Reindeer Biological self - developed CT103A clinical trial application approved by FDA!

On December 22, 2022, Reindeer Bio announced that its indigenously developed CT103A clinical trial IND has been approved by the US Food and Drug Administration (FDA) for clinical trials in relapsed/refractory multiple myeloma (R/R MM).

MM is the second largest hematological malignancy, and recurrence of refractory to no treatment is the outcome of most patients with MM. Multiple myeloma (MM) accounts for nearly 2% of all cancer cases and more than 2% of cancer deaths in the United States, according to the Fraser Sullivan report. The number of new cases of MM in the United States increased from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 in 2025. The number of Americans with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 in 2025.

CT103A is a CAR-T cell therapy targeting B-cell mature antigen (BCMA), whose CAR structure contains whole-human single-stranded variable fragments (scFvs) that allow it to bypass the host's potential anti-CAR immunogenicity while retaining antitumor activity. A Phase I/II study of CT103A (NCT05066646) in China showed excellent efficacy and safety. Data presented at the 2022 EHA Congress showed that in 79 patients receiving Phase II recommended dose (RP2D) of 1.0×106 CAR T cells/Kg, the median follow-up time was 9.0 months (1.2, 19.6), and the objective response rate (ORR) reached 94.9%. Median time to remission (mTTR) was only 16 days; 92.4% of the subjects achieved MRD negative, and those who achieved complete remission (CR) or above achieved MRD negative. Subjects who had previously received CAR T therapy continued to benefit from CT103A reinfusion. No grade 3 cytokine release syndrome (CRS) or immune effector cell associated neurotoxic syndrome (ICANS) was observed after CT103A reinfusion, and CRS and ICANS were resolved in all subjects after treatment.

CT103A has received an overview of regulatory milestones at home and abroad

In June 2022

CT103A was officially accepted by the NMPA as an NDA for the treatment of relapsed/refractory multiple myeloma and included in the priority review.

In February 2022

CT103A has been granted Orphan drug (ODD) designation by the FDA for the treatment of multiple myeloma.

In February 2021

CT103A has been granted "Breakthrough Therapy Agent" (BTD) designation by the NMPA for the treatment of relapsed/refractory multiple myeloma.

In August 2022

CT103A new expanded indication of AQP4-IgG positive optic neuromyelitis spectrum disease (NMOSD) IND approved by NMPA.

Dr. Wen Wang, CEO of Reindeer Biology, said:

The approval of CT103A U.S. IND is an important milestone in the internationalization process of Reindeer Biology, and also a new starting point. Reindeer Biology will accelerate the overseas clinical trial layout, accelerate the development and landing of overseas cellular immunotherapy drugs, and allow more patients to benefit earlier.

About CT103A

CT103A is a CAR T cell therapy targeting B cell maturation antigen (BCMA). Lentivirus was used as a gene vector to transfect autologous T cells. The CAR contained the full human scFv, CD8a hinge and transmembrane, 4-1BB co-stimulated and CD3ζ activated domains. Based on rigorous screening and comprehensive in vitro and in vivo function evaluation, CT103A has strong and rapid efficacy, with outstanding in vivo durability.

About reindeer biology

Reindeer Bio is a clinical biopharmaceutical company dedicated to the development of innovative cellular drugs. With the development of hematologic tumor cell drugs and antibody drugs as the cornerstone of innovation, the company has expanded into solid tumors and autoimmune diseases. It has a complete platform capability of the whole process from early discovery, registration and application, clinical development to commercial production, and a number of technology platforms including full human antibody discovery platform, high-throughput CAR T drug selection platform, general CAR technology platform, production technology platform, clinical transformation research platform and so on.

The company currently has 10 varieties in different stages of research and development, among which the marketing application (NDA) of Ikilense injection, the product candidate with the most rapid progress, has been officially accepted by the National Food and Drug Administration (NMPA) and included into the priority evaluation qualification for the treatment of relapsed/refractory multiple myeloma. The product has been included in the "breakthrough treatment drug" category by the NMPA and the "Orphan drug (ODD)" designation by the FDA. In addition to multiple myeloma, a clinical trial application (IND) for Ikelenxel injection has been approved by NMPA for a new expanded indication: antibo-mediated Neuromyelitis Optica Spectrum Disorder (NMOSD). CT120 (full human CD19/CD22 dual-target CAR T cell injection), an innovative product candidate independently developed by the company, has entered the clinical study stage. The indications are CD19/ CD22-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (B-ALL), which has been granted Orphan drug (ODD) designation by the FDA.

With its strong management team, innovative product line, owned GMP manufacturing and superior clinical development capabilities, Reindeer Bio aims to provide innovative therapies that are transformative, curable and affordable to meet the unmet medical needs of patients in China and around the world.