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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.

SCIB1 Clinical Study Report

Report confirms robust survival in late stage melanoma patients

SCIB1 Phase 2 combination study on track; IND expected to be filed in H1 2017

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today announces that the Clinical Study Report (CSR) on the SCIB1 Phase 1/2 clinical trial in patients with Stage III/IV malignant melanoma has been completed on schedule.

The Clinical Study Report includes safety, immunology and clinical data from all patients with Stage 3/4 melanoma up to 29 October 2015, the date of the last patient’s final dose in the main study. The main conclusions of the CSR are:

  • SCIB1 was safe and well tolerated over a dose range of 0.4 to 8mg with no serious adverse events related to SCIB1.
  • There was clear evidence of an immune response in most patients receiving SCIB1. There were significantly stronger responses to the 8mg dose than to the 2/4mg doses, indicating that this is the appropriate dose for future studies.
  • Immune responses were stronger in patients without tumour present at study entry than in patients with detectable tumour; SCIB1 may therefore be particularly effective as monotherapy in early stage patients with a low tumour burden. Continued and broader responses were seen for up to two years of treatment with SCIB1, suggesting that patients may derive benefit from long term administration.
  • In the nine patients with tumour present at screening who received either a 4mg or 8mg dose of SCIB1, there was evidence of clinical activity in two patients; one had a partial response by RECIST and a second patient had a greater than 30% reduction in tumour size in target lesions but progression in a non-target lesion.
  • In the 20 patients with no detectable tumour at screening, disease-free survival was much higher than expected based on historical comparisons.

Updated survival and disease recurrence data are as follows:

  • Currently 19 of the 20 patients with resected tumours at study entry remain alive
  • Of the 16 resected patients who received 2/4mg doses of SCIB1;
  • Median observation time since entry is 52 months and 58 months since first diagnosis of metastatic disease
  • Only five patients have progressed and one has died
  • One patient in this group has now reached their 5-year post-treatment survival time point;
  • Of the four resected patients who received 8mg doses of SCIB1 (recruited after lower dose cohorts)
  • Median observation time since entry is 21 months and 27 months since first diagnosis of metastatic disease
  • All patients are alive
  • Two of these patients experienced recurrence of their melanoma in Q4 2016 following early termination of their treatment in June 2016 pending manufacture of new SCIB1 supplies. One patient had received only one further dose of SCIB1 and the other had received two doses after the end of the main study period. Immune analysis from the patients recruited earlier suggests that patients may benefit from up to two years continuous treatment to effectively delay or prevent recurrence.

The Clinical Study Report will support the Company’s Investigational New Drug (IND) Application for SCIB1 which is anticipated to be filed with Food and Drug Administration (FDA) in H1 2017 subject to the outcome of the pre-IND meeting planned for Q1 2017. Scancell is expecting to conduct a Phase 2 checkpoint inhibitor combination study with SCIB1 in melanoma in 2017, led by Principal Investigator Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School. A key objective of this important study will be to evaluate safety and response rates in melanoma patients administered SCIB1 in addition to a checkpoint inhibitor compared to the checkpoint inhibitor alone.

Dr Richard Goodfellow, CEO of Scancell, said: “We are pleased that the Clinical Study Report on our SCIB1 Phase 1/2 clinical trial in patients with melanoma has now been finalised, and will be able to support our US IND submission. We are very encouraged by the compelling survival data generated in this study which now demonstrates a median observation time since trial entry of more than four years for the 16 patients with resected tumours and receiving 2/4 mg doses of drug. This is supported by our long-term immune analysis that suggests continued dosing of SCIB1 may control disease in resected patients."

“We continue to expect to file our IND for SCIB1 in the first half of 2017, and to start our US clinical study of SCIB1 in combination with a checkpoint inhibitor next year. We look forward to updating the market further on these plans in due course.”

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO    
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 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.

Research Update - Amendment

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

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

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

3 January 2017

Scancell Holdings Plc

("Scancell" or the "Company")

Final SCIB1 Phase 1/2 Clinical Study Report completed on schedule

Report confirms robust survival in late stage melanoma patients

SCIB1 Phase 2 combination study on track; IND expected to be filed in H1 2017

Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, today announces that the Clinical Study Report (CSR) on the SCIB1 Phase 1/2 clinical trial in patients with Stage III/IV malignant melanoma has been completed on schedule.

The Clinical Study Report includes safety, immunology and clinical data from all patients with Stage III/IV melanoma up to 29 October 2015, the date of the last patient's final dose in the main study.  The main conclusions of the CSR are:

  • SCIB1 was safe and well tolerated over a dose range of 0.4 to 8mg with no serious adverse events related to SCIB1.
  • There was clear evidence of an immune response in most patients receiving SCIB1.  There were significantly stronger responses to the 8mg dose than to the 2/4mg doses, indicating that this is the appropriate dose for future studies.
  • Immune responses were stronger in patients without tumour present at study entry than in patients with detectable tumour; SCIB1 may therefore be particularly effective as monotherapy in early stage patients with a low tumour burden.  Continued and broader responses were seen for up to two years of treatment with SCIB1, suggesting that patients may derive benefit from long term administration.
  • In the nine patients with tumour present at screening who received either a 4mg or 8mg dose of SCIB1, there was evidence of clinical activity in two patients; one had a partial response by RECIST and a second patient had a greater than 30% reduction in tumour size in target lesions but progression in a non-target lesion.
  • In the 20 patients with no detectable tumour at screening, disease-free survival was much higher than expected based on historical comparisons.

Updated survival and disease recurrence data are as follows:

  • Currently 19 of the 20 patients with resected tumours at study entry remain alive
  • Of the 16 resected patients who received 2/4mg doses of SCIB1
    • Median observation time since entry is 52 months and 58 months since first diagnosis of metastatic disease
    • Only five patients have progressed and one has died
    • One patient in this group has now reached their 5-year post-treatment survival time point
  • Of the four resected patients who received 8mg doses of SCIB1 (recruited after lower dose cohorts)
    •  Median observation time since entry is 21 months and 27 months since first diagnosis of metastatic disease
    •  All patients are alive
    • Two of these patients experienced recurrence of their melanoma in Q4 2016 following early termination of their treatment in June 2016 pending manufacture of new SCIB1 supplies.  One patient had received only one further dose of SCIB1 and the other had received two doses after the end of the main study period.  Immune analysis from the patients recruited earlier suggests that patients may benefit from up to two years continuous treatment to effectively delay or prevent recurrence

The Clinical Study Report will support the Company's Investigational New Drug (IND) Application for SCIB1 which is anticipated to be filed with Food and Drug Administration (FDA) in H1 2017 subject to the outcome of the pre-IND meeting planned for Q1 2017.  Scancell is expecting to conduct a Phase 2 checkpoint inhibitor combination study with SCIB1 in melanoma in 2017, led by Principal Investigator Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School.  A key objective of this important study will be to evaluate safety and response rates in melanoma patients administered SCIB1 in addition to a checkpoint inhibitor compared to the checkpoint inhibitor alone.

Dr Richard Goodfellow, CEO of Scancell, said:  "We are pleased that the Clinical Study Report on our SCIB1 Phase 1/2 clinical trial in patients with melanoma has now been finalised, and will be able to support our US IND submission.  We are very encouraged by the compelling survival data generated in this study which now demonstrates a median observation time since trial entry of more than four years for the 16 patients with resected tumours and receiving 2/4 mg doses of drug.  This is supported by our long-term immune analysis that suggests continued dosing of SCIB1 may control disease in resected patients."

"We continue to expect to file our IND for SCIB1 in the first half of 2017, and to start our US clinical study of SCIB1 in combination with a checkpoint inhibitor in the second half of the year.  We look forward to updating the market further on these plans in due course."

For Further Information:

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 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 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.

Results of AGM

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, announces that all resolutions proposed at the Annual General Meeting held today were duly passed.
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.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

Scancell’s ImmunoBody® treatments target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

 

Scancell 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.

Notice of AGM - Amendment

Scancell Holdings Plc 

Notice of AGM

Amendment

Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, will host its Annual General Meeting on Tuesday 18 October 2016.

AGM details are as follows:

Date: Tuesday 18 October, 2016
Time: 2.30pm
Venue: The Kassam Stadium
Grenoble Road
Oxford
OX4 4XP

 

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 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.

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.

Scancell to present at the 23rd Annual NewsMakers in the Biotech Industry Conference in NYC

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 23rd Annual NewsMakers in the Biotech Industry Conference. The conference is being held on 9 September 2016 at the Millennium Broadway Hotel & Conference Center in New York City, USA.

Dr John Chiplin, Executive Chairman of Scancell, will be presenting an overview of the Company at 15:00 ET in presentation room 311 and will 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

Dr Richard Goodfellow, Joint CEO

Scancell Holdings Plc

+1 858 900 2646

+ 44 (0) 20 3727 1000

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Booking)

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 NewsMakers in the Biotech Industry Conference


NewsMakers presents a hand-picked group of public biotech companies whose corporate and regulatory milestones will drive stock prices. NewsMakers is recognized as the industry's key venue for companies to take their story to Wall Street each Fall. Thus, NewsMakers remains the best opportunity for business development executives and key members of the institutional investment and analyst communities to compare notes and assess the industry landscape.

Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $480 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.

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.