Scancell Holdings PLC's (AIM:SCLP, OTC:SCNLF) prelims earlier brought into sharp focus the significant clinical progress made in the last 12 months, as well as spelling out what investors should expect next.
Its preparations follow encouraging results from its melanoma vaccine trial in July, and Panmure Liberum, its house broker, reckons the next 18 months will be busy.
The headline item is the design of a pivotal trial for iSCIB1+, Scancell’s off-the-shelf DNA vaccine for melanoma.
Panmure says the company is already in talks with the US Food and Drug Administration, the European Medicines Agency and the UK regulator, with a decision expected before the end of 2025.
It thinks the most likely design is a randomised study of more than 450 patients, pitched against today’s standard double immunotherapy.
Key measure
The key measure will probably be progression-free survival, the length of time before the cancer returns or worsens. Scancell has told the broker it could start that study in mid-2026 if funding or a partner is in place.
This forward-looking agenda only makes sense in the context of the SCOPE data.
Panmure described the results as “a strong improvement across all key metrics”.
In Cohort 1, progression-free survival was 22 months, while across Cohorts 1 and 3 combined, the objective response rate, or share of patients whose tumours shrank, was 69%. The disease control rate, which includes those whose disease stayed stable, was 88%.
Cohort 3, which tested iSCIB1+ alongside Bristol Myers Squibb’s drugs nivolumab and ipilimumab, showed a progression-free survival rate of 80.8% at 11 months of follow-up. The safety profile, Panmure notes, has been clean so far.
Key advantage
Off-the-shelf is the distinguishing feature here. Unlike personalised vaccines, which must be designed and manufactured for each individual patient, iSCIB1+ is made to a standard recipe.
That should mean lower costs, faster production and a treatment that can be rolled out more widely if it succeeds. Panmure points out that it is currently the only off-the-shelf DNA vaccine being developed for melanoma.
The groundwork for the larger study is underway. Panmure says Scancell has developed a commercial-scale manufacturing process and started talks with the contract research groups that run trials.
A fourth cohort of SCOPE is also progressing, testing delivery into the skin and a faster dosing schedule. The first eight patients have been treated safely, with results due later this year.
The NHS Cancer Vaccine Launch Pad, which was set up to direct patients into studies more quickly, should also help recruitment.
Not a one-way bet
Scancell is not a single-product bet. Modi-1, another off-the-shelf cancer vaccine, is being trialled in several solid tumours.
Panmure points to interim kidney cancer data expected in the third quarter of 2025 and more head and neck cancer data later in the year.
Management estimates the potential markets at $7.5 billion and $3 billion, respectively. As the broker reminds investors, those numbers describe the size of the market, not a projection of Scancell’s sales.
There is also GlyMab Therapeutics, a planned spin-out for Scancell’s antibody technology.
Panmure highlights that Genmab has already licensed two GlyMab assets, paying around $5 million upfront for each, with potential milestones worth more than $600 million apiece.
Spin-out
Moving GlyMab into a separate vehicle could draw in new partners and shift about 25 research staff off Scancell’s books if it is funded independently. The lead GlyMab drug, SC134, is being developed for small-cell lung cancer.
On the numbers, Scancell looks like most early-stage biotech groups. For the year to April, it reported £4.7 million of revenue, mainly from licensing, and an operating loss of £15 million.
Cash at the year end was £16.9 million, helped by an £11.3 million fundraising.
Panmure believes that it is enough to fund operations into the second half of 2026.
Beyond that, the cost of a 450-plus patient trial means Scancell will either need a partner to carry much of the load or to raise more money itself.
The broker also notes a convertible loan note, now shown as a current liability for accounting reasons, with redemptions in 2027. Redmile, the largest shareholder with 25.9%, is described as supportive.
Risk priced in?
Panmure keeps a 'buy' rating and a 32p target, compared with Thursday's 8.45p share price.
It argues that the shares already discount much of the risk. For retail investors, the attractions are clearer milestones than in the past.
Data from SCOPE and Modi-1, regulatory feedback, a potential partner for iSCIB1+ and progress with GlyMab are all in the diary.
The risk is still high. A randomised trial is expensive and demanding, and further funding will be needed.
But after years of work, Scancell has produced evidence that has convinced its broker to call it a step towards registrational development. The next question is whether it can persuade regulators and partners, too.