"In our view, the potential for SCIB1 [Scancell's skin cancer treatment], as already demonstrated by the survival data, is remarkable," said one broker recently

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Richard Goodfellow, chief executive of Scancell Holdings Plc (LON:SCLP), tells Proactive Cancer Research UK is to fund and sponsor a Phase I/II clinical trial of their SCIB2 lung cancer vaccine.

Goodfellow says the tie-up is a significant endorsement of their  ImmunoBody platform – the underlying technology behind both SCIB1 and SCIB2 - which helps to prime a patient’s immune system to recognise and kill specific cancer cells.

[View interview]

To download click here

Landmark five year survival achieved in resected SCIB1 patients

Emerging pipeline of three products across five cancer

Scancell Holdings plc, (‘Group’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2017.

Read the full document here

Highlights

• Strong survival data for patients with Stage III/IV malignant melanoma on SCIB1 Phase 1/2 clinical trial
  •  8 of 20 patients with resected disease remain alive, survival well beyond established norms
  •  Of the 16 resected patients who received a 2-4mg dose of SCIB1, seven patients have now survived for five years since starting treatment and only six patients have had recurrence of their disease, of whom, two have died
  •  Final Clinical Study Report completed in December 2016 which included safety, immunology and clinical data from patients with Stage III/IV melanoma up to 29 October 2015
• Investigational New Drug (IND) application for SCIB1 Phase 2 checkpoint inhibitor combination study expected to be submitted in early 2018, with patient enrolment planned for 2018
• Continued good progress in development of Modi-1, our lead product from the Moditope® platform
  • Ultra-efficient linked adjuvant identified that works at up to 100-fold lower doses than could be achieved previously
  • Aiming to file a Clinical Trial Application (CTA) in the UK for the planned Phase 1/2 clinical trial in breast cancer, ovarian cancer and sarcoma in 2018
  • Early feedback from the European Patent Office suggests that broad patent claims for the Moditope® platform may be allowable
• Opening of new offices in San Diego to support the Company’s US growth plans, and in Oxford for its UK corporate and development activities
• Loss for year of £3.5m (2016: loss £2.6m)
• Group cash balance at 30 April 2017 was £2.7m (30 April 2016: £6.5m)

Post Period Highlights:

• Raised £4.7m in a placing of new ordinary shares
  • Funds to be used to initiate the clinical development of Modi-1 and to continue to support the ImmunoBody® platform pipeline
• Patent granted in Europe for Scancell’s DNA ImmunoBody® technology
  • Counterparts to this patent have already been granted in the US, Australia and Japan

Dr Richard Goodfellow, CEO of Scancell, said:

“We have made further significant progress during the course of the past year on the development of our ImmunoBody® and Moditope® platforms.  We continue to report strong survival data in patients with Stage III/IV melanoma from our SCIB1 Phase 1/2 clinical trial, with survival times now exceeding five years in resected patients.

Moditope® is also progressing well with the identification of a new linked adjuvant for the first Modi-1 clinical trial in the UK in patients with breast cancer, ovarian cancer and sarcoma which is expected to increase the potency of the product up to 100-fold. We are continuing to explore a number of funding options to ensure that we have the resources to progress these programmes through their next phase and the Board believes that this funding could be best achieved following the execution of one or more partnerships on the ImmunoBody® or Moditope® platforms, on which significant progress has been made since the year end.”

For Further Information:

Scancell Holdings Plc

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell’s first ImmunoBody®, 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® 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.

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® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

To download click here

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® 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® 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® - Best-in-class DNA vaccine technology for use in combination with checkpoint inhibitors or as monotherapy for patients with resected disease
• Moditope® - Novel immunotherapy that destroys tumours and extends survival without the need for checkpoint inhibition

For further information, please contact:

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell’s first ImmunoBody®, 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® 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® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that a patent for its DNA ImmunoBody® technology has now been granted in Europe.
The European patent, number 2134357, granted by the European Patent Office, covers Scancell’s DNA ImmunoBody® platform technology and is key to the protection of the Company’s pipeline of ImmunoBody®vaccines, including lead candidates, SCIB1 and SCIB2.

On issuance, this patent will extend coverage of Scancell’s intellectual property into another important market for Scancell. Counterparts to this patent have already been granted in the United States, Australia and Japan.

The European patent covers the following countries: Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Sweden and Turkey.

Dr. Richard Goodfellow, Chief Executive Officer of Scancell, commented:
“The addition of this key European patent for DNA ImmunoBody® significantly bolsters our global intellectual property portfolio as we position the company for future growth.”

For Further Information:

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® an Moditope® technology platforms. Scancell’s first ImmunoBody®, 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® 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 Tlymphocyte 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® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.

Scancell Holdings plc

(“Scancell” or the “Company”)

Proposed Placing to raise up to £5.0 million

Funds raised will be used to initiate the clinical development of Modi-1, the first product from the Moditope® platform, and to continue to support the ImmunoBody® platform pipeline

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces a proposed placing of new Ordinary Shares in the Company (the “Placing Shares”) with existing and new institutional and professional investors to raise up to £5.0 million, before expenses, for the Company (the “Placing”).

The net proceeds of the Placing will be used to support the Company’s clinical development pipeline of novel cancer immunotherapies, in particular to initiate clinical development of the first product from the Moditope® platform, Modi-1, and to continue to support the pipeline arising from the ImmunoBody® platform. The Placing is within the Company’s existing allotment authorities granted at its prior annual general meeting.

The Chairman of the Company is expected to participate in the Placing with the intention to acquire approximately one million Placing Shares.

Dr Richard Goodfellow, Chief Executive Officer of Scancell, commented:

“We continue to make significant progress with both our ImmunoBody® and Moditope® platforms and believe that success in further clinical studies should add significant value to the Company."

“This proposed funding will principally allow us to begin clinical development of Modi-1, the lead product from our Moditope® platform. Compelling pre-clinical data suggests that Modi-1 should be effective in up to 90% of patients with triple negative breast cancer, up to 95% of patients with ovarian cancer and up to 100% of patients with sarcoma. We expect to begin a phase I/II study in sarcomas, breast and ovarian cancers in Q3 2018 with first efficacy and safety data expected in Q3 2019."

“Additionally, we will use funds for on-going support of SCIB1, the lead product from our Immunobody® platform, as we prepare to submit an Investigational New Drug application to the FDA in Q3 2017 ahead of our planned SCIB1 plus checkpoint inhibitor Phase II trial in Stage III/IV metastatic melanoma patients.”

The Placing will be conducted by way of an accelerated bookbuilding process (the “Bookbuild”) which will be launched immediately following this announcement in accordance with the Terms and Conditions set out in Appendix II. The Placing Shares are not being made available to the public. It is envisaged that the Bookbuild will be closed no later than 4.30 p.m. London time today, 11 May 2017.

Panmure Gordon (UK) Limited (“Panmure Gordon”) is acting as Financial Adviser, Nominated Adviser and sole Bookrunner to the Company in relation to the Placing.

Further information about the Company and the Placing is set out in Appendix I. Capitalised terms not otherwise defined in the text of this Announcement are defined in Appendix III.

The Market Abuse Regulation ("MAR") became effective from 3 July 2016. Market Soundings, as defined in MAR, were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in a Market Sounding are no longer in possession of inside information relating to the Company and its securities. The person responsible for arranging the release of this announcement on behalf of the Company is Dr Richard Goodfellow, a director of the Company.

For further information, please contact:

Read the full article here

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;
• Median observation time since entry is 52 months and 58 months since first diagnosis of metastatic disease
• Only five patients have progressed and one has died
• 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)
• Median observation time since entry is 21 months and 27 months since first diagnosis of metastatic disease
• All patients are alive
• 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:

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.
Scancell’s first ImmunoBody®, 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® 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 Tlymphocyte 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® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

This replaces the announcement number 0710T made on 3 January 2017 at 7:00am GMT due to the following amendment:

• In the quote by Dr Richard Goodfellow, "next year" is replaced by "in the second half of the year".

All other details remain unchanged. The full amended text is shown below.

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 III/IV 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
  • Median observation time since entry is 52 months and 58 months since first diagnosis of metastatic disease
  • Only five patients have progressed and one has died
  • 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)
  •  Median observation time since entry is 21 months and 27 months since first diagnosis of metastatic disease
  •  All patients are alive
  • 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 in the second half of the year.  We look forward to updating the market further on these plans in due course."

For Further Information:

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell's first ImmunoBody®, 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® 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® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.