Scancell Holdings (LON:SCLP) joint chief executive, professor Lindy Durrant, said the team continued to be excited by the “compelling data” being produced by its lead cancer treatment.
Called SCIB1, it uses the body’s immune system to tackle tough to treat melanoma and is undergoing phase I/II clinical trials.
The results so far have been impressive with all 20 patients that have undergone surgery to have the cancer cut out, or resected, alive today.
The median survival rate of the 16 on the 2-4 milligram (mg) doses of SCIB1 is over three years (39 months) since entering the trial or nearly four years (44 months) since diagnosis. Only five patients have progressed.
There are four patients who received an 8mg dose, who were recruited after lower-dose group. Median survival since entry to the drug programme is seven months and none of them has progressed.
The final clinical study report will be compiled by the first half of 2016.
“We continue to be excited by the compelling data emerging from our phase I/II clinical trial in metastatic melanoma with SCIB1, the lead pipeline candidate from our ImmunoBody platform,” said joint CEO Durrant ahead of the company’s annual meeting later today.
“In particular the encouraging survival data in patients with resected disease continues to support its potential to become the first effective, stand-alone adjuvant treatment for early stage metastatic melanoma.”
Depending on the results contained in the clinical study report, there is the possibility that SCIB1 might leapfrog from phase I/II trials straight into phase III, without carrying out a fuller phase II trial.
This would be an impressive feat if the US Food & Drug Administration (FDA) allows it and a vindication of the drug’s potential.
It would also propel the SCIB1 a lot further along the value chain.
Scancell has also created SCIB2 (for lung cancer) and SCIB3 (prostate) using the ImmunoBody platform. The former has generated some impressive pre-clinical data.
It has another, separate platform, called Moditope and the first drug off this particular production line is Modi-1, also for cancer. It is provisionally expected to enter first-in-man studies in the final quarter of next year.
"We look forward to communicating the findings from the final clinical study report from our SCIB1 phase I/II trial during the first half of 2016 and to progressing Modi-1 into the clinic towards the end of that year,” said Dr Richard Goodfellow, Scancell’s other joint CEO.
“While we continue to refine our roadmap for the future development of assets from both our platforms, we also continue to explore various options for the company that are consistent with maximising shareholder value."
The highly regarded biotech entrepreneur David Evans, who is Scancell’s chairman, said given the strength of the clinical data from SCIB1 and the pipeline of potential products, further investment is warranted and in his words “could add significant value to the company”.
“[The board] is actively evaluating the possibility of conducting one or more of these studies on its own behalf alongside other strategic opportunities for realising shareholder value,” he added.
“The company is poised for an exciting future as one of the leaders in immuno-oncology and we anticipate strengthening both the board and management as the company evolves into a later stage development business."