Scancell Holdings Regulatory News (SCLP)

Scancell and ImmunID announce collaboration to predict SCIB1 responders using ImmunTraCkeR® 

Nottingham, UK and Grenoble, France, 30 July 2015 - Scancell Holdings plc ('Scancell' LSE:AIM SCLP), the developer of novel immunotherapies for the treatment of cancer, and ImmunID, an immune molecular diagnostics company, today announce an agreement to collaborate on a research project aimed at predicting which patients will respond best to SCIB1 treatment.

The study will use ImmunID's flagship clinical product, ImmunTraCkeR®, before and during treatment, to assess the immune-modulatory effect of Scancell's SCIB1 ImmunoBody® vaccine in patients with Stage III/IV metastatic melanoma. The ImmunTraCkeR® assay will be used to:

i) understand pre-existing immunity of Stage III/IV metastatic melanoma patients;

ii) monitor T cell diversity over time in order to assess immune-modulatory effect of the SCIB1 cancer vaccine;

iii) make a preliminary assessment of ImmunTraCkeR® acting as a predictor of response to SCIB1; and

iv) identify any other predictive or prognostic clinical value of T cell diversity.

ImmunID has been a pioneer in the field of immune molecular diagnostics for a decade. Its clinical product ImmunTraCkeR® evaluates a patient's immune status, from a simple liquid biopsy (5ml EDTA blood), based on T lymphocyte repertoire diversity. ImmunID has developed and patented the ImmunTraCkeR® diagnostic assay and is expanding its clinical utility to become the general immune companion diagnostics for all immune therapies and especially immune checkpoint agents.

Scancell's first ImmunoBody®, SCIB1, is being developed for the treatment of melanoma and is currently being evaluated in a Phase 1/2 clinical trial. The latest data suggests that SCIB1 may have the potential to significantly extend survival times, especially in patients with resected disease.

Dr Richard Goodfellow, Joint Chief Executive Officer of Scancell, said: "We are delighted to be working with ImmunID. This collaboration will provide an insight into T cell diversity in patients treated with our SCIB1 vaccine and their response to the treatment over time. We believe that ImmunID's ImmunTraCkeR® test will deliver valuable data that will provide deeper insight into the strong clinical results we have generated to date with our novel treatment for metastatic melanoma."

Dr Bernhard Sixt, Chairman and CEO of ImmunID, added: "We see this collaboration as an opportunity to provide Scancell with a relevant tool to measure the patient's immune status in the rapidly growing immuno-oncology field, while also widening the clinical value of our ImmunTraCkeR® assay. Ultimately, ImmunTraCkeR® may be used to predict which patients respond best to treatment."

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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 being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell's ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

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

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

SCIB1 mechanism of action

SCIB1 is a DNA ImmunoBody® immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines cross-presentation with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

About ImmunID

ImmunID adds precision to the immuno-oncology revolution by personalizing immunotherapy. With its decade-long experience in immune molecular diagnostics, ImmunID provide doctors with clinically meaningful data on the highly complex immune system to select the right therapy for individual patients and to monitor their response. ImmunID's flagship CE-marked product, ImmunTraCkeR®, evaluates the patient's immune status based on the T lymphocyte diversity, from a simple liquid biopsy. The company is establishing ImmunTraCkeR® as the general immune companion diagnostic assay for immune checkpoint inhibitors and other immunotherapies. In addition, ImmunID collaborates with pharma and biotech companies to optimize the development of their next-generation immunotherapies. ImmunID is ISO 9001 and ISO 13485 certified and runs a CAP-accredited laboratory in the MINATEC high-tech campus in Grenoble, France.

www.immunid.com - Follow ImmunID on Twitter: @ImmunID

About ImmunTraCkeR®

ImmunTraCkeR® is a proprietary CE-marked immune molecular diagnostics assay, which evaluates a patient's immune status in the blood based on combinatorial T cell diversity. Unlike most companion diagnostics tests, ImmunTraCkeR® is patient-specific rather than drug- or disease-specific, as it approaches the disease from the patient's own immune system perspective. ImmunTraCkeR® provides information on the patient's complex immune profile to evaluate clinical benefit or risk under treatment with immunotherapies. ImmunTraCkeR® may ultimately be used as immune companion diagnostics and answer the urgent medical need for efficient patient stratification tools in melanoma and other solid cancers.