On May 12, 2025 Abbisko Therapeutics Co., Ltd. (02256.HK) reported that updated results from the phase 2 study of irpagratinib (ABSK011) in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the 2025 ESMO (Free ESMO Whitepaper) GI Congress, taking place in Barcelona, Spain from July 2 to July 5 (Press release, Abbisko Therapeutics, MAY 12, 2025, View Source [SID1234652895]). The oral presentation will highlight the regimen’s favorable safety and promising anti-tumor activity in both treatment-naive and previously treated FGF19+ HCC patients. The evident objective response rate (ORR) and progression free survival (PFS) benefit underscores the potential of irpagratinib-based combinations in the treatment of HCC.

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Event Details:

Session: Mini Oral session – Innovation in GI cancers
Presentation Format: Oral Presentation

Title: Irpagratinib (ABSK-011) plus Atezolizumab in First-line (1L) and Immune Checkpoint Inhibitors (ICIs) Treated Advanced Hepatocellular Carcinoma (HCC) with FGF19 Overexpression (+): Updated Results of the Phase 2 ABSK-011-201 Study

Presentation number：149MO

Presenter: Qi Cheng
Date and Time: Beijing Time 2Jul2025 23:15-23:20
Local time 2Jul2025 17:15-17:20

About Irpagratinib (ABSK-011)

Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC.

To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of aHCC patients with FGF19 overexpression.

In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. At the previous 2024 ESMO (Free ESMO Whitepaper) GI Congress, Abbisko presented clinical data demonstrating 220mg irpagratinib BID in combination with atezolizumab achieved a 50% objective response rate (ORR) in FGF19+ HCC patients who had previously received immune checkpoint inhibition therapy.

On May 12, 2025 RemeGen Co., Ltd. (688331.SH/9995.HK) reported that the Clinical Trial Application (CTA) for its novel ADC Drug RC278 has been submitted recently and accepted by National Medical Products Administration (NMPA) Center for Drug Reevaluation (CDE) on May 8th (Press release, RemeGen, MAY 12, 2025, View Source;cid=115&id=2650 [SID1234656125]).

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RC278, independently designed and developed by RemeGen, emerges as a potentially First-in-Class/Best-in-Class ADC molecule. RC278 can specifically recognize a new tumor target and contains an innovative linker-cytotoxicity system, showing broad-spectrum antitumor activity, manageable safety and pharmacokinetic characteristics in the pre-clinical study.

As an important drug candidate in RemeGen’s ADC pipeline, RC278 boasts unique target and differentiated molecule design, demonstrating RemeGen’s progress in ADC technology. RC278 will bring new treatment option for the advanced solid tumor patients.

On May 12, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Pamela D. Garzone, Chief Development Officer of Anixa, will present a poster at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place on May 30 – June 3, 2025, in Chicago, Illinois (Press release, Anixa Biosciences, MAY 12, 2025, View Source [SID1234652862]). Lead author on the poster is Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, and the principal investigator of the Phase 1 clinical trial of Anixa’s ovarian cancer CAR-T immunotherapy.

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Presentation Details:

Title: Phase 1 clinical trial of autologous T-cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer (OVCA)
Session: Developmental Therapeutics—Immunotherapy
Session Type: Poster Session
Date & Time: June 2, 2025, 1:30 PM – 4:30 PM CT
Abstract ID: TPS2682

On May 12, 2025 Galectin therapeutics presented its corporate presentation (Presentation, Galectin Therapeutics, MAY 12, 2025, View Source [SID1234652880]).

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On May 12, 2025 Caris Life Sciences(Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported MET Immunohistochemistry (IHC) testing as standard of care for all non-squamous non-small cell lung cancer (NSQ NSCLC) patients and is poised for future drug approvals (Press release, Caris Life Sciences, MAY 12, 2025, View Source [SID1234652896]). This advanced testing protocol aims to provide deeper insights into the molecular characteristics of NSQ NSCLC, facilitating more personalized and effective treatment strategies.

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Approximately 50% of NSQ NSCLCs lack a targetable gene driver mutation, making MET protein expression an important additional personalized target. Caris is addressing these challenges by leveraging the power of MET IHC testing, which evaluates the expression of the MET protein in cancer cells. This protein is known to play a crucial role in cell proliferation, invasion, and survival, making it a vital biomarker for targeted therapies.

"To our knowledge, Caris is the only lab in the US that has historically and is currently offering the MET (SP44) RxDx assay for NSQ NSCLC," said Caris President David Spetzler, MS, PhD, MBA. "With MET IHC testing already in place, we are poised and ready to provide a detailed molecular profile to inform targeted therapies and future drug development approvals."

Key Highlights of MET IHC Testing:
Comprehensive Molecular Profiling: Caris utilizes a multi-platform approach, including immunohistochemistry (IHC) and next-generation sequencing (NGS), to provide a detailed molecular profile of NSQ NSCLC tumors.

Identification of Actionable Targets: The MET IHC testing helps identify overexpression of the MET protein, which is associated with poor prognosis and can be targeted by specific therapies.

Enhanced Treatment Personalization: By understanding the molecular makeup of NSQ NSCLC tumors, oncologists can tailor treatment plans to the individual needs of patients, potentially improving outcomes and quality of life.

Caris remains committed to advancing cancer diagnostics and treatment through innovative technologies and rigorous scientific research. Deployment of MET IHC testing for NSQ NSCLC patients underscores this commitment and highlights Caris’ dedication to improving patient care and outcomes.

Caris’ comprehensive molecular profile testing includes MI Cancer Seek and Caris Assure. Caris received FDA approval in November of 2024 for MI Cancer Seek, a tissue-based assay which is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. Caris Assure is a powerful blood-based assay that uniquely identifies somatic tumor, incidental clonal hematopoiesis and incidental germline variants by sequencing both plasma and buffy coat through a WTS and WES-based assay.