unmet clinical needs
in terms of timing of maintenance therapy, treatment side effects and patient burden 。 DNT cells have strong anti-acute myeloid leukemia (AML) cell activity, and have strong tumoricidal activity, good safety (no toxicity to normal cells, no GvHD, no HvGR), strong in vitro expansion ability and other obvious advantages, the previous investigator-initiated clinical trial data completed by the Department of Hematology of the First Affiliated Hospital of University of Science and Technology of China (formerly Anhui Provincial Hospital) showed that RC1012 injection in the prevention of allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia It has a good safety and expected efficacy, which provides a new immune cell therapy option
for the prevention of recurrence after allogeneic hematopoietic stem cell transplantation in AML subjects.

Previously, the IND application of RC1012 injection for the indication of "treatment of relapsed and refractory acute myeloid leukemia" has obtained CDE clinical implied approval in November 2020, which is the first universal immune cell product approved for registration clinical trials in China (CDE acceptance number: CXSL2000248), August 2022.
RC1012 injection cryopreservation preparation was approved for IND clinical trial (CDE acceptance number: CXSB2200042), marking that RC012 injection has the potential to become the world's first non-gene editing spot general immune cell new drug, and is currently conducting registered phase I clinical trials at the bone marrow transplant center of the First Affiliated Hospital of Zhejiang University School of Medicine, and plans to enter pivotal phase II clinical trials
in 2023.

The approval of the new indication IND application of RC1012 injection means that the clinical indication of RC1012 injection as the world's first non-gene-edited off-the-shelf universal DNT immune cell therapy product has been further expanded
.

About RC1012 injection and RJMty19 injection

DNT cells, also known as double-negative T cells, are T cell subtypes that express CD3 molecules in normal peripheral blood, but do not express CD4 and CD8 molecules, and have stronger specific activity and longer in vivo duration than NK cells, and are a very promising spot universal T cell drug
for the treatment of a variety of clinical tumors 。 RC1012 injection (mainly composed of DNT cells) for the treatment of relapsed and refractory acute myeloid leukemia (r/r AML) is currently undergoing registration phase 1 clinical trials in China; The indication for the prevention of recurrence after allogeneic hematopoietic stem cell transplantation of acute myeloid leukemia has been approved by CED, and registration clinical trial research will be carried out soon; RJMty19 injection (CD19-CAR-DNT cells) for the treatment of relapsed and refractory B-NHL indications is currently undergoing clinical studies
of IIT.

About Ruishun Biologics

Guangdong Ruishun Biotechnology Co.
, Ltd.
takes "caring for life and benefiting mankind" and "being an affordable innovative cell drug" as its own responsibility, focusing on the research and development of off-the-shelf universal immune cell products with DNT cells as the core technology platform, and is the pioneer of DNT cell immunotherapy worldwide
.
Clinical studies have proved that allogeneic DNT cells do not cause graft-versus-host disease (GvHD) and other serious adverse reactions after being transfused into patients, have good safety and long-lasting anti-tumor activity, and have controllable product quality, and have great potential for commercialization of generic DNT cell products
.
The company currently has R&D and production bases
in Zhongshan, Guangdong, Fengxian Lingang, Shanghai and Keqiao, Shaoxing, Zhejiang.

About Ruichuang Biotech

Ruichuang Biotechnology Co.
, Ltd.
(hereinafter referred to as "Ruichuang Biotechnology") is a wholly-owned subsidiary of Ruishun Biotechnology, located in Keqiao District, Shaoxing City, Zhejiang Province, focusing on the clinical development and industrialization of off-the-shelf universal RC1012 injection products for relapsed and refractory acute myeloid leukemia, and the previously declared fresh preparation of "RC1012 injection" has been approved by the State Food and Drug Administration (NMPA) in November 2020 to carry out phase I registration clinical trials.
It is the first general immune cell new drug
approved for clinical trial registration in China.
In August 2022, the cryopreservation preparation of the supplementary application was approved by CDE, marking the potential of "RC1012 injection" to become the world's first off-the-shelf universal DNT immune cell therapy product for the treatment of r/r AML without gene editing, which is a major progress
in clinical trials of relapsed and refractory acute myeloid leukemia.