Admission to AIM
14 July 2010
Scancell Holdings Plc
(`Scancell Holdings' or the `Company')
Withdrawal from PLUS and Admission to AIM
The Board of Scancell Holdings plc, (PLUS:SCLP), the developer of therapeutic
cancer vaccines, is pleased to announce that it intends to apply for the
Company's Ordinary Shares to be admitted to trading on AIM and, immediately
prior to the Admission to AIM, it intends to withdraw the Company's Ordinary
Shares from trading on PLUS.
During 2010, the Company has raised £2.54 million, before expenses, to fund its
foreseeable working capital requirements. The Directors believe that the
existing funds held by or available to the Group together with future
anticipated revenues will be sufficient to allow completion of the Phase I/IIa
clinical trial of SCIB1, its lead melanoma therapeutic vaccine.
The Ordinary Shares of the Company were originally admitted to trading on PLUS
in September 2008. However, now that the Company has further strengthened its
financial position and progressed the development of SCIB1, the Directors
believe that it would be in the best interests of the Company and its
shareholders for the Ordinary Shares to be admitted to trading on the AIM
market of the London Stock Exchange.
The Directors believe that this represents a natural transition for the Company
and that the potential benefits of an AIM listing will include an increased
public profile for the Company.
Under the AIM Rules, prior to Admission, the Company is required to publish an
admission document. The Company is therefore sending an admission document to
Shareholders to inform them that the Ordinary Shares of the Company will be
withdrawn from trading on PLUS from the close of business on 29 July 2010 and
that the Ordinary Shares of the Company are expected to be admitted to trading
on AIM at 8.00 a.m. on 30 July 2010.
An extract from the Admission Document is set out below along with the expected
timetable of principal events.
A copy of this announcement and the Admission Document will be available for
download on the Company's website at http://www.scancell.co.uk/
The Directors of the issuer accept responsibility for this announcement.
For further information contact:
Professor Lindy Durrant Scancell Holdings Plc + 44 (0)207 245 1100
John Bick/Kirsty Corcoran Hansard Communications + 44 (0)207 245 1100
Ross Andrews/Tom Rowley Zeus Capital + 44 (0)161 831 1512
EXPECTED TIMETABLE OF PRINCIPAL EVENTS
2010
Admission document publication date 14 July
Withdrawal of Ordinary Shares from trading on PLUS 4.30 p.m. on 29 July
Admission to AIM and commencement of dealings in 8.00 a.m. on 30 July
the Ordinary Shares
Notes:
1. References to time in this document are to London time. lf any of the above
times or dates should change, the revised times and/or dates will be
notified to Shareholders by an announcement on an RIS.
2. The timing of events in the above timetable is indicative only.
1. Introduction
Scancell Holdings plc is a biopharmaceutical company focused on the cancer
therapeutics market and is developing a pipeline of DNA vaccines for the
treatment of cancer based on its patented ImmunoBody® platform, which has the
potential to overcome many of the limitations of conventional approaches to the
development of cancer vaccines.
Scancell's lead ImmunoBody® product, SCIB1, is a melanoma vaccine that has
repeatedly shown good antitumour effects in animal studies. A Phase I/IIa
clinical trial of Scancell's SCIB1 vaccine in advanced melanoma patients
commenced in June 2010 and is expected to be completed in 2012.
Earlier this year the Company raised £2.54 million, before expenses, to fund
its foreseeable working capital requirements. The Directors believe that these
proceeds, together with the existing funds available to the Group and future
anticipated revenues, will be sufficient to allow completion of the Phase I/IIa
clinical trial of SCIB1.
The Ordinary Shares of the Company were originally admitted to trading on PLUS
in September 2008.
However, now that the Company has further strengthened its financial position
and progressed the development of SCIB1, the Directors believe that it would be
in the best interests of the Company and its shareholders for the Ordinary
Shares to be admitted to trading on the AIM market of the London Stock
Exchange.
The Directors believe that this represents a natural transition for the Company
and that the potential benefits of an AIM listing will include an increased
public profile for the Company.
Under the AIM Rules, prior to Admission, the Company is required to publish an
admission document, and the Company is therefore writing to Shareholders to
inform them that the Ordinary Shares of the Company will be withdrawn from
trading on PLUS from the close of business on 29 July 2010 and that the
Ordinary Shares of the Company are expected to be admitted to trading on AIM at
8.00 a.m. on 30 July 2010.
You should read the whole of this announcement and the Admission document and,
in particular, you should consider carefully the "Risk Factors" set out in Part
II of the Admission document.
2. Information on the Company
Overview
Scancell is a biopharmaceutical company focused on the cancer therapeutics
market and is developing a pipeline of DNA vaccines for the treatment of cancer
based on its patented ImmunoBody® platform, which has the potential to overcome
many of the limitations of conventional approaches to the development of cancer
vaccines.
Cancer remains one of the world's most significant diseases and although there
have been considerable advances in the treatment of cancer over the last
decade, a high proportion of patients still die as a result of the disease. A
key challenge in the fight against cancer is overcoming the tumour's ability to
`mask' itself from the body's natural defence mechanism - the immune system -
and developing effective cancer vaccines.
There are two types of vaccines, namely prophylactic vaccines (that stimulate
an immune response prior to exposure to the disease and thereby prevent the
pathology associated with the disease) and therapeutic vaccines (which
stimulate an immune response to reject an established disease). The only
registered prophylactic cancer vaccines are Gardasil and Cervarix, which are
given to adolescent females to neutralise the HPV virus which causes cervical
cancer. Unfortunately very few cancers are known to be caused by viruses so
this approach cannot be used routinely and it is therefore necessary to develop
therapeutic vaccines. Scancell's mission is to develop therapeutic vaccines
that stimulate the patient's immune system to mount an active response to
`reject' or kill the growing tumour.
The Company has recently commenced a Phase I/IIa clinical trial for its lead
therapeutic melanoma vaccine, SCIB1, which is expected to be completed in 2012.
The Directors believe that a positive outcome would enable the Company to
position itself for a trade sale to one of the leading pharmaceutical or
biotechnology companies operating in the oncology market.
The Directors also intend to license the Company's ImmunoBody® technology on a
target by target basis to companies working in the protein and DNA vaccine
field. The manipulation and enhancement of patients' immune systems is also
relevant to the treatment of other diseases such as chronic infectious disease
and inflammation. Although Scancell does not intend to venture outside the
oncology arena itself, it intends to license its ImmunoBody® technology to
companies working in other therapeutic areas.
Background
Scancell was spun out from the University of Nottingham in 1996. It was
co-founded by Professor Lindy Durrant, PhD (the CEO of the Company). Since its
inception, Scancell has consistently focused its attention on harnessing the
power of the immune system to treat or prevent disease. Research activity in
the early days included the use of antibodies to screen maternal blood for
markers of Down's Syndrome although in recent years Scancell has directed its
attention exclusively at the cancer therapeutics market.
In December 2006, Scancell decided to divest its preclinical pipeline of cell
killing monoclonal antibodies to Arana Therapeutics (then known as Peptech UK
Limited) in a deal worth up to £4.85 million (less bonus payments payable to
certain of the Directors), in order to concentrate on the further development
of its proprietary ImmunoBody® vaccine technology.
The Company was listed on PLUS in September 2008.
Products and Technologies
ImmunoBody® Platform
Scancell's core technology is the ImmunoBody® Platform. The ImmunoBody®
technology uses an engineered human monoclonal antibody ("mAb") as a vector to
both target and activate key cells that are essential for stimulating a full
immune response against the target cancer. The Directors expect that the
Immunobody® platform technology will be able to provide the basis for
generating ImmunoBody® vaccines that target any tumour type and that the
technology may also be utilised in the development of vaccines against chronic
infectious diseases.
The key concept for the ImmunoBody® technology is that it generates a high
avidity response. Most cancer vaccines induce T-cells of low avidity that fail
to control tumour growth. In contrast, in vivo results consistently show that
the ImmunoBody® platform delivers high avidity T-cell responses that:
• Lyse tumour cells;
• Inhibit the growth of solid tumours; and
• Prevent the spread of metastatic disease.
The Directors believe that this vaccine technology has the potential to
materially change the way we treat certain cancers. In essence, an ImmunoBody®
is a vector designed to deliver information about a foreign agent or pathogen
(this might be a tumour or an infecting agent) to dendritic cells. Dendritic
cells use this information to activate an immunological cascade resulting in
the production of helper and cytotoxic T-cells ("CTLs") directed against the
target of interest (i.e. the tumour or the infecting agent). This is termed
`cellular immunity' which, alongside antibody production (known as `humoral
immunity'), forms the basis of the body's immune defence system.
Although it is relatively easy to produce a humoral immune response with a
vaccine to prevent disease, the primary objective of research for many years
has been to find a way of producing an effective immune response (high avidity
T-cells) that result in regression of established tumours. The ImmunoBody®
technology addresses this issue.
The Directors believe that ImmunoBody® technology is superior to traditional
technologies for the following reasons:
• 100 fold enhancement of avidity and 3 fold increase in frequency compared to
peptide vaccination;
• 1,000 fold enhancement in avidity and 10 fold enhancement in frequency
compared to DNA whole antigen immunisation;
• At least as good as the best possible conventional dendritic cellular vaccine
but much simpler and gives a more consistent response as it targets dendritic
cells in vivo;
• Better than viral carrier vaccines as there are no competing foreign T-cell
epitopes. Human IgG1 is an inert carrier with a long serum half life; and
• Better than other approaches that target dendritic receptors as CD64 is only
expressed on activated dendritic cells and therefore cannot induce tolerance.
Other dendritic receptors are expressed on immature dendritic cells and
these can induce tolerance.
Scancell is currently developing a number of ImmunoBody® products in order to
extend its product pipeline and further validate the technology. To facilitate
this, an ImmunoBody® `plug and play' epitope expression vector system has been
developed which enables new vaccines to be generated in a matter of weeks.
Scancell has secured a licensing agreement with Merck KGaA ("Merck"), for two
key patents required for the further development and commercialisation of
ImmunoBody® vaccines. Under the agreement, Scancell has nonexclusive worldwide
rights to use the two patents to further develop and commercialise ImmunoBody®
vaccines in all therapeutic areas in both humans and animals. Scancell has also
granted Merck an option to negotiate an exclusive license under Scancell's
ImmunoBody® platform technology for up to five Merck target products.
In addition, a research agreement has been signed with Canadian vaccine
development company ImmunoVaccine Technologies Inc. ("IVT"), to explore using
IVT's DepoVaxTM delivery system for Scancell's novel ImmunoBody® DNA vaccines.
DepoVaxTM has the potential to be a more practical delivery method for
Scancell's future ImmunoBody® DNA infectious disease and animal health vaccines
for which alternative delivery methods such as electroporation may be less
suitable.
Scancell has also announced a collaboration with ImmuneRegen BioSciences, Inc.
("ImmuneRegen"), a wholly owned subsidiary of IR BioSciences Holdings, Inc.
Under the agreement, Scancell and ImmuneRegen will work together to investigate
the synergy between ImmuneRegen's Homspera® and Scancell's ImmunoBody® vaccine
technologies.
Furthermore, in June 2010, the Company announced a research collaboration with
immatics biotechnologies GmbH to explore the development of novel ImmunoBody®
vaccines for colorectal cancer.
SCIB1
Scancell's lead ImmunoBody® product, SCIB1, is a melanoma vaccine that has
repeatedly shown good anti-tumour effects in animal studies. SCIB1 is designed
to stimulate a powerful immune response against the melanoma antigen tyrosinase
related protein 2 ("TRP-2"), a well-known melanoma target.
In the animal studies, SCIB1 prevented the development of lung metastases and
significantly inhibited the growth of established tumours. SCIB1 did not cause
systemic toxicity when administered at doses of 20μL per mouse per occasion on
five occasions at 3 week intervals over 13 weeks. Injection site inflammation
was observed at a greater incidence and severity in SCIB1 treated mice compared
to controls, however these changes were almost completely reversible after a 4
week recovery period. The ELISpot assay performed by the Company on spleen
cells from control and SCIB1 treated mice showed an increase in IFN-y response
in the SCIB1 treated group compared to the control group, indicating that the
treated mice had mounted an appropriate cell-mediated immune response to the
test material.
SCIB1 is specifically directed towards an important sub-set of melanoma
patients (HLA-A2), although it may be possible to further refine the product in
due course to permit the treatment of all melanoma patients. It is expected
that, once marketed, treatment will initially be approved for patients with
evidence of disease progression following surgery. The use of SCIB1 would be
expected to be extended to earlier stage patients following additional clinical
trials demonstrating an impact on survival and widespread use of the product,
enhancing the sales potential still further.
In January 2009, Scancell secured a deal with Cobra Biomanufacturing Plc for
the manufacture of its SCIB1 vaccine, enabling it to meet its target of
completing Good Manufacturing Practice ("GMP") manufacture of SCIB1 in the
fourth quarter of 2009.
Scancell has also signed a License and Supply Agreement with Ichor Medical
Systems Inc. ("Ichor") under which it is licensed to use Ichor's TriGridTM
electroporation device for the development, manufacture and commercialisation
of Scancell's vaccines delivered by Ichor's device. In vivo electroporation is
regarded as an effective method of enhancing the potency of DNA vaccines by up
to 100 fold compared to conventional methods of delivery. The Directors are
confident that TriGridTM will provide an effective delivery system for its
SCIB1 melanoma vaccine as it enters clinical trials. Scancell also has the
option to license TriGridTM for commercial use on payment of certain
undisclosed milestones and royalties.
In May 2010, Scancell's proposal to conduct a Phase I clinical trial on SCIB1
was approved by the Gene Therapy Advisory Committee (`GTAC') and by the
Medicines and Healthcare products Regulatory Agency (`MHRA') Medicines
Division. In addition, Ichor has obtained the required parallel approval from
the MHRA Devices Division for the use of Ichor's TriGridTM electroporation
delivery device to administer SCIB1 to patients participating in the trial of
SCIB1.
Following these approvals, recruitment commenced to find patients for the Phase
I clinical trial of SCIB1 at three leading UK hospital centres in Nottingham,
Manchester and Newcastle.
SCIB2
Scancell's second ImmunoBody® product, SCIB2, will be another DNA cancer
vaccine. Scancell has produced and tested a range of potential candidates from
which SCIB2 will be selected and tested to the animal proof of principle stage.
Development Plan and Strategy
A Phase I/IIa clinical trial of Scancell's SCIB1 vaccine in advanced melanoma
patients commenced in June 2010 and is expected to be completed in 2012. The
first patient was treated with the vaccine on 10 June 2010.
It is expected that preliminary immune response and safety data from Phase I of
the study will be available in 2011. Phase II of the study, which will be
conducted in less severely ill patients is expected to generate further immune
response data which, if positive, would provide clinical validation for both
SCIB1 and the entire ImmunoBody® Platform.
22 stage III/IV melanoma patients will be immunised with SCIB1. The trial has
the following objectives:
1. To assess toxicity and feasibility of SCIB1 DNA vaccination and to determine
the maximum tolerated (or maximum feasible) dose;
2. To determine efficacy in terms of high avidity anti-tumour immune responses
as determined by in vitro immune assays; and
3. To obtain preliminary data as to whether there is a dose relationship
between vaccine dose level and efficacy.
The Directors believe that the existing funds held by or available to the
Company, together with anticipated future revenues, will be sufficient to allow
completion of the Phase I/IIa clinical trial and, if there is a positive
outcome, this would demonstrate clinical proof of principle for SCIB1 in
melanoma patients. In addition the Company is planning to design and test its
second ImmunoBody® product, SCIB2, to the animal proof of principle stage. The
Directors believe that data from these studies, if positive, would
significantly enhance the value of the business and:
• provide the opportunity to conclude an advantageous deal with a larger
biotech or major pharmaceutical company on SCIB1; and
• permit the execution of multiple licensing deals on the ImmunoBody® platform
on a target by target basis;
thereby creating a company with both products in the clinic and the potential
for generating a pipeline of new products, an excellent profile for a drug
discovery business and an attractive acquisition opportunity.
Other Partnerships and Agreements
As with other small research based biotechnology companies, Scancell is reliant
upon forging partnerships with other companies to access technology and/or help
with the development of its products and/or commercialise its products. A
number of partnerships have been forged over the last few years in relation to
the ImmunoBody® platform including:
Biovation (MerckSerono)
Scancell licensed Biovation's DeImmunisationTM technology to DeImmunise its
epidermal growth factor receptor mAb, SC100, as its antibody vector for the
ImmunoBody® technology. In return, Scancell will pay to Biovation 5 per cent.
of all gross revenue received by Scancell relating to SC100 or any protein
ImmunoBody® products built around SC100 as a framework. The payments are not
expected to apply to SCIB1, which is a DNA vaccine.
Cancer Research Technology ("CRT")
Scancell has in-licensed certain rights of CRT, including exclusive rights to
sub-license, in respect of the ImmunoBody® technology for ImmunoBody® protein
(but not DNA) products. In return, Scancell will pay royalties in relation to
any licensing fees or milestone payments that it receives for any such
products.
Immunobiology Limited ("Immunobiology")
Scancell has entered into an agreement with Immunobiology for the development
of a vaccine for influenza using the ImmunoBody® protein fusion technology.
Intellectual Property
Scancell has a growing patent portfolio and has a policy of patenting wherever
possible to enhance value. Scancell's ImmunoBody® technology patents cover any
molecular construct containing an Fc binding domain that binds to the high
affinity CD64 receptor. They also cover the use of the ImmunoBody® DNA vector.
As noted above, Scancell has secured a licensing agreement with Merck KGaA
("Merck"), for two key patents required for the further development and
commercialisation of ImmunoBody® vaccines. Under the agreement, Scancell has
non-exclusive worldwide rights to use the two patents to further develop and
commercialise ImmunoBody® vaccines in all therapeutic areas in both humans and
animals.
Scancell has also signed an agreement with the National Institutes of Health, a
division of the US Department of Health and Human Services, for non-exclusive
licenses to patents related to the melanoma antigens TRP-2 and gp100. Under the
terms of this agreement Scancell will have the right to develop and
commercialise ImmunoBody® vaccines incorporating epitopes from these targets
for the treatment of melanoma in humans.
Monoclonal antibodies
Monoclonal antibodies ("mAbs") can be specifically used, inter alia, in cancer
treatment to bind to cancer cell-specific antigens and induce an immunological
response against the target cancer cell. The therapeutic potential of
monoclonal antibodies was recognised early, with the first monoclonal
antibodies being developed in the 1970s. However the first product for human
use was not approved until 1986.
Current antibody technologies have already given rise to a number of important
drugs and are likely to continue to do so. Scancell's ImmunoBody® products are
essentially mAbs that have been re-engineered as vaccines to induce a powerful
CTL response rather than the humoral (and less effective) immunity that
conventional vaccines elicit. The advantage of using an mAb structure for
ImmunoBody® vaccine discovery and development is that mAbs are proven, well
understood biological molecules that can be accelerated through the manufacturing,
development and regulatory process on an established development route. This is
expected to facilitate the development process and enhance the prospects for
licensing both the ImmunoBody® products and the technology.
The oncology market
The cancer market
Despite significant advances in treating cancer over the past 20 years, it
remains one of the world's most significant diseases, both in terms of
mortality and morbidity. Cancer is a generic term which includes over 200
different types of cancer affecting every organ in the body. 1 in 3 people will
develop cancer in their lifetime, although it is rare in children and young
people. Cancer is by and large an age related disease, with over 70 per cent.
of cancers occurring in people aged 60 and over.
In Europe and the US there are close to 20 million people that live with cancer
today, a figure that is increasing. Surgery is generally the first line of
attack for solid tumours, but is rarely a stand-alone treatment and is often
followed by radiotherapy or chemotherapy. Radiotherapy can be used in a targeted
manner to shrink tumours before, or to prevent spread after, surgery. Chemotherapy
can be used to treat both solid and blood borne (liquid) cancers and the drugs
or chemicals used preferentially to target and kill cancer cells. Unfortunately,
both radiotherapy and chemotherapy affect normal as well as cancer cells causing
side effects such as nausea, vomiting, ulceration and fatigue.
While there are additional drugs that can be administered to reduce certain
side effects, radiotherapy and chemotherapy have a major impact on patients'
quality of life and can limit the extent and duration of treatment. An
unfortunate feature of cancer cells is that they are able to develop resistance
to radiotherapy and chemotherapeutic drugs, reducing and in some instances
eliminating the effectiveness of repeat treatment.
The effectiveness of these treatment regimes, as measured by disease-free
intervals and recurrence, varies according to the cancer. Therefore, treatment
combinations can be effective in eliminating cancer, but there is still an
unacceptably high rate of recurrence and death due to poor specificity and side
effects limiting or preventing extended therapy. Immunotherapy involving the
direct or indirect use of the immune system to kill cancer cells is an emerging
treatment; either alone or in conjunction with the therapies described above.
It offers potential for the specificity needed to prevent the growth or spread
of cancer cells and there is a high level of activity in this field. However,
while the specificity of many of the immunotherapies under development allows
preferential targeting of cancer cells, there is substantial scope for
treatments that are more effective in killing cells and that have utility
against a range of tumour types. Scancell's proprietary ImmunoBody® products
are intended to address these needs.
The melanoma market
More than 50,000 new cases of melanoma are diagnosed in the EU every year and
the EU has the third highest incidence rate after Australia/New Zealand and
North America. Worldwide the incidence of melanoma is increasing.
Few effective therapies have been developed within the last 30 years, as
melanoma is one of the most resistant cancers to conventional cancer treatments
such as chemotherapy and immunotherapy. Malignant melanoma, although a less
common type of skin cancer, is the most serious. Incidence rates are correlated
with fairer skinned groups who are twenty times more likely than darker skinned
groups to develop melanoma. This is reflected in the world incidence in which
the highest rates occur where the majority of the population is descended from
European Caucasians who migrated to an area of higher UV index.
It is not only an incidence increase that is observed but also an increased
incidence of this disease which goes hand in hand with a worse prognosis.
Advanced disease leads to poor prognosis with a median survival of 6 to 24
months. Although malignant melanoma only constitutes between 4 and 11 per cent.
of all skin cancers it accounts for 75 per cent. of all skin cancer related
deaths. There is increasing evidence to link the rise in melanoma incidence
with changes in sun behaviour. It is believed that in the event of a 10 per
cent. thinning of the stratospheric ozone layer an increase of 300,000 cases of
nonmelanocytic skin cancer and 4,500 cases of melanoma per year will occur
worldwide.
Currently only surgery is curative in melanoma, and although many patients with
early disease can be cured with resection of the primary the majority with
later stage disease will die of their cancer. There is an urgent need for
treatments to use post resection to prevent development of metastatic disease
(adjuvant therapies) and for treatments for patients who have already developed
metastatic cancer. Successful therapeutic intervention therefore has the
potential to confer long term benefits to many patients. Few effective
therapies have been developed within the last 30 years as melanoma is one of
the most resistant cancers to conventional cancer treatments such as
chemotherapy and immunotherapy.
Competition
Because of the size of the cancer market, and the growth in the number of
cancer cases with the aging population, the market continues to attract huge
interest within the pharmaceutical sector with most of the major pharmaceutical
companies having interests in this area. In addition, because there is
significant scope for developing novel treatments based on biologicals, there
is a large number of small, specialised biotechnology companies focused in this
field.
The large number of participants in the cancer market provides competition but
also potential partners, given that Scancell intends to enter into deals to
license or co-develop its therapeutic products. In addition, not all cancer
treatments should be regarded as being in competition with Scancell's products.
Cancer therapy is moving towards a multi-treatment approach, where surgery,
chemotherapy, radiotherapy and immunotherapy are likely to be used side by
side. Thus, rather than being competitive, many of the treatments should more
reasonably be regarded as additive.
Many therapies have been tried in the treatment of melanoma, generally with low
response rates of 10 to 20 per cent. Dacarbazine is considered by most to be
the standard of care for stage IV melanoma and has a response rate of 10 to 20
per cent. with median survival of approximately 6 months.
A large proportion of cutaneous melanoma tumours contain activating oncogenic
mutations in the BRAF gene. This is an oncogene that mediates cellular response
to growth signals; genetic alterations to the BRAF gene are known to contribute
to the development of many cancers. A Phase I clinical study has recently been
reported in which the drug PLX4032, a selective inhibitor of the oncogenic
V600E mutant BRAF kinase, was administered to 16 melanoma patients with an
activating BRAF mutation. Partial responses were seen in nine patients showing
greater than 30 per cent. tumour regression and minor responses were seen in
another four patients. Some serious adverse events were however observed in
some patients after chronic treatment, including possibly drug-related
cutaneous squamous cell carcinoma. Further trials are underway.
New approaches to cancer vaccines continue to be sought by the major
pharmaceutical companies to overcome the limitations of existing technologies.
Competing immune system therapies for melanoma
Tumour cells are commonly considered as poor immunogens as there is a certain
degree of tolerance within the host. This makes generation of an anti-tumour
immune response more difficult. However, melanomas are good cancers for
considering vaccine therapy as they are some of the most immunogenic tumours
known.
Melanoma has been an active clinical research area for many years and although
there are other immune therapeutic products in clinical development, none has
yet shown a dramatic impact on survival. The following are examples of immune
system therapies on the market:
Interferon and Interleukin 2
It is known that the immune system does recognise melanoma cells but because of
the mechanisms designed to prevent autoimmune disease, the immune system mostly
tolerates the cancer. Interferon ("IFN") and interleukin 2 ("IL2") (both potent
immune system signalling molecules known as cytokines) have been used to
activate the immune system against melanoma as they sometimes overcome this
tolerance. Interferon is approved by both the FDA and EMA and is widely used as
an adjuvant therapy to surgical removal of tumours. Meta-analysis shows that
adjuvant interferon-alpha produces clear reductions in recurrence of high risk
melanoma, with some evidence of an effect of dose, but it is unclear whether
this translates into a worthwhile survival benefit or not.
High dose interleukin 2 (Proleukin) was approved in 1998 by the FDA for
treatment of metastatic melanoma as durable responses have been seen in a few
patients. These immune therapies provide a benchmark of 10 to 20 per cent.
response but with no effect or an unclear effect on survival. However, in the
few patients who respond, prolonged survival is seen, indicating that an
effective immune response is very beneficial. Obtaining a more effective
response is one of the key aims of SCIB1.
CTLA4 targeted therapies
Therapies targeting the immune regulatory molecule, cytotoxic T
lymphocyte-associated antigen 4 ("CTLA4"), have been shown to give significant
immune responses in patients with melanoma, and in a series of clinical
studies, treatment with the anti-CTLA4 antibody, ipilimumab, have shown
improved response and disease control rates. However despite reports of
emerging new therapies, the treatment of malignant melanoma continues to be an
unmet clinical need.
Information on the Group's premises
The Company uses laboratories within the Oncology Department at City Hospital
from the University of Nottingham. The premises include two dedicated
laboratories, an office and shared use of all the Oncology laboratory
facilities. The Directors consider these premises to be sufficient to allow
Scancell to achieve its current and medium term business objectives.
Information on the Group's equipment
The Group owns an extensive range of its own laboratory equipment including two
tissue culture suites including laminar flow cabinets, incubators, centrifuges
and microscopes, numerous fridges and freezers and liquid nitrogen facilities
and has the right to use a fully-equipped molecular biology lab which includes
a shaking incubator, a sorval centrifuge, 4 PCR machines, a UV doc system and
western blotting equipment; and a fully equipped analytical lab including
ELISPOT reader, an AKTA, a plate reader, a spectrophotometer and a flow
cytometer.
3. Current Trading and Prospects
Earlier today the Company announced its audited results for the year ended 30
April 2010. Revenue for the period was £nil (2009: £nil), the loss before tax
was £1,802,639 (2009: £833,890) and, as at 30 April 2010, the Company had cash
and cash equivalents of £2,830,145. The Company has continued to trade in line
with the Directors' expectations since 30 April 2010. A copy of the annual
report and accounts for the year ended 30 April 2010 can be found on the
Company's website at www.Scancell.co.uk.
Scancell is on course in its development of SCIB1, and will seek to continue
its progress in line with the original plans as set out in the admission
document when listing on PLUS in 2008. With the funds raised earlier this year,
the Board is confident that the Company will be able to bring SCIB1 through its
initial clinical phases and thereby create value for shareholders based on the
clinical data that is expected to be generated.
4. The Board
The Board comprises the following directors:
David Evans, Non-Executive Chairman (aged 50)
As its former CFO, David Evans guided Shield Diagnostics Limited through its
IPO and then, as its CEO, through its merger with Axis Biochemical ASA to form
Axis-Shield plc, a fully listed diagnostics company. In addition to being
Chairman of the Company he is currently non-executive Chairman of Epistem
Holdings plc, EKF Diagnostics Holdings plc, Immunodiagnostic Systems Holdings
plc and Omega Diagnostics Group plc, all of which are AIM listed biotechnology
companies.
Professor Lindy Durrant, Chief Executive Officer/Chief Scientific Officer (aged
52)
An internationally recognised immunologist in the field of tumour therapy,
Professor Durrant has worked for over 20 years in translational research,
developing products for clinical trials including monoclonal antibodies for
diagnostic imaging and therapy and cancer vaccines. She has a personal Chair in
Cancer Immunotherapy at the Department of Clinical Oncology at the University
of Nottingham and has over 120 publications on immunotherapy in world renowned
scientific journals. Professor Durrant was the co-founder of Scancell.
Dr. Richard Goodfellow, Commercial Director (aged 60)
Dr. Goodfellow has over 25 years international experience in the pharmaceutical
industry, both in major pharmaceutical and in smaller biotechnology companies.
During his time at Astra AB, he oversaw the launch of Losec and other key
products internationally. Thereafter, he held the post of Director of Licensing
and New Business Development at Scotia Pharmaceuticals Limited, where he was
involved with the company's flotation on the London Stock Exchange and
successfully negotiated numerous deals. Dr. Goodfellow was also a founder of
Paradigm Therapeutics Limited, a Cambridge based functional genomics company,
and is a former director of Enact Pharma plc. Richard has been a key member of
the Scancell management team since 1999 and was pivotal in negotiating the sale
of Scancell's antibody pipeline to Arana Therapeutics (then known as Peptech UK
Limited) in December 2006.
Michael Rippon, Non-Executive Director (aged 70)
Mike Rippon has over 40 years experience in the motor industry. He is an active
investor in small cap companies and is one of Scancell's major private
investors. He was originally appointed to the Board of Scancell Limited on 1
January 2004.
Dr. Matthew Frohn, Non-Executive Director (aged 43)
Dr. Matthew Frohn graduated from Oxford Brookes University with a degree in
Cell and Molecular Biology followed by a D.Phil in Biochemistry from Oxford
University. He worked on research collaborations with Zeneca, and a short
research post with a British Biotech plc subsidiary before joining Oxford
Technology Management, the manager of the Oxford Technology VCTs, in 1999.
Nigel Evans, Non-Executive Director and Company Secretary (aged 71)
Nigel Evans had 40 years in commercial and strategic roles at senior levels in
Rolls Royce plc in the UK and overseas. Now an active investor in public and
private companies, he oversees Scancell's corporate and financial activities.
He was Executive Chairman of Scancell for seven years, until 2007.
5. Dividend Policy
It is not presently intended that the Company pay dividends but, once it is
commercially prudent to do so, it is the intention of the Board to implement a
progressive dividend policy.
6. Lock-in Arrangements
At Admission, the Locked-in Persons will be interested in 2,943,165 Ordinary
Shares which together represent 18.48 per cent. of the Issued Share Capital.
The Locked-In Persons have each undertaken that, save in limited circumstances
set out in AIM Rule 7 of the AIM Rules for Companies, they will not (and will
procure, in so far as they are able, that any person with whom they are
connected for the purposes of Sections 252 to 254 of the 2006 Act will not)
during a period of twelve months from the date of Admission, dispose of any
interest in Ordinary Shares held by them. In addition, the Locked-In Persons
have each undertaken that, save with the prior written consent of the Nominated
Adviser, they will not (and will procure, in so far as they are able, that any
person with whom they are connected for the purposes of Section 252 to 254 of
the 2006 Act will not) during the period after the expiry of the Lock-in Period
and 30 days after publication of the audited results for the year ending 30
April 2011, dispose of any interest in Ordinary Shares held by them, other than
through the Company's broker.
7. Risk Factors
Your attention is drawn to the risk factors set out in Part II of the Admission
document and to the section entitled "Forward Looking Statements". In addition
to all other information set out in this announcement and the Admission
document, potential investors should carefully consider the risks described in
those sections before making a decision to invest in the Company.
Yours faithfully
David Evans
Non-Executive Chairman
DEFINITIONS
The following definitions apply throughout this announcement unless the context
requires otherwise.
"Act" the Companies Act 2006
"Admission" admission of the Ordinary Shares of the
Company to trading on AIM becoming effective
in accordance with rule 6 of the AIM Rules
"AIM" a market operated by London Stock Exchange plc
"AIM Rules" the AIM Rules for Companies published by
London Stock Exchange plc from time to time
(including, without limitation, any guidance
notes or statements of practice) which govern
the rules and responsibilities of companies
whose shares are admitted to trading on AIM
"Board" the board of directors of the Company at the
date of this announcement
"Company" Scancell Holdings plc
"CREST" the relevant system (as defined in the CREST
Regulations) in respect of which Euroclear UK
& Ireland Limited is the Operator (as defined
in the CREST Regulations)
"CREST Regulations" the Uncertificated Securities Regulations 2001
(SI2001 No. 3755), as amended, and any
applicable rules made under those regulations
"Directors" the directors of the Company
"Existing Ordinary Shares" the existing issued Ordinary Shares as at the
date of this document
"Existing Share Capital" the issued ordinary share capital of the
Company as at the date of this announcement
"Group" the Company and its subsidiary, Scancell
Limited
"Locked-in Persons" each of the Directors of the Company
"London Stock Exchange" London Stock Exchange plc
"Ordinary Shares" ordinary shares of 1p each in the capital of
the Company
"PLUS" the PLUS-quoted market operated by PLUS
Markets plc
"RIS" Regulatory Information Service
"Scancell" Scancell Limited, company number 03234881, the
Company's wholly owned subsidiary
"Shareholders" holders of Ordinary Shares
"UK" the United Kingdom of Great Britain and
Northern Ireland
"Zeus Capital" Zeus Capital Limited, a company registered in
England and Wales with registered no. 4417845
GLOSSARY
Antigen a molecule recognised by an antibody or T-cell
Avidity how strongly two cells interact
Cytokine a small protein that is secreted by specific
cells of the immune system and that carries
signals locally between cells
Cytotoxic T-cells or CTLs a type of white blood cell that recognises and
kills tumour or virally infected cells
Dendritic cells a type of white blood cell that initiates an
immune response
DNA deoxyribonucleic acid, the molecule that
encodes our genes
ELISpot assay a method for monitoring immune responses in
humans and animals
EMA the European Medicines Agency, a European
agency for the evaluation of medicinal products
Epitope a peptide that is recognised by a T-cell
FDA the Food and Drug Administration, an agency of
the United States Department of Health and
Human Services
Helper T-cell a type of white blood cell that recognises and
secretes molecules to alert the immune system
to the presence of a tumour or virally infected
cell
HPV Human Papillomavirus
IFN-γ a cytokine that is critical for innate and
adaptive immunity against viral and
intracellular bacterial infections and for
tumor control
ImmunoBody an antibody genetically engineered to express T
-cell epitopes from a tumour antigen
Monoclonal antibody or mAb an antibody produced from an immortalised cell
that recognises a single specificity
Peptide a string of amino acids
Phase I/IIa Clinical trials in patients designed to test the safety and
efficacy of new drugs in man
T-cell a type of white blood cell that is composed of
CTLs and helper T-cells
Vector a molecule that encodes an epitope and targets
the immune response