SCANCELL HOLDINGS PLC: Interim Results for the six months ended 31 October 2023

Life Sciences

Scancell’s Phase 2 SCOPE trial for advanced melanoma impressed – with Initial data from 11 patients showing an 82% objective response rate (ORR) to treatment, handily surpassing the 50% ORR seen with competing drugs.

Date: January 31, 2024

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Strong clinical progress in the SCOPE trial with 85% ORR reported from the first 13 patients with
unresectable melanoma
Post-period end capital raise of £11.9m to support important clinical milestones in 2024
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces its interim results for the six months ended 31 October 2023 and provides a business update on progress achieved to date.

Highlights (including post period):

SCIB1 (SCOPE trial)

  • SCIB1, an oncology vaccine, reported positive data from the first stage of its Phase 2 SCOPE trial for
    advanced melanoma.
  • SCIB1 in combination with checkpoint inhibitors (CPIs) showed an 85% objective response rate (ORR)
    to treatment in 13 patients, exceeding the target of 70% ORR and accompanied by meaningful tumour volume reduction. One patient achieved a complete response following treatment.
  • In the real word setting in patients receiving doublet standard of care CPI therapy alone, the ORR is
    50% with a progression free survival of 11.5 months.
  • Recruitment in the second stage is expected to be complete in Q1 2024 with highly anticipated data
    available in Q3 2024.
  • The addition of iSCIB1+ to the SCOPE trial has been approved by the MHRA. Recruitment in this third cohort is expected to start in Q1 2024 with early data available in Q3 2024. iSCIB1+ includes additional melanoma-specific epitopes so it has the potential to be even more effective in a broader patient population.
  • A clear development pathway for registration and approval of SCIB1/ iSCIB1+ in the medium term for
    advanced melanoma has been mapped out.
  • This represents a potential $1.5 billion per annum market and we anticipate significant interest from
    potential partners.

Modi-1 (ModiFY trial)

  • In July 2023, the ModiFY trial moved into the expansion cohorts, following approval by the safety
    review committee.
  • Early data from patients receiving Modi-1 as a monotherapy showed good T cell responses, safety
    and tolerability, with no dose limiting toxicities observed in dose escalation cohorts. Similar to SCIB1
    monotherapy in metastatic disease, one patient achieved a partial response and 60% of patients
    showed stable disease in response to Modi-1 monotherapy.
  • Modi-1 to be assessed in renal cell carcinoma in combination with double CPI therapy in the ModiFY
    study pending protocol amendment by the MHRA.
  • Early clinical data from patients treated with Modi-1 plus CPIs is anticipated in 2024.
  • Development of SC129, out licensed to Genmab, continues on track towards potential clinical
  • GlyMab® and AvidiMab® platforms provide potential out licensing opportunities with active discussions ongoing with pharmaceutical and biotech companies.
  • Sath Nirmalananthan appointed as Chief Financial Officer
  • Dr Mandeep Sehmi appointed as Head of Business Development
  • In December 2023, the Company raised gross proceeds of £11.9 million in aggregate (before
    expenses) through the capital raise with significant participation from both existing and new healthcare specialist investors.
  • Group cash balance at 31 October 2023 was £13.1 million (April 2023: £19.9 million) with cash funding through to important clinical milestones on clinical assets.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: “The Scancell team continues to
produce highly-significant data across its pipeline of cancer vaccines and we have made strong progress in all parts of the business in the first six months of the year. Most notably, we were pleased to announce exceptional data from the first stage of the SCOPE trial with SCIB1 showing an 85% ORR to treatment in 13 patients, exceeding 70% ORR expectations. With important clinical milestones expected this year, including further data from both the SCOPE and ModiFY trials, and with the recently secured funding in place, the company’s prospects in 2024 are exciting.”
Professor Lindy Durrant, Chief Executive Officer, and Sath Nirmalananthan, Chief Financial Officer, will also host a live webcast and Q&A session for analysts and investors today at 14:00 GMT. If you would like to join the webcast, please follow this link:

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