02:00 Fri 31 Jan 2020
Scancell Hlds - Interim Results
("Scancell" or the "Company")
Interim Results for the six months ended
ImmunoBody® and Moditope® progress; new AvidiMab™ platform garners three agreements
Scancell, the developer of novel immunotherapies for the treatment of cancer, announces its interim results for the six months ended
Highlights:
· The Company signed three collaboration agreements (including post period) for its new proprietary AvidiMab™ technology platform
· Initiation of
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· Modi-1 manufacturing and toxicity testing underway to support anticipated start of Phase 1/2 study in several solid tumour indications including triple negative breast, ovarian, head and neck, and renal cancer
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· The Company presented at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in
· Loss for the 6-month period of
· Group cash balance at
Post Period Highlights:
· The Company is now actively pursuing a new IND application for SCIB1 in the US and will update the market on the outcome of the
· The
"We are pleased to report another six months of progress at Scancell, which included welcoming
A full copy of the announcement can be found on the Scancell website: www.scancell.co.uk
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For Further Information:
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+44 (0) 20 3727 1000 |
Dr |
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(Nominated Adviser and Corporate broker) |
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+44 (0) 20 7886 2500 |
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FTI Consulting |
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+44 (0) 20 3727 1000 |
About Scancell
Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody®, Moditope® and AvidiMab™ technology platforms.
ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system. They have the potential to be used as monotherapy or in combination with checkpoint inhibitors and other agents. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.
· SCIB1, the lead programme, is being developed for the treatment of melanoma. A phase 1/2 clinical trial has so far successfully demonstrated survival data of more than five years.
· SCIB2 is being developed for the treatment of non-small cell lung cancer and other solid tumours. Scancell has entered into a clinical development partnership with
Moditope® represents a completely new class of potent and selective immunotherapy agents based on stress-induced post-translational modifications (siPTM). It stimulates the production of killer CD4 T cells which overcome the immune suppression induced by tumours, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Moditope® alone, or in combination with other agents, has the potential to treat a wide variety of cancers.
· Modi-1 is being developed for the treatment of solid tumours including triple negative breast cancer, ovarian cancer and head and neck cancer.
AvidiMab™ is a patent protected technology platform which increases the avidity of human antibodies by promoting non-covalent Fc-Fc interactions. This modification induces the direct tumour cell killing properties of Scancell's anti-glycan monoclonal antibodies (mAbs) but has broad potential to increase the avidity or potency of any therapeutic monoclonal antibody including those being developed for autoimmune diseases, as well as cancer.
For further details, please see our website: www.scancell.co.uk
CHAIRMAN'S STATEMENT
I am pleased to report on theresults of
There has also been good progress made with our three immuno-oncology platforms, which is outlined below.
ImmunoBody® platform
ImmunoBody® is designed to generate potent T cell responses capable of specific anti-tumour effects in a wide range of cancer types. ImmunoBody® vaccines target dendritic cells and stimulate both CD4 and CD8 T cells with the ability to identify, target and eliminate cancer cells. These cancer vaccines have the potential to be used as monotherapy or in combination with checkpoint inhibitors and other agents. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.
• SCIB1, our lead product, is being developed for the treatment of metastatic melanoma. In a Phase 1/2 clinical trial, survival with SCIB1 treatment appears superior to historical survival rates, with 14 of 16 resected patients receiving 2-4 mg doses of SCIB1 surviving for more than five years (as reported in
• SCIB2 is being developed for the treatment of non-small cell lung cancer (NSCLC) and other solid tumours. Scancell has entered into a clinical development partnership with
SCIB1 Phase 2 clinical trial in combination with a checkpoint inhibitor
The Phase 2 clinical trial is designed to assess whether the addition of SCIB1 to the checkpoint inhibitor pembrolizumab (Keytruda) will result in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with advanced melanoma.
Scancell submitted an Investigational New Drug (IND) application in the US to the
As reported in
Recruitment of patients at the current
SCIB2
SCIB2, Scancell's second ImmunoBody® therapy, targets an antigen called NY-ESO-1, which is expressed on a range of solid tumours, including NSCLC, oesophageal, ovarian, bladder and prostate cancers, neuroblastoma, melanoma and sarcoma.
Pre-clinical studies have demonstrated that administration of SCIB2 as a liposomal nanoparticle results in potent immune responses and prolonged survival. The nanoparticle technology utilises known lipid carriers that are optimised to deliver SCIB2 DNA to immune cells. The liposomal nanoparticles protect the DNA from degradation and facilitate efficient uptake, expression and T-cell activation against cancer cells. The nanoparticle delivery system provides an alternative approach to electroporation, which has been used to
deliver other ImmunoBody® agents to patients.
Moditope® platform
Scancell's Moditope® represents a completely new class of potent and selective immunotherapy agents based on stress-induced post-translational modifications (siPTMs). Examples of such modifications are citrullination, an enzyme-based conversion of arginine to citrulline, and homocitrullination (or carbamylation), in which lysine residues are converted to homocitrulline. Expression of peptides containing these modifications have been demonstrated to induce potent CD4 cytotoxic T-cells to eliminate cancer. Previous pre-clinical studies have demonstrated that conjugation of these Moditope® peptides to Amplivant® enhances anti-tumour immune responses 10-100 fold and resulted in highly efficient tumour eradication, including protection against tumour recurrence.
Modi-1
Mod-1 consists of two citrullinated vimentin peptides and one citrullinated enolase peptide each conjugated to Amplivant®. Vimentin and enolase peptides are highly expressed in triple negative breast, ovarian, head and neck, and renal cancer, as well as many other cancers.
In
Significant progress has been made since the May update, including successful completion of GMP drug substance manufacture for two of the three conjugates that comprise the Modi-1 product, with high yields and purity levels achieved. In addition, formal regulatory-compliant toxicity studies are nearing completion and a successful Scientific Advice meeting has been held with the Paul Ehrlich Institut regulatory authority (the leading European authority on the safety of vaccines). There have been some technical challenges regarding the third peptide conjugate which are being actively addressed. This has led to a delay in completing all the necessary processes and documentation required for regulatory submission to start our planned clinical study in the
The Company announced that it has appointed six world-leading clinicians to establish its
Patents
The
This patent will add to the protection of the Company's pipeline of Moditope® vaccines for the treatment of cancer. Commercial exclusivity will be provided in all major European territories such as:
AvidiMab™ and antibodies targeting tumour associated glycans (TaGs)
In
Most mAbs for the treatment of cancer target proteins on the cancer cell surface and subsequently mediate an immune response to eliminate that cell. However, there remains an unmet need for new and improved therapeutic targets, as well as improved approaches to mediate cell killing. All cells are covered by a dense layer of sugar structures, called glycans, which change when a normal cell turns into a cancerous one. Hence, tumour-associated glycans (TaGs) are motifs that are associated with tumour malignancies which can be targeted by antibodies. Scancell's development pipeline includes mAbs against specific TaGs with superior affinity and selectivity profiles, that have now been further engineered using the Company's AvidiMab™ technology; this confers the Scancell anti-TaG mAbs with the ability to directly kill tumour cells.
AvidiMab™ has broad potential to increase the avidity or potency of any therapeutic monoclonal antibody including those being developed for autoimmune diseases, as well as cancer. A patent application has been filed that seeks broad protection for the AvidiMab™ technology establishing it as Scancell's third proprietary immunotherapy platform technology, together with ImmunoBody® and Moditope®.
We are pleased to be able to report significant progress in recent months, having signed three collaboration and non-exclusive research agreements with leading antibody technology companies in
Corporate
During the six-month period Scancell announced the appointment of
Financial
Profit or Loss and Other Comprehensive Income Statement
The Group made an operating loss for the six months to
Development expenditure has increased slightly to
Statement of Financial Position
At
Current assets include tax receivable due at the end of the year of
As mentioned in the 2018/19 Financial Statements, we are carrying forward pre-paid expenditure relating to Modi-1 manufacture which will be expensed in the second half of the current financial year.
Consolidated Cash Flow Statement
The main reason for the increase in cash over the six-month period to
Outlook
This has been a busy period for Scancell with progress being made across all three platforms.
We have advanced our lead ImmunoBody® programme, initiating a Phase 2 clinical trial of SCIB1 in the
GMP drug substance manufacture of two of the three peptide conjugates comprising our Modi-1 vaccine has successfully been completed and regulatory-compliant toxicity studies are nearing completion. We have experienced some challenges with the GMP manufacture of the third conjugate, which are being addressed; as a result we anticipate the start of the clinical trial to take place during H2 2020. The clinical study will assess the safety and efficacy of Modi-1 in several solid tumour indications.
The AvidiMab™ platform and our anti-TaG antibodies are generating significant commercial interest. Three companies are now actively evaluating these antibodies in various formats which could potentially lead to one or more commercial transactions later this year.
The significant investment from Vulpes at the beginning of the financial period extended the Company's cash runway. However, as anticipated, in order to realise the potential of the technologies Scancell will need to raise further funding during 2020.
Chairman
Consolidated Profit or Loss and Other Comprehensive Income Statement
for the six-month period to
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Unaudited |
Unaudited |
Audited |
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6 months |
6 months |
Year to |
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£ |
£ |
£ |
Continuing operations |
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Development expenses |
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(1,976,791) |
(1,842,005) |
(4,151,950) |
Administrative expenses |
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(1,113,131) |
(1,834,848) |
(2,577,062) |
|
|
|
|
|
OPERATING LOSS |
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(3,089,922) |
(3,676,853) |
(6,729,012) |
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, |
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|
Interest receivable and similar income |
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8,098 |
7,395 |
15,002 |
|
|
|
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LOSS BEFORE TAXATION |
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(3,081,824) |
(3,669,458) |
(6,714,010) |
|
|
|
|
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Tax on loss on ordinary activities |
|
573,004 |
424,992 |
1,086,523 |
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|
|
|
|
|
|
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LOSS FOR THE PERIOD |
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(2,508,820) |
(3,244,466) |
(5,627,487) |
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, |
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EARNINGS PER ORDINARY SHARE (PENCE) Note 2 |
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Basic |
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(0.56) |
(0.84) |
(1.45) |
Diluted |
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(0.56) |
(0.84) |
(1.45) |
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Consolidated Statement of Changes in Equity
for the six-month period to
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Share |
Share |
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Share |
premium |
option |
Retained |
Total |
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capital |
account |
reserve |
earnings |
Equity |
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£ |
£ |
£ |
£ |
£ |
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Unaudited |
Unaudited |
Unaudited |
Unaudited |
Unaudited |
At |
387,797 |
34,638,688 |
381,562 |
(26,071,199) |
9,336,848 |
Share issue |
77,559 |
3,800,406 |
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3,877,965 |
Expenses of issue |
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