TIDMSCLP
RNS Number : 0710T
Scancell Holdings Plc
03 January 2017
3 January 2017
Scancell Holdings Plc
("Scancell" or the "Company")
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
Scancell Holdings plc, ('Scancell' or the 'Company') the
developer of novel immunotherapies for the treatment of cancer,
today announces that the Clinical Study Report (CSR) on the SCIB1
Phase 1/2 clinical trial in patients with Stage III/IV malignant
melanoma has been completed on schedule.
The Clinical Study Report includes safety, immunology and
clinical data from all patients with Stage 3/4 melanoma up to 29
October 2015, the date of the last patient's final dose in the main
study. The main conclusions of the CSR are:
-- 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 June
2016 pending manufacture of new SCIB1 supplies. One patient had
received only one further dose of SCIB1 and the other had received
two doses after the end of the main study period. Immune analysis
from the patients recruited earlier suggests that patients may
benefit from up to two years continuous treatment to effectively
delay or prevent recurrence.
The Clinical Study Report will support the Company's
Investigational New Drug (IND) Application for SCIB1 which is
anticipated to be filed with Food and Drug Administration (FDA) in
H1 2017 subject to the outcome of the pre-IND meeting planned for
Q1 2017. Scancell is expecting to conduct a Phase 2 checkpoint
inhibitor combination study with SCIB1 in melanoma in 2017, led by
Principal Investigator Dr Keith Flaherty, Director of the Termeer
Center for Targeted Therapy at Massachusetts General Hospital and
Associate Professor at Harvard Medical School. A key objective of
this important study will be to evaluate safety and response rates
in melanoma patients administered SCIB1 in addition to a checkpoint
inhibitor compared to the checkpoint inhibitor alone.
Dr Richard Goodfellow, CEO of Scancell, said: "We are pleased
that the Clinical Study Report on our SCIB1 Phase 1/2 clinical
trial in patients with melanoma has now been finalised, and will be
able to support our US IND submission. We are very encouraged by
the compelling survival data generated in this study which now
demonstrates a median observation time since trial entry of more
than four years for the 16 patients with resected tumours and
receiving 2/4 mg doses of drug. This is supported by our long-term
immune analysis that suggests continued dosing of SCIB1 may control
disease in resected patients.
"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 next year. We look forward
to updating the market further on these plans in due course."
For Further Information:
Scancell Holdings Plc
Dr John Chiplin, Executive
Chairman +1 858 900 2646
Dr Richard Goodfellow, Scancell Holdings +44 (0) 20 3727
CEO Plc 1000
Freddy Crossley (Corporate +44 (0) 20 7886
Finance) 2500
Tom Salvesen (Corporate Panmure Gordon +44 (0) 20 7886
Broking) & Co 2500
+44 (0) 20 3727
Mo Noonan/Simon Conway FTI Consulting 1000
About Scancell
Scancell is developing novel immunotherapies for the treatment
of cancer based on its ImmunoBody(R) and Moditope(R) technology
platforms.
Scancell's first ImmunoBody(R), SCIB1 is being developed for the
treatment of melanoma. Data from the Phase 1/2 clinical trial
demonstrate that SCIB1, when used as monotherapy, has a marked
effect on tumour load, produces a melanoma-specific immune response
and highly encouraging survival trend without serious side effects.
In patients with resected disease there is increasing evidence to
suggest that SCIB1 may delay or prevent disease recurrence.
Scancell's ImmunoBody(R) vaccines target dendritic cells and
stimulate both parts of the cellular immune system: the helper cell
system where inflammation is stimulated at the tumour site and the
cytotoxic T-lymphocyte or CTL response where immune system cells
are primed to recognise and kill specific cells.
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.
Scancell has also identified and patented a series of modified
epitopes that stimulate the production of killer CD4+ T cells that
destroy tumours without toxicity. The Directors believe that the
Moditope(R) platform could play a major role in the development of
safe and effective cancer immunotherapies in the future.
This information is provided by RNS
The company news service from the London Stock Exchange
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January 03, 2017 02:00 ET (07:00 GMT)