Posts in Category: SCIB1

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.

Update on patient recruitment in the ongoing SCIB1 clinical trial

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, today announces the recruitment and treatment of the final patient in the second part of its Phase 1/2 clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. This part of the trial is being conducted in five UK centres in  patients with Stage III/IV disease to further assess the safety of treatment and to assess the cellular immune response induced by SCIB1. Patients  are being treated with a 4mg dose of SCIB1 on five occasions over a period of 6 months.  

In December 2012, Scancell released 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. Also in December 2012, Scancellannounced that the Gene Therapy Advisory Committee ('GTAC') and the Medicines and Healthcare products Regulatory Agency ('MHRA') Medicines Division had given their approval to dose an extra group of patients with a higher, 8 mg, dose of SCIB1. Scancell is planning to start treating patients with the 8mg dose shortly.

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

 "As expected, the recruitment of patients in the second part of the trial proceeded faster than recruitment for the first part of the trial, as we were not constrained by the cohort study design requiring sequential dose escalation, and there were more patients available with earlier stage disease. The recruitment and dosing of the final patient in Part 2 gives us confidence that this phase of the study will be completed by the end of 2013, consistent with previous expectations."

Dr Richard Goodfellow, Joint CEO  of Scancell Holdings, commented:

 "The SCIB1 clinical programme is progressing on schedule and, as previously announced, we expect the results for Part 2 of the study to be available by the end of 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 encouraging 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.

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 Trial Update - Approval to dose patients for up to 5 years

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 increase the maximum treatment period from 6 months up to a further 5 years in its Phase I/II clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The continuation option will be available for patients with stable disease. Approval was also granted to further broaden the study inclusion criteria. 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 for this extended period.

The clinical trial of SCIB1 is being conducted at five leading UK hospital centres in Nottingham, Manchester, Newcastle, Leeds and Southampton.

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

“This approval from GTAC and MHRA provides our Investigators with the opportunity to continue dosing patients whose disease has not progressed whilst receiving the SCIB1 vaccine and will allow the Company to gather longer term data on late stage melanoma patients for whom the prognosis is poor.”

A copy of this announcement is available for download on the Company’s website at www.scancell.co.uk 

-ENDS-

For further information contact:

Professor Lindy Durrant/Dr Richard Goodfellow  Scancell Holdings Plc  + 44 (0)207 653 9850 
Graham Herring/ Heather Armstrong  Newgate Threadneedle  + 44 (0)207 653 9850 
Ross Andrews/Tom Rowley  Zeus Capital  + 44 (0)161 831 1512 

 

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 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 DNA vaccine encoding 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 can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of high avidity and high frequency 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 Ichor Medical Systems 

Ichor Medical Systems’ TriGrid™ Delivery System (TriGrid) i s the first integrated and fully automated device for electroporation-mediated DNA administration in humans. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on four continents to provide its enabling TriGrid platform as a means for delivery of DNA drugs and vaccines in disease indications such as melanoma, malaria, hepatitis B virus (HBV) infection, human immunodeficiency virus (HIV) infection, melanoma, Alzheimer’s disease, and others. For further info visit www.ichorms.com

Vesting of Ichor Options

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, announces that, further to the commencement of the Phase II clinical trial for SCIB1, the Company’s first cancer vaccine which is being developed for the treatment of melanoma, 3,184,620 options previously granted to ICHOR Medical Systems Inc ('ICHOR') have now vested. 

As announced on 10 July 2010, ICHOR was granted options over a total of 7,961,560 ordinary shares in the Company (as adjusted for the subdivision of the Company’s share capital announced on 30 June 2011). The subscription price payable upon exercise of the options is 4.5p per share. The options were originally granted under a License and Supply Agreement ('the Agreement') dated 13 July 2009 made between Scancell and ICHOR. 

Under the terms of the Agreement, ICHOR agreed to supply its TriGrid™ electroporation device for Scancell's pre-clinical and clinical studies with SCIB1 and gave Scancell an option to license TriGrid™ for commercial use on achievement of certain milestones and payment of royalties. 

In return, ICHOR was granted options to subscribe for ordinary shares in the Company. The options vest as follows: 1,592,310 options vested on regulatory approval being granted to start clinical trials in the UK (which has already occurred); 3,184,620 options vested on starting the first Phase II clinical trial (which has recently occurred); and 3,184,630 options will vest on completing the first Phase II clinical trial. Each tranche of the options may be exercised at any time in the five year period after the relevant vesting date. 

A copy of this announcement is available for download on the Company’s website at http://www.scancell.co.uk/ 

-ENDS-

For further information contact:

Professor Lindy Durrant/Dr Richard Goodfellow  Scancell Holdings Plc  + 44 (0)207 653 9850 
Graham Herring/ Heather Armstrong  Newgate Threadneedle  + 44 (0)207 653 9850 
Ross Andrews/Tom Rowley  Zeus Capital  + 44 (0)161 831 1512 

 

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 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 DNA vaccine encoding 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 can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of high avidity and high frequency 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 Ichor Medical Systems 

Ichor Medical Systems’ TriGrid™ Delivery System (TriGrid) i s the first integrated and fully automated device for electroporation-mediated DNA administration in humans. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on four continents to provide its enabling TriGrid platform as a means for delivery of DNA drugs and vaccines in disease indications such as melanoma, malaria, hepatitis B virus (HBV) infection, human immunodeficiency virus (HIV) infection, melanoma, Alzheimer’s disease, and others. For further info visit www.ichorms.com. 

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.

Interim Results for the six month period to 31 October 2011

Scancell Holdings plc (“Scancell” or the “Company” or the “Group”), the developer of therapeutic cancer and infectious disease vaccines based on its patented Immunobody® platform, is pleased to announce the interim results for the six month period ended 31st October 2011.

Highlights:

  • Sub-division of share capital and Placing to raise £1.73 million;
  • Development of new vaccine candidate for the treatment of lung cancer;
  • Phase 1 clinical trial of SCIB1 proceeded to highest dose level following safety review;
  • SCIB1 patent awarded; and
  • Change of board structure.

Post Period Highlights:

  • Receipt of second tranche payment of £2.85 million in November 2011 relating to the sale of a portfolio of antibodies to Arana Therapeutics.

For further information contact:

Scancell Holdings Plc
Dr Richard Goodfellow / Professor Lindy Durrant
=44 (0) 20 7653 9842*

Newgate Threadneedle (Financial PR)
Guy McDougall / Heather Armstrong
+44 (0) 20 7653 9842

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.

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