Another Milestone: Bonoy Bio's Next-Generation Allogeneic CAR-T Therapy Receives IND Approval in China

ShanghaiJuly 27, 2023PR Newswire -- July 27, 2023, BRL Medicine Inc., a Shanghai-based biotechnology company focusing on gene and cell therapy (hereinafter referred to as "BRL Medicine"), announced the development of a product based on its proprietary universal cell platform."TargetedThe Investigational New Drug (IND) application for the "CD19 Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection" (Pipeline Code: BRL-301) has officially been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration.The IND targets the indication of "Acute Lymphoblastic Leukemia." Notably, BRL-301, as an off-the-shelf allogeneic CAR-T product,With many advantages such as high accessibility, low cost, and stable quality,Previously, in clinical trials initiated by researchers,Demonstrated significant efficacy and high safety.

BRL-301 Approved IND Information

BRL Medicine's New Generation CD19 UCAR-T Product More Accessible to Patients!

As one of the earliest companies globally to engage in the research, development, and application of gene-editing technology, BRL Medicine's BRL-301 is based on its self-developed universal cell platform (TyUCell).^®) The brand-new generation of UCAR-T products developed byUsing gene editing technology to transform allogeneic immune cells effectively avoids potential issues in allogeneic cell transplantation.GVHD and HVG risks, while ensuring the safety and efficacy of cellular products, truly achieve the generalization of immune cell therapy products.The therapeutic area targeted by this product is B-cell malignancies.

B-cell malignanciesMain types include leukemia and lymphoma. The most common ones are Acute Lymphoblastic Leukemia (ALL) and Diffuse Large B-cell Lymphoma. ALL is a heterogeneous type of leukemia, with current treatments including chemotherapy, targeted therapy, BCR-ABL tyrosine kinase inhibitors, and hematopoietic stem cell transplantation. The 5-year disease-free survival rate is only 30%-40%. Allogeneic hematopoietic stem cell transplantation is the most effective salvage treatment, but it often faces challenges such as donor shortages, numerous complications, difficulty in controlling the disease, and a high recurrence rate even after successful transplantation. Currently, chimeric antigen receptor T cells (CAR-T) targeting CD19 have been clinically proven to effectively treat B-cell malignancies. Compared with traditional autologous CAR-T cells, allogeneic CAR-T cells can significantly expand patient access to treatment, especially for patients with defective autologous immune cell function or rapidly progressing hematological malignancies. Allogeneic CAR-T cells can save many patients who cannot benefit from autologous CAR-T cell therapy.

Compared with similar products at home and abroad,BRL Medicine New GenerationCD19 UCAR-T Product Has the Following Clinical Advantages:

1. Great patient accessibility

BRL Medicine's UCAR-T product has achieved effective immune escape through systematic gene editing and modification. During the treatment process, there is no need for HLA typing screening of patients, enabling true off-the-shelf availability and greatly expanding the product's applicability. Moreover, a production scale of over 200 doses per batch has been achieved, which not only significantly reduces production costs but also shortens patient waiting times, greatly enhancing the convenience of using cell therapy products in clinical practice and demonstrating outstanding advantages in clinical treatment.

2. Higher Clinical Safety

BRL Medicine's UCAR-T product does not require additional lymphodepletion or immunosuppression for patients. By adopting only conventional or even lower lymphodepletion regimens, it can achieve complete elimination of tumor cells while effectively avoiding risks such as infection, agranulocytosis, and slow lymphocyte recovery caused by excessive immunosuppression in patients, demonstrating extremely high clinical safety.

3. Better Clinical Treatment Outcomes

The T cells of BRL Medicine's UCAR-T product are derived from young and healthy donors, whose activity is far superior to the immune cells of patients with long-term hematological diseases. After infusion into the body, they exhibit excellent expansion potential and persistence. In the early IIT research of the product, BRL Medicine's UCAR-T demonstrated significant and durable tumor clearance capabilities, achieving rapid complete remission of the disease.

It can be said that BRL Medicine's new generation of UCAR-T products have solved the pain points and difficulties in the CAR-T treatment industry.Achieved a comprehensive improvement in efficacy, safety, and clinical accessibility, demonstrating significant industrialization advantages. Its excellent clinical safety, therapeutic effects, and extremely low production costs allow more cancer patients to fully benefit.The dividend brought by the high-tech CAR-T therapy.In the future, BRL Medicine will alsoFully PromoteClinical Translation and Application of UCAR-T in the Treatment of Autoimmune Diseases and Solid TumorsTo bring better treatment options to a wide range of patients.