Boruida Biotech's First-in-Class CAR-T Therapy BRD-01 Receives FDA Orphan Drug Designation for Anaplastic Large Cell Lymphoma-VCBeat

On January 29, 2024, Bio-Raid (Wuhan Boruida Biotechnology Co., Ltd.) announced,BRD-01 (Autologous T-cell Injection Modified by Chimeric Antigen Receptor Targeting CD30), a CAR-T cell therapy drug independently developed by Bio-Raid, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA)., used for the treatment of Anaplastic Large Cell Lymphoma (ALCL).

ODD is a designation granted by the Office of Orphan Products Development (OOPD) of the U.S. FDA to drugs (including biologics) that qualify for the prevention, treatment, and diagnosis of rare diseases. If an investigational drug (including biologics) can demonstrate its potential in treating, preventing, or diagnosing a rare disease in an ODD application, the OOPD will grant the drug ODD after reviewing the application materials. After obtaining ODD, the product will be eligible for several preferential policies, including FDA guidance and support for clinical research, special fee reductions, fast-track approval for marketing applications in the United States, and seven years of market exclusivity in the U.S. after approval for marketing.

BRD-01On April 20, 2020, it received the clinical trial tacit approval from the National Medical Products Administration (NMPA) for the treatment of CD30+ relapsed/refractory hematological tumors.The Target of This ProductCD30 is a transmembrane protein highly expressed on the surface of Anaplastic Large Cell Lymphoma (ALCL) and Hodgkin Lymphoma (cHL) cells, serving as a clinical diagnostic marker for HL and ALCL. Completed Phase I clinical trial data of BRD-01 shows that BRD-01 has favorable safety characteristics; none of the subjects enrolled in the clinical trial experienced CRS above grade 3, nor did they experience neurotoxicity. Additionally, BRD-01 achieved a best overall response rate of 91.7% in treated CD30-positive lymphoma patients (including 5 CRs and 6 PRs). Currently, BRD-01 is steadily advancing into Phase II clinical trials. This ODD granted to BRD-01 represents a high level of recognition by the FDA of bio-raid's core technology and products, and marks a significant victory for bio-raid’s commitment to developing First-in-class products for the global market.

About Anaplastic Large Cell Lymphoma

Anaplastic Large Cell Lymphoma (ALCL) is an aggressive non-Hodgkin lymphoma that consistently and strongly expresses CD30.

The initial treatment for ALCL typically includes combination chemotherapy with or without autologous hematopoietic stem cell transplantation (HCT) or radiotherapy. For patients with localized disease, local treatments such as surgical resection or radiotherapy can achieve a complete remission rate of >90%.^[1]However, despite these positive treatment modalities, most patients with systemic ALCL are highly prone to relapse in the long term. Currently, there is no consensus on the optimal treatment for relapsed/refractory ALCL. ALCL remains an unmet medical need, necessitating new and more effective therapeutic approaches.

About BRD-01

BRD-01, independently developed by Bio-Raid (Wuhan) Biotechnology Co., Ltd., is a CAR-T cell therapy drug targeting CD30+ hematological tumors in patients diagnosed with relapsed/refractory conditions. It is also the first CAR-T cell therapy product in China to receive clinical trial approval with CD30 as the target, and it is expected to become the world's first new drug for this targeted CAR-T product.

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