Strong Efficacy Signal for iSCIB1+ (PFS)
iSCIB1+ demonstrated progression-free survival (PFS) of 74% at 16 months in Phase II data; reported a 24% delta versus historic/real-world benchmarks (comparison with ipilimumab+nivolumab median PFS ~11.5 months). Company also reported a ~16% improvement for prior SCIB1 on overall survival versus the comparator in their dataset, and noted similarity in order of magnitude to published Moderna 5‑year follow-up data.
FDA IND Clearance for Phase III (Registrational Ready)
U.S. FDA granted IND clearance for the Phase III registrational study: accepted dose/delivery, study design, statistical plan, endpoints, manufacturing and nonclinical package. FDA acceptance included surrogate primary endpoint (supporting accelerated approval potential).
Phase III Plan and Timing
Planned randomized, double-blind 2-arm Phase III (~230 patients per arm, ~460 total) comparing ipi/nivo + placebo vs ipi/nivo + iSCIB1+, global enrollment (UK, Europe, US, Australia, others). Company targets commercialization in H2 2029 if data are positive.
Biomarker and Risk Mitigation
Biomarker identified from Phase II to enrich responders for Phase III, reducing development risk. Adaptive trial design and conservative statistical delta built into Phase III; patient characteristics compared closely with CheckMate 067 and recent real-world studies to ensure comparability.
Manufacturing, Delivery and Regulatory Support
Robust, scalable manufacturing process in place with favorable FDA feedback and long-term stability. Commercial agreement in place with PharmaJet for needle-free delivery device. Ongoing regulatory interactions (MHRA/EMA) and pursuing Breakthrough/Fast Track designations.
Pipeline Depth and Partnered Upside
Multiple programs: Modi‑1 (ongoing Phase II in head & neck and renal), GlyMab antibody portfolio (preclinical, lead SC134 for small cell lung cancer with patented co‑dosing approach), and two partnered antibodies with Genmab progressing toward clinic. Genmab licensing includes up to $630 million in potential milestone payments plus low single-digit royalties.
Near-Term Milestones and Data Catalysts
Expect Modi‑1 data in H1 (calendar year), anticipated Genmab milestone(s) in the year, and development milestones for SC129 expected in the calendar year—these are potential non-dilutive/value catalysts.
Financial Execution and Cost Control
R&D spend of $6.2M for the 6 months (reduced vs prior period due primarily to lower manufacturing costs), administrative expenses GBP 2.7M, operating loss GBP 8.9M, net loss GBP 5.7M. Demonstrated cost control and discretionary spend flexibility.