EB103 / Estrella Biopharma - LARVOL DELTA

Estrella Advances STARLIGHT-1 Trial into Phase II Following Positive DSMB Recommendation (Businesswire) - "An independent Data Safety Monitoring Board (DSMB) confirms EB103’s favorable safety profile with no treatment-related serious adverse events (SAEs) even in high-risk patients who are ineligible for currently available commercial CD19 products; DSMB recommends advancement of STARLIGHT-1 to Phase II at the Recommended Phase II Dose (RP2D); High-dose cohort of Phase I achieved a 100% complete response (CR) rate at Month 1."

DSMB • P1 data • CNS Lymphoma • Large B Cell Lymphoma

Estrella Immunopharma Completes Second Dose Cohort in STARLIGHT-1 Trial of EB103 with Complete Responses in All Evaluable Patients (Businesswire) - "The study has achieved a 100% complete response (CR) rate at Month 1 in all evaluable patients treated in the second dose cohort. All patients treated are considered high-risk group who are not suitable to receive commercial CD19 products, including one with Central Nervous System (CNS) lymphoma. No treatment-related serious adverse events (SAEs) were reported during this study phase....Following the completion of this dose cohort, a Data and Safety Monitoring Board (DSMB) will review the cumulative study data..."

DSMB • P1/2 data • Trial status • B Cell Non-Hodgkin Lymphoma • CNS Lymphoma

Estrella Immunopharma Announces Activation of Additional Site for Phase I/II STARLIGHT-1 Trial in B-cell Non-Hodgkin’s Lymphoma (Businesswire) - "Estrella Immunopharma...announced the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103...in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). The new site, Baylor Research Institute d/b/a Baylor Scott & White Research Institute in Dallas, Texas, is now open for patient enrollment....The Phase I/II clinical trial for EB103 is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of EB103 autologous T-cell therapy and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL."

Trial status • Non-Hodgkin’s Lymphoma

Estrella Immunopharma Initiates Second Cohort and Doses First Patient in STARLIGHT-1 Trial of EB103 in Advanced B-Cell Non-Hodgkin’s Lymphomas (Businesswire) - "Estrella Immunopharma...announced that the first patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103, a CD19-redirected ARTEMIS T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin’s Lymphomas (NHL)....The second cohort will evaluate EB103 at a higher dose level following a review of safety data from the first dose cohort. As previously announced, no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) were observed in the first cohort."

Trial status • Non-Hodgkin’s Lymphoma

Estrella Immunopharma Completes First Dose Cohort in STARLIGHT-1 Trial and Receives Approval to Initiate Higher Dose Cohort (Businesswire) - P1/2 | N=21 | STARLIGHT-1 (NCT06343311) | Sponsor: Estrella Biopharma, Inc. | "Estrella Immunopharma...announced the successful completion of the first dose cohort in its ongoing STARLIGHT-1 Phase I/II clinical trial. Following a review of safety and efficacy data, the Data and Safety Monitoring Board (DSMB) has approved the initiation of the second dose cohort, which will administer 5 million receptor-positive T cells per kilogram of body weight of EB103 CD19-Redirected ARTEMIS T-cell therapy....The first dose cohort included patients with relapsed/refractory B-cell non-Hodgkin lymphoma ('NHL') who have failed multiple prior lines of therapy. Preliminary data from this cohort demonstrated a favorable safety profile, with no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) observed. Additionally, tumor response, were noted in all patients at Month 1."

DSMB • P1 data • Trial status • Non-Hodgkin’s Lymphoma

First Patient Dosed Achieves Complete Response in Estrella Immunopharma’s Trial for CD19-Targeted T-cell Therapy EB103 in B-Cell Lymphomas (CGTLive) - "'CAR-T therapies have improved outcomes for patients with B-cell nonHodgkin lymphomas (NHLs) compared with traditional standard-of-care treatments,' Mehrdad Abedi, MD...'However, patients battling relapsed/refractory (r/r) NHL, especially those with high-risk conditions such as HIV-associated lymphoma, central nervous system lymphoma, and additional high-grade NHL subtypes urgently need new therapeutic options that minimize the risk of potential life-threatening side effects, including severe CRS and neurotoxicity. EB103 ARTEMIS T-cell therapy represents an innovative treatment option that may potentially benefit a wider range of r/r B-cell NHL patients.'"

Media quote

Estrella Immunopharma Achieves Complete Response in First Patient Treated with CD19- Redirected ARTEMIS T-cells (Businesswire) - "Estrella Immunopharma, Inc...today announced that the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial has achieved a complete response (CR) one month after receiving an infusion of EB103 CD19- Redirected ARTEMIS T Cells....Given the patient’s high tumor burden and multiple comorbidities, the patient was considered at high-risk, which might have increased the severity of side effects like cytokine release syndrome (CRS) and neurotoxicity with commercially available CAR-T treatments. However, no treatment-related serious adverse events (SAEs) were observed in this case."

Trial status • Follicular Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Starlight-1: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma (NHL) (clinicaltrials.gov) - P1/2 | N=21 | Recruiting | Sponsor: Estrella Biopharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Estrella Immunopharma Doses First Patient in Phase I/II Trial of EB103 in Advanced B-cell Non-Hodgkin’s Lymphomas (EIN Presswire) - "Estrella Immunopharma, Inc...today announced the dosing of the first patient in its Phase I/II clinical trial (STARLIGHT-1) for EB103, an autologous T-cell therapy for adult patients with relapsed/refractory (R/R) B-cell Non-Hodgkin’s Lymphomas (NHL)."

Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Starlight-1: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov) - P1/2 | N=21 | Not yet recruiting | Sponsor: Estrella Biopharma, Inc.

New P1/2 trial • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Estrella Immunopharma Announces Publication in Blood Demonstrating ARTEMIS T Cell’s Potential in Addressing AML (EIN Presswire) - "Estrella Immunopharma, Inc...today announced the publication of a paper...in Blood...This Blood publication reported the engineering of an antibody-T cell receptor (AbTCR) against the intracellular antigen Wilm's tumor 1 protein (WT1), and a costimulatory signaling receptor (CSR) against surface antigen CD33, creating ARTEMIS T cells that are cytotoxic to WT-1 positive AML cells, while sparing healthy hematopoietic cells. As both WT1 and CD33 are highly expressed on most AML cells, this paper demonstrates the potential of ARTEMIS T cells in addressing AML with promising specificity and potency....Estrella expects to commence the Phase I/II clinical trial for EB103 in the United States in the first half of 2024."

New P1/2 trial • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TradeUP Acquisition Corp. and Estrella Biopharma, Inc. Announce Completion of Business Combination (PRNewswire) - "Estrella Immunopharma, Inc...today announced the successful closing of its business combination with Estrella Biopharma, Inc. ('Estrella'), a preclinical-stage biopharmaceutical company developing T-cell therapies with the capacity to address treatment challenges for patients with blood cancers and solid tumors. The resulting combined company will operate under the name Estrella Immunopharma, Inc. and will be led by Estrella Founder and CEO Dr. Cheng Liu. The combined company's common stock and warrants will trade on NASDAQ under the symbols 'ESLA,' and 'ESLAW,' respectively, effective October 2, 2023.On or about October 2, 2023, all remaining UPTD units will separate into their underlying components, which consist of one share of combined company's common stock and one-half of one warrant. The transaction was approved by UPTD's stockholders at the special meeting held on July 31, 2023."

M&A • Acute Lymphocytic Leukemia • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

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 (PRNewswire) - "Estrella Biopharma...and TradeUP Acquisition Corp....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...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....Initiation of Phase I/II Clinical Trial (Starlight-1) Expected to Occur in Second Half of 2023."

IND • New P1/2 trial • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology