Scancell Holdings has made significant progress in the past year, not that you would know this from the share price, which has drifted despite the welter of positive data it has delivered in that time.
Last week’s preliminary results, backed by bullish commentary from its house broker Panmure Liberum, suggest the next 18 months could finally prove decisive.
The highlight is the design of a pivotal study for iSCIB1+, an ‘off-the-shelf’ DNA vaccine for melanoma. Scancell is already in discussions with regulators in the US, Europe and the UK, with feedback due before the end of next year.
Panmure reckons the trial is likely to recruit more than 450 patients and test the vaccine against the current double immunotherapy standard.
Progression-free survival, the period before the cancer returns or worsens, looks set to be the key measure.
None of this would be credible without the SCOPE data. Analysts described July’s results as a strong endorsement of the science.
Panmure points out that it is the only such DNA vaccine for melanoma in clinical development.
In the first cohort, progression-free survival stretched to 22 months. Combining cohorts one and three, the objective response rate reached 69 per cent and disease control 88 per cent.
Cohort three, which added Bristol Myers Squibb’s nivolumab and ipilimumab to iSCIB1+, produced an 80.8 per cent progression-free survival rate at 11 months. Safety has been clean so far.
The appeal lies in the ‘off-the-shelf’ design. Personalised vaccines must be individually made for each patient, an expensive and time-consuming process. iSCIB1+, by contrast, follows a standard recipe, meaning faster production, lower costs and broader access if it proves itself.
Panmure points out that it is the only such DNA vaccine for melanoma in clinical development.
Preparations for a large trial are underway. Scancell has scaled up manufacturing, opened discussions with contract research groups, and is running a fourth SCOPE cohort exploring new dosing schedules and delivery into the skin.
Results from those patients are due later this year. Recruitment could also be boosted by the NHS Cancer Vaccine Launch Pad, designed to funnel patients quickly into studies.
Importantly, Scancell is not a one-product story. Modi-1, another off-the-shelf cancer vaccine, is in trials for several solid tumours. Panmure highlights kidney cancer data expected next summer and head and neck cancer results later in the year.
Management estimates the potential markets at $7.5 billion and $3 billion, respectively, although the broker reminds investors these figures reflect market size, not company forecasts.
There is also GlyMab, Scancell’s antibody platform. Two assets have already been licensed to Genmab, which paid about $5 million upfront each, with milestones of more than $600 million apiece.
Scancell plans to spin out GlyMab into a separate vehicle, potentially attracting new partners and shifting 25 staff off its books. The lead programme, SC134, is in development for small-cell lung cancer.
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