22:33 Tue 03 Jan 2017
Scancell Hlds - Research Update - Amendment
This replaces the announcement number 0710T made on
· In the quote by Dr
All other details remain unchanged. The full amended text is shown below.
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Final SCIB1 Phase 1/2 Clinical Study Report completed on schedule
Report confirms robust survival in late stage melanoma patients
SCIB1 Phase 2 combination study on track; IND expected to be filed in H1 2017
The Clinical Study Report includes safety, immunology and clinical data from all patients with Stage III/IV melanoma up to
· SCIB1 was safe and well tolerated over a dose range of 0.4 to 8mg with no serious adverse events related to SCIB1.
· There was clear evidence of an immune response in most patients receiving SCIB1. There were significantly stronger responses to the 8mg dose than to the 2/4mg doses, indicating that this is the appropriate dose for future studies.
· Immune responses were stronger in patients without tumour present at study entry than in patients with detectable tumour; SCIB1 may therefore be particularly effective as monotherapy in early stage patients with a low tumour burden. Continued and broader responses were seen for up to two years of treatment with SCIB1, suggesting that patients may derive benefit from long term administration.
· In the nine patients with tumour present at screening who received either a 4mg or 8mg dose of SCIB1, there was evidence of clinical activity in two patients; one had a partial response by RECIST and a second patient had a greater than 30% reduction in tumour size in target lesions but progression in a non-target lesion.
· In the 20 patients with no detectable tumour at screening, disease-free survival was much higher than expected based on historical comparisons.
Updated survival and disease recurrence data are as follows:
· Currently 19 of the 20 patients with resected tumours at study entry remain alive
· Of the 16 resected patients who received 2/4mg doses of SCIB1
o Median observation time since entry is 52 months and 58 months since first diagnosis of metastatic disease
o Only five patients have progressed and one has died
o One patient in this group has now reached their 5-year post-treatment survival time point
· Of the four resected patients who received 8mg doses of SCIB1 (recruited after lower dose cohorts)
o Median observation time since entry is 21 months and 27 months since first diagnosis of metastatic disease
o All patients are alive
o Two of these patients experienced recurrence of their melanoma in Q4 2016 following early termination of their treatment in
The Clinical Study Report will support the Company's Investigational New Drug (IND) Application for SCIB1 which is anticipated to be filed with
Dr
"We continue to expect to file our IND for SCIB1 in the first half of 2017, and to start our US clinical study of SCIB1 in combination with a checkpoint inhibitor in the second half of the year. We look forward to updating the market further on these plans in due course."
For Further Information:
Dr Dr |
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+1 858 900 2646 +44 (0) 20 3727 1000 |
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Panmure Gordon & Co |
+44 (0) 20 7886 2500 +44 (0) 20 7886 2500 |
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FTI Consulting |
+44 (0) 20 3727 1000 |
About
Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors.
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