HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2025

On October 2, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology ("ESMO") Congress 2025, taking place on October 17-21, 2025 in Berlin, Germany (Press release, Hutchison China MediTech, OCT 2, 2025, View Source [SID1234656377]).

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Results from the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma will be presented in a Mini Oral session. Additionally, further analyses of the fruquintinib FRUSICA-1 study in endometrial cancer and the savolitinib SACHI and SAVANNAH studies in non-small cell lung cancer will be presented during the poster sessions.

Details of the presentations are as follows:

Abstract titlePresenter / Lead authorPresentation details

SPONSORED STUDIES
Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): results from phase 3 part of a randomized, open-label, active-controlled phase 2/3 study (FRUSICA-2) Zhenhua Liu
(Chengdu, China) 2592MO
Mini Oral Session 1:
GU tumours, renal & urothelial
Friday, Oct 17, 2025
Karlsruhe Auditorium – Hall 5.2
16:00 – 17:30 CEST
A Fruquintinib Expanded Access Program (EAP) to Provide Treatment for Patients With Metastatic Colorectal Cancer (mCRC) Stefan Kasper-Virchow
(Essen, Germany) 794P
Poster Session:
Colorectal cancer
Fruquintinib plus tislelizumab in microsatellite stable metastatic colorectal cancer: Results from a phase 1b/2 study N. Arvind Dasari
(Houston, USA) 799P
Poster Session:
Colorectal cancer
A novel artificial intelligence (AI) imaging biomarker of tumor vascularity and heterogeneity radiomics to predict survival benefit of fruquintinib vs placebo in metastatic colorectal cancer (mCRC) Sara Lonardi
(Padua, Italy) 804P
Poster Session:
Colorectal cancer
Safety and tolerability of fruquintinib: Pooled analysis of three placebo-controlled studies in patients with metastatic colorectal cancer Cathy Eng
(Nashville, USA) 811P
Poster Session:
Colorectal cancer
Association between Metabolic Syndrome (MetS) and clinical outcomes of Fruquintinib plus Sintilimab in Previously Treated Advanced Endometrial Cancer (EMC) Patients with pMMR Status: results from FRUSICA-1 study Danbo Wang
(Shenyang, China) 1230eP
Poster Session:
Gynaecological Cancer
ctDNA analysis in phase 3 SACHI trial: savolitinib (savo) plus osimertinib (osi) versus chemotherapy (chemo) in MET-amplified (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI) Yongfeng Yu
(Shanghai, China) 1954P
Poster Session:
NSCLC, metastatic
SAVANNAH: Safety and tolerability of osimertinib (osi) + savolitinib (savo) in EGFRm advanced NSCLC with MET overexpression and/or amplification (OverExp/Amp) following disease progression on osi Quincy Siu-chung Chu
(Edmonton, Canada) 1955P
Poster Session:
NSCLC, metastatic
MET testing and treatment (tx) sequencing after progression on first line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): interim analysis of a global real world (rw) study Julia Rotow
(Boston, USA) 1956P
Poster Session:
NSCLC, metastatic

INVESTIGATOR-INITIATED STUDIES
Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated surgical and survival results from the single-arm, phase 2 clinical trial Fei Ma
(Zhengzhou, China) 2159P
Poster Session: Oesophagogastric cancer
Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, Phase II Study Wangjun Liao
(Guangzhou, China) 898eP
E-poster Session:
Colorectal cancer
The efficacy and safety of surufatinib combined with chemotherapy in the first-line treatment of advanced periampullary carcinoma: a single arm, prospective, exploratory clinical study Qianqian Wang
(Nanjing, China) 929P
Poster Session:
Developmental therapeutics
Surufatinib-Based Late-Line Therapy Outcomes in Recurrent Metastatic NSCLC: Monotherapy and Vinorelbine Combination Regimens Yanfang Zheng
(Guangzhou, China) 1884P
Poster Session:
NSCLC, metastatic
Surufatinib combined with Toripalimab, Pemetrexed, and Platinum in Advanced Non-Squamous Non-Small Cell Lung Cancer (nsg-NSCLC): Final Phase ll Results from a Single-Center Trial Wenfeng Fang/ Li Zhang
(Guangzhou, China) 1887P
Poster Session:
NSCLC, metastatic
Efficacy/safety and preliminary scRNA-seq results of surufatinib plus gemcitabine and nab-paclitaxel as neoadjuvant therapy in resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao
(Tianjin, China) 2236P
Poster Session:
Pancreatic cancer
Efficacy and Safety of Surufatinib in Patients with Advanced Soft Tissue Sarcoma After Failure of Anthracycline Chemotherapy and Prior Effective Antiangiogenic Therapy: A Single-Arm, Prospective, Exploratory Phase II Study Xiaowei Zhang/ Zhiguo Luo (Shanghai, China) 2716P
Poster Session:
Sarcoma

About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") -1, ‑2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA.

About Savolitinib
Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS.

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA. HUTCHMED currently retains all rights to surufatinib worldwide.

Biosceptre Secures £8.1 Million to Accelerate Innovative Cancer Therapies

On October 2, 2025 Biosceptre International Limited reported the successful completion of its 2025 fundraise, securing £8.1 million through the issue of 40,500,000 new shares (Press release, Biosceptre, OCT 2, 2025, View Source;utm_medium=rss&utm_campaign=biosceptre-secures-8-1-million-to-accelerate-innovative-cancer-therapies [SID1234656397]).

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This achievement underscores the strong confidence of investors in Biosceptre’s pioneering approach to developing novel treatments for hard-to-treat cancers.

Biosceptre CEO Gavin Currie commented:

"This fundraise marks an important milestone for Biosceptre as we accelerate the development of our therapeutic pipeline. With the continued support of our investors, we are advancing towards our vision of bringing transformative treatments to patients worldwide. Our team is deeply committed to tackling some of the most pressing challenges in oncology and to building a future where patients have access to more effective and targeted therapies."

With this new capital in place, Biosceptre will continue to progress its therapeutic pipeline and deliver on key milestones in the months ahead.

The newly issued shares are scheduled to be dispatched by 8th October 2025.

MEDSIR and Ataraxis AI Launch Research Collaboration to Evaluate AI-Powered Platform as a Predictive Tool in Breast Cancer Randomized Clinical Trials

On October 2, 2025 Ataraxis AI, a frontier laboratory developing artificial intelligence (AI)–powered prognostic tools for oncology, and MEDSIR (Medica Scientia Innovation Research), a global leader in oncology research, reported a strategic collaboration to integrate artificial intelligence into multiple major international trials (Press release, MedSIR, OCT 2, 2025, View Source [SID1234656415]). These studies, involving data from more than 1,000 patients across randomized clinical trials, aim to identify biomarkers that can optimize treatment strategies for breast cancer, including therapies with CDK4/6 inhibitors and antibody-drug conjugates (ADCs).

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MEDSIR has been a key contributor to oncology clinical trials, helping support the advancement of transformative therapies into standard practice. These efforts have expanded access to novel treatment options and improved outcomes for patients worldwide. The introduction of new therapeutics creates an opportunity but also a challenge to select the right drug for every patient. Ataraxis addresses this critical need with Ataraxis Breast, the first AI-native platform in breast cancer developed to predict patient outcomes and treatment effects. By integrating insights from standard digital pathology slides with clinical data, the platform provides a new evidence-based layer to support treatment decisions and personalize care.

Building upon Ataraxis’ previous positive clinical validation results showing efficacy across major breast cancer subtypes, the research collaboration between MEDSIR and Ataraxis AI will focus on leveraging artificial intelligence to predict outcomes across key breast cancer subtypes—including HR+ and HER2+ cohorts—encompassing patients in early-stage and metastatic settings. The goal is to enhance clinical decision-making by integrating AI-driven insights into routine oncology workflows.

"Breast cancer treatment continues to improve, with new therapies becoming available every year. However, this creates a challenge in selecting the right drug at the right time. At Ataraxis, we are developing AI-native tools to accurately predict patient outcomes and treatment response for all cancer patients. We are proud to partner with MEDSIR to validate our breast cancer platform using data from practice-changing clinical trials," said Jan Witowski, Chief Executive Officer and Co-Founder of Ataraxis AI.

"At MEDSIR, we are committed to accelerating innovation in oncology through collaborative research that brings real value to patients and clinicians," said Alicia García, Scientific Director at MEDSIR. "Partnering with Ataraxis AI allows us to integrate cutting-edge artificial intelligence into clinical trials, generating evidence that can transform treatment decision-making in breast cancer. This collaboration represents an important step toward a future where precision oncology is not just a concept, but a standard of care."

This announcement demonstrates the commitment to building global collaborative networks for both MEDSIR and Ataraxis AI. With strategic headquarters in Europe and the United States, MEDSIR has built an extensive global network of more than 600 researchers and has conducted 65 clinical trials across more than 200 sites in 14 countries. Ataraxis AI has partnerships with over 40 institutions on the development, validation, and deployment of AI-based tools for treatment selection. Additionally, this collaboration marks a milestone in building clinical evidence for Ataraxis Breast moving beyond retrospective observational studies and into prospective trials investigating new therapies.

Data on Clarity’s SAR-bisFAP to be presented at the World Molecular Imaging Conference 2025

On October 2, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that data on Clarity’s pan-cancer theranostic, 64/67Cu-SAR-bisFAP, will be presented at the upcoming World Molecular Imaging Conference (WMIC) 2025 from the 29th September to October 3rd in Anchorage, Alaska by Dr. Michele De Franco, a research fellow at the Memorial Sloan Kettering Cancer Center (MSK) and Clarity’s collaborator (Press release, Clarity Pharmaceuticals, OCT 2, 2025, View Source [SID1234656399]).

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Clarity is developing 64/67Cu-SAR-bisFAP as potential pan-cancer theranostics targeting fibroblast activation protein (FAP), which is expressed on cancer associated fibroblasts (CAFs), a particular cell type found in the tumour microenvironment (cancer ‘infrastructure’ called the tumour stroma). FAP is found to be highly expressed in a broad range of cancers (e.g. breast, colorectal, pancreatic, lung, brain and ovarian cancers), but only minimally in normal tissue, making it a promising pan-cancer target for both imaging and treatment of cancers1. CAFs form part of the environment surrounding the cancer cells, and they can promote cancer growth and the spread of the tumour throughout the body2. Targeting the tumour stroma is an alternative way to treat cancer whereby the architecture of the tumour mass is targeted rather than the tumour cells directly.

As part of the optimisation process, Clarity developed and assessed two versions of the FAP-targeted product, one with a singular targeting molecule, SAR-FAP, and a dimeric version of the same molecule, SAR-bisFAP. Whilst both molecules have shown high tumour-specific uptake and targeting, the dual-targeting SAR-bisFAP has shown superior tumour targeting and retention in FAP-expressing mouse models.

Comparison between the ex vivo biodistribution of 64Cu-SAR-FAP and 64Cu-SAR-bisFAP in FAP-positive U-87 MG (human glioblastoma) xenografts, showing how much product accumulated in each location, expressed as the percentage of the injected activity (%IA/g), at 1, 4, and 24 h post-injection.

Consistent with the enhanced tumour uptake observed using the dual-targeting 64Cu-SAR-bisFAP, 67Cu-SAR-bisFAP also showed improved efficacy in therapeutic mice studies, with a doubling in the median survival time of the mice who received 30 MBq of 67Cu-SAR-bisFAP compared to those who received 30 MBq of the 67Cu-SAR-FAP monomer or an industry benchmark, 177Lu-FAP-2286 (median survival time was 28.5, 14.5, and 11.5 days, respectively).

Based on this data and results from previously completed pre-clinical studies, Clarity is aiming to progress the dual-targeting SAR-bisFAP theranostic products into human clinical studies, with a focus on the diagnostic in the first instance.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: "FAP-targeted products represent an exciting new generation of radiopharmaceuticals with the potential to target a range of cancer indications with high unmet needs. Consistent with our approach to high quality research and science, we continue to explore and optimise the most promising products in the field and going the extra mile to maximise their viability and success in the clinic. Starting from the benchtop, we work with thought leaders in the field to overcome the shortcomings of the existing products in development and generate strong data to support this. As a result of this commitment to excellence, we are now excited for our colleagues at MSK to share the results of the SAR-bisFAP products at one of the leading conferences in the field as they pave the way for clinical research in the near future.

"The diagnostic products using copper-64 and the therapeutics using copper-67 have shown high tumour targeting and retention in FAP-expressing xenograft mice models of cancer, with the dual-targeting 64Cu-SAR-bisFAP showing improved retention compared to the monomer alone, and 67Cu-SAR-bisFAP displaying improved efficacy compared to both 67Cu-SAR-FAP and an industry benchmark, 177Lu-FAP-2286. We believe these benefits are enabled by the optimised "bis" structure of our FAP product as well as the advantages offered by the perfect pairing of copper-64 and copper-67, securely held by our proprietary SAR chelator.

"Based on this data, we are currently conducting product development to enable a Phase I clinical trial in 2026 with 64Cu-SAR-bisFAP, which will be followed by exploring potential treatment opportunities of cancers based on their unmet medical needs using 67Cu-SAR-bisFAP in subsequent clinical trials."

Cartography Secures $67 Million Series B Financing to Advance Differentiated Oncology Pipeline of Antibody-Based Therapies into the Clinic

On October 2, 2025 Cartography Biosciences, Inc., an oncology company advancing an innovative pipeline of T-cell engaging bispecific and multi-specific antibody therapeutics that target novel and highly specific tumor antigens, reported the close of a $67 million Series B financing (Press release, Cartography Biosciences, OCT 2, 2025, View Source [SID1234656416]). The funding will help support the advancement of Cartography’s lead program, CBI-1214, into the clinic and the continued acceleration of additional, highly differentiated oncology programs generated from its ATLAS and SUMMIT drug discovery platforms.

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The Series B was led by new investor Pfizer Ventures and was joined by additional new investors LG Corp, Amgen Ventures, Finchley H.V., Global BioAccess Fund, and Lotte Holdings CVC, as well as existing investors Andreessen Horowitz (a16z) Bio + Health, 8VC, Wing Venture Capital, Catalio Capital Management, AME Cloud Ventures, ARTIS Ventures, and Gaingels. As part of the financing, Michael Baran, MBA, Ph.D., Partner at Pfizer Ventures, has joined Cartography’s Board of Directors. Additionally, Troy E. Wilson, Ph.D., J.D., who had previously joined as an Independent Director, has been elected as Chairman of the Board.

"Cartography is uniquely positioned to lead the potential next generation of T-cell engagers with a novel late preclinical program for colorectal cancer," said Michael Baran. "With a strong discovery platform and a growing pipeline, Cartography is quickly emerging as a leader in antibody therapeutics, and Pfizer Ventures is excited to support their progress in bringing potential new treatments to patients."

Cartography’s lead program CBI-1214 is a T-cell engager molecule that targets LY6G6D, an emerging and highly specific tumor antigen for treating colorectal cancer (CRC) patients. The target, which has minimal expression on healthy cells, is uniquely expressed within the microsatellite stable (MSS) and microsatellite instability-low (MSI-L) subtypes of CRC, which represent the vast majority of CRC patients and remains a major area of unmet medical need. CBI-1214 has protein engineering features that are specifically designed to optimize anti-tumor activity.

Kevin Parker, Ph.D., CEO of Cartography Biosciences said, "Combining insights from thousands of patient tissue samples, our ATLAS and SUMMIT platforms have identified several novel targets and target pairs that we have engineered new T-cell engagers against. CBI-1214, our first announced program, has the potential to be a first- and best-in-class molecule targeting CRC and positions Cartography as an emerging leader in new targeted therapies. We are grateful for the support of Pfizer Ventures and a world-class roster of strategic and financial investors as we move forward with CBI-1214, which is on track for an investigational new drug application later this year and trial enrollment in early 2026."