TIDMSCLP
RNS Number : 5950K
Scancell Holdings Plc
11 July 2017
11 July 2017
Scancell Holdings Plc
("Scancell" or the "Company")
Continued progress on SCIB1 - eight patients reach 5 year
survival milestone
US IND on schedule for submission in 3Q17; New batch of SCIB1
for planned US CI combination study successfully manufactured
Most resected Stage III and IV melanoma patients from the SCIB1
Phase 1/2 clinical trial remain alive and without disease
recurrence
ImmunoBody patent approved in all major markets
Scancell Holdings plc, ('Scancell' or the 'Company') the
developer of novel immunotherapies for the treatment of cancer,
today provides an update on SCIB1, the lead programme from the
Company's ImmunoBody(R) platform, and its future plans for a US
clinical trial in malignant melanoma.
Dr Richard Goodfellow, CEO of Scancell, said: "We are pleased to
report that most patients with resected disease enrolled in the
SCIB1 clinical trial are still alive and without disease
recurrence, including the majority of patients who were previously
undergoing continuation treatment. As previously announced, our
next study, which will be in the US, will assess the potential for
an increase in response rate in patients with malignant melanoma
when treated with SCIB1 and a checkpoint inhibitor. We remain on
track to submit the IND for this study in 3Q17.
Dr Keith Flaherty, Director of the Termeer Center for Targeted
Therapy at the Massachusetts General Hospital Cancer Center and
Professor of Medicine at Harvard Medical School, commented:
"Despite the plethora of combination regimens under evaluation in
melanoma, we believe that the SCIB1 / Checkpoint Inhibitor
combination represents a novel, rational and safe approach that
offers considerable clinical potential in a disease that still has
significant medical need."
SCIB1 Survival Update
As of July 2017, SCIB1 continues to deliver strong survival
data:
-- Overall, 18 of 20 stage III/IV melanoma patients with
resected disease remain alive with survival well beyond the
established norms
-- Of the 16 resected patients who received 2-4mg doses of
SCIB1, only six patients have had recurrence of their disease and
of whom, only two have died. The median observation time for this
group of patients is now 4.75 years, with seven patients surviving
for more than 5 years since starting treatment and only three
having evidence of disease recurrence during that period. *
-- One patient with unresected disease has also survived for
more than 5 years since starting treatment with SCIB1, despite
disease progression.*
-- Two of four resected patients who received 8 mg doses of
SCIB1 have experienced disease recurrence although none have died.*
The median observation time for this group of patients is 28
months
*All patients who relapsed went on to receive additional
therapies for their melanoma
Recurrence-free survival at 3 years in 951 resected stage III
patients was 46.5% on ipilimumab and 34.8% on placebo (Eggermont et
al Lancet Oncol 2015 May;16 (5):522-30) versus 69% at 3 years in 16
resected stage III/IV patients treated with SCIB1.
SCIB1 drug product manufacture and US IND
The new batch of SCIB1 has been manufactured successfully and
will be released for clinical use in 3Q17. Following the pre-IND
meeting held with the FDA in February 2017, we remain on track to
submit the IND for a Phase 2 SCIB1/CI combination study in
3Q17.
SCIB1 continuation treatment
Of the eight patients who were previously receiving long term
continuation treatment until this was suspended in June 2016, three
have experienced a recurrence of their melanoma. The other five
patients remain disease-free. Following a review with our clinical
investigators it has been decided not to continue the SCIB1 long
term continuation treatment in the five remaining disease-free
patients. These patients have received between six and 17 doses of
SCIB1 prior to a dosing holiday of more than 15 months. The company
believes that the effects of any further dosing would therefore be
difficult to interpret and to justify to the regulatory
authorities.
ImmunoBody patent
As previously reported, a patent for its DNA ImmunoBody(R)
technology has now been granted in Europe. This patent will extend
global coverage of Scancell's intellectual property with
counterparts already granted in the United States, Australia and
Japan.
Investor Events
Proactive One2One Forum, 13 July 2017 - Dr Richard
Goodfellow
The event will commence at 6.00pm at the Chesterfield Mayfair
Hotel, 35 Charles Street, Mayfair. Attendance is free. Proactive
Investors One2One Forums have rapidly gained global recognition for
companies to present to an audience of astute high net worth
investors, fund managers, private client brokers and analysts. See
Proactive Investors website for more details:
http://www.proactiveinvestors.co.uk/register/event_details/106
The Company will provide a corporate presentation and will
provide an update on its immunotherapy platform technologies:
-- ImmunoBody(R) - Best-in-class DNA vaccine technology for use
in combination with checkpoint inhibitors or as monotherapy for
patients with resected disease
-- Moditope(R) - Novel immunotherapy that destroys tumours and
extends survival without the need for checkpoint inhibition
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
+44 (0) 20 7886
Freddy Crossley (Corporate 2500
Finance) Panmure Gordon +44 (0) 20 7886
Maisie Atkinson (Sales) & Co 2905
+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(R) 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(R) 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
END
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