Blogs

Flexible, expedient management of our clinical trials

6 Aug 2020

CellCentric is developing a first-in-class p300/CBP inhibitor, CCS1477, to treat specific cancers.  The small molecule drug is formulated as an oral capsule product and is in clinical trials to treat drug-resistant prostate cancer, haematological malignancies as well as selected tumours characterised by specific molecular drivers.

Our clinical trials are now open in 8 hospitals across the UK, with the number set to double over the next 12 months.  The prostate and solid tumour study is headed by Prof Johann de Bono, the world-leading research clinician based at the Royal Marsden Hospital/Institute of Cancer Research, who was previously a driving force behind the development of abiraterone and olaparib. The haematological malignancy programme is headed by Prof Tim Somervaille, a leukaemia expert at The Christie Hospital, Manchester, with active research interest in myeloid cancers and epigenetic therapies.

Unlike many other development stage companies, CellCentric has built a core internal expert team which then directly coordinates the functionality of the clinical programme itself.  This has proven to allow maximum flexibility and expediency, which has been particularly key in recent times with the impact of COVID-19.  It has also meant that strong relationships have been built directly between CellCentric and the physicians and the wide group of study site staff.  Safety Review Committee meetings are highly engaged, as well as periodic updates on the programme as a whole.

Certain functions within clinical operations are still carried out by specialist groups, including pharmacovigilance (TMC Pharma) and eCRF/clinical database maintenance and management (SQN); Alderley Analytical have provided rapid turnaround of samples for pharmacokinetic analyses.  This mirrors CellCentric’s operational model during its drug discovery phase, where a core team coordinated activity with multiple expert contract providers and consultants. 

CellCentric works with over 30 niche specialist providers, with over 220 personnel involved in the clinical programme. CellCentric’s clinical operations maintains a core ethos; operating with the same quality and integrity of the best pharmaceutical corporations, whilst acting as flexibly and expediently as a small biotech. 

The UK’s regulatory authority, the MHRA, were extremely interactive during the planning phase of the clinical programme.  By initiating our clinical work in the UK we were very quickly able to start treating patients at doses and exposures that were likely to have meaningful clinical effects.  Parallel discussions have also taken place with the FDA, and CellCentric will be expanding Phase IIa in the US through the Prostate Cancer Clinical Trial Consortium, acting as local coordinator of sites, including for the haem and targeted tumour work.

The US activity builds on long-standing research and translational relationships, most notably with Prof Karen Knudsen and colleagues at SKCC/Thomas Jefferson University, Philadelphia but also Prof Leif Bergsagel (Mayo Clinic) and Prof Laura Pasqualucci (SKMCC/Columbia Uni, New York). Translational research also happens with our Chief Investigators at The Royal Marsden and Christie Hospitals.  Some of this is validation of mechanism of action work, but now also biomarker and biopsy analysis.  This has helped foster the feel that this is a shared clinical research programme, together. 

CellCentric is well resourced to progress its programme to initial proof of clinical concept in multiple settings. The COVID-19 lockdown has significantly impacted new patient recruitment into our trials.  However this is now re-establishing, as hospitals balance the needs of late-stage cancer patients with the challenges of the viral pandemic.  Recruitment is likely to continue to be slower than usual in the near to mid-term as hospitals work through new ways of working in the safest possible way, however strong progress continues to be made.  The adjusted expectation is that we should be able to announce safety and initial PoC efficacy clinical data in the first half of 2021, having moved from dose escalation to dose expansion in multiple settings.