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.

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

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.

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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])

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).

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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])

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.

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"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])

On November 3, 2025 Incyte (Nasdaq:INCY) reported that data from key programs in its oncology portfolio will be presented in both oral and poster sessions at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 6 – 9, 2025, in Orlando.

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"This year’s Incyte presentations highlight the potential of our portfolio to transform the treatment of blood cancers, specifically for patients with myeloproliferative neoplasms (MPNs)," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "New data for our first-in-class mutCALR-targeted monoclonal antibody, INCA033989, as a monotherapy in patients with myelofibrosis (MF) who are intolerant or refractory to ruxolitinib, and in combination with ruxolitinib in patients with MF who experience a suboptimal response to ruxolitinib monotherapy will be highlighted as an oral presentation. Updated data for INCA033989 in essential thrombocythemia (ET) will also be presented. Additionally, we look forward to sharing the results from axatilimab in graft-versus-host disease (GVHD) and tafasitamab in follicular lymphoma (FL) – all of which showcase the progress and promise of our oncology portfolio."

Details on Incyte data presentations at ASH (Free ASH Whitepaper) include:

Oral Presentations

INCA033989 (mutCALR)

Molecular Characterization Of Patients (Pts) With Myeloproliferative Neoplasms Treated With INCA033989 Demonstrates Selective Targeting Of CALR Mutant Hematopoietic Cells
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Precision Targeting in MPN. [December 6, 9:30 – 11:00 a.m. ET]. Publication #71.)

Safety And Efficacy Of The Mutant Calreticulin-Specific Monoclonal Antibody INCA033989 As Monotherapy Or In Combination With Ruxolitinib In Patients (Pts) With Myelofibrosis (MF): Preliminary Results From Dose Escalation Of Two Global Phase 1 Studies
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Between a Rock and a Ropeg – Innovative Therapies for MPNs. [December 7, 9:30 – 11:00 a.m. ET]. Publication #484.)

Safety And Efficacy Of INCA033989, A Novel First In Class Mutant Calreticulin-Specific Monoclonal Antibody, In Patients With Essential Thrombocythemia
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Drivers and Mast Cells and Blasts, Oh My! – Insights and Treatments for MPNs and Mastocytosis. [December 8, 4:30 – 6:00 p.m. ET]. Publication #1024.)

Axatilimab (Niktimvo)

Safety And Feasibility Of 0.6 mg/kg Every 4 Weeks Dosing Of Axatilimab In Patients Treated In The AGAVE-201 Study
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Acute and Chronic GVHD and Immune Reconstitution. [December 6, 2:00 – 3:30 p.m. ET]. Publication #272.)

INCB057643 (BET)

Safety And Efficacy Of Bromodomain And Extra-Terminal Protein Inhibitor INCB057643 Monotherapy In Patients With Relapsed Or Refractory Myelofibrosis And Other Advanced Myeloid Neoplasms: A Phase 1 Study
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Beyond JAK Inhibition – Therapeutic Innovation and Transplant Strategies in Myelofibrosis. [December 8, 2:45 – 3:00 p.m. ET]. Publication #907)

Ruxolitinib (Jakafi)

Risk Factors For Progressive Kidney Impairment Among Patients With Polycythemia Vera (PV) Are Recapitulated And Treatable In Mouse Models Of PV
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Treatment and Outcomes in the Real-World. [December 7, 12:00 – 1:30 p.m. ET]. Publication #605.)

Poster Presentations

Axatilimab (Niktimvo)

Pharmacodynamic Analysis Of AGAVE-201 Indicates Changes In CSF-1R–Expressing Cells And Associated Biomarkers Potentially Contributing To Chronic Graft-Versus-Host Disease Resolution
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2458.)

Trial In Progress: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of Axatilimab And Corticosteroids As Initial Treatment For Moderate To Severe Chronic Graft-Versus-Host Disease
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #4256.)

Long-Term Treatment Duration And Safety Of Axatilimab Among Patients With Chronic Graft-Versus-Host Disease In AGAVE-201
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6010.)

Safety Analysis Of Axatilimab In Patients With Chronic Graft-Versus-Host Disease In An Expanded Access Program
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6008.)

Axatilimab In Combination With Ruxolitinib In Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease: Interim Safety Analysis Of A Randomized, Phase 2 Study
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6012.)

INCB000928 (ALK2)

The Activin Receptor-Like Kinase-2 Inhibitor Zilurgisertib (INCB000928) As Monotherapy Or With Ruxolitinib In Patients With Anemia Due To Myelofibrosis: Phase 1/2 Study Final Results
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3795.)

INCB057643 (BET)

INCB057643, A Bromodomain And Extra-Terminal Protein Inhibitor, In Combination With Ruxolitinib In Patients With Myelofibrosis: A Phase 1 Study Of Safety And Efficacy
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5574.)

INCB160058 (JAK2V617F)

INCB160058 Selectively Targets JAK2V617F-Driven Hematopoiesis In Diverse And Drug-Resistant Models Of Myeloproliferative Neoplasms
(Session Title: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster II. [December 7. 6:00 – 8:00 p.m. ET]. Publication #3275.)

A Multicenter, Open-Label Phase 1 Study Of INCB160058, A First-In-Class JAK2V617F Mutant–Selective Inhibitor, In Patients With Myelofibrosis, Polycythemia Vera, Or Essential Thrombocythemia
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2051.)

Ruxolitinib (Jakafi)

Impact Of Ruxolitinib On Corticosteroid Treatment Patterns In 1147 Patients With Chronic Graft-Versus-Host Disease In Real-World Practice In The United States: A Long-Term Follow-Up Analysis
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2452.)

Clinical And Disease Characteristics Of Initial Participants At Time Of Enrollment In THRIVE, A Prospective, Observational Cohort Study Of Patients At Risk For Chronic Graft-Versus-Host Disease
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2446.)

Ruxolitinib Duration Of Treatment And Effect On Phlebotomy Use Among 2369 Patients With Polycythemia Vera: A Real-World Analysis Of The Medicare Fee-For-Service Claims Database
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2826.)

Longitudinal Genomic Shifts Associated With Disease Transformation In Patients With Polycythemia Vera (PV) Enrolled In REVEAL
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3749.)

Identification Of Biomarkers To Predict Disease Progression Via Molecular Analysis Of Patients (Pts) With Low-Risk Myelofibrosis (MF) Enrolled In The MOST Study
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5526.)

Real-World Treatment Duration Of Ruxolitinib And Use Of Transfusion Among 2268 Patients With Myelofibrosis: An Analysis Of The Medicare Fee-For-Service Claims Database
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6391.)

Ruxolitinib XR

Bioequivalence Of Ruxolitinib Once-Daily Extended-Release Vs Twice-Daily Immediate-Release Tablets In Healthy Adults
(Session Title: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5045.)

Tafasitamab (Monjuvi)

Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes By Age
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3582.)

Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes Of Patients Receiving Second-Line Treatment
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #1819.)

CD19 Expression Is Preserved Following CD19-Directed Monoclonal Antibody Therapy With Tafasitamab
(Session Title: 629. Aggressive Lymphomas, Immunotherapy Including Bispecific Antibodies: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5515.)

Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes Of High-Risk Patients
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5367.)

All regular abstracts accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting 2025 are available online via the ASH (Free ASH Whitepaper) website. More information regarding the 2025 ASH (Free ASH Whitepaper) Congress can be found at: View Source

Conference Call and Webcast
Incyte will host an investor event and webcast on Sunday, December 7, 2025, from 11:00 a.m.-12:30 p.m. ET to discuss key mutCALR data being presented at ASH (Free ASH Whitepaper).

The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 30 days.

(Press release, Incyte, NOV 3, 2025, View Source [SID1234659307])