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Imugene selected for Oral Presentation at Prestigious ASH Annual Meeting in Florida

On November 4, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that an abstract regarding azer-cel has been selected for oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held from 6-9 December 2025 in Orlando, Florida.

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The ASH (Free ASH Whitepaper) Annual Meeting is the world’s premier event in malignant and non-malignant haematology, attracting more than 30,000 clinicians, scientists, and industry representatives from over 100 countries. Each year, the meeting highlights the most significant scientific and clinical advances in the field, with oral abstracts representing the highest tier of accepted submissions.

Imugene’s abstract, titled "Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T", has been selected for presentation within the session "Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Next Generation CAR-T Clinical Trials in Relapsed/Refractory B-cell NonHodgkin Lymphoma and Multiple Myeloma."

The oral presentation will take place on Saturday 6 December 2025, from 2:30pm to 2:45pm US Eastern Time in West Hall D2 of the Orange County Convention Center.

The abstract published overnight includes clinical activity and safety data from the Company’s azer-cel (allogeneic CD19 CAR T) program, evaluating the combination with low-dose IL-2 in patients with relapsed or refractory large B-cell lymphoma (LBCL) following prior autologous CAR T-cell therapy. The abstract is linked on Imugene’s website at View Source

Imugene’s Managing Director and Chief Executive Officer, Leslie Chong, said: "We are honoured that azer-cel has been selected for oral presentation at ASH (Free ASH Whitepaper), it being the world’s leading haematology conference. This puts a spotlight on the growing clinical interest in allogeneic CAR T approaches and represents an exciting opportunity to share new insights from our ongoing study with the global haematology community."

(Press release, Imugene, NOV 4, 2025, View Source [SID1234659294])

Geek Gene Announces IND Clearance for GK01, Advancing the Novel T-Cell Therapy Against Solid Tumor to Registrational Trial

On November 3, 2025 Geekgene Biotechnology reported the company has received Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for GK01.

(Press release, Geekgene Biotechnology, NOV 3, 2025, View Source [SID1234662198])

Jecho Laboratories, Inc. Announces Abstract Selected for Poster Presentation at the 16th Annual World ADC Congress

On November 3, 2025 Jecho Laboratories, Inc. reported it will present emerging preclinical data on JLC059, a novel GPC3/PD-L1 bispecific antibody drug conjugate (bsADC) at the 16th Annual World ADC Congress. GPC3 is a tumor-associated antigen highly expressed in liver and other solid tumors, while PD-L1 plays a key role in suppressing immune responses. JLC059 is composed of a fast-internalizing anti-GPC3 arm and a non-internalizing anti-PD-L1 arm, which enables targeted delivery of a cytotoxic payload to tumors and disrupts immunosuppressive signaling while minimizing toxicity to immune cells.

The World ADC Congress will be held November 3-6, 2025 in San Diego, CA.

Details on the presentation are below:

Abstract 8: JLC059, a novel GPC3/PD-L1 bsADC integrating checkpoint inhibition for enhanced anti-tumor activity

Abstract Presentation Number: 8
Session Time: Tuesday, November 4, 2025 viewing 10:00 a.m. – 5:00 p.m. PST
Location: Town & Country, San Diego

(Press release, Jecho Laboratories, NOV 3, 2025, View Source [SID1234660000])

Estrella Immunopharma Completes Second Dose Cohort in STARLIGHT-1 Trial of EB103 with Complete Responses in All Evaluable Patients

On November 3, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported the successful completion of the second dose cohort in Phase I portion of its STARLIGHT-1 Phase I/II clinical trial of EB103, a CD19-redirected ARTEMIS T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin’s Lymphomas (NHL).

Key Findings:

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.
"Completing the second dose cohort with a 100% CR rate marks a significant milestone in our EB103 clinical program," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "We’re especially encouraged by the favorable safety profile observed in this high-risk group, including a CNS-involved patient, which demonstrates the potential of EB103 as a safe and effective treatment for a broader population of cancer patients who have limited options. We look forward to taking EB103 into the dose expansion phase of STARLIGHT-1."

The second dose cohort included patients with relapsed/refractory B-cell NHL who have failed multiple prior lines of therapy. Following the completion of this dose cohort, a Data and Safety Monitoring Board (DSMB) will review the cumulative study data to evaluate the safety and efficacy of EB103, and to determine the Recommended Phase II Dose (RP2D) for the expansion phase. The DSMB is an independent group of experts that assesses the study’s progress and makes recommendations to the trial’s sponsor.

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 RP2D in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study includes a dose escalation phase followed by an expansion phase. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, 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 bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Biopharma, NOV 3, 2025, View Source [SID1234659309])

Arcellx to Present New Data for Its iMMagine-1 Study and Continues Scientific Momentum with Multiple Presentations at the 67th ASH Annual Meeting and Exposition

On November 3, 2025 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported it will share two presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 6-9, 2025, in Orlando, Florida, including updated clinical data from iMMagine-1, its Phase 2 pivotal study (publication #256) of anitocabtagene autoleucel (anito-cel) in patients with relapsed and/or refractory multiple myeloma (RRMM). Additionally, an abstract (publication #7644) describing the fast off-rate of anito-cel’s D-Domain binder will be published in a supplemental issue of Blood in November 2025. The company will also have a medical affairs booth (#1363) at the Orange County Convention Center.

"We’re pleased to share that, along with our partners at Kite, we conducted our pre-BLA meeting with the FDA and remain confident in our planned 2026 commercial launch of anito-cel," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "This milestone marks a significant step toward bringing our innovative therapy to the multiple myeloma community. We look forward to sharing updated clinical data from our iMMagine-1 study in an oral presentation at ASH (Free ASH Whitepaper). These are exciting times at Arcellx!"

ASH Presentation Details:

Title: Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine-1
Speaker: Krina K. Patel, MD, MSc, MD Anderson Cancer Center
Session Name: 655. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma
Session Date: Saturday, December 6, 2025
Session Time: 2:00 p.m. – 3:30 p.m. ET
Presentation Time: 2:45 p.m. ET
Location: OCCC – West Hall E1
Publication Number: 256
Submission ID: abs25-4541

Title: Visualizing geographic variation and systemic inequities of disease burden and CAR T-cell therapy access in multiple myeloma in the US
Speaker: Brandon Blue, MD, Moffitt Cancer Center
Session Name: 907. Outcomes Research: Plasma Cell Disorders: Poster III
Session Date: Monday, December 8, 2025
Session Time: 6:00 p.m. – 8:00 p.m. ET
Location: OCCC – West Halls B3-B4
Publication Number: 6344
Submission ID: abs25-2093

Title: The fast off-rate of anito-cel’s D-Domain binder contributes to its distinctive pharmacology profile in preclinical models of multiple myeloma
Disposition: Online Publication
Publication Number: 7644
Submission ID: abs25-1695

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About Anitocabtagene Autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

(Press release, Arcellx, NOV 3, 2025, View Source [SID1234659308])