Estrella Biopharma Announces FDA Clearance of IND Application for Phase I/II Clinical Trial (Starlight-1) of EB103, a CD19-Targeted ARTEMIS® T Cell Therapy, to Patients with B-Cell Lymphomas

09 Mar 2023
pipelinereview.com
Cell TherapyImmunotherapyClinical StudyINDLicense out/in
Initiation of Phase I/II Clinical Trial (Starlight-1) Expected to Occur in Second Half of 2023
EMERYVILLE, CA and NEW YORK, NY, USA I March 08, 2023 I 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.
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 cancerCD19-positive cancer cells, bind to these cells, and destroy them.
Estrella is a preclinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies with the capacity to address treatment challenges for patients with blood cancers and solid tumors. Estrella's mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer. To accomplish this mission, Estrella's lead product candidate, EB103, utilizes Eureka's ARTEMIS® technology to target CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, which also utilizes Eureka's ARTEMIS® technology to target not only CD19, but also CD22, a protein that, like CD19, is expressed on the surface of most B-cell malignancies. Estrella is also collaborating with Imugene Limited and its product candidate, CF33-CD19t an oncolytic virus ("CF33-CD19t"), to research the use of EB103 in conjunction with CF33-CD19t to treat solid tumors using a "mark and kill" strategy.
About TradeUP
TradeUP Acquisition Corp. is a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. TradeUP was incorporated under the laws of the State of Delaware on January 6, 2021.
Important Information and Where to Find It
TradeUP has filed with the SEC a registration statement on Form S-4 (File No.: 333-267918) (the "Form S-4") containing a preliminary proxy statement and a preliminary prospectus of TradeUP containing information about the proposed business combination and the respective businesses of TradeUP and Estrella, initially filed on October 18, 2022 and as amended from time to time, and after the Form S-4 is declared effective, TradeUP will mail a definitive proxy statement/prospectus relating to the proposed business combination to its stockholders and Estrella's shareholders. This press release does not contain all the information that should be considered concerning the proposed business combination and is not intended to form the basis of any investment decision or any other decision in respect of the business combination. TradeUP's stockholders and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus and the amendments thereto and the definitive proxy statement/prospectus and other documents filed in connection with the proposed business combination, as these materials will contain important information about Estrella, TradeUP and the proposed business combination. When available, the definitive proxy statement/prospectus and other relevant materials for the proposed business combination will be mailed to stockholders of TradeUP as of a record date to be established for voting on the proposed business combination. Such stockholders will also be able to obtain copies of the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other documents filed with the SEC, without charge, once available, at the SEC's website at www.sec.gov, or by directing a request to TradeUP Acquisition Corp., 437 Madison Avenue, 27th Floor, New York, New York 10022, and its telephone number is (732) 910-9692, Attention: Jianwei Li, Co-Chief Executive Officer.
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