Oxford Cancer: Clinical Positioning Services
Ameliorating the global burden of cancer through industry-academia partnerships
We are Oxford Cancer: Clinical Positioning Services (OCCPS), an Oxford-based network of scientists and clinicians designed to partner with commercial organisations, and accelerate the clinical development and positioning of novel cancer diagnostic and therapeutic strategies.
We focus on supporting commercial organisations with assets nominated for clinical development who are looking to develop biologically driven studies and/or seeking early positioning advice on the following issues:
- What are the key studies that we should prioritise in order overcome regulatory hurdles and get our novel compound/combination into the clinic?
- What are the different diseases, indications or clinical settings that our asset might be applied to?
- How can we design our early phase clinical studies to ensure better decision-making during further clinical development?
- What companion diagnostics (histopathology, genetic, ctDNA) will complement our clinical studies based on its mechanism of action?
What we offer
Oxford University (OU) and Oxford University Hospitals Foundation Trust (OUH) are home to some of the world’s leading clinical, translational and fundamental cancer researchers with expertise and experience critical for the effective and efficient clinical development and implementation of novel cancer diagnostic and treatment products.
OCCPS utilises this expertise to provide tailored peer review of clinical development strategies and CMO-level advice on positioning products for the UK and international oncology market. This is comprised of an initial three-stage consultation process.
Areas we can help
How we work
- Stage One – First Contact. Partners are asked to submit a 1-2-page non-confidential synopsis highlighting the broad scope of the asset and its development position.
- Stage Two – Introductory Tcon – A 30-minute teleconference will then be held, led by a nominated member of the OCCPS to discuss project details and review any relevant data packages under CDA. The aim of this is to identify the central aims of the project and enable the tailoring of the review panel. [cost: free of charge]
- Stage Three – Specialist Peer Review Meeting – A 2-3-hour meeting will then be held with a panel selected from our clinicians, facilities and laboratories. You’ll have a chance to present your clinical development plan in detail with subsequent Q&A for the panel to dig deeper into your data and plans. Each internal specialist will provide an overview of their thoughts on your programme and make initial suggestions for future directions based on their capabilities and expertise. This discussion will form the basis of a 3-5 page report summarising the panel’s feedback (includes signposting to internal or external facilities) within 10 working days. [cost: £15,000]
The ultimate desired outcomes of the process would be:
- Sign-posted to commercial or academic partners who would be best placed to deliver the proposed suggestions.
- Support with project/programme development and delivery locally or through national or international networks.
- Assisted development of funding proposals for submission to grant/governmental funding bodies or investors.
Oxford is home to a world leading clinical trial development and delivery infrastructure for early phase oncology clinical trials. Currently, the portfolio (summarised in the panel below) contains 86 studies at varying stages of development, in a range of disease sites, in collaboration with a range of different partners.
|Acerta Pharma||CellCentric Ltd||NuCana|
|ADC Therapeutics||Constellation Pharmaceuticals||Pfizer|
|Agalimmune Ltd||Forty Seven Inc||Pharmacyclics|
|Agios Pharmaceuticals||Genmab B.V.||Pronai Therapeutics Incorporated|
|ARRAY Biopharma Inc||Imago BioSciences, Inc||REDx Pharma Plc|
|Astex Pharmaceuticals, Inc.||Immunocore Ltd.||Regeneron Pharmaceuticals|
|AstraZeneca||Incyte Corporation||Replimune, Inc|
|Boehringer Ingelheim||Ludwig Cancer Research Ltd.||Sanofi Limited|
|Bristol Myers Squibb||Medivir AB||Sierra Oncology Inc.|
|Carrick Therapeutics||Merck||TESARO Inc|
Examples of Oxford’s contribution to a section of the above programmes can be found below.
In 2019, NuCana approached Oxford Cancer researchers for clinical positioning input. They were supported from an initial 68 patient PK profiling study which was followed by combination studies and studies testing 2nd/3rd generation agents. In parallel mechanistic research was undertaken at the University that lead to the development of a companion diagnostic assay which was subsequently published and integrated into studies to help identify early signs of efficacy. Subsequently Nucana has gone on to launch an international registration phase 3 trial and is valued at IPO at $463M.
Immunocore approached Oxford cancer researchers in 2009 for advice on patient recruitment, regulatory development and trial design. They were advised on protocol development, regulatory approval and patient recruitment. We supported them through the MHRA special route that was implemented in response to the TeGenero scandal and delivered a phase -1 proof of concept package with built in early measures of efficacy, that lead to combination studies in multiple indications. At one stage the company was valued at $320M and work into their lead compounds mechanistic activity continues at Oxford.
Agalimmune were a small biotech company at an early stage of development of a rabbit poly-clonal antibody-based therapy. They approached Oxford cancer researchers who advised on the development of a synthetic mimic and then developed a trial protocol as an investigator led study. We were in the process of applying for grant funding to launch the study locally when they were bought out for $12M by BioLineRx who sponsored the study and subsequent clinical development.
Initiated as a spin out based on an Oxford-Stanford collaboration lead by Irv Wiessman, Oxford cancer researchers developed and delivered the haematological malignancy study that provided the first evidence of benefit for targeting CD47. This was a challenging study with significant toxicity liability that relied on supporting the co-design of a complementary pre-clinical package to enable regulatory approval. Subsequent developments have focussed on blood cancers and they are in the process of being bought out by Gilead for $4.9B.
Celleron approached Oxford cancer researchers with an in-licenced HDAC inhibitor asset. Co-investment from our trials unit and local trust in a shared risk scheme was rewarded with significant ROI during the early stage development of CXD101 for advanced cancer. Preliminary efficiency and safety was demonstrated which was used to support >$20M international investment.
Our Research Facilities
In addition to a range of fundamental and discovery research expertise spanning 170 independent academic research groups, clinical development support is provided through the following groups and laboratories.
- Oxford Molecular Diagnostics Centre – ISO accredited clinical genetic facility providind services from whole genome sequencing and targeted panels on tumour, sorted cells and cfDNA.
- Translational Histopathology Laboratory – GCP standard translational pathology and histopathology services including immunohistochemistry, multi-plex immunofluorescence staining, digital analysis and clinical pathologist review.
- Immune-monitoring – a range of deep phenotyping assays including flow cytometry, CyTOF, proteomics, and microbiome analysis.
- Single Cell Facility – semi-automated single cell RNA and DNA sequencing using a range of off the shelf and bespoke assays.
- Oncology Clinical Trials Office and Early Phase Clinical Trials Unit – trial design, protocol development, regulatory affairs, statistics, and trial execution.
- Human Tissue Laboratory – specialising in ex vivo analysis of fresh tumour biopsies and tissue fluid to advance pre-clinical research and translational science.