First tetraspecific antibody GNC-038 in the world

First tetraspecific antibody GNC-038 in the world.

The world’s first tetraspecific antibody GNC-038 entered the clinic trials. At the Shenzhen International Biomedical Industry Innovation and Development Conference held recently, the world’s first four-specific antibody drug GNC-038, which was approved to enter the clinic trials, debuted for the first time, arousing strong responses from the participating biomedical experts.

This drug comes from Chengdu. It is an innovative drug that has been developed by Baili Pharmaceutical Co., Ltd., in Chengdu, China, that targets 4 targets at the same time.

The current frontiers of tumor treatment include “targeted therapy” and “immunotherapy”. This tetra-specific antibody can achieve “targeted immunotherapy” and may bring breakthrough curative effects for patients with lymphoma, leukemia and various solid tumors. .

In early November, GNC-038 officially started phase I clinical research at the Institute of Hematology, Chinese Academy of Medical Sciences.

The first “four antibodies”

Since the world’s first monoclonal antibody product came out in 1986, after decades of efforts, monoclonal antibodies have achieved great success in the treatment of various diseases, especially tumors.

In recent years, the double and tertiary antibodies have more powerful therapeutic effects. The world’s first quaternary antibody to enter the clinic was developed by Bailey Pharmaceutical.

First tetraspecific antibody GNC-038 in the world — *The world’s first tetraspecific antibody GNC-038 entered the clinic trials*

It is understood that this achievement has caused quite a stir in the international medical community. An industry insider said, “I thought the four-specific antibodies were still under construction, but I didn’t expect it to be realized so soon!” Indeed, international biopharmaceutical giants Sanofi and Amgen are studying tri-specific antibodies, but the first four Specific antibodies have been preempted by Chinese companies.

Five years: From “A Dream” to entering the clinic trials

It takes a long time for an innovative drug to go from development to market. Bailey Pharmaceuticals GNC-038, which officially entered the clinic at the beginning of this month, had its conception started as early as 2015.

Dr. Zhu Yi, chairman of Bailey Pharmaceuticals, recently introduced that the company has established a biotech innovation research and development company in Seattle, USA, and has assembled a world-class team of scientists for drug research and development. In 2015, when Dr. Zhu Yi proposed the idea of the development of tetraspecific antibodies, even some scientists in Seattle thought it was a “fantasy”. But soon, the drug entered the research and development track.

GNC-038 was screened from more than 100 molecules and determined the basic structure, and then it was continuously optimized. From June 2018 to June 2020, the team of scientists completed the preclinical study of GNC-038 in two years.

In June 2020, Baili Pharmaceutical filed a clinical application with the National Medical Products Administration (NMPA) of China, and obtained an implied license in September 2020.

According to Dr. Zhu Yi, GNC-038 has four antigenic domains targeting CD19, CD3, PD-L1 and 4-1BB, which can activate the first and second signals of T cells through anti-CD19 and PD-L1 structures. The domain targets and kills tumor cells.

Baili established a special “Dort antibody” plant

Currently, GNC-038 has been producing samples for clinical research in Wenjiang. The company has established a dedicated “multi-specific antibody” plant for the production of multi-specific antibodies.

Because all production processes are carried out in a sterile GMP workshop. According to the production manager, GNC-038 samples need to be cultured in the cell culture workshop, and then transferred to the purification workshop for purification after harvest, and then made into a stock solution, then transferred to the preparation workshop to form a preparation, and then placed in a 4℃ warehouse for storage.

These preparations will be shipped in batches to the Institute of Hematology, Chinese Academy of Medical Sciences in Tianjin for clinical research.

About GNC-038

What do pre-clinical research experts say?

Innos:

Four specific antibody drugs are at the forefront of international innovation

Although Bailey Pharmaceutical is quite low-key, people in the industry still have a voice. The first to make this announcement was Shanghai Innos Biotechnology Co., Ltd., which provided a full set of non-clinical evaluation studies on toxicology, pharmacokinetics, and receptor occupancy for GNC-038. Innos is one of the five national GLP centers established by the Ministry of Science and Technology during the “Ninth Five-Year Plan” period, and it is also the first batch of certified GLP institutions in the country.

Dr. Tang Naping, Director of Innos Toxicology Research Division, said that the four specific antibody drugs are at the forefront of international innovation.

Currently, most of the antibody drugs that have been marketed are mainly monoclonal antibodies, but there are more and more double antibodies and even polyclonal antibodies.

Such antibodies can bind two or more antigens or epitopes at the same time, and then can explore treatment opportunities that cannot be reached by monoclonal antibodies, and have therapeutic effects that cannot be achieved by monoclonal antibodies.

At this stage, there are hundreds of dual-antibody drugs in clinical trials, but the four-specific antibody enters the clinic, Baili GNC-038 is the first. “Innos is honored to provide a complete set of non-clinical evaluation studies for the world’s first tetraspecific antibody.”

What do clinical research experts say?

Institute of Hematology, Chinese Academy of Medical Sciences:

Four antibodies are truly internationally leading original innovations

On November 2, 2020, GNC-038 officially launched Phase I clinical research at the Institute of Hematology, Chinese Academy of Medical Sciences, a leading institution in the development of hematology in China.

At the launching ceremony, Professor Wang Jianxiang, deputy director of the Institute of Hematology, Chinese Academy of Medical Sciences, said that GNC-038 is the world’s first tetraspecific antibody to enter the clinic. This is a big leap based on double antibodies, which is truly international Leading original innovation. The novel structure and function design of GNC-038 has demonstrated a breakthrough anti-tumor effect in pre-clinical research. We look forward to the breakthrough effect in pre-clinical studies, which can be clinically verified to benefit the majority of cancer patients.

First tetraspecific antibody GNC-038 in the world

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First tetraspecific antibody GNC-038 in the world