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.

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.

Eisai Highlights Breadth of Oncology Research at ESMO 2025

On October 1, 2025 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, which is taking place in Berlin, Germany from October 17 to 21 (Press release, Eisai, OCT 1, 2025, View Source [SID1234656400]).

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Among the notable presentations is data from the Phase 3 Study 309/KEYNOTE-775 trial, which evaluated lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA*1), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy versus treatment of physician’s choice for patients with advanced endometrial carcinoma. The presentation will feature 5-year overall survival data providing deeper insights into long-term treatment for patients affected by this disease (NCT03517449; Abstract #1119P).

"The 5-year overall survival follow-up from Study 309/KEYNOTE-775 being presented at ESMO (Free ESMO Whitepaper) highlights the consistency of the study data over time, supporting the established role of lenvatinib plus pembrolizumab in the treatment landscape of endometrial cancer and underscoring Eisai’s commitment to generating the long-term evidence that patients, families, and healthcare providers rely on to make informed treatment decisions," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. "Our research in endometrial cancer, alongside our data in renal cell carcinoma and innovative pipeline approaches, reflects our dedication to our human health care concept to address unmet medical needs and advance treatment options for people living with cancer."

Further endometrial cancer research includes additional 1-year follow-up results from the Phase 3 LEAP001 study in first-line advanced or recurrent endometrial carcinoma (NCT03884101; Abstract #1114P), as well as a combined analysis examining post-(neo)adjuvant therapy outcomes from both the Study 309/KEYNOTE-775 and LEAP-001 studies (Abstract #1124P). In renal cell carcinoma (RCC), final analysis data from the CLEAR study comparing lenvatinib plus pembrolizumab versus sunitinib in patients with advanced RCC with or without bone metastases will be presented (NCT02811861; Abstract #2603P).

Research from Eisai’s pipeline includes clinical and biomarker results from Study 102 evaluating E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced or recurrent endometrial carcinoma (NCT04008797; Abstract #1153P).

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. Regular abstracts will be made available via the ESMO (Free ESMO Whitepaper) website on 12:05 AM Central European Summer Time (CEST) on Monday, October 13, 2025. Latebreaking abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) as a Proffered Paper or Mini Oral will be published on the ESMO (Free ESMO Whitepaper) website at 12:05 AM CEST on the day of presentation. Posters will be on display from 9:00 AM – 5:00 PM CEST on the day of their poster session.

Cancer Type Study/Compound Presentation Title Presentation Type & Details
Lenvatinib Plus Pembrolizumab
Gynecologic Cancer
Study 309/
KEYNOTE-775
Lenvatinib plus pembrolizumab (L+P) vs
treatment of physician’s choice (TPC) for
advanced endometrial cancer (EC): 5-Year
outcomes from Study 309/KEYNOTE-775
Poster Session
Presentation #1119P
October 18, 2025
LEAP-001
First-line lenvatinib + pembrolizumab (L+P) vs
chemotherapy (CT) for advanced or recurrent
endometrial cancer (EC): additional 1-year
follow-up results from ENGOT-en9/LEAP-001
Poster Session
Presentation #1114P
October 18, 2025
Study 309/
KEYNOTE-775 and
LEAP-001
Lenvatinib + pembrolizumab (L+P) in participants
(Pts) with advanced or recurrent endometrial
cancer (aEC): Study 309/KEYNOTE-775 and
ENGOT-en9/LEAP-001 post-(neo)adjuvant
therapy outcomes
Poster Session
Presentation #1124P
October 18, 2025
Gastrointestinal Cancer LEAP-014
Lenvatinib plus pembrolizumab and
chemotherapy versus pembrolizumab and
chemotherapy in untreated metastatic
esophageal squamous cell carcinoma: the
randomized Phase 3 LEAP-014 Study
Proffered Paper Session
Presentation #LBA79
October 17, 2025
2:40-2:50 PM
Genitourinary Cancer CLEAR
Final analysis of lenvatinib + pembrolizumab
(L+P) vs sunitinib (S) in patients with advanced
renal cell carcinoma (aRCC) with or without bone
metastases in CLEAR
Poster Session
Presentation #2603P
October 18, 2025
Pipeline
Gynecologic Cancer E7386*2
Clinical and biomarker results from E7386 study
102: global dose-expansion cohort of E7386 +
lenvatinib (LEN) in patients (pts) with
advanced/recurrent endometrial cancer (aEC)
that progressed on platinum-based
chemotherapy (PBC) and an anti-PD-(L)1
immunotherapy (IO)
Poster Session
Presentation #1153P
October 18, 2025
The following presentations represent studies including lenvatinib treatment sponsored by MSD.
Cancer Type Study/Compound Presentation Title Presentation Type & Details
Genitourinary Cancer
LITESPARK-010
Belzutifan plus lenvatinib for Chinese participants
(pts) with previously treated advanced clear cell
renal cell carcinoma (ccRCC): updated results of
cohort 1 of the LITESPARK-010 study
Poster Session
Presentation #2615P
October 18, 2025
KEYMAKER-U03A
First-line pembrolizumab-based regimens for
advanced clear cell renal cell carcinoma:
KEYMAKER-U03 substudy 03A
Proffered Paper Session
Presentation #LBA96
October 18, 2025
8:30-8:40 AM
Melanoma KEYMAKER-U02B
First-line pembrolizumab alone or with
investigational agents for advanced melanoma:
updated results from the phase 1/2 KEYMAKERU02 substudy 02B
Poster Session
Presentation #1621P
October 20, 2025

In March 2018, Eisai and MSD, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy from MSD, pembrolizumab. Eisai and MSD are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program. Lenvatinib plus pembrolizumab is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC and certain types of advanced endometrial carcinoma. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

Bolt Biotherapeutics Provides Update on BDC-4182 and Extends Cash Runway into 2027

On October 1, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported an update on the ongoing Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology (Press release, Bolt Biotherapeutics, OCT 1, 2025, View Source [SID1234656398]). A strong immune response was observed at the initial dose levels and the Company is in the process of modifying the clinical trial protocol to allow for step-up dosing, which has been successfully used commercially for T-cell engagers. BDC-4182 preclinical data supports this approach.

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As a result of the update to the clinical trial protocol for BDC-4182, Bolt now expects to report initial clinical data in the third quarter of 2026. To conserve capital and maintain long-term shareholder value, the Company is implementing a workforce reduction of approximately 50%, extending its cash runway into 2027.

"I want to sincerely thank all of our colleagues impacted by this decision. Their commitment and valuable contributions have been essential in developing our novel BoltbodyTM ISAC technology and these potential new treatment options for patients with cancer," said Willie Quinn, President and Chief Executive Officer. "Amid challenging market conditions, our strategic imperative is the clinical advancement of BDC-4182 and the support of our ISAC collaborations to increase shareholder value. We look forward continuing our mission and to providing updates on BDC-4182 later next year."

KaliVir Immunotherapeutics Announces Completion of First Intravenous Patient Cohort of STEALTH-001 Study Evaluating VET3-TGI in Patients with Advanced Solid Tumors

On October 1, 2025 KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapy programs, reported the successful completion of the first cohort in the intravenous (IV) infusion arm of its STEALTH-001 (NCT06444815) clinical study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors (Press release, KaliVir Immunotherapeutics, OCT 1, 2025, View Source [SID1234656389]).

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Patients received VET3-TGI, the Company’s lead oncolytic immunotherapy candidate, which is designed to selectively kill tumor cells and remodel the tumor microenvironment by delivering a potent immuno-stimulatory transgene payload composed of interleukin-12 (IL-12) and a TGFbeta inhibitor.

"The dosing of patients in the IV arm marks a significant advancement for the STEALTH-001 study and the broader field of systemic oncolytic viral immunotherapy," said Dr. Yana Najjar, MD, Associate Professor in the Department of Medicine at the University of Pittsburgh and Director of the Clinical and Translational Research Center at UPMC Hillman Cancer Center. "Delivering VET3-TGI intravenously opens the door to using oncolytic virotherapy to treat patients with tumors that are not easily accessible for direct injection, expanding the potential reach of this therapeutic approach."

The continuation of IV dosing complements continued enrollment in the intratumoral (IT) arm of the Phase 1/1b trial, where patients are now being treated in cohort 3, and supports plans for combining VET3-TGI with checkpoint inhibitor therapy. The STEALTH-001 trial is evaluating VET3-TGI as both a monotherapy and in combination with a checkpoint inhibitor in patients with advanced, unresectable, or metastatic solid tumors.

"Systemic delivery of VET3-TGI is essential to realizing its full therapeutic potential, and this first IV dose brings us closer to that goal," said James Burke, MD, Chief Medical Officer of KaliVir Immunotherapeutics. "VET3-TGI was engineered to selectively infect tumor cells and deliver a potent combination of IL-12 and a TGFbeta inhibitor, stimulate a strong immune response and overcome tumor-driven immunosuppression. This milestone supports our broader goal of developing multi-mechanistic oncolytic immunotherapies that can address a wide range of solid tumors."

About VET3-TGI and the STEALTH-001 Study
VET3-TGI is a novel oncolytic virus developed using KaliVir’s proprietary VET platform. It is designed to selectively replicate in tumor cells, stimulate local immune responses, and remodel the immunosuppressive tumor microenvironment through the expression of IL-12 and a TGFβ inhibitor. The STEALTH-001 study is a first-in-human, open-label, dose escalation and expansion Phase 1/1b trial assessing both intratumoral and intravenous administration of VET3-TGI.VE

The STEALTH-001 trial is a dose escalation and expansion study evaluating VET3-TGI administered through direct IT injection and IV infusion. The trial is evaluating VET3-TGI as a monotherapy and in combination with a checkpoint inhibitor in patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. The study continues to progress as planned through its dose escalation phase.