On March 8, 2023 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, reported 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 (Press release, Estrella Biopharma, MAR 8, 2023, View Source [SID1234628358]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.
About EB103
EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes Eureka Therapeutics, Inc.’s ("Eureka’s") ARTEMIS technology pursuant to Estrella’s license agreement with Eureka to target CD19. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cells, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.