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(Sharecast News) - Scancell reported further positive clinical data for its DNA cancer immunotherapy iSCIB1+, on Tuesday, saying updated phase two results supported its selection for late-stage development in first-line advanced melanoma and reinforce the target patient population.
The AIM-traded company said it would present the data at the ESMO Immuno-Oncology Congress in London later this week.
In cohort three of the 'SCOPE' trial, iSCIB1+ in combination with standard checkpoint inhibitors ipilimumab and nivolumab delivered a progression-free survival rate of 74% at 16 months in patients with selected HLA types, compared with 50% at 11.5 months for checkpoint inhibitors alone.
Scancell said the improvement was consistent across subgroups typically associated with reduced treatment response, including PD-L1 low and BRAF wild-type patients.
Early overall survival trends were also favourable, showing a 14% improvement at 26 months over standard of care.
The data confirmed the company's decision to advance iSCIB1+ and focus on a target HLA population representing around 80% of melanoma cases.
Patients outside the group showed limited benefit, supporting the use of HLA selection as a biomarker for a registrational trial.
Cohort three included 50 patients, 39 of whom were within the target HLA group.
"The prolonged progression-free survival demonstrates iSCIB1+ in combination with checkpoint inhibitors has potential to redefine standard of care," said Dr Heather Shaw, principal investigator at the Mount Vernon Cancer Centre.
"This therapy combination increases the number of advanced melanoma patients who would benefit and improves the duration of their clinical response versus equivalent timepoints with checkpoint inhibition alone, thus representing an important step forward for patient outcomes."
The company also reported an overall response rate of 56% and a disease control rate of 79% in the target population, with strong T-cell responses correlating with clinical benefit.
Scancell noted that the iSCIB1+ intramuscular delivery method was proving optimal and would be taken forward, leading to the decision not to pursue further development of cohort four's intradermal route.
Dr Nermeen Varawalla, chief medical officer, said the data showed "a significant 24% improvement in PFS over standard of care and more efficacy than the first generation SCIB1," adding that the Immunobody platform is "being taken forward towards registrational trials."
Chief executive Dr Phil L'Huillier said the latest results "give further momentum to our advanced planning for late-stage clinical development," noting that discussions with the US Food and Drug Administration (FDA) and other regulators supported phase three plans, including the use of progression-free survival as the primary endpoint.
He added that Scancell was in active partnering discussions as it considered options to finance phase three development.
At 1308 GMT, shares in Scancell Holdings were down 3.9% at 9.85p.
Reporting by Josh White for Sharecast.com.