Senlang Bio's Anti-CD7 CAR-T Therapy SENL101 Granted FDA Orphan Drug Designation for Relapsed/Refractory T-LBL/ALL

On September 6, Senlangbio issued a press release stating that it had received an official written response from the US FDA Office of Orphan Products Development (OOPD) regarding its development ofCD7-Targeted CAR-T Cell Product (SENL101 Autologous T Cell Injection)Granted Orphan Drug Designation forTreatment of Adult Relapsed or Refractory T-Lymphoblastic Lymphoma/Leukemia (T-LBL/ALL)。

T-Lymphoblastic Lymphoma/Leukemia (T-LBL/ALL) is a disease originating from lymphoblasts.Highly Aggressive Hematologic Tumor, both belong to the same biological disease. The clinical manifestations of the disease include the invasion of peripheral blood and bone marrow, mediastinal invasion, hepatosplenomegaly, lymphadenopathy, and involvement of other extranodal sites. Currently, there are unmet treatment needs for such patients.CD7 is an abnormal marker on the surface of tumor cells in hematological malignancies, and it is overexpressed in relapsed/refractory T-ALL/LBL.Therefore, CAR-T therapy targeting CD7 is expected to bring new treatment options for these patients.

SENL101 Autologous T-cell Injection is aCAR-T Cell Product Based on CD7 Nanobody, Mainly Targeting CD7-Positive T Cell-Originated Lymphohematopoietic Malignancies. Previously, the product was used to treat T-LBL/ALLEfficacy and safety have been validated in early clinical studies., which was approved for clinical use in China in June 2023 and has been continuouslyBLOODPresented at the magazine and the annual meeting of the American Society of Hematology (ASH).

According to the press release from Senlangbio, the granting of orphan drug designation was primarily based on the comprehensive preclinical studies of SENL101 autologous T-cell injection and the positive results obtained from an investigator-initiated clinical trial (IIT) conducted in China.

References:

[1]Senlangbio's CD7-Targeted CAR-T Cell Product (SENL101 Autologous T-cell Injection) Granted "Orphan Drug" Designation by U.S. FDA. Retrieved Sep 6, 2023, from https://mp.weixin.qq.com/s/nQC2iFGaDhbYclKinbC8lA