Scancell Holdings Regulatory News (SCLP)

Early Immune Effect of SCIB1 Cancer Vaccine Observed in Blood by ImmunTraCkeR® Companion Diagnostic

ImmunTraCkeR® to be incorporated into SCIB1's upcoming Phase II checkpoint inhibitor combination clinical trial

ImmunTraCkeR® represents potential companion diagnostic for early detection of patient response to SCIB1 immunotherapy

Nottingham, UK and Grenoble, France, January 11, 2016 - Scancell Holdings plc ('Scancell' LSE:AIM SCLP), the developer of novel immunotherapies for the treatment of cancer, and immune companion diagnostic developer ImmunID, today released data showing patient immunologic response to cancer vaccine SCIB1 can be demonstrated through monitoring changes in the diversity of T cells found in the blood.

The collaboration between Scancell and ImmunID to predict SCIB1 responders using ImmunTraCkeR® was announced in a press release on 30 July 2015.

"This initial data shows promise for the development of ImmunTraCkeR® as a companion diagnostic for SCIB1 cancer immunotherapy" said Dr Nicolas Pasqual, Co-Founder & Chief Science Officer of ImmunID. "The ability to identify patient responders to immuno-oncology treatments early is a key unmet clinical need which is likely to improve cancer patient outcomes."

Prof Lindy Durrant, Joint Chief Executive Officer of Scancell, said: "These results provide further evidence that SCIB1 can induce T cell responses that are associated with disease control. ImmunTraCkeR® shows promise as an assay for predicting which patients will benefit most from SCIB1 and we are looking forward to conducting additional research on this during our planned checkpoint inhibitor combination trial."

Dr Bernhard Sixt, Chairman & Chief Executive Officer of ImmunID, added: "These early but promising results are pointing towards the value ImmunID brings as a partner to biotech companies. We are convinced that ImmunTraCkeR® stratification will help to shorten clinical trial times, accelerate regulatory approval in the field of immuno-oncology and enhance investor confidence."

The data was generated through a pilot study performed in conjunction with Scancell's Phase 1/2 trial of the SCIB1 cancer vaccine in patients with resected stage III/IV metastatic melanoma. ImmunID's ImmunTraCkeR® assay was used to assess T cell diversity in the blood from patients before and during treatment with SCIB1. Results showed variations in T cell diversity kinetics during SCIB1 treatment, underlining the immune-modulatory effect of the vaccine, and indicated that patients had developed an immunological response to SCIB1. Interestingly, data also suggested that patients who relapsed did not have an adequate immunological response to the vaccine. These preliminary results will be confirmed in a larger patient population through an extended collaboration between Scancell and ImmunID.

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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 for cancer patients. 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.