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.

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”)

Placing raises £5.0 million,

Issue of Equity

and

PDMR shareholding

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the completion of the Placing announced earlier today (the “Placing Launch Announcement”).

A total of 50,499,999 Placing Shares have been conditionally placed by Panmure Gordon at a Placing Price of 10.0 pence per Placing Share to raise a total of approximately £5.0 million for the Company (before expenses). The Placing Shares represent approximately 19.3 per cent. of the existing Ordinary Shares of the Company. The Placing Price represents a discount of approximately 12.1 per cent. to the middle market closing price of an Ordinary Share as at 10 May 2017, being the last practicable date prior to the publication of the Placing Launch Announcement. The Placing, which was oversubscribed, has received support from both new and existing shareholders.

The net proceeds of the Placing of approximately £4.7 million (after fees and expenses) 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.

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

Issue of Equity

The Placing Shares will be issued credited as fully paid and will, on issue, be identical to and rank pari passu in all respects with the existing Ordinary Shares, including the right to receive all dividends and other distributions thereafter declared, made or paid following the date of Admission.

Completion of the Placing remains conditional upon the Placing Agreement having become unconditional in all respects and on Admission. Application will be made to the London Stock Exchange for the admission to trading on AIM of the 50,499,999 new Ordinary Shares to be issued under the Placing. It is expected that Admission will become effective and that dealings in the Placing Shares on AIM will commence at 8.00 a.m. on 16 May 2017.

The total number of Ordinary Shares following Admission will be 312,058,098 with each Ordinary Share carrying the right to one vote. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in Scancell under the FCA's Disclosure and Transparency Rules.

PDMR shareholding

Dr John Chiplin, a PDMR of the Company, has today subscribed for Placing Shares pursuant to the Placing at the Placing Price. The number of Placing Shares subscribed for by Dr Chiplin, and his resulting shareholding on Admission, is set out below:

Capitalised terms used in this announcement have the meaning as defined in the Placing Launch Announcement unless otherwise stated.

The information contained within this announcement constitutes inside information stipulated under MAR. The person responsible for arranging the release of this announcement on behalf of the Company is Dr Richard Goodfellow, a director of the Company.

- ENDS -

For more information, please contact:

Notes for Editors

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.

Important Notice

This Announcement has been issued by, and is the sole responsibility, of the Company. No representation or warranty express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by Panmure Gordon or by any of its affiliates, directors, officers, employees, advisers or agents as to or in relation to, the accuracy or completeness of this Announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed. Panmure Gordon has not authorised the contents of, or any part of, this Announcement.

Panmure Gordon, which is authorised by the FCA, is acting exclusively for the Company and no-one else in connection with the Placing and will not regard any other person as a client in relation to the Placing and will not be responsible to anyone other than the Company for providing the protections afforded to its clients or for providing advice in relation to the Placing or any other matter referred to herein.  Its responsibilities as nominated adviser and broker to the Company are owed to the London Stock Exchange and the Company and not to any other person including, without limitation, in respect of any decision to acquire Placing Shares in reliance on any part of this Announcement.

There are matters set out within this announcement that are forward-looking statements. Such statements are only predictions, and actual events or results may differ materially. For a discussion of important factors which could cause actual results to differ from forward-looking statements, refer to the Company's Annual Report and Accounts for the period ended 30 April 2016. Neither the Company nor Panmure Gordon undertakes any obligation to update publicly, or revise, forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent legally required. You should not place undue reliance on forward-looking statements, which speak only as of the date of this announcement. No statement in this announcement is or is intended to be a profit forecast or profit estimate or to imply that the earnings of the Company for the current or future financial periods will necessarily match or exceed the historical or published earnings of the Company. The price of shares and the income from them may go down as well as up and investors may not get back the full amount invested on disposal of the shares.

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

Professor Lindy Durrant, Scancell’s CSO, to chair and present in a session entitled: “Combining Checkpoint Inhibitors with Other Modalities”

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces that it will be participating in the upcoming Inaugural Combination Immunotherapy meeting, part of the Second Annual Immuno-Oncology Summit Europe 2017, 20-24 March 2017 at the Hilton Canary Wharf, London, UK, alongside other industry leaders from Merck, Sharp and Dohme, Brystol-Myers Squibb and Cancer Research UK.

Prof. Lindy Durrant, Ph.D., Chief Scientific Officer of Scancell and Professor of Cancer Immunotherapy, University of Nottingham, will chair the session entitled: “Combining Checkpoint Inhibitors with Other Modalities” on Thursday 23 March 2017. Prof. Durrant is also featured as a presenter in this session and will deliver a presentation entitled: “Combinations of Novel Vaccines with Checkpoint Inhibitors”, scheduled to take place at 14.20 GMT.

During the presentation, Prof. Durrant will discuss progress made with Scancell’s two cancer immunotherapy platforms, ImmunoBody® and Moditope®.
ImmunoBody® utilises both cross- and direct-presentation to increase T-cell avidity by 100 fold. In Phase 1/2 trials, it induced T-cell responses, tumour regression and long term survival. In combination with checkpoint inhibitors, it induced 100% tumour regression in established models. Phase 2 trials of ImmunoBody® vaccines in combination with checkpoint inhibitors in melanoma and non-small cell lung cancer are being planned.

Moditope® stimulates powerful anti-tumour T-cell responses against neo-epitopes produced by enzymes induced by cellular stress. First-in-man clinical studies for breast cancer, ovarian cancer and osteosarcoma are anticipated to commence in 2018.

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.

About Immuno-Oncology Summit Europe 2017
Following the success of our inaugural Cancer Biotherapeutics conference in London, we are pleased to announce the Immuno-Oncology Summit Europe 2017, to be held 20-24 March in the heart of London’s Canary Wharf Business District.

With an expanded three-track program, attendees can now experience a full week of cutting-edge science and discussion. The first track on Novel Approaches for Cancer focuses on advances in T-cell technology including next-generation CAR Ts, TCRs, and TILs. In addition it covers bispecifics: for T and NK cell engagement; in the clinic; and modelling for optimal affinity. The track also presents genetic engineering technologies for T cells, preclinical models, and production strategies, and focuses on specificity, off-target tox, and safety. The second track on Immunomodulatory Approaches will present advances with checkpoint inhibitors, agonistic receptor engagement, NK and macrophage activation, Fc-engineering technologies, and cytokine-based therapies, and address the challenge of tumours unresponsive to checkpoint blockade. It includes a keynote session on current understanding of the role of the immune system in cancer. Combination Immunotherapy will review the strategies and clinical trials for designing rational combination immunotherapies, provide case studies of immune modulator combinations, as well as combinations of checkpoint inhibitors with other modalities, and discuss biomarker- and mechanism-based selection of IO combinations.

Addario Lung Cancer Medical Institute and Scancell Holdings PLC Form Partnership to Advance Lung Cancer Vaccine Clinical Trials

Collaboration builds a world-class network to develop innovative treatment alternatives for lung cancer patients

(January 30, 2017) — The Addario Lung Cancer Medical Institute (“ALCMI”), the Bonnie J. Addario Lung Cancer Foundation (“ALCF”) and Scancell Holdings PLC (“Scancell”) today announce a collaboration to evaluate the use of Scancell’s second innovative cancer vaccine, SCIB2, from its ImmunoBody® platform to treat non-small cell lung cancer (“NSCLC”).

Scancell’s ImmunoBody® cancer vaccine platform is a novel immunotherapy treatment under development that stimulates the immune system to potentially treat and prevent cancer. The Company recently successfully completed a Phase 1/2 clinical trial with SCIB1 in patients with melanoma.

The Addario Advanced Collaboration Program brings patients into clinical trials from ALCMI’s extensive research consortium of international researchers and member institutions and ALCF’s patient support programs. ALCMI plans to assist Scancell in the design and development of a Phase 1/2 clinical trial with SCIB2 in patients with NSCLC which is planned to begin in 2018 and complete approximately 18 months later.

“This partnership enables us to access an important clinical program that could also accelerate the development of this groundbreaking immunotherapy technology,” said ALCMI President and COO Steven Young. “Combining our two foundations’ unique resources will increase patient engagement with the goal to bring new treatment options to non-small cell lung cancer patients,” added Bonnie J. Addario, a 12-year lung cancer survivor and founder and chair of ALCF and founder of ALCMI.

According to the Centers for Disease Control and Prevention, lung cancer accounts for 27 percent of all cancer deaths, more than breast, prostate and colon cancer combined. More than 228,000 people receive a cancer diagnosis in the United States alone and more than 160,000 will not survive. It remains one of the most difficult cancers to treat.

“Immunotherapy has dramatically improved many patients' outcomes across various cancer types. One of the next steps is how we can further enhance the immune response to cancer. Early clinical data on ImmunoBody® suggests it is extremely well tolerated and may significantly improve outcomes, which would be ideal. I'm excited to work with Scancell and hopeful that we will take another important step in the fight against lung cancer,” said Jacob M. Sands, MD, assistant professor, medical oncology, Lahey Hospital & Medical Center in Burlington, Massachusetts.

SCIB2 has the potential to complement existing treatments and has potential value where current treatments either do not work or are not available. By stimulating immune responses to specific lung cancer antigens, SCIB2 should assist the body in targeting and fighting NSCLC, leading to longer survival rates.

“We have generated preclinical data that suggests that SCIB2 could be the ideal complement to existing and emerging checkpoint inhibitor therapies to treat NSCLC and so provide an effective new potential treatment option for patients with this devastating disease,” said Scancell CEO Richard Goodfellow.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

Addario Lung Cancer Medical Institute

Scancell Holdings Plc

About the Addario Lung Cancer Medical Institute (ALCMI)
The Addario Lung Cancer Medical Institute (ALCMI, voiced as “Alchemy”) was founded by advanced stage lung cancer survivor Bonnie J Addario in 2008 as a nonprofit organization. Working in tandem with our “partner” foundation the Bonnie J. Addario Lung Cancer Foundation (ALCF), ALCMI and ALCF contribute resources and join together to power collaborative, patient-centric initiatives in genetic (molecular) testing, therapeutic discoveries, targeted treatments and early detection. ALCMI overcomes barriers to collaboration via a world-class team of investigators from 25 institutions in the USA, UK and Europe, supported by dedicated research infrastructures such as centralized project management and biorepositories and data systems. ALCMI directly facilitates research by combining scientific expertise found at leading academic institutions with patient access through our network of community cancer centers – accelerating novel research advancements to lung cancer patients. Byproviding access to critical masses of patient stakeholders, academic, community and industry researchers, ALCMI, in partnership with the ALCF, is making progress towards its goal of transforming lung cancer into a chronically managed disease by 2023.

About the Addario Advanced Collaboration Program
The Addario Advances Collaboration Program accelerates novel therapeutic medical device and diagnostics into patient trials. The program incentivizes the collaboration of the non-profit community and emerging life science companies to reduce development times, improve clinical trial designs, reduce costs and, most critically, accelerates more effective diagnostics and therapies to lung cancer patients globally.

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.

• SCIB2 will be developed for the treatment of non-small cell lung cancer in combination with a checkpoint inhibitor
• Latest SCIB2 data published in peer-reviewed journal OncoImmunology confirms potent antitumour activity was further enhanced by checkpoint blockade
• Extension of clinical application from melanoma to lung cancer highlights potential of ImmunoBody® platform technology to target broad range of cancers

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today announces its intention to develop its SCIB2 ImmunoBody® for the treatment of non-small cell lung cancer (NSCLC) in combination with a checkpoint inhibitor. Scancell’s Board approved the decision based on the outstanding results from the SCIB1 melanoma clinical trial which extended several years beyond the original completion date due to the unexpectedly long survival times. Planning for Phase I/II clinical trials in NSCLC is currently underway.

The latest data on SCIB2 has recently been published in OncoImmunology^1, a highly regarded journal at the frontier between oncology and immunology. The results confirmed that SCIB2, an ImmunoBody® encoding NYESO-1 epitopes, induced potent anti-tumour immunity which was further enhanced by checkpoint blockade.

Prof Lindy Durrant, Chief Scientific Officer of Scancell, said: “Our clinical experience with the first ImmunoBody®, SCIB1, in the melanoma setting will greatly facilitate planning and execution of our planned lung cancer clinical trials with SCIB2. We believe that success with this clinical programme will highlight that ImmunoBody® has the potential to be applicable to cancers with very different characteristics and underlying genetics.”

Dr Richard Goodfellow, Chief Executive Officer of Scancell, said: “It is recognised that the successful exploitation of novel therapeutic mechanisms, such as that underlying our ImmunoBody® platform, will be critical to further improving the poor mortality rates of patients with lung cancer. The data we have generated to date with the SCIB2 ImmunoBody® suggest that it should be well tolerated and be an ideal complement to existing and emerging portfolios of checkpoint inhibitor therapies in the treatment of NSCLC.”

The Company will now begin to assemble a lung cancer investigator team in the United States to assist in finalising the clinical trial design.

Lung cancer remains one of the most prevalent and difficult to treat cancers in need of novel therapeutic approaches. According to the Bonnie Addario Lung Cancer Foundation, one of the largest philanthropic organisations targeting the disease, more than 228,000 people are diagnosed with lung cancer in the United States alone, and more 160,000 will go on to die. Lung cancer accounts for 27% of all cancer deaths, more than breast, prostate and colon cancers combined.² ImmunoBody® is designed to be used to complement existing treatments in combination approaches, but may also be valuable where current treatments are either unsuitable or unavailable.

¹ SCIB2, an antibody DNA vaccine encoding NY-ESO-1 epitopes, induces potent antitumor immunity which is further enhanced by checkpoint blockade. Xue W, Metheringham RL, Brentville VA, Gunn B, Symonds P, Yagita H, Ramage JM, Durrant LG. OncoImmunology.
2016 Apr 22;5(6):e1169353. doi: 10.1080/2162402X.2016.1169353. eCollection 2016 Jun. PMID: 27471648

² Bonnie J. Addario Lung Cancer Foundation (http://www.lungcancerfoundation.org/about-us/lung-cancer-facts/)

For Further Information:

About ImmunoBody®
ImmunoBody® is an injectable DNA based immunotherapy with a customizable targeting mechanism for multiple specific cancer types. Two additional major practical advantages of ImmunoBody® are a benign toxicity profile and a relatively low cost of manufacture.

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.

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’s ImmunoBody® treatments 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.

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, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces the appointment of Dr Alan J. Lewis to the Board of Scancell as Non-Executive Director with immediate effect.

Alan has extensive experience in the US life sciences industry with a proven track record of raising funds and advancing drug discovery and development in both biotechnology and large pharmaceutical companies. Since 2000, as CEO, Alan has successfully led several life sciences companies through rapid growth to a successful exit. At Medistem he oversaw the acquisition by Intrexon in March 2014 for a stock and cash transaction of $26 million. Whilst at Novocell, he supervised the $25.4 million fundraising and was responsible for its multi-year drug discovery collaboration with Pfizer. As CEO of Signal Therapeutics, Alan oversaw multi-year alliances with a number of leading pharmaceutical companies including Akzo Nobel, Roche Biosciences and Novartis, and subsequently managed its $275 million acquisition by Celgene.

Alan has also held senior positions at Celgene, Ambit Biosciences, and the Juvenile Diabetes Research Foundation and initially worked in research at Organon Laboratories (Merck) and Wyeth Laboratories (Pfizer).

He is currently President and CEO of DiaVacs, a San Diego based clinical stage biotechnology company developing products to reverse the onset of autoimmune diseases by re-inducing tolerance into the patient’s immune system to halt the vicious cycle of autoimmunity.

Alan has a B.Sc in Physiology and Biochemistry from Southampton University, UK, a Ph.D in Pharmacology from the University of Wales, UK where he was later made an Honorary Research Fellow in 2008. He has held research fellowships at University of Guelph, Canada and Yale University, USA, and has published over 120 full manuscripts, 100 abstracts as well as written and edited seven books.

Speaking upon his appointment, Dr Lewis said: “I am very much looking forward to joining the Board of Scancell. This is an exciting time for immuno-oncology and I am delighted to be involved in the cutting edge science that underpins the company’s research and development.”

Dr John Chiplin, Executive Chairman of Scancell continued: “We welcome Alan to the Scancell Board. He brings with him a wealth of industry experience, both commercially and financially. Most importantly though,
Alan has extensive experience in drug discovery and development, which combined with his close connections to key players in the sector, will be invaluable to Scancell as it begins to accelerate the development of a range of new products from the ImmunoBody® and Moditope® platforms from next year."

Schedule Two information regarding Dr Alan James Lewis, age 70:

Current Directorships
Assembly Biosciences, Inc. (US)
Batu Biologics, Inc. (US)
Biocom (US)
BioMarin Pharmaceutical, Inc. (US)
Capella Therapeutics (US)
Cellastra, Inc. (US)
DiaVacs, Inc. (US)
Habit Rx (US)
International Association of Inflammation Societies (US)
Neurometrix Rx (US)
The Stem Cell Advisors, Inc. (US)
Targazyme, Inc. (US)

Directorships in the past five years
Ambit Biosciences Corporation (US)
Biotica Technology Ltd. (UK)
Cytochroma (CA)
Medistem, Inc. (US)
Rincon Pharmaceuticals (US)

There are no other disclosures required in relation to Rule 17 or paragraph (g) of Schedule 2 of the AIM Rules for Companies.

This announcement contains inside information.

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.
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.

Leading DNA plasmid manufacturer Eurogentec appointed to manufacture new SCIB1 material 

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today announces an agreement with Eurogentec S.A, an FDA inspected CMO specialised in the GMP production of plasmid DNA and recombinant proteins, for the manufacture of new supplies of Scancell’s SCIB1 ImmunoBody® vaccine for use in the US clinical study of SCIB1 in combination with a checkpoint inhibitor, expected to commence in 2017. Upon completion and once fully evaluated, which is expected to take approximately 9-12 months, this clinical trial material will also be available to recommence dosing of patients in the Company’s long-term extension of the Phase 1/2 SCIB1 clinical study in malignant melanoma (subject to regulatory approval).

Eurogentec’s biologics division produces clinical trial and commercial biopharmaceutical material compliant with current Good Manufacturing Practice (cGMP) for all major markets according to US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) requirements. The company is FDA inspected (2011, 2013, 2014) and currently manufactures a biopharmaceutical marketed in the US. In the field of plasmid DNA, Eurogentec is a recognised leading CMO having recently manufactured 150g of plasmid DNA material for a major pharmaceutical company with plans to scale the process to commercial
requirements.

Dr Richard Goodfellow, CEO of Scancell, said: 
“We are delighted to be working with Eurogentec, a world class manufacturer, to provide the new batch of SCIB1 material. As can be seen from the latest data from our Phase 1/2 clinical trial, SCIB1 continues to deliver compelling survival data in patients with resected stage III/IV melanoma. This new supply will not only be used in our upcoming US checkpoint inhibitor combination trial, but also enable us to recommence treating patients in the long-term extension of the Phase 1/2 study.
“Access to Eurogentec’s expertise and proprietary manufacturing processes has the potential to substantially increase the yields of SCIB1 and fast-track the scale-up that will be required for future Phase III and commercial supply.”

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 thePhase 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.
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.

About Eurogentec

Eurogentec S.A., part of Kaneka Corporation, is a leading global supplier of innovative reagents, kits, specialty products and custom services. Through its three inter-related business units, the company provides high quality products to scientists involved in the life science, biotechnology, diagnostic and pharmaceutical markets. Eurogentec is fully ISO 9001, ISO 13485 certified, cGMP accredited by the Belgian Ministry of Health and approved by the US FDA for the commercial manufacturing of a biologic marketed in the US.

www.eurogentec.com