On May 27, 2025 BostonGene, a leader in AI-powered solutions for drug discovery and development, reported that six abstracts have been accepted at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), scheduled to take place May 31 – June 3, 2025, at McCormick Place Convention Center in Chicago, IL (Press release, BostonGene, MAY 27, 2025, View Source [SID1234653420]). BostonGene will also exhibit at booth #15147.

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BostonGene will showcase the impact of its validated, multimodal AI platform, which combines deep molecular profiling, immune system characterization and advanced analytics to accelerate and de-risk oncology drug development. Across six accepted studies—conducted independently and in collaboration with leading academic institutions—BostonGene will demonstrate how its platform uncovers novel biomarkers, refines patient stratification and predicts therapeutic response across a range of tumor types. Presentations will highlight advancements in transcriptomic analysis, immune microenvironment profiling, histomolecular subtyping and blood-based predictors—key tools for improving clinical trial design and driving precision treatment strategies.

Details about the abstracts selected for presentation can be found below:

Abstract number: 11536
Title: Molecular subtyping and insights into sarcoma biology and prognosis
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Nikita Kotlov, BostonGene

In this study, BostonGene’s multiomic Tumor PortraitTM test was used to identify distinct molecular patterns in various sarcoma subtypes that correlated with survival outcomes. These findings demonstrate the potential clinical impact of advanced analytics paired with molecular sequencing in diverse diseases such as sarcoma.

Abstract number: 1049
Title: Macroscale Genomic Alterations in Histomolecular Invasive Lobular Carcinoma Compared to Other Breast Cancer Subtypes
Date & time: June 2 | 9:00 AM – 12:00 PM
Presenter: Jason Mouabbi, MD, The University of Texas MD Anderson Cancer Center

In collaboration with MD Anderson, BostonGene used its advanced analytic platform to identify unique histologic and molecular findings in invasive lobular carcinoma (ILC), a subtype of breast cancer for which treatment options are often inferred. Profiling of over 600 patients resulted in the discovery of biologic mechanisms and alterations that could direct future therapeutic and drug development strategies.

Research done in collaboration with MD Anderson Cancer Center

Abstract number: 11561
Title: Detecting hotspots of intra- and transchromosomal fusions in liposarcomas by RNA sequencing
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Lev Bedniagin, MD, BostonGene

Leveraging BostonGene’s extensive internal cohort and advanced sequencing technologies, this study conducted transcriptome analysis of Liposarcoma (LPS) samples, revealing novel hotspots of gene fusions in LPS patients. These discoveries can be used to improve diagnostic accuracy and the development of novel therapeutics in LPS and similar diseases.

Abstract number: 4198
Title: Uncovering the Tumor Microenvironment (TME): Exploring survival and immunotherapy (IO) response in Cancer of Unknown Primary (CUP)
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Joelle Allam, MD, The Texas University MD Anderson Cancer Center

In this study, BostonGene utilized its Tumor PortraitTM test to characterize Cancer of Unknown Primary (CUP). The analysis revealed correlations of clinical factors, the tumor microenvironment and immunotherapy response with survival outcomes, offering new insights into this challenging and poorly defined cancer.

Research done in collaboration with MD Anderson Cancer Center

Abstract number: 2634
Title: Tertiary lymphoid structures and their association with immune checkpoint inhibitor response and survival outcomes in patients with non-small cell lung cancer
Date & time: June 2 | 1:30 PM – 4:30 PM
Presenter: Lev Bedniagin, MD, BostonGene

Leveraging BostonGene’s AI-driven Kassandra deconvolution algorithm to analyze transcriptomic data from patients with non-small cell lung cancer, this study identified unique tertiary lymphoid structures within the tumor microenvironment that may serve as predictive and prognostic biomarkers, enhancing the efficacy of immune checkpoint inhibitor therapy.

ONLINE ONLY:
Title: The impact of PTEN deletion, TMPRSS2:ERG fusion, and androgen receptor variant 7 (AR-V7) on resistance to novel hormone therapies (NHTs) in castrate-resistant prostate cancer

This study demonstrated the clinical utility of the BostonGene Tumor PortraitTM test in guiding treatment selection for castrate-resistant prostate cancer based on tumor microenvironment-related gene signatures. These findings underscore the importance of precision medicine in managing cancer subtypes that are resistant to traditional interventions.

For more information, please visit the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting website. The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

On May 27, 2025 Sanofi reported the completion of its acquisition of DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., a private clinical-stage biopharmaceutical company (Press release, Sanofi, MAY 27, 2025, View Source [SID1234653524]). The acquisition bolsters Sanofi’s ambition to become the foremost immunology company and broadens the company’s leading immunology pipeline.

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DR-0201, now named SAR448501, has shown robust B-cell depletion in pre-clinical and early clinical studies. The potential first-in-class targeted bispecific myeloid cell engager targets and engages specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis.

Recent pre-clinical and early clinical study data in autoimmune diseases suggest that deep B- cell depletion has the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.

Sanofi acquired DR-0201 through the acquisition of the Dren Bio affiliate Dren 0201, Inc. for an upfront payment of $600 million and potential future payments totaling $1.3 billion upon achievements of certain development and launch milestones. Dren Bio will continue to operate independently to advance its pipeline of antibody therapeutics that selectively deplete pathogenic cells and other disease-causing agents.

On May 26, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint (Press release, Immutep, MAY 26, 2025, View Source [SID1234653375]). The novel combination significantly exceeded the study’s prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sarcoma (STS).

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Tumour hyalinization/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients.1,2 The trial’s investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting.

Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO and the trial’s principal investigators, said: "It is very encouraging to see the chemotherapy-free combination with efti far exceed the ambitious target we initially set for the trial’s primary endpoint in resectable soft tissue sarcoma. These results support our belief that efti’s activation of antigen-presenting cells, and in turn a broad adaptive and innate immune response, helps transform the immunosuppressed tumour microenvironment of soft tissue sarcomas leading to strong anti-cancer efficacy. There remains a very high unmet need in this aggressive orphan cancer indication and we look forward to presenting detailed results at a medical meeting later this year."

As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTISARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025.

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3

For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863).

About Eftilagimod Alfa (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On May 26, 2025 Abbisko Therapeutics (HKEX Code: 02256) reported that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Hepatocellular Carcinoma (HCC) (Press release, Abbisko Therapeutics, MAY 26, 2025, View Source [SID1234653376]). Irpagratinib is the first therapeutic agent to leverage molecularly defined biomarkers for precision-targeted treatment in patients with HCC.

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During clinical trials, innovative drugs or modified new drugs intended to prevent or treat life-threatening diseases or conditions that severely impact quality of life—where no effective prevention or treatment exists, or where substantial evidence shows significant clinical advantages over existing therapies—may be eligible to apply for the CDE’s Breakthrough Therapy Designation program[1]. The approval of irpagratinib for Breakthrough Therapy Designation is based on its promising Phase I clinical trial data.

Patients with advanced or unresectable HCC currently lack effective treatment options following treatment with ICI- and mTKI-based therapies. Those with FGF19 overexpression often face significantly worse prognosis, and thus new treatment options are urgently needed. The Breakthrough Therapy Designation granted to irpagratinib will expedite its subsequent application and approval process with the CDE, bringing renewed hope and transformative possibilities to patients.

Recently, Abbisko launched a pivotal registrational clinical study of irpagratinib for the treatment of HCC patients with FGF19 overexpression at Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, and Nanjing Tianyinshan Hospital.

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 HCC 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 26, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the European Commission has granted orphan drug designation (ODD) to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer (Press release, Alligator Bioscience, MAY 26, 2025, View Source [SID1234653378]). HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

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This designation follows the ODD granted by the U.S. Food and Drug Administration (FDA) in March 2025, further highlighting HLX22’s potential as a treatment for HER2-positive gastric cancer.

Henlius is conducting a global Phase 3 clinical trial (NCT06532006) to evaluate HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer.

Søren Bregenholt, CEO of Alligator Bioscience, commented:
"The orphan designation to HLX22 in Europe represents another important regulatory milestone for this program. Following the earlier FDA designation, this reinforces the potential clinical and commercial value of the antibody. While Alligator is not directly involved in the development, we look forward to following its progress as it may contribute future revenue to Alligator."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.