Posts in Category: SCIB1

New data for SCIB1 in metastatic melanoma

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce encouraging results from Part 2 of its on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody® as well as an update from patients in Part 1 of the study.

Highlights

Part 2 study results

  • All 14 study patients produced a melanoma-specific T-cell response to treatment
  • All patients are still alive; only three patients have any evidence of disease progression
  • Median survival time of Part 2 patients since initiating treatment is currently 15 months; 21 months since diagnosis of metastatic disease
  • Six patients are continuing on extended, long-term treatment with SCIB1
  • SCIB1 therapy was well tolerated with no reports of serious drug-related side effects in line with results reported from Part 1 of the study

Part 1 study update

  • The four patients who were alive at the time of the initial Part 1 report (December 2012) remain alive
  • Median survival time in Part 1 patients who received at least three treatments with the 2mg/4mg doses of SCIB1 is now 25 months

These results confirm that Scancell’s SCIB1 ImmunoBody® therapy is producing a melanoma-specific immune response in patients with Stage III/IV melanoma. This is particularly evident in patients with resected disease. Together with the immunological and clinical data from Part 1 of the study, the results suggest that these induced immune responses might also be contributing to the control of tumour in these patients.

Prof Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: “These results exceeded our highest expectations confirming that SCIB1 induces a consistent melanoma-specific immune response in Stage III/IV melanoma patients, especially in those with resected disease. Whilst the numbers are still small, it suggests that SCIB1 may be contributing to prolonged survival by controlling tumour growth and supports our belief that the highly targeted ImmunoBody® approach generates potent and specific T cells that can control malignant disease.”

Prof Poulam Patel, the principal investigator in the trial and Prof of Clinical Oncology at the University of Nottingham, added: “This promising new data further supports our hypothesis that SCIB1 can harness the body’s own immune system to control metastatic melanoma in a safe and effective way. More generally it also adds to the growing belief that training T cells to target and control tumour growth is one of the most promising new ways of treating cancer. In patients with more extensive metastases, it is feasible that combining SCIB1 with the latest checkpoint inhibitor drugs, which allow T cells to work better within the tumour environment, may offer further patient benefit.”

Study Design

The first part of this single arm, open label, Phase 1/2 clinical trial was conducted in five UK centres in 11 patients, ten with Stage IV and one with Stage III malignant melanoma. Patients were to be given five doses of 0.4mg, 2mg or 4mg of SCIB1, delivered by Ichor Medical Systems’ TriGrid™ electroporation delivery device, over a period of six months. One patient in the 0.4mg dose group and one in the 4mg dose group who received only a single dose of SCIB1 were withdrawn from the study due to progressive disease shortly after study entry and were replaced to ensure that at least three patients in each dose cohort could be fully evaluated for immune response. During the course of the study, regulatory approval was granted to increase the SCIB1 dose from 2mg to 4mg in patients in the 2mg cohort, if the treatment was well tolerated. Two patients in this group received two 4mg doses of SCIB1 and one patient received a single 4mg dose. Regulatory approval was subsequently obtained for treating a cohort of patients with 8mg of drug. Dosing of these patients is currently on-going.

In Part 2 of the study, 14 patients with resected Stage III/IV melanoma (eight with Stage III and six with Stage IV) entered the study. One patient was only able to tolerate three doses of 2mg and withdrew from the study. Of the remaining patients, 12 received a full 4mg dose of SCIB1 on five occasions over a period of 6 months and one received four doses of 4mg and one dose of 2mg.

During the course of the study, regulatory approval was granted to continue treating eligible patients for a period of up to 5 years from the formal end of the study. During this period patients can receive a 4mg dose of SCIB1 every 3-6 months.

Clinical response

Part 1

Four out of the six patients in the 2mg/4mg cohorts who received at least three doses of SCIB1 are still alive and one remains disease-free more than 2 years after starting treatment. All of the patients in the 0.4mg dose group have died from melanoma progression. The median survival time for the six evaluable patients in the 2mg/4mg cohorts is currently 25 months. 

One patient in the 4mg dose group with multiple tumour lesions present at the start of treatment showed a “differential response” pattern in which all of her lung lesions decreased in size or disappeared completely following six months of treatment with SCIB1 whereas one abdominal wall tumour nodule grew and was resected. Staining of tissue taken from the resected nodule showed it had lost expression of one of the target melanoma antigens, gp100, but had high levels of PD-1 protein, which is known to attenuate high avidity T cell responses; this suggests that combining SCIB1 treatment with anti-PD-1 monoclonal antibodies may be an effective therapeutic approach. The patient continued on extended treatment with SCIB1 until she was subsequently found to have recurrent melanoma in her intestines; this tumour was also excised and treatment was discontinued.

Part 2

All of the resected Stage III/IV patients treated with SCIB1 in Part 2 remain alive and only three have had progressive disease to date. One patient had their lesion excised in January 2013 and has no further disease progression to date. The other two patients have progressed within the last month. The median survival time for Part 2 patients is currently 15 months from study entry and 21 months from diagnosis of metastatic disease. 

Immune response

Immune response was measured by peptide-specific proliferation. A positive response required at least twice the background control at each time point and at least twice the pre-treatment control value on two or more of the six time points measured. In addition, responses were assessed using an enzyme-linked immunosorbent (ELISPOT) assay after T cell expansion in vitro, where a positive response was more than three standard deviations above the pre-treatment control value on two or more of the six time points measured. Fresh samples were analysed in both assays, except for one patient where the controls for the fresh proliferation assay were not validated and the assay was repeated using frozen samples.

Part 1

One patient in the 0.4mg cohort, all three patients in the 2mg/4mg dose cohort and two patients in the 4mg dose cohort mounted a measurable proliferation response to the melanoma-specific epitopes in SCIB1. In addition, the patient with the differential clinical response was assessed using the ELISPOT assay and made a strong response to the melanoma TRP-2 antigen.

Part 2

All 14 patients responded to treatment in either the proliferation or ELISPOT assay. Twelve patients were immune responders in the proliferation assay, 13 patients responded in the ELISPOT assay and 11 patients responded in both assays, including the patient who only received three doses of 2mg of SCIB1. Broad, high frequency responses were seen against both the two CD8+ T cell epitopes and against the two CD4+ T cell epitopes. Six patients responded to all four epitopes, five patients responded to three epitopes and three patients responded to two epitopes. Statistically significant responses (p>0.0001) were seen after three, four or five immunisations but not after two, indicating that at least three doses are required for a strong immune response to develop.

Due to these encouraging results six patients are continuing on extended, long-term treatment with SCIB1. 

Tolerability and Safety

The SCIB1 immunotherapy produced very few side effects, none of which were serious, with no new or unexpected issues found over those reported with the results from Part 1 of the study where no systemic doselimiting toxicities were observed. The most commonly reported adverse events were injection site reactions and cold- and flu-like symptoms. The electroporation procedure itself was less well-tolerated in some patients and, in certain cases, required pre-treatment sedation. However, only one patient has withdrawn from the study for this reason and seven chose to continue treatment in Part 2 of the study (one has since discontinued).

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 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.

Unaudited interim results for 6 months ending 31st October 2013

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the six months ended 31 October 2013.

Highlights during the period:

  • Recruitment of 8mg dose patient cohort continues as part of the previously announced  extension to Part 1 of the Phase1/2 study of ImmunoBody® vaccine, SCIB1  in patients with advanced melanoma
  • Planning for preclinical and clinical development of Modi-1, lead pipeline vaccine from Moditope® platform underway
  • Australia becomes first jurisdiction to grant DNA ImmunoBody® technology patent.  Counterpart pending in major territories around the globe
  • Operating loss for the period, £1.31m (2012: loss of £0.99m). Net loss £ 1.19m (2012: loss £0.92m)
  • Cash at bank at 31 October 2013 was £6.40m (30 April 2013: £1.49m), following a Placing and Open Offer of shares in August that raised £6.09 million (net of expenses) 
    • Data anticipated by 2014 calendar year end
    • Provisionally positioned as a novel immunotherapeutic for the treatment of triple-negative breast cancer, ovarian and endometrial cancers
    • First in-man clinical studies are scheduled to start in 2016

Post period highlights:

  • Important positive data from Part 2 as well as an update from Part 1 of the on-going Phase 1/2 clinical trial with SCIB1 in patients with Stage III/IV melanoma were announced today (see separate announcement)
  • Scancell granted an extension of the Option to commercialise Ichor’s proprietary Trigrid™ electroporation delivery system with SCIB1 
    • Melanoma-specific immune response seen in all Part 2 patients
    • Continuing positive survival trend in Part 1 subjects, although patient numbers are small
    • No serious adverse events reported

Richard Goodfellow, Joint CEO of Scancell, said:

“We are delighted with the results and progress generated from both our ImmunoBody® and Moditope® platform technologies during the period.  In particular, the immune response data released today from our lead programme, the SCIB1 ImmunoBody® vaccine for advanced melanoma, has exceeded our highest expectations.  We anticipate reporting data from the high dose 8mg arm of this Phase 1/2 trial by 2014 calendar year end.  While treated patient numbers are small, we believe our results to date add to the growing body of evidence that suggests that training T cells to target and control tumour growth could be one of the most promising new ways of treating cancer.  With that in mind, the discovery of the Moditope® platform technology could add a new dimension to cancer immunotherapy and form the basis of a completely new class of immuno-oncology treatments.  We are actively planning the preclinical and clinical development for Modi-1, our lead vaccine arising from this platform, as an immunotherapeutic provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers.

“As previously indicated at the time of our investor update in October, in view of the short to medium term licensing and partnership potential that both the Moditope® and ImmunoBody® programmes now bring to the Company, our strategy requires a more flexible approach.  Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will also consider technology validating and revenue generating deals on each platform in order to enhance the value of the Company when it is eventually sold.”

For Further Information:

Dr Richard Goodfellow, Joint CEO

Scancell Holdings Plc + 44 (0) 20 7831 3113

Professor Lindy Durrant, Joint CEO

Scancell Holdings Plc  

Camilla Hume/Stephen Keys

Cenkos Securities Plc

+44 (0) 20 7397 8900

Mo Noonan/Simon Conway FTI Consulting

+ 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 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.

CHAIRMAN’S STATEMENT

I am pleased to report the Company’s interim results for the six month period ended 31st October, 2013. During this period the Group has continued progress with the SCIB1 clinical trials and in August 2013 raised £6.1m (net proceeds) in additional investment through a placing and open offer of shares. These funds will enable the Company to commence work on the pre-clinical development of the first Moditope® immunotherapy product and will provide working capital for the completion of the existing SCIB1 clinical trials as well as enable the Company to recruit the further ten patients for the 8mg cohort of the Phase 1/2 trial.

We have also announced today (see separate release) the extremely encouraging new results from the ongoing Phase 1/2 clinical trial in patients with advanced melanoma. This data from Part 2 of the trial shows that all 14 patients produced a melanoma-specific immune response to treatment and all are still alive. Only three patients have any evidence of disease progression to date. In addition, the four patients from Part 1 of the study who were still alive at the time of the Part 1 report (December 2012) are still alive with a median survival time since treatment commenced of 25 months. Furthermore no serious drug related adverse events have been reported.

Financial

Profit and Loss Account

The Group made an overall operating loss for the six month period to 31st October 2013 of £1,306,556 (2012: loss of £989,981).

Overall the loss for the six month period was £1,187,574 (2012: loss £923,020).

Balance Sheet

The cash at bank at 31 October 2013 was £6,395,927 (30 April 2013: £1,491,320) and net assets amounted to £10,006,318 (30th April, 2013: £5,092,145)

SCIB1 melanoma vaccine

Clinical Trial

Additional encouraging results from the on-going Phase 1/2 clinical trial with SCIB1 in patients with Stage III/IV melanoma were announced today (see separate announcement).

In Part 1 of the study, 5/6 patients allocated to the 2mg and 4mg dose cohorts and who received at least three doses of SCIB1 produced a melanoma-specific immune response to treatment and 4/6 are still alive. In one of these patients all of the lung metastases showed partial or complete regression during treatment. All four surviving patients from Part 1 are still alive after a further 12 months on study. The median survival time from study entry in these two higher dose groups is now 25 months, although in three of these patients there is evidence of disease progression.

Part 2 of the study was conducted in 14 patients with resected Stage III/IV disease. All 14 patients (100%) produced a melanoma-specific SCIB1-induced T cell response to treatment. Only three patients have experienced progressive disease to date and all patients are still alive. The median survival time since initiating treatment with SCIB1 in Part 2 is currently 15 months and 21 months from diagnosis of metastatic disease. Six of these patients are continuing on extended, long-term treatment with SCIB1.

There have been no serious drug-related adverse events to date.

As a result of the positive results and minimal side effects seen with the 4mg dose, Scancell commenced evaluating an 8mg dose in parallel with Part 2 of the Phase 1/2 study. The higher 8mg dose SCIB1 study has been implemented for two reasons:

Firstly, one of the goals of Part 1 of the Phase 1/2 study was to establish a "maximally tolerated dose" of SCIB1 for use in Part 2. As there were no drug related side effects observed at 4mg, a maximally tolerated dose was not reached and a higher dose could improve the immune response even further.

Secondly, we were pleased to see a significant effect on tumour burden in one late stage patient in the Part 1 study. The Part 2 study, however, is primarily designed to assess immune response in resected Stage III/IV patients and although we will be monitoring the time to disease progression, we will not be able to measure an effect on tumour size. The extended Part 1 study using the 8mg dose is in patients with tumour load and will therefore provide the opportunity to assess whether we can reproduce the valuable data reported from Part 1 in an additional group of patients and at a higher dose. Data from this cohort of patients is expected in by 2014 calendar year end.

Moditope® vaccine technology platform

The Company has developed a new platform technology, Moditope® which has been used to develop the lead product, which will henceforth be described as Modi-1. Planning is underway for the preclinical and clinical development of Modi-1 as an immunotherapeutic, provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers. First in-man clinical studies are scheduled to start in 2016. Moditope® harnesses CD4+ cells to eradicate tumours and represents a new class of immunotherapeutic agents. The platform deploys citrullinated tumour-associated peptide epitopes to overcome self-tolerance and destroy tumour cells, with no requirement for blockade inhibitors (for example CTLA4 antibodies and PD-1 inhibitors). It can potentially be expanded to develop multiple immunotherapeutic agents for different cancers.

The ImmunoBody® platform induces a high avidity CD8+ T cell response to tumour associated antigens. As the Moditope® platform stimulates a potent CD4+ T cell response to modified self-antigens both platforms are complementary relying on a response by different classes of T cell for their therapeutic effect. Thus, in principle, a combination of ImmunoBody® and Moditope® derived therapeutics may be a powerful approach to the treatment of both early and late stage cancers.

Patents

A patent for Scancell’s DNA ImmunoBody® technology has been granted in Australia. This is the first jurisdiction to approve the DNA patent and is a key landmark on the road to comprehensively protecting Scancell’s DNA ImmunoBody® platform technology.

The patent, which covers the DNA ImmunoBody® platform technology and is of importance for the protection of Scancell’s entire pipeline of ImmunoBody® vaccines, has also been filed in the US, Europe and other major markets. The composition of matter patent for SCIB1, Scancell’s ImmunoBody® vaccine for the treatment of melanoma, has already been granted in Europe, Turkey and South Africa. Scancell’s protein ImmunoBody® patent has also been approved in the US, Europe, Japan and Australia.

A broad patent for Scancell’s Moditope® has been filed to protect this platform and covers the use of multiple tumour-associated modified epitopes for the treatment of cancer.

Ichor

Scancell signed an agreement with Ichor in July 2009 which provides for the supply and use of the TriGrid™ device for Scancell’s pre-clinical and clinical studies with SCIB1 and gives Scancell an option (‘The Option’) to license TriGrid™ for commercial use on payment of certain undisclosed milestones and royalties. The Option could be exercised at any time up to July 2014. In return, Ichor was granted share options to subscribe for Scancell shares at a subscription price of 4.5p including an option over 1,592,310 shares upon regulatory approval to start clinical trials being granted in the UK.

Since the end of the period, Scancell has been granted an extension of The Option to commercialise Ichor’s proprietary TriGrid™ electroporation delivery system with SCIB1, Scancell’s ImmunoBody® vaccine for the treatment of melanoma. Under the terms of the extension, Scancell’s Option, which had been due to expire in July 2014, will be extended until July 2016. In exchange, Scancell agreed to waive the two year lock-in period following the exercise of Ichor’s options over 1,592,310 shares at 4.5p which have been subsequently placed on the market.

Share Capital – Placing and Open Offer

On 1st August 2013 the shareholders of the Company approved resolutions for; (i) the placing of 20,000,000 ordinary 0.1p shares at a price of 22.5p and (ii) an open offer to qualifying shareholders, who had not taken part in the placing, to subscribe for 8,888,888 ordinary 0.1p shares at a price of 22.5p. Following the approval of these resolutions the company raised £6.1m, net of costs.

Outlook

The results released today from Part 2 of the Phase 1/2 study with the SCIB1 vaccine in advanced melanoma support the encouraging results from Part 1 of the study reported last year. Importantly, we have confirmed that SCIB1 induces a consistent melanoma-specific immune response in Stage III/IV melanoma patients, especially in those with resected disease. Whilst the numbers are still small, the results suggest that SCIB1 may be contributing to prolonged survival by controlling tumour growth. We remain confident that, as further long-term data is generated, both in these patients and those treated with the higher 8mg dose, the clinical and commercial potential of Scancell’s ImmunoBody® vaccine approach will be fully apparent. The results from this trial to date have exceeded our highest expectations and support our belief that the highly targeted ImmunoBody® approach is delivering potent T cells that can control malignant disease and adds to the growing body of evidence that suggests that training T cells to target and control tumour growth could be of the most promising new ways of treating cancer. Furthermore, in patients with more extensive metastases, it is feasible that combining SCIB1 with the latest checkpoint inhibitor drugs, which allow T cells to work better within the tumour environment, may offer further patient benefit.

The discovery of the Moditope® platform technology and its ability to induce potent CD4+ T cells against tumour associated epitopes could add a new dimension to cancer immunotherapy and form the basis of a completely new class of immune-oncology treatments.

As previously indicated at the time of our investor update in October, in view of the short to medium term licensing and partnership potential that both the Moditope® and ImmunoBody® programmes now bring to the Company, our strategy requires a more flexible approach. Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will also consider technology validating and revenue generating deals on each platform in order to enhance the value of the Company when it is sold.

Extension to Ichor Option and Issue of Equity

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 an extension of its option to commercialise Ichor’s proprietary Trigrid™ electroporation delivery system with SCIB1, Scancell’s ImmunoBody® vaccine for the treatment of melanoma. Under the terms of the extension, Scancell’s option, which had been due to expire in July 2014, will be extended until July 2016. In exchange, Scancell has agreed to waive the two year lock period following the exercise of Tranche 1 share options (over 1,592,310 shares).

The agreement with Ichor, signed in July 2009, provides for the supply and use of the TriGrid™ device for Scancell’s pre-clinical and clinical studies with SCIB1 and gives Scancell an option (the “Option”) to license TriGrid™ for commercial use on payment of certain undisclosed milestones and royalties. The Option could be exercised at any time up to July 2014. In return, Ichor was granted share options to subscribe for Scancell shares at a subscription price of 4.5p as follows: on regulatory approval to start clinical trials in the UK, 1,592,310 share options (“Tranche 1); on starting the first Phase II clinical trial, 3,184,620 share options (“Tranche 2); and on completing the first Phase II clinical trial, 3,184,620 share options (“Tranche 3”). Tranches 1 and 2 have already vested.

On 15 November 2013 Ichor exercised Tranche 1 of the share options. Following this exercise the Company has applied for 1,592,310 ordinary shares to be admitted to trading on AIM (“Admission”). It is expected that Admission will become effective and that dealings will commence in these Ordinary Shares at 21 November 2013.

Following admission of the 1,592,310 new ordinary shares the Company’s share capital will consist of 224,950,683 voting ordinary shares.

The above figure (224,950,683) may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Scancell under the FCA’s Disclosure and Transparency Rules.

Richard Goodfellow, Joint CEO of Scancell, said:

“Ichor’s proprietary TriGrid electroporation delivery system is central to our current studies on SCIB1. We are delighted to have extended the option agreement to commercialise the technology with the Company beyond July 2014. It enables us to continue to evaluate its potential to effectively deliver our vaccine now that we have decided to expand the Phase1/2 clinical trial on SCIB1 to include a further 13 patients on an 8mg dose and the need to continue treating patients being placed on long term maintenance therapy.”

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 7831 3113

 

About Ichor and the TrigridTM 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 TriGrid™ 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 and is in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

Scancell’s ImmunoBody® immunotherapies 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, Immunobody® and Moditope® are trade marks of Scancell Limited.

Investor update showcases Moditope® platform and updates SCIB1 trial progress

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, will today hold an investor update. Following an introduction by Prof. Peter Stern, Institute of Cancer Sciences, University of Manchester, Dr Richard Goodfellow and Prof Lindy Durrant, Scancell’s joint CEOs will present a business update as well an overview of the ImmunoBody® platform and SCIB1 clinical programme, including its current status.  A detailed introduction to the new Moditope® platform will also be given for the first time. 

Prof Durrant will review the SCIB1 clinical trial programme and confirm that the ongoing studies remain on track.  Further results from this trial are expected by the end of 2013.  SCIB1 is Scancell’s first cancer immunotherapy and is a product of the Company’s ImmunoBody® platform.  It is being developed for the treatment of malignant melanoma and is currently in Phase 1/2 clinical trials.  Encouraging results from Part 1 of the study have previously been presented and provide the first clinical evidence that Scancell’s ImmunoBody® immunotherapy approach is producing an immune response in cancer patients which may also be associated with clinical benefit.  Prof Durrant will today add that four out of the six evaluable patients treated with either the 2mg or 4mg dose of SCIB1 still remain alive. The mean survival time in this group of five Stage IV and one Stage IIIb patients is currently 21 months from trial entry. 

In view of the positive results and minimal side effects seen with the 4mg dose (Part 1) of the SCIB1 Phase 1/2 trial, the Company has initiated evaluation of an 8mg dose in up to six patients with measurable tumours.  Five patients have been recruited to date: one patient will no longer be evaluable due to delivery of an incomplete dose of SCIB1 and a further patient was not able to complete dosing within the required timeframe.  A safety review of the data from the 8 mg cohort in Part 1 will be conducted and, if adequate safety is demonstrated, Scancell plans to recruit a further 10 patients with measurable disease into Part 2 of the study.  An amendment has been submitted to the appropriate regulatory authorities to request approval to treat these additional patients at the 8 mg dose.  

Prof Lindy Durrant, the inventor of the Moditope® platform, will present a detailed overview of the technology and its potential.  She will describe how the technology was used to generate the lead product, SCMod1.  Planning is underway for the preclinical and clinical development of SCMod1 as an immunotherapeutic, provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers.  First-in-man clinical studies are scheduled to start in 2016.  Moditope® harnesses CD4+ T cells to eradicate tumours and represents a new class of immunotherapeutic agents.  The platform deploys citrullinated tumour-associated peptide epitopes to overcome self-tolerance and destroy tumour cells, with no requirement for blockade inhibitors (for example CTLA4 antibodies and PD-1 inhibitors).  It can potentially be expanded to develop multiple immunotherapeutic agents for different cancers.  A broad patent has been filed to protect this platform and covers the use of multiple tumour-associated modified epitopes for the treatment of cancer.

It will be recalled that the ImmunoBody® platform induces a high avidity CD8+ T cell response to tumour associated antigens.  As the Moditope® platform stimulates a potent CD4+ T cell response to modified self-antigens both platforms are complementary relying on a response by different classes of T cell for their therapeutic effect.  Thus, in principle, a combination of ImmunoBody® and Moditope® derived therapeutics may be a powerful approach to the treatment of both early and late stage cancers. 

In the second part of the seminar, specialist guest speakers, led by Professor Karol Sikora, Dean of Medicine at University of Buckingham, Medical Director of CancerPartnersUK and honorary Consultant Oncologist at Hammersmith Hospital, will form an interactive panel to discuss the increasing importance of immunotherapy for the treatment of cancer and how Scancell’s technology fits into this emerging landscape. 

Dr. Richard Goodfellow, joint CEO of Scancell, commented:  “We welcome this opportunity to update investors following the recent successful fundraising completed in August.  The SCIB1 clinical programme remains on track and further data is expected by the end of 2013.  Having now filed and exemplified the patents covering our Moditope® technology, we can provide more detail on how this second platform technology has the potential to generate a completely new class of potent and selective immunotherapy agents and which could have a profound effect on the way that cancer immunotherapies are developed.  In particular, the technology may overcome the immune suppression induced by tumours themselves without the need for checkpoint blockade inhibitors, thereby allowing activated T cells seek out and kill tumour cells that would otherwise be hidden from the immune system.

“In view of the short to medium term licensing and partnership potential that both the Moditope® and Immunobody® programmes now bring to the Company, our strategy requires a more flexible approach.  Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will now consider technology validating and revenue generating deals on each individual platform when and where appropriate in order to enhance the value of the company when it is sold.”

-ENDS-

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Eleanor Clarke FTI Consulting + 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials.  Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

Scancell’s ImmunoBody® immunotherapies 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.

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, Immunobody® and Moditope® are trade marks of Scancell Limited.

Investor Day Agenda

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is to host an Investor Update on Tuesday, 1 October 2013. Details of the event are:

Location  FTI Consulting
Holborn Gate
26 Southampton Buildings
London, WC2A 1PB
10.45 Registration with refreshments
11.00

Introduction David Evans,

Scancell Non-Executive Chairman

11.05

Cancer immunotherapy

Prof Peter Stern, Head of the Immunology Group, Paterson Institute for Cancer Research, University of Manchester

11.20

Scancell corporate update

Dr Richard Goodfellow, Joint CEO of Scancell

11.30

SCIB1 trial update and introduction to Moditope™

Prof Lindy Durrant, Joint CEO of Scancell

11.45 Q&A
12.00

Interactive panel discussion

Led by Prof Karol Sikora, Dean of Medicine , University of Buckingham; Honorary Consultant Oncologist at Hammersmith Hospital

Panellists include:

Prof Lindy Durrant,

Prof Peter Stern,

Dr Steve Chan, Consultant Oncologist, City Hospital, Nottingham University

and Prof Christian Ottensmeier, Dept. of Experimental Medicine, University of Southampton

12.45 Buffet lunch
13.30 Close

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Eleanor Clarke FTI Consulting + 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 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.

Investor Day

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is to host an Investor Update on Tuesday, 1 October 2013.

Joint CEO’s, Dr Richard Goodfellow and Professor Lindy Durrant will present an update on Scancell’s SCIB1 trial and an introduction to their new Moditope™ platform.  Specialist guest speakers, led by Professor Karol Sikora, will form an interactive panel to discuss how the natural immune system can be harnessed to eradicate tumour cells and the prospects for this emerging class of immunotherapies as effective treatments for cancer.  The event will be followed by a lunch.

Scancell is developing novel therapeutic vaccines for the treatment of cancer based on its ground-breaking ImmunoBody® and Moditope™ technology platforms.

Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of malignant melanoma and is in Phase 1/2 clinical trials.  Encouraging results from the Phase 1 part of the study provided the first evidence that Scancell’s ImmunoBody® vaccine approach is producing an immune response in cancer patients which may also be associated with clinical benefit.  In view of the positive results and minimal side effects seen with the 4 mg dose (Part 1) the Company has initiated evaluation of an 8 mg dose in parallel with Part 2 of the study. 

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer immune cells that destroy tumours without toxicity.  This Moditope™ platform has the potential to generate a completely new class of potent and selective immunotherapy agents and could have a profound effect on the way that cancer vaccines are developed.  In particular, the technology can overcome the immune suppression induced by tumours themselves without the need for checkpoint blockade inhibitors (for example CTLA4 antibodies and PD-1 inhibitors), thereby allowing activated T cells seek out and kill tumour cells that would otherwise be hidden from the immune system.

For further details of the event, please contact Mo Noonan or Eleanor Clarke at FTI Consulting.

-ENDS-

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0 497
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc  
Camilla Hume/Stephen Keys Cenkos Securities plc + 44 (0) 20 7397 8900
Mo Noonan/Eleanor Clarke FTI Consulting + 44 (0) 20 7831 3113

 

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 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.

DNA IB Patent in Australia

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that a patent for its DNA ImmunoBody® technology has been granted in Australia. This is the first jurisdiction to approve the DNA patent and is a key landmark on the road to comprehensively protecting Scancell’s DNA ImmunoBody® platform technology. 

The patent, which covers the DNA ImmunoBody® platform technology and is of importance for the protection of Scancell’s entire pipeline of ImmunoBody® vaccines, has also been filed in the US, Europe and other major markets. The composition of matter patent for SCIB1, Scancell’s ImmunoBody® vaccine for the treatment of melanoma, has already been granted in Europe, Turkey and South Africa.

Scancell’s protein ImmunoBody® patent has been approved in the US, Europe, Japan and Australia.

Dr. Richard Goodfellow, Joint Chief Executive of Scancell, commented:

"Our lead ImmunoBody® for melanoma, SCIB1, currently in Phase I/II clinical trials is based on the DNA approach. The approval of this DNA patent is therefore a very important step in the development and commercialisation of our ImmunoBody® platform. Scancell continues to build its growing portfolio of intellectual property in parallel with advancing the clinical trial programme on SCIB1.”

-ENDS-

For Further Information:

Scancell Holdings Plc  Dr Richard Goodfellow, Joint CEO  + 44 (0) 74 2323 0 497 
  Professor Lindy Durrant, Joint CEO   
Cenkos Securities Camilla Hume +44 (0) 20 7397 8900
  Stephen Keys  
FTI Consulting Simon Conway +44 (0) 20 7831 3113
  Mo Noonan  

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

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.

Frankfurt Listing

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that the Company’s ordinary shares have been included on the Quotation Board of the Open Market of the Frankfurt Stock Exchange with effect from today.  Scancell has appointed ACON Actienbank AG as Listing Coordinator for providing the quote on the Borse Frankfurt (Frankfurt Stock Exchange) under the symbol “SCP”.

The compliance listing is in addition to Scancell’s existing listing on the AIM market of The London Stock Exchange.

Richard Goodfellow, Joint CEO of Scancell, said: 

“Following meetings earlier in the year and our recent successful fundraising, we have received significant interest in the Company from German investors.  A quotation on the Borse Frankfurt gives these investors the opportunity to trade in Scancell and alongside our London listing.  We anticipate that having this Frankfurt listing will encourage regular trading by German retail investors, enhance liquidity in the Company’s shares and create a broad investor base to allow greater visibility amongst the European investment community.  The coming year is pivotal for Scancell as we await results from clinical trials on SCIB1 in malignant melanoma and the further development of our Moditope™ platform.”

 For Further Information:

Scancell Holdings Plc  Dr Richard Goodfellow, Joint CEO  + 44 (0) 74 2323 0 497 
  Professor Lindy Durrant, Joint CEO   
Cenkos Securities Camilla Hume +44 (0) 20 7397 8900
  Stephen Keys  
FTI Consulting Simon Conway +44 (0) 20 7831 3113
  Mo Noonan  
Dr. Reuter Investor Relations Eva Reuter [+49 251 980 1561]
  Kim von Ahn  

 

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

 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.

 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 8mg Study Update

Scancell Holdings plc, ("Scancell" or the "Company") the developer of novel immunotherapies for the treatment of cancer, was informed on 11 July 2013 that one of the three patients recruited into the higher 8mg dose study of SCIB1 will no longer be eligible for evaluation due to delivery of an incomplete dose of SCIB1 following a fault with the electroporation device for that patient. Scancell will recruit a replacement patient as soon as possible in order to complete the initial phase of the 8mg study which is to assess the safety and immune response produced by the 8mg dose prior to expanding the study to include a further ten patients as planned. The initial part of the study is now expected to be completed early next year.

The higher 8mg dose SCIB1 study has been implemented for two reasons:

  • Firstly, one of the goals of Part 1 of the Phase 1/2 study was to establish a "maximally tolerated dose" of SCIB1 for use in Part 2. As there were no drug related side effects observed at 4mg, a maximally tolerated dose was not reached and a higher dose could improve the immune response even further.
  • Secondly, we were pleased to see a significant effect on tumour burden in one late stage patient in the Part 1 study. The Part 2 study, however, is primarily designed to assess immune response in resected Stage 3 patients and although we will be monitoring the time to disease progression, we will not be able to measure an effect on tumour size. The extended study using the 8mg dose will be in patients with tumour load and will therefore provide the opportunity to assess whether we can reproduce the valuable data reported from Part 1 in an additional group of patients and at a higher dose.

Richard Goodfellow, Joint CEO of Scancell, said:

“With the higher dose study underway, we are now looking to recruit a new patient to ensure adequate safety and immune response data ahead of the extended trial of SCIB1 in patients with tumour load. We firmly believe that the data we gain from this additional trial will add further value to SCIB1 and the ImmunoBody® platform and look forward to reporting the results in due course.”

For Further Information:

Scancell Holdings Plc: + 44 (0) 74 2323 0 497
Dr Richard Goodfellow, Joint CEO
Professor Lindy Durrant, Joint CEO

Cenkos Securities: +44 (0) 20 7397 8900
Camilla Hume
Stephen Keys

FTI Consulting: +44 (0) 20 7831 3113
Simon Conway
Mo Noonan

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 in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

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.

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 2013

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 2013.

Highlights during the period:

  • Successful completion of Part 1 of the SCIB1 Phase 1/2 clinical trial
  • Part 2 of the SCIB1 Phase 1/2 clinical trial fully recruited and on track for completion by the end of 2013
  • Additional 8mg dose study underway, also expected to be completed by the end of 2013
  • Development of new Moditope™ platform
  • Strengthened IP with patents awarded in the US and Japan for protein Immunobody® technology platform
  • Peter Allen appointed as a Director

Post period highlights:

  • Placing and Open offer up to £6.5 million (announced today)

Richard Goodfellow, Joint CEO of Scancell, said:

“We have made excellent progress this year with the successful completion of Part 1 of our Phase 1/2 clinical trial for SCIB1, Part 2 remains on track and our additional 8mg dose study has also commenced. We are delighted that four of the six patients from the 2mg and 4mg dose groups are still alive with one patient remaining disease free two years after initiating treatment.

“We believe our innovative Moditope™ platform has the potential to generate a new class of powerful cancer immunotherapy treatments. We are putting funding in place to identify a lead from this programme and develop it through to the point at which we have secured regulatory approval to start clinical trials, a key value inflexion point. We are confident that such targeted further development of the Immunobody® and Moditope™ platforms will both strengthen Scancell's position as a leading immunotherapy player and allow it to realise an enhanced value for shareholders.”

Click here to read the full news article


For Further Information:

Scancell Holdings Plc   + 44 (0) 74 2323 0 497
Dr Richard Goodfellow, Joint CEO
Professor Lindy Durrant, Joint CEO 

Cenkos Securities    +44 (0) 20 7397 8900
Camilla Hume
Stephen Keys

FTI Consulting    +44 (0) 20 7831 3113
Simon Conway
Mo Noonan