Precision Bio Announces MC-1-50 CD19 CAR-T Granted IND Approval with 100% ORR in r/r B-ALL and Advances Toward IPO

According toCDE's official website shows that Chongqing Precision Biotech Co., Ltd. (hereinafter referred to as "Precision Biotech")"MC-1-50 Cell Preparation" has obtained clinical trial implied permission, indicated for patients aged ≥18 years with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.。

MC-1-50 is the second-generation CD19-targeted CAR-T cell therapy independently developed by Chongqing Precision Biotech Co., Ltd. based on the PRIMCAR platform.`, with the advantages of lower dosage, fewer side effects, and longer duration. The clinical data of this candidate product was disclosed at the 2022 ASCO Annual Meeting.`Among 13 patients with relapsed/refractory acute B lymphoblastic leukemia (r/r B-ALL) who received treatment, the ORR reached 100%.；In terms of safety, 84% of patients experienced CRS, including 7 cases (54%) of grade 1 CRS and 4 cases (30%) of grade 2 CRS. No CRS of grade 3 or higher was observed, indicating an overall favorable safety profile.

And in the new data announced at the 2023 ASCO Annual Meeting,The ORR of 19 patients with r/r B-ALL remained at 100%, and more than 50% of the patients achieved sustained CR without undergoing transplantation., and its safety is significantly better than traditional CAR-T products targeting the same site. Moreover, most patients can still achieve long-term sustained remission without bridging transplantation.

In addition, the phase 1 clinical data of MC-1-50 in treating patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) showed that: the cell preparation time for all 13 patients was around 2 days, all patients in the 5*10^5 CAR+/kg dose group achieved CR, and those who achieved CR experienced prolonged CR. The drug was well tolerated. It is worth mentioning that on September 15 this year, the IND application for this candidate product was accepted by the CDE.

Chongqing Precision Biotech Co., Ltd. was established in 2016. It is a biotechnology enterprise dedicated to the innovation and commercial application of gene and cell technologies. The company has built18,000 square metersIncluding preclinical research, technology development, analytical testing, and technical production, it supports the entire upstream and downstream integrated platform for cell-based drug development, covering IND and NDA.It is one of the few gene and cell pharmaceutical companies in China that have been approved for the CAR-T "Drug Production License."。

Recently, Precision Biotech has made significant progress. In October this year, Professor Qian Cheng, Chairman and Chief Scientist of Precision Biotech, was named one of the Top 10 Chongqing Science and Technology Innovation Figures of 2023. Precision Biotech has successively been awarded the "Top 100 Innovative Pharmaceutical Enterprises in China" and the "Chongqing Enterprise Innovation Award". Its "Cell and Gene Technology Innovation Center" was also recognized as a Chongqing Technology Innovation Center, receiving widespread acclaim.

At this year's ASCO conference, Chongqing Precision Biotech Co., Ltd. had three abstracts detailing clinical and preclinical research findings published on the ASCO official website. Two of these were selected for oral presentation, while one was included in the online abstracts of the ASCO Annual Meeting. In addition to data related to MC-1-50 CAR-T, Precision Biotech’s PRIMCAR platform boasts several distinctive features.It can reduce the manufacturing time to approximately 2 days and enrich more stem cell-like memory T (Tscm) cells in the product.，and the data released also suggests that this platform could become a potential platform for outpatient management.

Currently, Precision Biotech has established six major original platform systems,打通了自主研发、自主生产、自主检测全产业链, and obtained multiple CAR-T indications through tacit approval. It has also developed a pipeline covering both hematological tumors and solid tumors, while accelerating the advancement of these therapies.