Posts in Category: Immunobody

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

Proposed Firm Placing and Open Offer and Notice of General Meeting

THIS ANNOUNCEMENT IS RESTRICTED AND IT IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA, THE REPUBLIC OF IRELAND OR AUSTRALIA OR NEW ZEALAND OR ANY OTHER STATE OR JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Scancell Holdings plc (AIM:SCLP), the AIM-quoted developer of novel immunotherapies for the treatment of cancer, is pleased to announce a conditional Firm Placing and Open Offer to raise up to £6.5 million (before expenses) to enable the Company to commence work on the pre-clinical development of the first Moditope™ immunotherapy product, provide working capital for the completion of the Phase 1/2 SCIB1 clinical trial and for the recruitment of a further ten patients on the 8mg dose. As previously announced the Company expects to announce the preliminary results of the Phase 1/2 trial (excluding the patients on the 8mg dose) by the end of 2013.

The Company announces a conditional Firm Placing of 20,000,000 new Ordinary Shares at 22.5 pence each to raise gross funds of approximately £4.5 million by a means of a Firm Placing with investors in various EIS and VCT funds managed by Calculus Capital. In addition, and in order to provide Qualifying Shareholders with an opportunity to subscribe for new Ordinary Shares at the same price, the Company announces a proposed Open Offer to raise up to a further £2.0 million (before expenses).

Highlights

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

The funds raised in the Firm Placing and Open Offer, together with existing cash resources will enable the Company to:

  • identify a lead product from the Moditope™ platform to take into pre-clinical and clinical development by the third quarter of calendar year 2014. Scancell has provisionally selected triple-negative breast cancer (TNBC), ovarian and endometrial cancers as the initial target indications for the first clinical study which is scheduled to start in 2016;
  • provide working capital for the completion of the existing SCIB1 clinical trial;
  • and enable the Company to recruit a further ten patients for the recently initiated higher dose 8mg cohort of the Phase 1/2 trial.

The Board remains firmly committed to a trade sale at an optimal point where significant shareholder value has been created on both the ImmunoBody® and Moditope™ platforms.

Shareholders should be aware that if the Resolutions are not approved at the General Meeting, the Company will be unable to complete the Firm Placing. The Board is of the opinion that, without completion of the Firm Placing, the working capital currently available to Scancell will not be sufficient for its requirements for the next 12 months following the date of the Circular.

David Evans, Non-Executive Chairman of the Company, said: “We are delighted with the continued strong support for Scancell from its shareholders. Both our Immunobody© and newer Moditope™ technology platforms hold great promise as novel immunotherapy-based approaches for the treatment of cancer. We are committed to realising their potential for the benefit of both patients and shareholders.

“This financing, together with our existing cash resources, will allow Scancell to progress products from both technology platforms to significant value inflexion points in the near and medium term. We remain committed to a trade sale of the Company and while we acknowledge this additional work may delay such plans, we believe it will ultimately result in a markedly improved return to shareholders”

Reasons for the Fundraising

On 15 August 2012 the Company announced the development of a new platform technology (Moditope™). The Moditope™ platform stimulates the production of killer CD4 T cells with powerful anti-tumour activity. CD4 responses to cancer associated antigens have been notoriously difficult to generate whether presented as peptides, proteins or DNA. CD4 cells are vital for effective anti-tumour immunity. Scancell has identified and patented a series of modified epitopes that overcome this limitation. Scancell's Moditope™ technology produces killer CD4 T cells that destroy tumours without apparent toxicity. Tests have shown that not only do these epitopes stimulate CD4 killer T cell responses but that cancer patients can produce an immune response to these epitopes. The Board believes that the Moditope™ epitopes can be used to develop both DNA and peptide vaccines and could become an important component of many therapeutic vaccines in the future, both under development at Scancell and other companies.

The Board is excited about the potential of this innovative discovery and has been actively evaluating the strategic options for Moditope™ to determine which, in the Board’s opinion, will create the greatest value for shareholders. Following a detailed review of the options, the Board believes that significant additional value can be delivered to shareholders by the further development of the new Moditope™ platform technology. Although the Moditope™ platform is currently at an early stage, the Directors believe that the potential of this novel immunotherapy platform is likely to be considerable. Accordingly, the Board plans to identify a lead product to take into pre-clinical and clinical development by the third quarter of calendar year 2014. Scancell has provisionally selected triple-negative breast cancer (TNBC), ovarian and endometrial cancers as the initial target indications for the first clinical study which is scheduled to start in 2016.

In addition, and as previously announced, preliminary results from Part 1 of the Phase I/II clinical trials on SCIB1 have provided the first evidence that Scancell's ImmunoBody® vaccine approach is producing an immune response in cancer patients. In view of the positive clinical results and minimal side effects seen with the 4mg dose, the Company is currently evaluating an 8mg dose in 3-6 patients with evaluable disease. This additional cohort will permit an assessment of the safety and immunogenicity of an increased dose of SCIB1 in addition to the effect of this higher dose on tumour burden. The 8mg cohort is being evaluated in parallel with the second part of the Phase 1/2 study which is primarily designed to assess the effect of the 4mg dose on immune response in patients who have had all tumour removed prior to treatment. Three patients have been recruited to the 8mg dose cohort to date. The Board believes that it will also be important to demonstrate the safety and efficacy of the 8mg dose in a larger number of patients prior to a sale of the Company. As such, the Company intends, provided the 8 mg dose is well tolerated, to seek approval to recruit an additional ten patients with evaluable disease to strengthen the data set on the 8mg dose prior to closing the SCIB1 Phase1/2 programme. The Directors believe that the availability of data from additional patients will position the Company as a more attractive sale opportunity.

Accordingly, the Board believes that the Firm Placing and Open Offer are in the best interests of the Company and Shareholders as the funds raised 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.

Click here to read the full news article

For more information, please contact:

Scancell Holdings Plc
David Evans, Non Executive Chairman +44 (0) 7740084452 
Dr Richard Goodfellow, Joint CEO + 44 (0) 74 2323 0 497

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

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

Notes to Editors

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope™ technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma 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.

ImmunoBody® Patent Approved for Grant in Japan

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that a patent for its protein ImmunoBody® vaccine technology has been approved for grant in Japan. The patent has already been approved in the US, Europe and Australia.

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

“This is a further important step in the development and commercialisation of the ImmunoBody® platform and provides further evidence to support the novelty of Scancell’s  ImmunoBody®  technology in another key pharmaceutical market.  Scancell will continue building its growing portfolio of intellectual property in parallel with driving the clinical trial programme on SCIB1 forward during 2013.”

The Directors of the issuer accept responsibility for this announcement.

-ENDS-

For Further Information: 

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0497 
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0497 
     
Annie Cheng, CFA Visible Value LLP + 44 (0) 74 2323 0497 
     
Camilla Hume/Stephen Keys Cenkos + 44 (0) 20 7397 8900
     

About Scancell

Scancell is developing therapeutic vaccines for the treatment of cancer based on its ImmunoBody® and Moditope™ technology platforms. Scancell’s first cancer vaccine 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.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

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 have a profound effect on the way that cancer vaccines are developed.

SCIB1 Trial Update – Higher Dose Allowed in Phase 1/2 Trial

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that the Gene Therapy Advisory Committee (‘GTAC’) and the Medicines and Healthcare products Regulatory Agency (‘MHRA’) Medicines Division have given their approval to dose an extra group of patients with a higher, 8 mg, dose of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma.

The new cohort will recruit up to six more patients and will be recruited in parallel with the patients being recruited into Part 2 of the study.  Patients with metastatic tumour present may enter the new cohort so that their tumour response can be assessed, whereas patients who have had their tumours surgically removed may enter Part 2.  In addition, Scancell’s partner Ichor Medical Systems (‘Ichor’) has obtained the required parallel approval from the MHRA Devices Division for the use of Ichor’s TriGrid™ electroporation delivery device to administer SCIB1 to this additional group of patients.

Scancell is planning to start treating patients with the 8mg dose in the new year.

This update follows the announcement made by Scancell on 6th December 2012, of preliminary results from Part 1 of the Phase 1/2 clinical trial of SCIB1 in patients with Stage III/IV malignant melanoma. In view of the encouraging results and minimal side effects seen with the 4mg dose, the Company stated that it intended to evaluate an 8mg dose in parallel with Part 2 of the Phase1/2 study

Part 2 of the study continues to be on track to be completed by the end of 2013. A successful outcome, if achieved, would confirm the potential of SCIB1 as a new cancer treatment as well as validating the Immunobody® platform technology.

Prof. Lindy Durrant, Joint CEO of Scancell, commented:

“This approval from GTAC and MHRA provides Scancell   with the opportunity to determine whether a higher dose of SCIB1 would be even more effective in inducing immune response and clinical benefit in late stage melanoma patients.”

The Directors of the issuer accept responsibility for this announcement.

-ENDS-

For Further Information: 

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0497 
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0497 
     
Annie Cheng, CFA Visible Value LLP + 44 (0) 74 2323 0497 
     
Camilla Hume/Stephen Keys Cenkos + 44 (0) 20 7397 8900
     

The design  of the Phase 1/2 study

Part 1 of this Phase1/2 clinical trial was conducted in five UK centres in 11 patients with Stage III/IV malignant melanoma.  Patients were to be  given five doses of 0.4mg, 2mg or 4mg of SCIB1, delivered using the Ichor Medical Systems’ TriGrid™ electroporation delivery device, over a period of six months at the start of the trial, as well as at three weeks, six weeks, three months, and six months after the initial dose.

As this was the first human trial of SCIB1, safety of each dose was assessed before patients were given a higher dose.

In view of the positive results and minimal side effects seen with the 4mg dose the Company intends to evaluate an 8mg dose in parallel with Part 2 of the Phase1/2 study.

Part 2 of the study is being conducted in 13 patients with resected Stage III/IV disease and is designed to further assess  the cellular immune response, safety and tolerability of the 4mg dose when given over a period of 6 months.

About Scancell

Scancell is developing therapeutic vaccines for the treatment of cancer and infectious diseases based on its ImmunoBody® and Moditope™ technology platforms. Scancell’s first cancer vaccine 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.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

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 have a profound effect on the way that cancer vaccines are developed.

Update on SCIB1 Phase 1/2 clinical trial

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce preliminary results from Part 1 of the Phase 1/2 clinical trial of its DNA ImmunoBody® vaccine in patients with Stage III/IV malignant melanoma. Of the six patients allocated to the 2mg and 4mg dose cohorts and who received at least four doses of SCIB1, four have shown a vaccine-induced T cell response to treatment.

Although the study was not designed primarily to measure tumour response, one patient in the 4mg dose cohort with multiple tumour lesions at study entry had a differential response to treatment including partial or complete regression of all lung metastases. A further two patients who had all their tumours surgically removed prior to SCIB1 treatment have remained disease-free more than a year after first dosing. The vaccine produced very few side effects, none of which were serious.

These encouraging results provide 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 4mg dose the Company intends to evaluate an 8mg dose in parallel with Part 2 of the Phase1/2 study.

The first part of this 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 vaccine was well tolerated. Two patients in this group received two 4mg doses of SCIB1 and one patient received a single 4mg dose.

Clinical response

Three of the four patients in the 4mg cohort are still alive and one remains disease-free more than a year after starting treatment. The fourth patient progressed and died too soon after first dosing for any effect to be seen. Two out of the three patients in the 2/4mg cohort are still alive and one remains disease-free more than a year after starting treatment. The third patient died of progressive disease after 63 weeks. Three out of four patients in the 0.4mg dose group have died. The fourth patient is still alive 27 months after starting treatment.

One patient in the 4mg dose group had a long history of metastatic disease and multiple tumour lesions present at the start of treatment (including several in her lungs), all of which decreased in size or disappeared completely following six months of treatment with SCIB1 except for one abdominal tumour nodule which increased in size and which will be resected. This "differential response" pattern is typical of immunotherapeutic agents and is the first signal that SCIB1 may be having an impact on the course of the disease as well as inducing an immune response.

Two further patients on SCIB1 remain disease-free more than one year after treatment started. The first patient had a history of gradual disease progression in the six months prior to study entry, including the development of multiple tumour nodules, which were excised prior to study treatment. This patient was dosed five times with 4mg SCIB1 and had no tumour present at study entry so could not be evaluated for tumour response but is still disease-free 15 months after first dosing and 18 months after the last tumour surgery. The second patient (in the 2/4mg cohort), who also received two 4mg doses at three and six months after the start of dosing, was entered into the study after all recurrent tumour had been resected and remains disease-free, 17 months after first dosing and 23 months after the last tumour excision. Whilst these results are promising it should be emphasised that they will have to be confirmed in larger, controlled studies in due course.

Immune response

All three patients in the 2/4mg dose cohort and one patient in the 4mg dose cohort produced an immune response to the melanoma specific epitopes in SCIB1. Only one of the patients in the lowest dose group showed any immune response to treatment.

Immune response was measured by peptide-specific proliferation that was 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. The patient with the differential clinical response was also assessed using a cultured enzyme-linked immunosorbent (ELISPOT) assay and made a strong response to the melanoma TRP-2 antigen.

These preliminary results suggest that therapeutic vaccination with SCIB1 induces specific immune responses that may lead to clinical benefit. In view of the positive results and minimal side effects seen with the 4mg dose the Company intends to evaluate an 8mg dose in a further cohort of three to six patients with evaluable disease, thereby permitting an assessment of the safety and immunogenicity of an increased dose of SCIB1 in addition to the effect of this higher dose on tumour burden. This additional cohort will be evaluated in parallel with the second part of the Phase 1/2 study which is primarily designed to assess the effect of the 4mg dose on immune response in patients who have had all tumour removed prior to treatment.

Prof Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: “These preliminary results show for the first time that Scancell’s ImmunoBody® vaccine, SCIB1, can elicit melanoma-specific immune responses in patients that appear to be associated with clinical benefit and provides clinical validation for the ImmunoBody® approach. The assessment of a higher dose in patients with evaluable disease and the further assessment of immune responses in Part 2 of the Phase 1/2 trial should provide further evidence to support the use of ImmunoBody® vaccines for the treatment of cancer”.

Prof Poulam Patel, Principle Investigator and Prof of Clinical Oncology at the University of Nottingham, commented: “ I am pleased that we have successfully completed the first part of this study and that we have seen measurable immune responses in patients. I am particularly interested in the shrinkage of the tumours we have seen in a patient with lung secondaries and look forward to seeing the results of the next part of the study,”

Leading oncologist Karol Sikora, Professor of Cancer Medicine and external assessor to Scancell commented: “The positive immune response data and impressive clinical response in the patient with multiple lung metastases is encouraging news for patients with malignant melanoma. The temporal relationship of the disappearance of the lung metastases in this patient is very suggestive of the effective immune destruction of the cancer. I look forward to seeing the results of the ongoing studies and in particular whether a higher dose of SCIB1 will confirm the impact of SCIB1 on active disease.”

Dr Richard Goodfellow, Joint CEO of Scancell Holdings, commented: " This is a defining moment for Scancell. These preliminary yet encouraging results provide the first clinical endorsement for the groundbreaking cancer vaccine research undertaken by Scancell under the scientific leadership of Prof Durrant. We will continue to gather additional longer term data on these patients and those in Part 2 of the study during 2013.”

The Directors of the issuer accept responsibility for this announcement.

-ENDS-

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0497   
Professor Lindy Durrant, Joint CEO  Scancell Holdings Plc + 44 (0) 74 2323 0497

Annie Cheng, CFA Visible Value LLP + 44 (0) 74 2323 0497

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


The design of the Phase 1/2 study

Part 1 of this Phase1/2 clinical trial was conducted in five UK centres in 11 patients with Stage III/IV malignant melanoma. Patients were to be given five doses of 0.4mg, 2mg or 4mg of SCIB1, delivered using the Ichor Medical Systems’ TriGrid™ electroporation delivery device, over a period of six months at the start of the trial, as well as at three weeks, six weeks, three months, and six months after the initial dose.

As this was the first human trial of SCIB1, safety of each dose was assessed before patients were given a higher dose.

In view of the positive results and minimal side effects seen with the 4mg dose the Company intends to evaluate an 8mg dose in parallel with Part 2 of the Phase1/2 study.

Part 2 of the study is being conducted in 13 patients with resected Stage III/IV disease and is designed to further assess the cellular immune response, safety and tolerability of the 4mg dose when given over a period of 6 months.

About SCIB1

SCIB1 is a plasmid DNA which encodes a human antibody molecule engineered to express a melanoma antigen called Tyrosinase-Related Protein 2 (TRP2) plus two helper T cell epitopes. Following immunisation, the engineered antibody will be expressed and be taken up by dendritic cells, resulting in the development of immune responses against tumour cells expressing the TRP2 antigen.

SCIB1 was designed so that the Fc component of the engineered antibody will be recognised by the high affinity CD64 receptor present on dendritic cells, leading to a significant enhancement of both the frequency and avidity of the T cell immune response. The induction of high avidity T cells against TRP-2 is expected to lead to the inhibition and regression of both primary and metastatic tumour growth.

About ImmunoBody®

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

About Scancell

Scancell is developing therapeutic vaccines for the treatment of cancer and infectious diseases based on its ImmunoBody® and Moditope™ technology platforms. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

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 have a profound effect on the way that cancer vaccines are developed.

SCIB1: First patient treated in Phase II clinical trial

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce the recruitment and treatment of the first patient in the second part of its Phase I/II clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The Phase II part of the trial will be conducted in five UK centres in thirteen patients with Stage III/IV disease to further assess the safety of treatment and to assess the cellular immune response induced by SCIB1. Patients will be treated with a 4mg dose of SCIB1 on five occasions over a period of 6 months. The study is expected to take 18 months to complete. 

Professor Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: 

“Although the recruitment of patients to early stage cancer studies can be very challenging, we expect recruitment for the Phase II part of the study to be substantially faster than for Phase I as we will not be constrained by the cohort study design required for dose escalation, there are more patients available and they are likely to have earlier stage disease.” 

For further information contact:

Scancell Holdings Plc  Dr Richard Goodfellow / Professor Lindy Durrant  + 44 (0)20 7653 9850* 
Newgate Threadneedle (Financial PR)  Graham Herring / Heather Armstrong  + 44 (0)20 7653 9850 
Zeus Capital - Nominated Adviser/Joint Broker  Ross Andrews/Tom Rowley  + 44 (0)161 831 1512 
XCAP - Joint Broker  Jon Belliss/ Adrian Kirk  +44 (0)207 101 7070 

*calls to this number will reach Newgate Threadneedle, at Scancell’s instruction. 

About Scancell 

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is currently in Phase II clinical trials. 

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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. 

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations. 

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses. 

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases. 

SCIB1 Trial Update

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce the completion of recruitment to the Phase I clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial is being conducted in five UK centres in patients with Stage III/IV disease, and it is anticipated that Phase II trials will commence in the next few weeks. 

Scancell has obtained approval from the Cohort Review Committee to commence the Phase II study using the 4mg dose, the highest dose used in the Phase I part of the study. The approval is based upon safety data collected after all patients have been treated for 6 weeks. The Phase I patients will continue to be treated and followed up for a total of 6 months. 

Professor Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: 

“The recruitment of patients to early stage cancer studies can be very challenging and it is a tribute to both the dedicated Scancell team and the efforts of our clinical investigators that we have now completed recruitment for the Phase I part of the study. We expect recruitment for Phase II to be substantially faster than for Phase I and hope to treat the first patient in this part of the study within the next few weeks.” 

For further information contact: 

Scancell Holdings Plc  Dr Richard Goodfellow / Professor Lindy Durrant  + 44 (0)20 7653 9850*
Newgate Threadneedle (Financial PR)  Guy McDougall / Heather Armstrong  + 44 (0)20 7653 9850 
Zeus Capital - Nominated Adviser/Joint Broker  Ross Andrews/Tom Rowley  + 44 (0)161 831 1512 
XCAP - Joint Broker  Jon Belliss/ Adrian Kirk 

+44 (0)207 101 7070 

*calls to this number will reach Newgate Threadneedle, at Scancell’s instruction

ImmunoBody® Patent Approved in US

Scancell Holdings plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that its protein ImmunoBody® vaccine patent has been approved in the United States. The patent, which has already been approved in Europe and Australia, will further strengthen Scancell’s IP position around its proprietary ImmunoBody® vaccine platform.

Scancell’s lead vaccine, SCIB1 is being developed for the treatment of melanoma and is currently in Phase I clinical trials. It is an innovative DNA vaccine being developed using Scancell’s ImmunoBody® technology. Phase 2 trials are due to start in Q2 2012.

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

“The USA remains the most important market in which to commercialise our ImmunoBody ® vaccines. The award of this US patent confirms the innovative nature of the ImmunoBody ® platform and provides a sound basis on which to commercialise the technology in the US.  Scancell will continue building its growing portfolio of intellectual property in parallel with driving the clinical trial programme forward during 2012”.  

Enquiries:

For further information contact: 

Scancell Holdings Plc  Dr Richard Goodfellow / Professor Lindy Durrant  + 44 (0)20 7653 9850*
Newgate Threadneedle (Financial PR)  Guy McDougall / Heather Armstrong  + 44 (0)20 7653 9850 
Zeus Capital - Nominated Adviser/Joint Broker  Ross Andrews/Tom Rowley  + 44 (0)161 831 1512 
XCAP - Joint Broker  Jon Belliss/ Adrian Kirk 

+44 (0)207 101 7070 

*calls to this number will reach Newgate Threadneedle, at Scancell’s instruction

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1 is being developed for the treatment of melanoma and entered clinical trials in 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

 The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

SCIB1: Patent Awarded

Scancell Holdings plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, announces that a composition of matter patent (European Patent number 2193803) has been granted for the Company’s lead vaccine, SCIB1. SCIB1 is being developed for the treatment of melanoma and is currently in Phase I clinical trials. It is an innovative DNA vaccine being developed using Scancell’s ImmunoBody® technology. This patent will protect the unique composition of the vaccine until March 2028.

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

“This patent grant is a further important step in the development and commercialisation of SCIB1. Scancell will continue building its growing portfolio of intellectual property in parallel with driving the clinical trial programme forward during 2012”.

For further information contact:

Scancell Holdings Plc
Professor Lindy Durrant/Dr Richard Goodfellow
+44 (0)207 245 1100*

Hansard Group (Financial PR)
Adam Reynolds/Guy McDougall
+44 (0)207 245 1100

Zeus Capital - Nominated Adviser
Ross Andrews/Tom Rowley
+44 (0)161 831 1512

XCAP Securities Plc - Broker
John Belliss/Adrian Kirk
+44 (0) 207 101 7070

*this number will direct callers to Hansard Group, at the Company’s request.

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1, which entered clinical trials in 2010, is being developed for the treatment of melanoma.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

SCIB1: Safety Review and Dose Escalation

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that the  second group of patients receiving the 2mg dose of SCIB1 (its DNA ImmunoBody® vaccine being developed for the treatment of melanoma) in the Phase I clinical trial has been evaluated by the Cohort Review Committee.

Following review of the safety data from this mid-dose level group of three patients, the Cohort Review Committee has approved further escalation of the dose to 4mg and recruitment of the final group of patients as planned. 

The trial, which commenced in June 2010, is designed to evaluate the safety and tolerability of SCIB1 in patients with late stage melanoma and also to gather data on the effects of SCIB1 on tumour growth and cellular immune response. 

Professor Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: “We are pleased that the Cohort Review Committee has given us the go-ahead to escalate the dose of SCIB1 to the highest dose level. This data, combined with the recent recruitment of a fifth trial centre at Southampton demonstrates that we are continuing to make good progress in our Phase 1 study. We expect to commence the Phase 2 study in late 2011/early 2012 as planned.”

For further information contact:

Scancell Holdings Plc
Professor Lindy Durrant/Dr Richard Goodfellow
+ 44 (0)207 245 1100
   
Hansard Communications
Adam Reynolds/Guy McDougall
+ 44 (0)207 245 1100
   
Zeus Capital - Nominated Adviser
Ross Andrews/Tom Rowley
+ 44 (0)161 831 1512

XCAP Securities Plc - Broker
Jon Belliss/Parimal Kumar
+44 (0) 207 101 7070About Scancell

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell’s first cancer vaccine SCIB1, which entered clinical trials in 2010, is being developed for the treatment of melanoma.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.