Let’s be honest. Cancer vaccines have a BIT of a credibility problem.
Over a decade of swing-and-miss results have made the field a punchline at every JPM dinner (maybe after a few drinks when people loosen up).
Then, every once in a while, someone shows up with numbers that make the room shut up.
Scancell Holdings, the Oxford-based immunotherapy company that’s been quietly building its ImmunoBody platform since 2008, received FDA Fast Track Designation for iSCIB1+ in advanced melanoma.
They paired the announcement with updated data from the SCOPE Phase 2 trial that should turn heads.
iSCIB1+ is a DNA-based vaccine that encodes a modified antibody scaffold designed to display the melanoma antigens gp100 and TRP-2 to antigen-presenting cells, kicking off a high-avidity T cell response.
The trial combined iSCIB1+ with ipilimumab and nivolumab in 140 previously untreated stage IIIB/IV melanoma patients.
The headline number: 77% progression-free survival at 20 months.
Historical PFS for checkpoint inhibitors alone in this setting sits at roughly 43%.
Progression-free survival at 20 months in advanced melanoma
77%
43%
Source: Scancell SCOPE Phase 2, n=140, no formal statistical comparison reported
Before you dive into that deep dish of crow, we have to caveat the obvious.
This is not a head-to-head randomized trial.
The 43% comparator is a historical benchmark, not a control arm. Still, its tempting to make the comparison, but any oncologist worth their salt will, correctly, want to see the Phase 3 readout before declaring victory.
And yet, that’s a 34-percentage-point absolute delta…
Even if the historical control gets generously revised upward, even if you give the iSCIB1+ arm a major haircut, for selection effects, you have to work hard to make those numbers look unimpressive.
The FDA giving Fast Track here is a separate vote of confidence on top of the data.
The other tactically interesting move: in their January announcement of FDA IND clearance for the Phase 3 registrational trial, Scancell mentioned they identified a selection marker from Phase 2 to enrich the Phase 3 trial for likely responders.
That’s a rare admission, by Phase 2 standards, that the company has figured out who responds and who doesn’t, and is willing to pre-spec on it. Phase 3 starts the back half of 2026, with PFS and early OS data anticipated in 2027.
About 80% of advanced melanoma patients carry the relevant HLA haplotypes for iSCIB1+, so the addressable population is real. Scancell also has Modi-1 in Phase 2 across renal, head and neck, ovarian, and TNBC, and through Glymab subsidiary has GlyMab antibodies licensed to Genmab. So this is not a one-asset story even if iSCIB1+ flames out.
But if it doesn’t, you’re looking at the strongest cancer vaccine readout in a decade.
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