The company is planning to make a fresh batch of SCIB1 and has recently signed an agreement with a new GMP manufacturer
Scancell Holdings, the developer of novel immunotherapies for the treatment of cancer, is suspending dosing with the current clinical trial supplies of SCIB1 with immediate effect.
Ongoing quality control analysis has revealed that the stored drug product is no longer within the original specification. In discussion with the MHRA Clinical Trials Unit, and with patient safety of primary importance, the company has concluded that it is no longer suitable for further use, although no new side-effects have emerged.
The suspension of dosing affects eight patients in the long-term extension arm of the Phase 1/2 trial, SCIB1-001 (out of the 35 patients that have been dosed), investigating SCIB1 as a monotherapy for the treatment of melanoma. All study investigators have been informed and their patients will be notified as soon as possible.
SCIB1-001 was originally started in 2010 with a prospectively planned treatment period of only six months. However, continuing encouraging results and an excellent side-effect profile led to successive amendments to the clinical trial protocol to investigate increasing doses of the drug and eventually to examine a long-term dosing regimen. As a result, some of the trial materials have now been stored for more than seven years.
The company is planning to make a fresh batch of SCIB1 and has recently signed an agreement with a new GMP manufacturer. The primary reason for this is to support a new study of SCIB1 in combination with a checkpoint inhibitor, as previously announced.
However, the company also intends to make this material available to patients currently in the long-term extension of SCIB1-001 who wish to continue receiving the drug. While it is expected that there will be a delay of approximately 9–12 months before the new SCIB1 material will be available for clinical use, it is anticipated that the anti-tumour response induced by SCIB1 should persist and eliminate any remaining tumour cells.
Further doses of SCIB1 have been given for added protection to ensure the immune cells continue to patrol for any emerging cancer cells; subsequent administration of the new SCIB1 material should reactivate these memory immune cells to eliminate any recurring tumours.
Prof. Poulam Patel, chief investigator for the SCIB1-001 clinical trial and Professor of Clinical Oncology at the University of Nottingham, commented: ‘Results from the SCIB-001 trial to date have been very encouraging and SCIB1 clearly warrants further investigation as a potential treatment for melanoma. However, as patient safety is our primary concern, the deterioration of stored clinical trial material from the original specification necessarily means that dosing of SCIB1 must be suspended until new drug product becomes available.’
Dr Richard Goodfellow, CEO of Scancell, added: ‘Patient safety has always been our primary responsibility. Although we have seen no new adverse events, it is unfortunate, but nevertheless appropriate, that we suspend dosing of SCIB1 at this time while we work as quickly as possible to secure new supplies of this promising potential treatment for melanoma. Starting further efficacy studies with SCIB1 is only possible because of the results we have seen so far in the long-running SCIB1-001 study and we would again like to convey our thanks to the patients in that trial for their participation and support during the past six years.’