Bonovo Biotech Successfully Launches Multicenter Phase 1/2 Registrational Clinical Trial of BRL-101 Gene Therapy for β-Thalassemia

ShanghaiSeptember 26, 2022/PR Newswire/ --On September 25, 2022, BRL Medicine Inc. successfully held the "BRL Medicine BRL-101 Project Phase 1/2 Investigator Meeting" in both online and offline formats. The offline meeting was grandly held at the Courtyard by Marriott Shanghai Zizhu Hotel.

Attending the meeting were core management leaders of BRL Medicine, including Chairman Mingyao Liu, CEO Biao Zheng, Chief Strategy Officer Yang Gao, Vice Presidents Dali Li and Yuxuan Wu, Medical and Clinical Vice President Wei Li, along with expert representatives from participating research centers—Yajing Xu from Xiangya Hospital of Central South University, Yongrong Lai from the First Affiliated Hospital of Guangxi Medical University, Xiaoqin Feng and Chongyuan Xu from Nanfang Hospital of Southern Medical University, and Director Jun Shi from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences—as well as relevant responsible persons from ClinChoice. Together, they witnessed this historic moment.

Group Photo of All Attending Guests

Patient-Centered, BRL MedicineBRL-101"Multicenter Phase 1/2 Registration Clinical Study Initiated"

This investigator meeting is based on"Evaluation of Single-Dose Intravenous InfusionPhase 1/2 Clinical Study on the Safety and Efficacy of BRL-101 in Transfusion-Dependent β-ThalassemiaHosted, at the conference, Professor Mingyao Liu, Chairman of BRL Medicine, Dr. Biao Zheng, CEO, along with Principal Investigator representatives Professor Yajing Xu from Xiangya Hospital of Central South University and Professor Yongrong Lai from the First Affiliated Hospital of Guangxi Medical University, delivered speeches.

Chairman of BRL Medicine, Professor Mingyao Liu, Delivers a Speech

Professor Mingyao Liu, Chairman of BRL Medicine, delivered a speech first,"Looking back on the journey of our research team from the laboratory to the current registered clinical trials, we are thrilled to see the official launch of the multi-center registered clinical study for the BRL-101 project. We are also deeply grateful to all the clinical experts, patients, and their families who have participated in and supported this research. At BRL Medicine, our corporate mission has always been 'to lead innovation with gene editing, develop breakthrough therapies, and benefit humanity.' We hope that through collaboration with many clinical experts, we can smoothly and rapidly advance the product development in this clinical study, enabling BRL-101 to soon benefit more patients with β-thalassemia."

BRL Medicine CEO Dr. Zheng Biao Delivers a Speech

In this regard,BRL MedicineDr. Zheng Biao, CEO, said,"We believe that as the participating centers successively initiate the registrational clinical trial of BRL-101 and enroll the first patient, we are one step closer to our goal of bringing a one-time curative therapy to patients with transfusion-dependent β-thalassemia. As one of the earliest companies globally to engage in the research and application of gene editing technology, BRL Medicine has already assembled a group of internationally advanced scientific research teams. Moving forward, we will continue to build on our increasingly comprehensive industry layout and global R&D network, actively advancing multiple R&D pipelines based on gene editing technology for severe genetic diseases, malignant tumors, and autoimmune disorders, providing better treatment options for patients in China and around the world."

At the meeting, experts had a heated discussion and exchange.

Subsequently, Director Xu Yajing from Xiangya Hospital of Central South University and Director Lai Yongrong from the First Affiliated Hospital of Guangxi Medical University spoke as representatives of the principal investigators.Director Xu stated,Focusing on the current treatment status of thalassemia, we are also very pleased to collaborate clinically with the BRL Medicine team. We hope to leverage advanced gene editing technology to address the high costs and difficulties in hematopoietic stem cell matching faced by traditional thalassemia therapies, thereby benefiting a wide range of thalassemia patients.Director Lai also expressed,Previously, the investigator-initiated clinical trial (IIT) conducted by BRL Medicine in collaboration with Xiangya Hospital of Central South University and the 923rd Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army has demonstrated excellent clinical outcomes. All six IIT thalassemia patients have been free from blood transfusion dependence for over a year, with the longest two cases having gone without transfusions for more than two years. This research represents a breakthrough achievement in the clinical translation of gene-editing technology in China, placing the country at an internationally leading level in basic to clinical translational research. Compared to traditional therapies, gene therapy holds the potential to become a more accessible treatment option for the broader population. It is also hoped that in the future, beyond focusing on thalassemia, gene-editing therapies will be able to treat more patients with other rare genetic disorders.

In addition, at this meeting, the expert representatives had a heated discussion and exchange on the strategy of this clinical trial centered around patients, and provided many constructive suggestions; finally, Dr. Li Wei, Vice President of Medical and Clinical at BRL Medicine, gave a detailed introduction to the company and its research products to the guests present, and led all the guests on a tour of BRL Medicine Inc.'s Shanghai headquarters. The successful convening of this investigator meeting is believed to benefit BRL Medicine.BRL-101"The multi-center Phase 1/2 registrational clinical study provides significant support, which will undoubtedly accelerate the translation and implementation of this product, thereby benefiting thalassemia patients sooner."