Posts in Category: Moditope

Final Results for the year ended 30 April 2017

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

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)    
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

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.

Continued progress on SCIB1 – eight patients reach 5 year survival milestone

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:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon  +44 (0) 20 7886 2500
Maisie Atkinson (Sales)   +44 (0) 20 7886 2905
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

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.

 

Placing raises £5.0 million, Issue of Equity and PDMR shareholding

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:

Name   Number of Ordinary Shares currently held Percentage of existing Ordinary Shares Number of Placing Shares subscribed for Number of Ordinary Shares held on Admission Percentage of Ordinary Shares on Admission
Dr John Chiplin 58,823 0.02% 1,041,177 1,100,000 0.35%

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:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley/Duncan Monteith (Corporate Finance) Panmure Gordon +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)    
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

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.

Proposed placing to raise up to £5.0 million

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:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley/Duncan Monteith (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)    
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

Read the full article here

Scancell to present at the Immuno-Oncology Summit Europe 2017

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:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)   +44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

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.

Scancell to present at the World Immunotherapy Congress in Basel and at the Biotech and Money Inv€$tival Showcase in London

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces that it will be presenting at the World Immunotherapy Congress being held on 14-16 November 2016 in Basel, Switzerland and at the Biotech and Money Inv€$tival Showcase on 18 November 2016 in London, UK.

At the World Immunotherapy Congress, Professor Lindy Durrant, Chief Scientific Officer of Scancell, will be presenting: “SCIB1, SCIB2 and Moditope novel cancer vaccines” at 11:25am on 16 November 2016 as part of the Cancer Vaccines segment.

At the Biotech and Money Inv€$tival Showcase, Dr Richard Goodfellow, Chief Executive Officer of Scancell, will be presenting an overview of the Company at 10:45am on 18 November 2016. Dr Richard Goodfellow will also be available to participate in one-on-one meetings with investors who are registered to attend the conference.

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)   +44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

About The World Immunotherapy Congress
Immunotherapy currently offers the brightest hope for cancer treatment. New developments with checkpoint inhibitors and co-stimulatory targets have enabled some stunning breakthroughs and high optimism for the
sector. Recently, there have been some incredibly exciting new therapies in the field.

Our vision is to bring together the full community and provide a single meeting point for the whole value chain. It is where science meets business to make immunotherapy the cornerstone of the fight against
cancer.

The event is new, though the ideas and relationships are not. The event comes out of our discussions with leading clinicians, pharmaceutical companies, biotechs and research institutes held every year at the
successful European Antibody Congress, now in its twelfth successful year.


About The Biotech and Money Inv€$tival Showcase
Biotech and Money connects corporates to capital, and we have partnered with Jefferies for Inv€$tival to showcase the latest investable private and public life science opportunities.

Presenting companies will range from the latest start-ups through to growing public companies, delivering succinct powerful presentations to an audience of global investors and pharma. All companies will also have
their presentations recorded and a corporate interview video produced, forming a full corporate profile on the exclusive Biotech and Money Investor Portal.

For investors, Inv€$tival will help uncover and identify investable opportunities. And all of this in collaboration and with backing from the global investment bank Jefferies, co-located with their annual London Healthcare Conference.

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.

Final Results for the year ended 30 April 2016

Landmark four year survival achieved in resected SCIB1 patients
Emerging pipeline of three products across five cancer indications

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2016.

Read the full document here

Highlights

  • SCIB1 continues to deliver significant survival data from the Phase 1/2 clinical trial in patients with Stage III/IV melanoma
    • Currently 19 of the 20 patients with resected tumours at study entry remain alive
    • Of the 16 patients who received 2-4mg doses of SCIB1
      • Median observation time since entry is 49 months, a landmark survival milestone
      • Only two new incidences of disease progression have been recorded since December 2013
    • Of the four patients who received 8mg doses of SCIB1
      • Median observation time since entry is 18 months
      • None have progressed and none have died
    • As announced on 17 June 2016, treatment for the eight patients in the long-term continued dosing phase has been suspended due to the clinical trial supplies no longer being within the original specification
    • New SCIB1 material being manufactured to support a new study of SCIB1 in combination with a checkpoint inhibitor will also be made available to these continuation patients (subject to regulatory approval)
    • Plans for the US clinical study of SCIB1 in combination with a checkpoint inhibitor remain on track, enrolment expected to commence in Q3 2017
    • The final Clinical Study Report will be issued later this year and will support our US IND submission
  • Continued progress made in development of lead product, Modi-1, from Moditope® platform
    • Enrolment for first-in-man clinical study in triple negative breast cancer, ovarian cancer and osteosarcoma expected to commence in early 2018
  • Strategic collaboration with Karolinska Institutet to explore the role of citrullination in cancer, a key mechanism underpinning the Moditope® platform
  • £6.2m (£5.8m net) raised through a firm placing and open offer involving both existing and new shareholders
  • John Chiplin appointed Chairman
  • Loss for the year of £2,583,273 (2015: loss £2,414,630)
  • Group cash balance at 30 April 2016 was £6,527,435 (30 April 2015: £3,059,001)

Post Period Highlights

  • Scancell’s executive management team restructured to align expertise with the strategic direction outlined in fundraising
  • Dr Alan Lewis appointed to Board as Non-Executive Director
  • Opening of new offices in San Diego, US and Oxford, UK to support Company’s growth plans

Dr John Chiplin, Executive Chairman of Scancell, said:

“We have continued to make significant progress in the period, both in terms of the maturing clinical data with SCIB1 and further scientific developments on both the ImmunoBody® and Moditope® platforms. We now have a pipeline of three products across five cancer indications and clinical success with any one of these products could transform the value of the business. The Board believes that further clinical studies could add significant value to the Company and is continuing to explore a number of funding options to ensure that the Company has the resources to progress these programmes further.

“Scancell has arrived at an exciting point in its development. We now have the opportunity to transform the business from a small UK-based and largely scientifically-based enterprise into an international force in immuno-oncology. We remain committed to driving this process forward in the US and elsewhere, and to realising the value that has been accumulating over recent years, both for the benefit of our shareholders and cancer patients.”

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen(Corporate Banking) Panmure Gordon & Co +44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

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.

Dr Alan J. Lewis appointed as Non-Executive Director

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:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Maisie Atkinson (Sales) Panmure Gordon & Co +44 (0) 20 7886 2905
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

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.

Publication highlights advantages of Moditope® technology platform

Peer-­reviewed publication highlights advantages of Moditope® technology platform

Potential to develop completely new class of immuno-­oncology therapeutics

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the publication of an invited review in the scientific journal Autophagy entitled: “Autophagy, citrullination and cancer”, which describes Scancell’s pre-­clinical data that supports the innovation and potential of the Company’s Moditope® platform1.

The review, whose lead author is Professor Lindy Durrant, Scancell’s Chief Scientific Officer, discusses the concept that citrullinated peptides produced during autophagy offer attractive vaccine targets for cancer therapy. Scancell’s Moditope® platform utilises this mechanism to stimulate the production of highly active CD4+ T cells that overcome self-­tolerance and destroy tumour cells.

The data described in the review, and published in the peer-­reviewed journal Cancer Research2, showed that a single immunization with Moditope® peptides, up to 14 days after tumour implant, resulted in long-­term survival in up to 90% of mice, with no associated toxicity.

Professor Lindy Durrant, Chief Scientific Officer of Scancell commented:
 “The interplay between autophagy, citrullination and cancer support the rationale behind our Moditope® platform technology. Moditope® has a unique mechanism of action that overcomes the immune suppression induced by tumour cells, allowing T cells to seek out and kill tumours that would otherwise be hidden from the immune system. We believe this platform has the potential to develop a new class of immuno-­oncology therapeutics and look forward to progressing our first vaccine into the clinic as soon as possible.”

The first clinical trials of Modi-­1, the lead candidate from the Moditiope® platform, are expected to target patients with triple negative breast cancer, ovarian cancer and osteosarcoma.

The full abstract of the review can be found below.

Abstract

Autophagy, citrullination and cancer

A cell needs to maintain a balance between biosynthesis and degradation of cellular components to maintain homeostasis. There are 2 pathways, the proteasome, which degrades short-­lived proteins, and the autophagy/lysosomal pathway, which degrades long-­lived proteins and organelles. Both of these pathways are also involved in antigen presentation or the effective delivery of peptides to MHC molecules for presentation to T cells. Autophagy (macroautophagy) is a key player in providing substantial sources of citrullinated peptides for loading onto MHC-­II molecules to stimulate CD4 T cell responses. Stressful conditions in the tumor microenvironment induce autophagy in cancer cells as a mechanism to promote their survival. We therefore investigated if citrullinated peptides could stimulate CD4 T cell responses that would recognize these modifications produced during autophagy within tumor cells. Focusing on the intermediate filament protein VIM (vimentin), we generated citrullinated VIM peptides for immunization experiments in
mice. Immunization with these peptides induced CD4 T cells in response to autophagic tumor targets. Remarkably, a single immunization with modified peptide, up to 14 days after tumor implant, resulted in long-­term survival in 60% to 90% of animals with no associated toxicity. These results show how CD4 cells can mediate potent antitumor responses against modified self-­epitopes presented on tumor cells, and they illustrate for the first time how the citrullinated peptides produced during autophagy may offer especially attractive vaccine targets for cancer therapy.

1. Lindy G. Durrant, Rachael L. Metheringham & Victoria A. Brentville (2016): Autophagy, citrullination and cancer, Autophagy, DOI: 10.1080/15548627.2016.1166326
2. Victoria A. Brentville, Rachael L. Metheringham, Barbara Gunn, Peter Symonds, Ian Daniels, Mohamed Gijon, Katherine Cook, Wei Zue & Lindy G Durrant (2015): Citrullinated vimentin presented on MHC-­II in tumor cells is a target for CD4+ T cell-­mediated autitumor immunity, Cancer Research 76(3), 548-­560.

For Further Information:

Dr John Chiplin, Executive Chairman

Dr Richard Goodfellow, CEO

Scancell Holdings Plc

+1 858 900 2646

+44 (0) 20 3727 1000

Freddy Crossley (Corporate Finance)

Maisie Atkinson (Sales)

Panmure Gordon & Co

+44 (0) 20 7886 2500

+44 (0) 20 7886 2905

Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

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.