Therapy Areas: AIDS & HIV
Estrella Biopharma and TradeUP Acquisition receives US FDA approval for EB103 IND application
9 March 2023 -

US-based Estrella Biopharma, Inc., a biopharmaceutical company, and TradeUP Acquisition Corp. (NASDAQ:UTPD), a special purpose acquisition company formed for the purpose of effecting a merger, acquisition or similar business combination, announced on Wednesday that the US Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for its lead product candidate, EB103, a T-cell therapy aimed at CD19, a protein expressed on the surface of almost all B-cell leukaemia's and lymphomas.

This move will pave way for the company to start a Phase I/II clinical trial of EB103 intended to treat relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) patients, including approval to treat patients with some of the highest unmet medical requirement, including those with human immunodeficiency virus (HIV)-associated lymphoma, and primary and secondary central nervous system (CNS) lymphoma.

The Starlight-1 Phase I/II clinical trial is aimed at evaluating the safety, tolerability, recommended Phase II dose (RP2D), and preliminary anti-cancer activity of EB103 for the treatment of R/R B-cell NHL patients. The study is likely to enrol subjects initially at UC Davis Health.