On April 25, 2024 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported the presentation of four abstracts (including one oral presentation and three poster presentations) at the 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 31st to June 4th at the McCormick Place Convention Center in Chicago, IL, the United States (Press release, Antengene, APR 25, 2024, View Source [SID1234642365]).

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Details of the Oral Presentation:

ATG-008 (mTORC1/2 Inhibitor)
Title: A phase I/II study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors: Cervical cancer cohort
Abstract: 5509
Session: Clinical Science Symposium – Stronger Together: Novel Combinations Across the Gynecologic Cancer Spectrum
Date: June 1, 2024
Time: 1:15 PM – 2:45 PM (Central Daylight Time)
2:15 AM – 3:45 AM, June 2, 2024 (Beijing Time)

Details of the Poster Presentations:

ATG-031 (anti-CD24 monoclonal antibody)
Title: A first-in-human phase I study of ATG-031, anti-CD24 antibody, in patients with advanced solid tumors or B-cell non-Hodgkin lymphomas (PERFORM)
Abstract: TPS2691
Session: Developmental Therapeutics—Immunotherapy
Date: June 1, 2024
Time: 9:00 AM – 12:00 PM (Central Daylight Time)
10:00 PM, June 1 – 1:00 AM, June 2, 2024 (Beijing Time)

ATG-022 (Claudin 18.2 Antibody-drug Conjugate)
Title: An open-label, multicenter, phase I study of ATG-022 in patients with advanced/metastatic solid tumors (CLINCH)
Abstract: 3032
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date: June 1, 2024
Time: 9:00 AM – 12:00 PM (Central Daylight Time)
10:00 PM, June 1 – 1:00 AM, June 2, 2024 (Beijing Time)

Selinexor (XPO1 Inhibitor)
Title: Selinexor combined with tislelizumab in patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL): Results of dose escalation of cohort C, from a multicenter, single-arm, phase I/II study (TOUCH)
Abstract: 7065
Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date: June 3, 2024
Time: 9:00 AM – 12:00 PM (Central Daylight Time)
10:00 PM, June 3 – 1:00 AM, June 4, 2024 (Beijing Time)

On April 25, 2024 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, reported the acceptance of an abstract related to the clinical study of C-CAR031, an autologous, armored GPC3-targeting chimeric antigen receptor T-Cell (CAR-T) therapy, in hepatocellular carcinoma (HCC) for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago May 31 to June 4, 2024 (Press release, AbelZeta, APR 25, 2024, View Source [SID1234642364]). C-CAR031 is based on a novel GPC3-targeting CAR-T designed by AstraZeneca (LSE/STO/Nasdaq: AZN) using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armoring discovery platform and is manufactured by AbelZeta in China. C-CAR031 is being developed in China under a co-development agreement between AbelZeta and AstraZeneca.1

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Details of the oral presentation are as follows:

Abstract Title: "Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC)."
Abstract Number: 4019
Session Type and Title: Rapid Oral Abstract – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: 6/3/2024; 9:45 AM-11:15 AM CDT

On April 25, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with an entire industry chain, reported that the Phase I/II clinical study results of the novel Nectin-4-targeting ADC 9MW2821 for multiple advanced solid tumors will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which will be held in Chicago, USA, from May 31-June 4, 2024 (Press release, Mabwell Biotech, APR 25, 2024, View Source;mabwell-to-present-clinical-data-of-9mw2821-in-multiple-advanced-solid-tumor-302127436.html [SID1234642363]).

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Oral Presentation

Abstract Title: 9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study.
Session Date and Time: 6/3/2024; 8:00 AM-9:30 AM CDT
Presenter: Prof. Zhang Jian Chief Physician/Doctoral Supervisor (Fudan University Shanghai Cancer Center)
Abstract Number for Publication: 3013

About 9MW2821

9MW2821 is the first site-specific conjugated novel ADC targeting Nectin-4 developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. Multiple clinical studies of 9MW2821 have been conducted in China to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of 9MW2821 in patients with various advanced solid tumors.

The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The phase I/II clinical study of 9MW2821 in combination with PD-1 inhibitors is also ongoing, with the first patient already enrolled. 9MW2821 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in February 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Currently, 9MW2821 is the first therapeutic drug candidate targeting Nectin-4 in the world to disclose clinical efficacy and safety data for indications of cervical cancer and esophageal carcinoma.

On April 25, 2024 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that, based on the strength of the science and its relevance, VIRAGE – the Phase 2b randomized, open-label, placebo-controlled, multicenter clinical trial of systemically administered VCN-01 in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) – has been accepted for presentation as a trial-in-progress poster at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, IL, from May 31-June 4 (Press release, Theriva Biologics, APR 25, 2024, View Source [SID1234642361]).

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ASCO Presentation Details

Title: VIRAGE: A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer
Presenter: Dr. Rocío García-Carbonero
Session Title: Poster Session – Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary
Poster Session Date and Time: 01 June 2024, 1:30 PM-4:30 PM US CDT
Abstract Number: TPS4210

On April 25, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported a comprehensive overview of its lead candidate MDG1015, a first-in-class 3rd generation T cell receptor engineered T cell (TCR-T) therapy, at CHI’s 8th Annual Immuno-Oncology Summit Europe from April 23-25, 2024, in London (Press release, MediGene, APR 25, 2024, View Source [SID1234642360]). MDG1015, which is advancing towards the clinic, targets NY-ESO-1 / LAGE-1a (New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a) and is armored and enhanced by the PD1-41BB costimulatory switch protein

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The presentation with the title "MDG1015: a 3rd Generation TCR-T Therapy Incorporating the PD1-41BB Costimulatory Switch Protein, Advancing to the Clinic" is available on Medigene’s website: View Source

Targeting tumors expressing cancer-testis antigens (CTAs) shows promising clinical benefits. However, improving efficacy, safety, and ensuring a sustained response are areas needing improvement. Medigene tackles these challenges with a comprehensive approach, which starts with the development of a potential best-in-class, 3S (sensitive, specific, and safe) TCR. Next, the 3S TCR is enhanced with the Company’s exclusive PD1-41BB costimulatory switch protein (CSP) on the engineered TCR-T cells. Finally, Medigene generates a meticulously customized drug product (DP) composition.

"At Medigene, our innovative approach not only enhances TCR-T cell functionality by combining our 3S TCRs with the PD1-41BB costimulatory switch protein but also places a significant emphasis on the DP manufacturing process. This process is vital for producing effective, safe, and durable TCR-T therapies," stated Kirsty Crame, MD, VP Clinical Strategy & Development. "With our focus on the DP composition, we aim to reduce the time required to manufacture DP ex-vivo and hence reduce the overall vein-to-vein timeframe for patients, while maintaining the highest standards of safety, efficacy and durability."

Medigene has developed a streamlined 6-day manufacturing process that focuses on the enrichment of CD8+ T cells whilst simultaneously maintaining a high degree of stemness. This allows for creating highly effective DPs, as the field has shown that more stem-like DPs exhibit greater potency and durability of response. The inclusion of the PD1-41BB CSP eliminates the need for CD4+ T cells within the DP, as CD8+ T cells are empowered to autonomously produce supporting cytokines. By doing so, the potential risks posed by CD4+ T cells can be circumvented and therefore potentially enhance both clinical safety and therapeutic efficacy.

Multiple in vitro studies for MDG1015 have clearly demonstrated enhanced anti-tumor immune responses for MDG1015 in comparison to TCRs without the CSP. This enhancement is evidenced by increased TCR-T cell proliferation and marked augmentation of Interferon γ (IFNγ) release, serving as a reliable indicator of superior TCR-T cell functionality. Furthermore, MDG1015 showed elevated polyfunctionality and clear durability of effect, with rapid and sustained tumor cell eradication upon multiple serial rechallenges of CTA / PD-L1 positive cells.

IND/CTA approval for MDG1015 is expected in the second half of 2024. Clinical indications for MDG1015 were primarily chosen based on the high unmet medical need, expression of the target antigen and/or PD-L1. This led to the selection of gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma as the initial focus areas for clinical evaluation. First patient enrolment will follow by the end of 2024, subject to financing. Based on this, the Company expects to present early data from the dose escalation phase in the fourth quarter of 2025.