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Scancell drug receives positive write-up in leading journal as company updates on survival data

Immuno-therapy SCIB1, which is expected to progress into Phase II clinical trials in the second-half of the year, was the focus of a peer-reviewed paper in OncoImmunology
researcher filling a vial
The company expects to embark on the next phase of clinical trials in the second half of the year

The cancer specialist Scancell Holdings PLC’s (LON:SCLP) said its lead drug has received a glowing write-up in a leading cancer journal as it released data from melanoma patients five years on from receiving the treatment.

Immuno-therapy SCIB1, which is expected to progress into Phase II clinical trials in the second-half of the year, was the focus of a peer-reviewed paper in OncoImmunology.

It assessed the data from Scancell’s Phase I/II study of patients with late-stage melanoma, which had been operated on and received five doses of SCIB 1.

READ: Our Big Picture article on Scancell 

The authors concluded SCIB1 was “worthy of further study” particularly in an “adjuvant setting”. An adjuvant enhances the drug’s response.

Importantly, the researchers thought there may be a role for the drug to be used in combination with drugs called checkpoint inhibitors in the late stages of the disease (which will be the focus of the next trial).

An extract from the paper appears below:

SCIB1 is a novel class of anti-cancer immunotherapy that induces T cells which can cause tumour regression in patients with melanoma. The high frequency of responses, their breadth and durability suggest that SCIB1 is worthy of further study in a larger cohort of patients. This is particularly the case in the adjuvant setting, where all of the patients responded immunologically and where absence of toxicity is an important clinical consideration. Furthermore, the stimulation of potent de novo immune responses by SCIB1 may provide an opportunity for synergistic combination therapy with checkpoint inhibitors in late stage disease.

On Monday, the company also updated on those who received the therapy in that early trial, with 18 of 20 stage III/IV melanoma sufferers still alive.

Of the 16 who received 2-4 mg doses of SCIB1, only six patients have had recurrence of their disease, with only two deaths.

All 14 surviving patients in this group have passed the five year time point since study entry. 

The four patients who had disease recurrence went on to receive other treatments for their melanoma. The other 10, who had received multiple different drugs before entering the trial, had no treatment other than SCIB1.

Impressive survival data 

“The continuing survival of these patients is impressive as many had undergone multiple resections of their tumours prior to SCIB1 treatment but have had no evidence of any further disease recurrence,” said Scancell chief executive, Dr Cliff Holloway.

“This compares extremely favourably with checkpoint inhibitors, but has the advantage of being associated with significantly less toxicity.

“We remain on track to submit an IND to enable our phase II study combining SCIB1 with a checkpoint inhibitor to start in the second half of this year."

As mentioned above, the Phase II study of SCIB1 is expected to get underway in the second half of 2018 following the completion of all the pre-trial formalities and submissions.

Combination therapy

The drug will be tested in combination with a checkpoint inhibitor and the programme will be overseen by Dr Keith Flaherty, a director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and an Associate Professor at Harvard Medical School. 

He said: "Although the checkpoint inhibitors have improved the prognosis for many melanoma patients, a significant proportion of patients do not respond to these new regimes. 

“The combination of SCIB1 with a checkpoint inhibitor may significantly expand the population of patients who benefit from immunotherapy."

The shares, up 36% in the last week, rose a further 3.6% in morning trade to 13.68p.

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Scancell Holdings Plc Timeline

February 08 2018

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