Posts in Category: Immunobody

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.

ALCMI - Scancell Collaboration in Lung Cancer

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

Julia Spiess Lewis Perry Communications Group +1 916-658-0144
[email protected]

 

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)   +44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

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.

Scancell preparing SCIB2 for clinical study in lung cancer

  • 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 OncoImmunology1, 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:

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 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.

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.

Appointment of Eurogentec as SCIB1 manufacturer

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:

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)

Tom Salvesen (Corporate Broking)

Panmure Gordon & Co

+44 (0) 20 7886 2500

+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 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

Extension to Ichor Commercial Option

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer is pleased to announce that it has been granted a further extension to its option to licence the commercial use of Ichor Medical Systems’ (“Ichor’s”) proprietary TriGrid® electroporation delivery system with SCIB1, Scancell’s ImmunoBody® vaccine for the treatment of melanoma. In exchange, Scancell has granted a partial waiver over the lock-up which prohibited the sale, during the two years following their issue, of ordinary shares in the Company (“Ordinary Shares”) issued pursuant to exercise of the Tranche 2 share options (over 3,184,620 Ordinary Shares), issued as part payment for the licence option, as originally announced 16 July 2009 and extended in July 2014. Subject to exercise of the Tranche 2 share options, Ichor will remain under an orderly market agreement requiring any sale of such Ordinary Shares during that two year period to be effected through Scancell’s brokers.

Under the terms of the agreed extension, Scancell’s licence option, which had been due to expire on 13 July 2016, has been extended until 13 July 2018.

Richard Goodfellow, CEO of Scancell, said:

“Ichor’s proprietary TriGrid® electroporation delivery system remains central to our studies on SCIB1 and in particular, to our upcoming US clinical study of SCIB1 in combination with a checkpoint inhibitor, expected to commence in 2017. We are delighted to have extended the licence option agreement to commercialise their technology on the terms as set out above and we appreciate Ichor’s continued support of our SCIB1 programme as we continue its clinical development as a potential treatment for patients with melanoma.”

Robert Bernard, President & CEO of Ichor, added:

“Scancell has continued to generate outstanding survival data using our TriGrid® electroporation delivery system in conjunction with their lead ImmunoBody® vaccine, SCIB1. We believe that SCIB1 has the potential to be a significant new treatment option for patients with melanoma, and we look forward to continuing to work with Scancell on this exciting product.”

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)

Tom Salvesen (Corporate Broking)

Panmure Gordon & Co

+44 (0) 20 7886 2500

+44 (0) 20 7886 2500

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

About Ichor and the TriGrid® Delivery System

Ichor is dedicated to the clinical application and commercialization of electroporation technology for the delivery of DNA drugs and vaccines to treat and prevent debilitating or life threatening diseases. They are applying their proprietary TriGri® Delivery System to enable delivery of DNA drugs to address unmet medical needs in areas including therapeutic cancer vaccines, therapeutic proteins and vaccines for serious infectious disease.

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.

SCIB1 continues to deliver compelling survival data in melanoma

Scancell to present update at the Oxford Technology VCT AGM and Proactive Investors One2One Forum

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today provides an update from the SCIB1 Phase 1/2 clinical trial in malignant melanoma, the lead programme from the Company’s ImmunoBody® platform and will be presenting at the Oxford Technology VCT AGM and Proactive Investors One2One Forum later this week.

Dr Richard Goodfellow, CEO of Scancell, said: “SCIB1 continues to deliver compelling survival data in patients with resected Stage III/IV melanoma. It is particularly interesting to note that there has only been one new case of disease progression since November 2013 in the resected patients receiving 4mg doses of SCIB1, which gives us hope that SCIB1 might offer curative potential in this currently untreated patient group.”

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: “The SCIB1 overall survival and progression free survival data generated to date go well beyond established norms for this group of melanoma patients. We have a lot of enthusiasm for validating these results in subsequent trials.”

SCIB1 Survival Update

As of 27 June 2016, SCIB1 continues to deliver strong survival data:

  • Currently 19 of the 20 patients with resected tumours at study entry remain alive
  • One patient who first experienced disease progression in September 2013 died in April 2016, despite additional treatment with checkpoint inhibitors and radiation therapy
  • Of the 16 patients who received 2-4mg doses of SCIB1 Median observation time since entry is 46 months and 52 months since first diagnosis of metastatic disease
  • Only five patients have progressed and one has died
  • Only one new incidence of disease progression has been seen since November 2013
  • Of the four patients who received 8mg doses of SCIB1 (recruited after lower dose cohorts)
  • Median observation time since entry is 16 months and 21 months since first diagnosis of metastatic disease
  • 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)
  • New SCIB1 material will be ready for use in approximately 9-12 months
  • Plans for the US clinical study of SCIB1 in combination with a checkpoint inhibitor remain on track
  • The final Clinical Study Report, which will be issued later this year, will provide safety, immunology and clinical data from all patients up to 29 October 2015 (the date of the last patient’s dose in the main study) to support our US regulatory submission


Investor Events

Proactive One2One Forum, 7 July 2016 – 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/65

Oxford Technology VCT AGM, 8 July 2016 – Dr John Chiplin

Scancell will be speaking as part of the portfolio review at the Oxford Technology VCT AGM which commences at 11am at the Magdalen Centre, Oxford Science Park, Oxford OX4 4GA. 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:

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 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.

ImmunoBody® vaccine to be developed for the treatment of glioblastoma multiforme

Research undertaken by scientists at Nottingham Trent University and the University of Portsmouth

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, announces that researchers at Nottingham Trent University and the University of Portsmouth have initiated a new preclinical study aimed at developing a vaccine for the treatment of glioblastoma multiforme (GBM) by utilising Scancell’s ImmunoBody® technology platform.

GBM is the most common and aggressive form of glioma and carries a very poor prognosis. Around 5,000 people are diagnosed with a primary malignant brain tumour in the UK each year and GBM accounts for just over half of them. Treatments are limited and even with intensive chemotherapy patients have an average survival time of just 14 months.

Due to the highly aggressive nature of GBM and the lack of successful curative treatments to date, there is an urgent need for novel therapeutic approaches such as immunotherapy.

By using Scancell’s ImmunoBody® technology platform, scientists at Nottingham Trent University and the University of Portsmouth are aiming to develop a vaccine that stimulates protective immune responses against tumour molecules such as ‘HAGE’ and ‘TRP2’, which are proteins that are expressed in the cancer cells of GBM patients.

The vaccine treatment will be assessed for its ability to generate strong anti-GBM tumour immunity, as well as the ability to reduce and eradicate established tumours.

The researchers will also determine whether the vaccine stimulates HAGE and/or TRP2-specific immune cells in the blood of GBM patients that are capable of recognising the GBM tumours. This will demonstrate the ability of a patient’s immune system to identify and kill the cancer cells, providing insight into the effectiveness of the treatment.

The £95,000 study is being funded by the Headcase Cancer Trust, the only UK charity which dedicates its funding solely to research which aims to find a cure for GBM brain tumours.

Professor Lindy Durrant, Chief Scientific Officer of Scancell commented:

“We are keen to collaborate on this exciting project to add HAGE to our TRP-2/gp100 vaccine to target GBM. It is an aggressive disease and we believe the high avidity T cells generated by ImmunoBody® will be needed to control its growth.”

Dr Stephanie McArdle, a scientist in the John van Geest Cancer Research Centre at Nottingham Trent University, said:

“Vaccines can be extremely powerful when correctly formulated, so we are very hopeful that combining HAGE and TRP-2/gp100 with Scancell’s ImmunoBody® technology will lead to better disease outcomes.”

-ENDS-

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
     
Dave Rogers (Senior Press Officer) Nottingham Trent University +44 (0) 115 848 8782
Helen Breese (Senior Press Officer)   +44 (0) 115 848 8751
     
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +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 and is being evaluated in a Phase 1/2 clinical trial. Data from the 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 John van Geest Cancer Research Centre, Nottingham Trent University

Nottingham Trent University’s John van Geest Cancer Research Centre is a unique purpose-built scientific facility. Its aim is to save lives and speed recovery by improving the early diagnosis and treatment of cancer.

The centre focuses on two key approaches to the treatment of patients with cancer:

Improving the diagnosis and management of breast and prostate cancers

Developing effective vaccines and immunotherapies that will significantly improve the survival rates and quality of life for cancer sufferers

Visit the John van Geest Cancer Research Centre website to find out more about its work, or to make a donation towards its vital scientific research.

Scancell Opens US Headquarters in San Diego - Key Management Changes to Support Future Growth

Scancell Holdings Plc, (AIM:SCLP), today announces the opening of new offices in San Diego to support the Company’s ambitious US growth plans together with plans to establish a new base in the Oxford area for its UK corporate and development activities.

In addition, the following changes have been made to the structure of Scancell’s executive management team to optimally align management expertise with the strategic direction outlined in the £6.2m ($9m) fundraising completed in April.

Dr John Chiplin, who is based in the US and is currently Scancell’s Non-Executive Chairman, will assume the role of Executive Chairman. John will be directly involved in raising the corporate profile of the Company in the US. Recent US transaction experience, as a director/CEO, includes Benitec Biopharma (US IPO), Medistem (acquired by Intrexon), Arana (acquired by Cephalon) and Domantis (acquired by GSK). Prior to Scancell John was CEO of Polynoma, a Phase III cancer vaccine company, based in San Diego.

Dr Richard Goodfellow, currently Joint CEO, will become Chief Executive Officer and Professor Lindy Durrant, currently Joint CEO, will become Chief Scientific Officer, allowing her to focus fully on the innovative drug discovery that underpins Scancell’s novel technology platforms.

Dr Sally Adams will remain as Development Director.

Dr John Chiplin, Executive Chairman of Scancell commented: “The Board believes that these changes align management with the strategic direction outlined at the time of our recent £6m fundraising and optimally leverage expertise with the needs of the Company. Scancell’s next generation cancer vaccine platforms, ImmunoBody® and Moditope®, are delivering outstanding results and I am convinced that Scancell will secure wider recognition for its innovative technologies and products in both the United States and Europe over the coming months.”

-ENDS-

Dr John Chiplin, Executive Chairman Scancell Holdings Plc + 44 (0) 20 3727 1000
Dr Richard Goodfellow, CEO    
Rob Naylor (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2714
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 and is being evaluated in a Phase 1/2 clinical trial. Data from the 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.