Scancell Holdings Regulatory News (SCLP)

01 July 2019

Scancell Holdings plc

("Scancell" or the "Company")

H1 2019 Business Update

Scancell, the developer of novel immunotherapies for the treatment of cancer, today announces a business update following the progress made in H1 2019.

SCIB1 Phase 2 trial

As reported in April, the Company has received the necessary regulatory and ethical approvals to initiate the UK arm of the SCIB1 clinical trial. Operational activities for clinical centre initiation have been completed and active patient recruitment is anticipated in the coming weeks. The Company continues its dialogue with both Ichor and the FDA with respect to the TriGrid® v2.0 device specific questions and awaits further feedback from the agency with regards to the IND approval which is required to initiate the US arm of the study. The Company will update the market as soon as additional information is available.

Modi-1 manufacturing and preclinical programme

In May, the Company provided an update on progress towards initiating the Modi-1 Phase 1/2 clinical trial, with initiation of Good Manufacturing Practice (GMP) synthesis of the Modi-1 peptide conjugates at the PolyPeptide Group's facilities in The Netherlands. This has been progressed further with formulation work well underway to produce the final product for clinical testing and initiation of the preclinical toxicity testing programme.

Cancer Research UK SCIB2 partnership

Scancell and Cancer Research UK provided an update in May on their clinical development partnership for the development of Scancell's ImmunoBody® vaccine, SCIB2, as a potential treatment for patients with solid tumours. Pre-clinical studies demonstrated that administration of SCIB2 as a liposomal nanoparticle results in potent immune responses and prolonged survival, therefore SCIB2 will be administered using this new nanoparticle formulation in the planned Phase 1/2 clinical trial in patients with solid tumours.

Strengthened team and Clinical Advisory Board established

In January, Scancell strengthened its team by appointing Dr Samantha Paston as Head of Research and Dr Adrian Parry as Head of Manufacturing. Their expertise will be invaluable as we expand our R&D and manufacturing capabilities to further advance our ImmunoBody® and Moditope® pipeline products through clinical development. In May, Scancell appointed six world-leading clinicians to establish its Clinical Advisory Board, chaired by Professor Robert Coleman, to provide strategic guidance around the Moditope® clinical development programme.

Strengthened IP portfolio

During this period, the Company was granted a US patent that provides protection for Modi-1, the first clinical candidate from Scancell's Moditope® platform, a patent that provides protection for the Moditope® platform in Japan, and a European patent relating to FG88, a monoclonal antibody directed to tumour associated glycans.

Vulpes investment and Board position

In June, Scancell raised gross proceeds of £3,877,965.55 by the issue of 77,559,311 new ordinary shares to Vulpes Life Sciences Fund. Following this investment, Martin Diggle, Co-Founder and Portfolio Manager of Vulpes Investment Management, has been appointed to the Company's Board of Directors as a Non-Executive Director.

Dr Cliff Holloway, Chief Executive Officer, Scancell, commented:

"It has been a busy and productive six months for Scancell. We were pleased to welcome Vulpes as a shareholder in June and their investment not only strengthens our cash position, but provides a ringing endorsement of Scancell's future potential. We look forward to working with Martin Diggle, who will provide valuable insight as a Non-Executive Director.

In addition to expanding our team and establishing a Clinical Advisory Board of world class clinical oncologists, we further advanced our ImmunoBody® and Moditope® pipeline and expanded our intellectual property portfolio. In April, we received UK regulatory approval to initiate the new SCIB1 Phase 2 clinical trial and we look forward to updating the market on the US arm of this trial and patient recruitment in due course." 

For Further Information:

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system. They have the potential to be used as monotherapy or in combination with checkpoint inhibitors and other agents. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.

· SCIB1, the lead programme, is being developed for the treatment of melanoma. A phase 1/2 clinical trial has so far successfully demonstrated survival data of more than five years.

· SCIB2 is being developed for the treatment of non-small cell lung cancer and other solid tumours. Scancell has entered into a clinical development partnership with Cancer Research UK (CRUK) for SCIB2.

Moditope® represents a completely new class of potent and selective immunotherapy agents based on stress-induced post-translational modifications (siPTM). It stimulates the production of killer CD4 T cells which overcome the immune suppression induced by tumours, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Moditope® alone, or in combination with other agents, has the potential to treat a wide variety of cancers.

· Modi-1 is being developed for the treatment of solid tumours including triple negative breast cancer, ovarian cancer and head and neck cancer.

For further details, please see our website: www.scancell.co.uk