TIDMSCLP
RNS Number : 5035E
Scancell Holdings Plc
12 February 2018
12 February 2018
Scancell Holdings Plc
("Scancell" or the "Company")
Peer-reviewed publication highlights potential of SCIB1 therapy
for melanoma patients
Compelling 5-year survival data with most resected stage III and
IV patients remaining alive
Phase 2 trial anticipated to start in H2 2018
Scancell Holdings plc, ('Scancell' or the 'Company') the
developer of novel immunotherapies for the treatment of cancer, is
pleased to announce the publication of a peer-reviewed research
paper in the scientific journal OncoImmunology entitled: "Targeting
gp100 and TRP-2 with a DNA vaccine: incorporating T cell epitopes
with a human IgG1 antibody induces potent T cell responses that are
associated with favourable clinical outcome in a Phase 1/2 trial".
The Company also provides an update on current survival data along
with its future plans for a US clinical trial in patients with
malignant melanoma.
The publication describes the outcome of the Company's Phase 1/2
clinical trial of SCIB1 in patients with malignant melanoma up to
the date when all patients had received five doses of SCIB1 in the
main part of the study. The paper concludes that "SCIB1 is a novel
class of anti-cancer immunotherapy that induces T cells which can
cause tumour regression in patients with melanoma. The high
frequency of responses, their breadth and durability suggest that
SCIB1 is worthy of further study in a larger cohort of patients.
This is particularly the case in the adjuvant setting, where all of
the patients responded immunologically and where absence of
toxicity is an important clinical consideration. Furthermore, the
stimulation of potent de novo immune responses by SCIB1 may provide
an opportunity for synergistic combination therapy with checkpoint
inhibitors in late stage disease." The full abstract of the paper
can be found below.
SCIB1 ongoing survival data
Since the cut-off date for the publication, the Company has
continued to collect survival data for the trial patients and, as
of February 2018, SCIB1 continues to deliver increasingly
impressive results:
-- Overall, 18 of 20 stage III/IV melanoma patients with resected disease remain alive.
-- Of the 16 resected patients who received 2-4 mg doses of
SCIB1, only six patients have had recurrence of their disease with
only two deaths.
-- All 14 surviving patients in this group have passed the five
year time point since study entry. The four patients who had
disease recurrence went on to receive other treatments for their
melanoma. However, despite having received multiple interventions
and recurrences prior to study entry, the other 10 patients had no
treatment other than SCIB1.
-- One patient with unresected disease has also survived for
more than five 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 currently
35 months.
*All patients who relapsed went on to receive additional
therapies for their melanoma
SCIB1 US IND and Phase 2 study
The Company's Investigational New Drug (IND) application for
SCIB1 is expected to be filed with the Food and Drug Administration
(FDA) during the first half of 2018. Following the pre-IND meeting
in 2017, the FDA suggested that technical data from Ichor's new
TriGrid 2.0 clinical device should be submitted 30-60 days prior to
Scancell's own FDA submission. Ichor has now submitted the required
data to the FDA, and therefore, subject to funding, patient
enrolment into this trial is now expected to commence in the second
half of 2018.
The study, which will be a Phase 2 checkpoint inhibitor
combination study with SCIB1 in patients with advanced melanoma,
will be 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.
Dr Keith Flaherty commented: "Although the checkpoint inhibitors
have improved the prognosis for many melanoma patients, a
significant proportion of patients do not respond to these new
regimes. The combination of SCIB1 with a checkpoint inhibitor may
significantly expand the population of patients who benefit from
immunotherapy."
Dr Cliff Holloway, CEO of Scancell, said: "We are delighted to
see the data from our Phase 1/2 study published in the respected
peer-reviewed journal OncoImmunology. The continuing survival of
these patients is impressive as many had undergone multiple
resections of their tumours prior to SCIB1 treatment but have had
no evidence of any further disease recurrence. This compares
extremely favourably with checkpoint inhibitors, but has the
advantage of being associated with significantly less toxicity. We
remain on track to submit an IND to enable our Phase 2 study
combining SCIB1 with a checkpoint inhibitor to start in the second
half of this year."
Abstract
Targeting gp100 and TRP-2 with a DNA vaccine: incorporating T
cell epitopes with a human IgG1 antibody induces potent T cell
responses that are associated with favourable clinical outcome in a
phase 1/2 trial
A DNA vaccine, SCIB1, incorporating two CD8 and two CD4 epitopes
from TRP-2/gp100 was evaluated in patients with metastatic
melanoma. Each patient received SCIB1 via intramuscular injection
with electroporation. The trial was designed to find the safest
dose of SCIB1 which induced immune/clinical responses in patients
with or without tumour. Fifteen patients with tumour received SCIB1
doses of 0.4-8 mg whilst 20 fully-resected patients received 2-8 mg
doses. Twelve patients elected to continue immunization every 3
months for up to 39 months. SCIB1 induced dose-dependent T cell
responses in 88% of patients with no serious adverse effects or
dose limiting toxicities. The intensity of the T cell responses was
significantly higher in patients receiving 4 mg doses without
tumour when compared to those with tumour (p< 0.01). In
contrast, patients with tumour showed a significantly higher
response to the 8 mg dose than the 4 mg dose (p< 0.03) but there
was no significant difference in the patients without tumour. One
of 15 patients with measurable disease showed an objective tumour
response and 7/15 showed stable disease. 5/20 fully-resected
patients have experienced disease recurrence but all remained alive
at the cut-off date with a median observation time of 37 months. A
positive clinical outcome was associated with MHC-I and MHC-II
expression on tumors prior to therapy (p=0.027). We conclude that
SCIB1 is well tolerated and stimulates potent T cell responses in
melanoma patients. It deserves further evaluation as a single agent
adjuvant therapy or in combination with checkpoint inhibitors in
advanced disease.
Poulam M Patel, Christian H Ottensmeier, Clive Mulatero, Paul
Lorigan, Ruth Plummer, Hardev Pandha, Somaia Elsheikh, Efthymios
Hadjimichael, Naty Villasanti, Sally E Adams, Michelle Cunnell,
Rachael L Metheringham, Victoria A Brentville, Lee Machado, Ian
Daniels, Mohamed Gijon, Drew Hannaman & Lindy G Durrant.
Oncolmmunology; accepted author version posted online: 01 Feb
2018.
For Further Information:
Scancell Holdings Plc
Scancell
Dr John Chiplin, Chairman
Dr Cliff Holloway, Scancell Holdings
CEO Plc +1 858 361 6288
Freddy Crossley (Corporate
Finance)
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(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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