09 March 2023 | Thursday | News
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Estrella Biopharma, Inc. ("Estrella"), a biopharmaceutical company whose mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer with safe, effective therapies, and TradeUP Acquisition Corp. ("TradeUP") (NASDAQ: UTPD), a special purpose acquisition company formed for the purpose of effecting a merger, acquisition or similar business combination, today announced that the U.S. Food and Drug Administration ("FDA") has cleared Estrella's Investigational New Drug ("IND") application for Estrella's lead product candidate, EB103, a T-cell therapy targeting CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas, paving the way for Estrella to initiate a Phase I/II clinical trial of EB103 to treat relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) patients, including clearance to treat patients with some of the highest unmet medical needs, including those with human immunodeficiency virus (HIV)-associated lymphoma, and primary and secondary central nervous system (CNS) lymphoma.
"We are thrilled to have received FDA clearance for our IND application for EB103, which will allow us to evaluate its safety and efficacy in a broader range of patients, including those who are typically excluded from other clinical trials, often due to cytokine release syndrome (CRS) and neurotoxicity," said Dr. Cheng Liu, President and Chief Executive Officer of Estrella. "Our goal is to develop a safe and effective therapy that can help address the unmet medical needs of patients with R/R B-cell malignancies, including those who are currently underserved by existing therapies. We hope to enroll our first patient in the second half of 2023."
The Starlight-1 Phase I/II clinical trial is designed to assess 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 expected to enroll patients initially at UC Davis Health.