The purpose of this clinical trial is to evaluate the safety and tolerability of amivantamab and to determine the preliminary antitumour activity of amivantamab administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study a biomarker defined arm will be opened, initially in the relapsed GMB setting, enrolling 12 patients. These patients will be treated with amivantamab monotherapy. Amivantamab will be administered intravenously (IV) weekly for the first 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity. The first dose will be given as a split infusion, 350 mg IV over 4 hours on cycle 1 day 1 and 1400 mg IV over 6 hours on cycle 1 day 2. Subsequent infusions are given at a dose of 1750 mg IV over 2-5 hours in cycle 1 and between 2-3 hours from cycle 2 onwards if the first dose was well-tolerated with no significant toxicity.
Progression to Phase 2 is dependent on emergent data and funding.

Start Date09 Oct 2024

Sponsor / Collaborator

The Institute of Cancer Research: Royal Cancer Hospital

[+5]

NCT06630260 / RecruitingPhase 1/2IIT

A Phase 1/2 Trial of the Doublet Combination of Avutometinib and Defactinib and As a Triplet in Combination with Temozolomide in Patients with High Grade Malignant Brain Tumours Within the 5G Platform

The purpose of this clinical trial is to evaluate the safety and tolerability of avutometinib and defactinib and to determine the preliminary antitumour activity of avutometinib and defactinib administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study parallel biomarker defined arms will be opened, initially in the relapsed GMB setting, enrolling 12 patients onto each arm. These patients will be treated with avutometinib and defactinib double therapy. Avutometinib will be administered orally at 3.2mg twice a week (e.g., on Monday / Thursday or Tuesday / Friday) with or without a meal. The total weekly dose of avutometinib is 6.4mg. Defactinib will be administered orally, at 200mg, twice a day within 30 min after a meal. The total daily dose of defactinib is 400mg.
Once a treatment in any biomarker arm has met the "GO" decision (≥3 successes/12 patients) for relapsed GBM in Phase 1b, that arm can progress to Phase 2. The primary objective of Phase 2 is to determine the antitumour activity of investigational agents administered at the RP2D in patients with molecularly defined malignant brain tumours.

Start Date01 Oct 2024

Sponsor / Collaborator

The Institute of Cancer Research: Royal Cancer Hospital

[+5]

NCT06380816 / RecruitingPhase 1/2IIT

A Cancer Research UK Phase I/II Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of UCB4594 Alone and in Combination With Anti-cancer Treatments in Participants With Advanced Malignancies

This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.
The four main aims of the clinical trial are to find out:
1. The best dose of UCB4594 that can be given safely to participants in the trial.
2. What the side effects of UCB4594 are and how they can be managed.
3. What happens to UCB4594 inside the body and how it affects cancer cells.
4. Whether UCB4594 can cause cancer to shrink.

Start Date09 Jul 2024

Sponsor / Collaborator

Cancer Research UK

[+1]

100 Clinical Results associated with Cancer Research UK

0 Patents (Medical) associated with Cancer Research UK

3,922

Literatures (Medical) associated with Cancer Research UK

05 Sep 2024·Cancer Research

Abstract A066 Acquired resistance to temozolomide in the Th-MYCN mouse as a clinically-relevant platform to evaluate novel therapeutic strategies against high-risk neuroblastoma

Author: Liang, Tong ; Heuss, Sara ; Workman, Paul ; Jamin, Yann ; Poon, Evon ; Chesler, Louis ; Barone, Giuseppe ; Robinson, Simon P. ; Lin, Charles ; Costa, Barbara M.

AbstractAdvances in preclinical models that recapitulate chemorefractory and relapsed disease are needed to better predict the efficacy of an expanding and promising armamentarium of drug candidates being tested in early-phase pediatric clinical trials. Here, we used longitudinal magnetic resonance imaging to design an individualized, dose-escalating treatment regimen that induces evolution of neuroblastoma in the Th-MYCN genetically-engineered mouse model, concomitant with the acquisition of resistance to temozolomide, a standard chemotherapy used in treatment of refractory, relapsed neuroblastoma patients within European early-phase clinical trials. MRI longitudinally identified the development of intra-tumoral heterogeneity. Molecular profiling of expanding, treatment-refractory regions identified prominent up-regulation of the nor-adrenergic core regulatory signature and deregulation of the CDK2 pathway. Treatment with a CDK2/9 inhibitor led to significant response and an overall survival benefit in temozolomide-resistant Th-MYCN tumors and allografts generated from these resistant tumours. These findings demonstrate the utility of genetically-engineered mouse models as platforms to dissect the evolution of chemoresistance in neuroblastoma and they provide a mechanistic rationale to support the evaluation of CDK2/9 in ongoing paediatric phase I studies of chemotherapy combined with temozolomide in relapsed, treatment refractory neuroblastoma patients.Citation Format: Evon Poon, Tong Liang, Giuseppe Barone, Barbara M. Costa, Sara Heuss, Simon P. Robinson, Charles Lin, Paul Workman, Yann Jamin, Louis Chesler. Acquired resistance to temozolomide in the Th-MYCN mouse as a clinically-relevant platform to evaluate novel therapeutic strategies against high-risk neuroblastoma [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Advances in Pediatric Cancer Research; 2024 Sep 5-8; Toronto, Ontario, Canada. Philadelphia (PA): AACR; Cancer Res 2024;84(17 Suppl):Abstract nr A066.

01 Aug 2024·Annals of Oncology

A phase I dose escalation and expansion trial of the next-generation oral SERD camizestrant in women with ER-positive, HER2-negative advanced breast cancer: SERENA-1 monotherapy results

Article

Author: Ruiz-Borrego, M ; Incorvati, J ; Boni, V ; Gibbons, L ; Turner, N ; Brier, T ; García-Corbacho, J ; Lindemann, J P O ; Ciruelos, E M ; Kabos, P ; Baird, R D ; Oliveira, M ; Hernando, C ; Morrow, C J ; Sykes, A ; Twelves, C ; Patel, M R ; Armstrong, A ; Klinowska, T ; Hamilton, E ; Vaklavas, C

BACKGROUNDSERENA-1 (NCT03616587) is a phase I, multi-part, open-label study of camizestrant in pre- and post-menopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Parts A and B aim to determine the safety and tolerability of camizestrant monotherapy and define doses for clinical evaluation.PATIENTS AND METHODSWomen aged ≥18 years with metastatic or recurrent ER+, HER2- breast cancer, refractory (or intolerant) to therapy, were assigned 25 mg up to 450 mg once daily (QD; escalation) or 75, 150, or 300 mg QD (expansion). Safety and tolerability, antitumor efficacy, pharmacokinetics, and impact on mutations in the estrogen receptor gene (ESR1m) circulating tumor (ct)DNA levels were assessed.RESULTSBy 9 March 2021, 108 patients received camizestrant monotherapy at 25-450 mg doses. Of these, 93 (86.1%) experienced treatment-related adverse events (TRAEs), 82.4% of which were grade 1 or 2. The most common TRAEs were visual effects (56%), (sinus) bradycardia (44%), fatigue (26%), and nausea (15%). There were no TRAEs grade 3 or higher, or treatment-related serious adverse events at doses ≤150 mg. Median t_max was achieved ∼2-4 h post-dose at all doses investigated, with an estimated half-life of 20-23 h. Efficacy was observed at all doses investigated, including in patients with prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) and/or fulvestrant treatment, with and without baseline ESR1 mutations, and with visceral disease, including liver metastases.CONCLUSIONSCamizestrant is a next-generation oral selective ER antagonist and degrader (SERD) and pure ER antagonist with a tolerable safety profile. The pharmacokinetics profile supports once-daily dosing, with evidence of pharmacodynamic and clinical efficacy in heavily pre-treated patients, regardless of ESR1m. This study established 75-, 150-, and 300-mg QD doses for phase II testing (SERENA-2, NCT04214288 and SERENA-3, NCT04588298).

01 Jul 2024·The European Journal of Health Economics

Estimating surgery, radiotherapy and systemic anti-cancer therapy treatment costs for cancer patients by stage at diagnosis

Article

Author: Nagarwalla, Diana ; Pearson, Clare ; Fardus-Reid, Fahmina ; Wills, Lorna ; McPhail, Sean ; Shelton, Jon ; Harrison, Samantha ; Hinchliffe, Rose ; Sharpless, Ben ; Ambler, Lyndsy

AbstractBackgroundThe increasing burden of cancer has economic implications for the healthcare system in England. However, there is limited evidence on the cost of cancer treatment. We calculated the costs of initial cancer treatment (resection, radiotherapy, systemic anti-cancer therapy [SACT]) based on stage at diagnosis.MethodsData from England’s National Cancer Registration Dataset were matched to English Hospital, Radiotherapy and SACT data for breast, lung, prostate, colon and rectal cancers diagnosed between 2016 and 2018. Treatment data were matched to National Schedule of Reference Costs data to calculate the cost of each treatment event.ResultsBreast, colon and rectal cancers treated with resection, radiotherapy or SACT had increasing costs with later stage at diagnosis; costs for lung and prostate cancers were lower at stages 1 and 4 compared to stages 2 and 3. In general, surgery and SACT were the most expensive treatments. Radiotherapy and SACT costs showed little change across stages 1–3; radiotherapy costs decreased in stage 4, while SACT costs increased.ConclusionsThis analysis estimates initial treatment costs by stage based on observed data. Future research can build on this to provide more comprehensive costings associated with cancer; this is important for future planning of cancer services.

247

News (Medical) associated with Cancer Research UK

24 Oct 2024

·www.prnewswire.com

Cancer Research UK and KisoJi Biotechnology Collaborate to Advance the First Naked Antibody Against TROP2 Into the Clinic

LONDON and MONTREAL, Oct. 24, 2024 /PRNewswire/ -- Cancer Research UK, one of the world's largest funders of cancer research, and KisoJi Biotechnology Inc., a company focussed on the discovery and development of antibody therapeutics, have signed a landmark agreement to bring KisoJi's lead asset, KJ-103, into a first-in-human clinical trial. KJ-103 is a naked anti-TROP2 antibody that has been created by KisoJi using its proprietary antibody technology. Continue Reading Cancer Research UK Logo Under the agreement, Cancer Research UK's Centre for Drug Development (CDD) will sponsor, design and deliver a Phase 1/2a clinical trial of KJ-103, in selected TROP2 expressing solid tumours. KisoJi will supply the antibody for the clinical trial and work with CDD to complete the preclinical package. Cancer Research Horizons, Cancer Research UK's innovation arm, will manage the commercial relationship. Unlike antibody drug conjugates (ADCs), KJ-103 does not require a cytotoxic payload but instead functions by recruiting immune cells to kill tumour cells. KJ-103 binds to TROP2 in a location distinct from where current TROP2 ADCs bind. It uses TROP2 as a way of directing macrophage activation and phagocytosis of the tumour cells expressing it, leading to tumour cell death. KJ-103 may provide an alternative treatment option for TROP2-expressing cancers in which TROP2 ADCs have proven ineffective or are not suitable due to their toxicity profile. Tumour types expressing TROP2 include: colorectal, head and neck, ovarian, breast, bladder and lung cancers. Lars Erwig, Director of the CDD, said: "We are excited to collaborate with KisoJi to bring KJ-103 into clinical development. This partnership aligns with our mission to explore innovative therapeutic approaches for hard-to-treat cancers. With KJ-103's unique mechanism of action, which harnesses the body's immune system without the potential toxicity of a drug conjugate, we hope to offer new treatment options for patients with TROP2-expressing solid tumours." David Young, co-founder and CEO of KisoJi said: "We are thrilled to be advancing KJ-103 into the clinic in partnership with Cancer Research UK. As the first naked antibody to target TROP2 cancers, KJ-103 is the first of a new wave of antibodies to come from our modernised technology platform that leverages AI grounded in biology to create transformative antibody therapeutics." About Cancer Research UK's Centre for Drug Development Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. Six of these new agents have made it to market, including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase 3 trials. Thirteen agents remain in active development with the potential to reach the market. It currently has a portfolio of 16 projects in preclinical development, Phase 1 or early Phase 2 clinical trials. About KisoJi Biotechnology KisoJi is a Canadian biotechnology company that deploys the latest scientific and AI tools to conduct therapeutic antibody discovery in a fundamentally new way. KisoJi has developed a multi-species transgenic mouse to generate highly diverse single domain antibodies, as well as a modular multi-specific antibody scaffold with high stability and productivity. Most recently, KisoJi has used advanced AI tools to visualise the universe of all antibodies against a target in order to uncover novel biology and new therapeutic antibody capabilities for its partners and its own pipeline. About KJ-103 KJ-103 is a single domain antibody that binds to a unique epitope on TROP2. It acts via effector cell mechanisms, including the activation of macrophages, to kill tumour cells. KJ-103 has been shown to have significant anti-tumour potency with no evidence of toxicity or resistance across a number of preclinical solid tumor models. KJ-103 was humanised by LifeArc. Cancer Research UK Contact: Tim Bodicoat [email protected] +44 203 469 8300 +44 203 469 8301 (out of hours) KisoJi Biotechnology Contact: Investors and Media Argot Partners Sam Martin/Cameron Willis [email protected] +1 212 600 1902 SOURCE KisoJi Biotechnology Inc.; Cancer Research UK WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3ADC

21 Oct 2024

·www.globenewswire.com

Astex Pharmaceuticals Announce Key Data Presentations at the 36th EORTC-NCI-AACR Symposium

CAMBRIDGE, United Kingdom, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, a pharmaceutical company based in Cambridge, UK, dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it will make five key data presentations at the 36th EORTC-NCI-AACR Symposium on molecular targets and cancer therapeutics, 23rd-25th October 2024, Barcelona, Spain. The Astex presentations will focus on its novel small-molecule CBP/p300 HAT domain inhibitor, ASTX528 in preclinical development and its Phase II-ready MDM2 antagonist, ASTX295. Astex data presentations at 36th EORTC-NCI-AACR Symposium, 23rd-25th October 2024, Barcelona TitlePresentationDate/Time/Session Title/PresenterPresentation numberA Novel Small-Molecule CBP/p300 HAT Domain Inhibitor Demonstrates PotentIn VivoActivity and a Favourable Safety Profile in Preclinical SpeciesPosterDate: Wed, 23rdOct 2024Time: 12:00 - 19:00Session Title: Molecular Targeted AgentsPresenter: Gianni Chessari, Astex Pharmaceuticals, UKCatalog #42Presentation #PB030Targeting the Catalytic HAT Domain of CBP/p300 for the Treatment of Hormone-Dependent Breast and Prostate CancersPosterDate: Wed, 23rdOct 2024Time: 12:00 - 19:00Session Title: Molecular Targeted AgentsPresenter: John Lyons, Astex Pharmaceuticals, UKCatalog #73Presentation #PB061From a Preclinical Therapeutic Concept to the Clinic. ASTX295: Discovery of a bone marrow sparing MDM2 antagonistOralDate: Wed, 23rdOct 2024Time: 16:55 -17:15Session Title:Optimising of preclinical models for drug developmentPresenter: Maria Ahn, Astex Pharmaceuticals, UKWorkshop 2Room 113+114Identification of Biomarkers Predictive of Response to ASTX295, a Next-Generation MDM2 Antagonist, in Solid Tumors Carrying Wild-type p53PosterDate: Wed, 23rdOct 2024Time: 12:00 - 19:00Session Title: Molecular Targeted AgentsPresenter: Maria Ahn, Astex Pharmaceuticals, UKCatalog #28Presentation #PB016Pulsatile Induction of the p53 Pathway by MDM2 Antagonist ASTX295 Shows an Enhanced Therapeutic Indexin vivoPosterDate: Thu, 24thOct 2024Time: 9:00 - 17:30Session Title: Translational StudiesPresenter: Andrea Biondo, Astex Pharmaceuticals, UKCatalog #289Presentation #PB277 ASTX528 - CBP/p300 HAT Domain Inhibitor - Preclinical ASTX528 is a novel small molecule CBP/p300 HAT domain inhibitor with potent in vivo activity and a favourable safety profile in preclinical species that was discovered by Astex using its proprietary fragment-based drug discovery approach. CREB binding protein (CBP) and its paralog, EP300 (p300), are lysine acetyltransferases and transcriptional cofactors implicated in human cancers. Dose-limiting tolerability issues have been observed with dual CBP/p300 bromodomain (BRD) inhibitors, which may limit their clinical utility. We hypothesised that a dual inhibitor targeting the histone acetyltransferase (HAT) domain may improve the therapeutic window. Our presentations will describe the effects of CBP/p300 HAT domain inhibition in preclinical models of AR- and ER-driven cancers and the characterisation of ASTX528, a potent, fragment-derived CBP/p300 HAT domain inhibitor with a low predicted human dose and promising preliminary toxicity evaluation. Astex is interested in discussing the further development of ASTX528 with potential partners. ASTX295 – Bone Marrow-Sparing MDM2 Antagonist, Phase II-ready ASTX295 is an oral, potent inhibitor of the p53-MDM2 protein-protein interaction that was discovered by Astex using its proprietary structure-based drug design approach. The compound was specifically designed to overcome the on-target toxicity seen in the first generation MDM2 antagonist compounds which have shown dose-limiting haematological toxicities in the clinic. In contrast, ASTX295 is a potent MDM2 antagonist with a clean CYP/hERG profile and a shorter human half-life allowing for pulsatile pathway modulation while avoiding myelosuppression. ASTX295 therefore has bone-marrow sparing characteristics which permit a differentiated safety profile. ASTX295 was discovered by Astex in collaboration with the Cancer Research UK Drug Discovery Unit at Newcastle University. Astex has an exclusive license to research, develop and commercialise ASTX295 under its drug discovery alliance agreement with Newcastle University and Cancer Research Technology Limited. About Astex Pharmaceuticals Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has several partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan. For more information about Astex Pharmaceuticals, please visit: http://www.astx.com For more information about Otsuka Pharmaceutical, please visit: https://www.otsuka.co.jp/en/ Contact At the Company:Jeremy CarmichaelSVP Corporate DevelopmentHead of Business DevelopmentTel: +44(0)1223 226289Email: jeremy.carmichael@astx.comFor Media Enquiries:Sue CharlesCharles ConsultantsTel : +44(0)7968 726585Email: sue@charles-consultants.com

License out/inPhase 1AACR

07 Oct 2024

·www.globenewswire.com

IMU Biosciences joins ground-breaking UK research consortium investigating patient response to cancer immunotherapies

PRESS RELEASE IMU Biosciences joins ground-breaking UK research consortium investigating patient response to cancer immunotherapies Consortium includes leading research institutions, NHS Trusts and industry members and aims to make pioneering immunotherapies safer and more effective London, UK, 7 October 2024 – IMU Biosciences (or “the Company”), a biotechnology company pioneering systems-level immune profiling with AI to drive breakthroughs in precision medicine, is pleased to announce its participation in MANIFEST (Multiomic ANalysis of Immunotherapy Features Evidencing Success and Toxicity), a new UK-wide platform to understand immunotherapy response and side effects in patients with cancer. The MANIFEST consortium, led by the Francis Crick Institute and the Royal Marsden NHS Foundation Trust, has been awarded £9 million in funding from the UK government's Medical Research Council and Office for Life Sciences, with an additional £12.9 million in matched funds from industry partners. This four-year project aims to evaluate the many barriers to the success of immunotherapy and develop predictive biomarkers related to patient response, resistance, and immune-related adverse events following immuno-oncology treatments. IMU Biosciences will play a crucial role in this nationwide effort by analysing thousands of blood samples from patients undergoing immunotherapy. The Company's cutting-edge technology platform, which incorporates high-resolution spectral cytometry integrated with AI-powered analytics, can identify and analyse over 2,000 immune cell subsets, to develop novel systems-level immune signatures and insights. IMU’s technology will be instrumental in the study to help identify and understand how an individual’s immune system influences the responsiveness to immuno-therapy treatments. Using its AI and machine learning analytics, IMU is developing predictive models to improve treatment selection and patient outcomes. The research will initially focus on melanoma, renal cell carcinoma, bladder cancer, and triple-negative breast cancer, involving 6,000 patients across the UK. The consortium's findings aim to help understand which patients are most likely to benefit from immunotherapy and provide insights for potential new treatments, such as vaccines and cell therapies. Adam Laing, President and CSO of IMU Biosciences commented: “The IMU team is thrilled to contribute our cutting-edge, AI-driven immune profiling platform to this groundbreaking UK consortium, helping to deepen the understanding of the immune system’s role in cancer therapy and response, with the ultimate goal of improving clinical outcomes for patients. This collaboration with world-class institutions and industry partners underscores IMU Biosciences' commitment to driving innovation in precision medicine and showcases our potential to make a real impact in healthcare." The MANIFEST consortium brings together 15 academic institutions, including The Francis Crick Institute and the Cancer Research UK National Biomarker Centre, alongside six NHS Trusts, 11 industry collaborators including IMU Biosciences, as well as patient advocacy groups and other networks. -ENDS- Contacts: Adam Laing, CSO and Co-founder, IMU Biosciencesmedia@imubiosciences.com ICR Consilium Tel: +44 (0) 20 3709 5700Sukaina Virji/Lucy Featherstone/Jonathan EdwardsIMUBiosciences@consilium-comms.com About IMU Biosciences IMU Biosciences has developed proprietary platform technologies that generate and translate vast system-level immune data into actionable insights and tools to drive the development of precision medicines across a variety of diseases. Built on over a decade of research at King’s College London and the Francis Crick Institute, IMU leverages advanced immune profiling with proprietary AI and machine learning analytics to uncover novel clinical immune signatures. IMU continues to establish partnerships with leading Pharma and Biotech companies to advance disease diagnosis, optimise product selection, and improve patient stratification and monitoring—while also building its own pipeline of innovative products. To learn more please visit https://www.imubiosciences.com/. Follow us on LinkedIn.

Immunotherapy

100 Deals associated with Cancer Research UK

100 Translational Medicine associated with Cancer Research UK

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Pipeline Snapshot as of 17 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Nezutatug ( HER3 )	Castration-Resistant Prostatic Cancer More	Phase 2 Clinical
UCB-4594 ( HLA )	Advanced Malignant Solid Neoplasm More	Phase 2 Clinical
Human papillomavirus vaccine TA-CIN(Xenova Ltd.) ( HPV E6 x HPV E7 x HPV L2 )	Vulvar Neoplasms More	Phase 2
MVA-EL(The Chinese University of Hong Kong) ( EBV Protein )	Nasopharyngeal Neoplasms More	Phase 2
IMA-950 ( HLA )	Glioblastoma More	Phase 2

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