Accepted again!

Recent popular reports from Yimaike ★Reindeer Medical's fully human CD19/CD22 dual-target CAR-T product clinical trial application has been accepted Yimai Meng broke the news ★ASCO&EHA | Genxi Bio will announce BCMA/CD19 dual-targeting CAR-T cells The latest results of the therapy GC012F in the treatment of relapsed or refractory multiple myeloma May 22, 2021/eMedClub News/--Yesterday, Reindeer Medical announced its self-developed CD19-CD22 fully human dual-target CAR -The second indication of T cell injection (CT120)-the clinical trial application for relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL) has been approved by the Center for Drug Evaluation of the National Medical Products Administration (CDE) Acceptance (acceptance number: CXSL2101088, CXSL2101089).

The acceptance is only one day away from the acceptance of the first indication-CD19/CD22-positive relapsed/refractory acute B-lymphocytic leukemia (B-ALL).

The results of this application further demonstrate the company's innovation speed and strength in the development of new CAR-T drugs.

CAR-T cell injection is a new and complex biological product with high technical barriers and difficult industrialization.

Especially in the development of dual-target CAR, the development of CD19 antibody is regarded as an industry problem.

CT120 is developed by the company's fully human antibody platform and high-throughput CAR-T drug optimization platform.

The company's antibody discovery platform has the industry's top library capacity of more than 240 billion, with strong antibody screening capabilities and speed.

Not only that, the company uses high-quality IMARS antibody library to obtain fully human candidate antibodies with excellent activity and druggability, which has laid a solid foundation for the development of dual-target CAR-T products.

In terms of cell drug screening, the company's high-throughput CAR-T drug optimization platform adopts cutting-edge single-cell analysis and NGS technology, which can realize high-throughput functional screening of CAR-T lead drugs and greatly shorten the screening time of candidate drugs.

In terms of clinical development and commercial production, the company has mature and stable CMC platform technology, which can realize the large-scale and high-quality production of CAR-T drugs.

B-cell non-Hodgkin's lymphoma (B-NHL) is a group of hematological malignancies derived from B lymphocytes.

At present, the commonly used clinical treatments include chemotherapy, radiotherapy, hematopoietic stem cell transplantation, molecular targeted drugs, etc.
Most patients can get effective relief after being given standard treatments.

But for some patients, especially some relapsed or refractory patients, these conventional treatments are ineffective or unable to obtain long-term remission.

At present, treatment options for such patients are limited, and CAR-T therapy is considered to be one of the most promising therapies.

Among them, single-target CAR-T therapy with CD19 as the target has shown good efficacy in clinical studies, but there are still some patients who progress or relapse within a short period of time after CD19 CAR-T treatment.

The loss or decreased expression of CD19 target on the surface of tumor cells is considered to be one of the possible mechanisms.

Studies have shown that normally CD22 and CD19 are simultaneously expressed on the surface of many B-cell tumors such as B-NHL.

Similar to CD19, the expression of CD22 in normal tissues has certain specificity and is considered to be another good therapeutic target.

Therefore, the use of CD19 and CD22 combined targeting CAR-T therapy can theoretically reduce the risk of tumor treatment escape due to the loss of a single target after treatment, and is expected to further reduce disease recurrence and bring patients more long-term survival gains.
beneficial.

Dr.
Wang Wen, CEO of Reindeer Medical, said: “The IIT research conducted in Tongji Hospital Affiliated to Tongji Medical College of Huazhong Keji University and the First Affiliated Hospital of Zhejiang University School of Medicine has shown that CT120 products with full human origin and dual targets can not only enable CAR-T naïve of relapsed / refractory B-aLL, B-NHL patients benefit, but also the past murine, patients benefit single target CAR-T progress, whether it is the market outlook is still have a bright future benefit of patients.

more Importantly, the submission of this product IND marks the maturity of the company's antibody discovery platform based on the phage antibody library.
In the future, fully human products based on this antibody library will continue to serve the company's cell therapy and antibody therapy.
Big pipeline.

We will continue to expand the pipeline of new reindeer medical products to benefit more patients.

"About NHL lymphoma originates from cells of the immune system and can endanger any organ in the body, accompanied by complex pathological processes.

Lymphoma is divided into Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL).

Approximately 85% of non-Hodgkin's lymphomas are derived from B cells.

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of mature B-cell tumors in NHL.

In European and American countries, the incidence of DLBCL accounts for about 31% of non-Hodgkin's lymphoma, and in Asian countries it is greater than 40%.
The incidence increases with age.

According to statistics, from 206 to 2016, the standardized incidence and mortality of non-Hodgkin's lymphoma in China were 429/100,000 and 2.
45/100,000 respectively.

About CT120 CT120 is a fully human-derived chimeric antigen receptor T cell (CAR-T) product that targets CD19 and CD22 independently developed by Reindeer Medical.

This research product uses fully human antibody single-chain variable regions targeting CD19 and CD22, 4-1BB and CD3ζ as costimulatory signal molecules and stimulatory signal molecules, constructs CAR structure, and prepares lentivirus through the third-generation virus packaging system The vector is used to transduce autologous T cells, which are expanded in vitro to obtain CT120 cells, and the final cryopreserved CT120 injection is obtained through preparation.

After the CT120 injection product binds to the CD19 and/or CD22 antigens on the target cell membrane, it releases granzyme/perforin to directly kill the target cells, and at the same time releases cytokines to stimulate the expansion of CAR-T cells to continue to exert anti-tumor effects.

About Reindeer Medical Reindeer Medical is an innovative biopharmaceutical company that focuses on the development and industrialization of cellular drugs and antibody drugs.

Founded in 2017, the company has established an international management team with extensive experience in new drug development, clinical research and commercialization.

The company takes the development of hematological tumor cell drugs and antibody drugs as the cornerstone of innovation, and expands to solid tumors and autoimmune diseases.
It has complete platform capabilities from early detection, registration and application, clinical development to commercial production, and includes all Five major technology platforms, including human antibody discovery platform, high-throughput CAR-T drug optimization platform, general CAR technology platform, production technology platform, and clinical translational research platform.

There are currently 10 products under research at different stages of development.
Among them, the most rapidly progressing product CT103A (fully human BCMA chimeric antigen receptor autologous T cell injection) is in the late stage of clinical development and will be approved by the state in February 2021.
The Center for Drug Evaluation (CDE) included "Breakthrough Therapy Drug Varieties".

With a strong executive management team, rich product pipeline, unique innovative R&D and business model, Reindeer Medical is committed to becoming the most influential innovative pharmaceutical company in the industry, and promoting innovative drugs that truly solve clinical pain points and have market competitiveness.
From the clinic to the market, it opens up new treatment paths for patients and brings new hope.

Article source: Reindeer Biotechnology "Received Acceptance!" Reindeer Medical’s full-human source CD19/CD22 dual-target CAR-T clinical trial application for the second indication was accepted by CDE" Yimike has always been committed to original news reports such as cutting-edge technology, industry trends, industry insights, etc.
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