Biosceptre announces today its membership of the COST Group (European Cooperation in Science & Technology) project COST BMBS 1406. This project, established in 2014, created the Ion chan-Immune response network that brings together internationally recognised scientists and companies across 15 European countries with the common goal of understanding the function of ion channels in immune cells.

Biosceptre joins BMBS1406 as a private research industry representative, with the goal of strengthening its collaborations and developing synergies with the scientific community. As an ion channel involved in immune response, P2X7 is the centre of significant interest for the COST Group BMBS 1406. By joining BMBS1406, Biosceptre is seeking to expand its understanding of its novel oncology target non-functional P2X₇ (nfP2X₇), a variant of the P2X₇ ion channel which Biosceptre has shown to play a critical role in cancer cell survival.

The specific aims of the BMBS1406 Ion channel-Immune response network are

1. to develop a strong European workforce to understand the role of ion channels in immune cells, and how deregulation of their function can cause disease, and
2. to identify new targets for therapeutic immuno-interventions through modulation of ion channels.

The European project COST BMBS 1406 Ion channel – Immune response aims to connect specific ion channels with specific functions and diseases of our immune system.

Biosceptres’ clinical candidates specifically target a non-functional form of the P2X₇ ion channel that is present only on the surface of cancer cells. Each of these clinical candidates has shown promising signs of efficacy in pre-clinical development as well as indicative efficacy and safety in compassionate access patients.

Biosceptre looks forward to contributing to COST 1406 as it seeks to achieve its goal of identifying new targets for therapeutic immuno-interventions through modulation of ion channels, and looks forward to participation within the group helping to increase understanding of the potential value of therapies targeting nfP2X₇.

About Biosceptre:

Biosceptre is a Cambridge, UK headquartered biotechnology company focused on developing next generation cancer treatments targeting nfP2X₇. Biosceptre’s programs include topical products, as well as systemic antibody-based therapeutics and vaccines, intended to treat a range of cancer types. With one successful phase I trial completed, Biosceptre will be progressing a range of candidates through the clinic, including:

• BIL06v, a therapeutic vaccine for treatment of solid tumours (Phase 1)
• BIL010t, a topical antibody treatment for Basal Cell Carcinoma (Phase 2)
• BIL03s, a systemic human domain antibody for treatment of solid tumours (Phase 1)These trials will further advance the establishing of nfP2X₇ as a new and important target for the successful treatment of a range of human cancers.

Biosceptre’s appointment of a CMO marks a major milestone in progression to the clinic of its therapeutic anticancer vaccine BIL06v against the novel oncology target nfP2X7.

Biosceptre is pleased to announce that Professor Paul de Souza has accepted the role of Chief Medical Officer at the company. Initially, Dr de Souza will provide guidance and insight on the Phase I clinical trial for Biosceptre’s cancer vaccine product BIL06v. The trial is expected to commence in Australia in 2H 2017.

Professor Paul De Souza is Foundation Chair of Medical Oncology, School of Medicine, at Western Sydney University; a conjoint Professor in the Faculty of Medicine, UNSW; and an Honorary Professor of the NHMRC Clinical Trials Centre, University of Sydney. He has over 20 years’ experience in caring for patients, especially those with brain cancer and genitourinary cancer, and clinical trials experience over the same period, including a stint as a Clinical Research Physician in a global research-based pharmaceutical company.

Paul will oversee the execution of the clinical trial protocol for Biosceptre’s innovative therapeutic cancer vaccine BIL06v, which targets the novel and promising oncology target nfP2X7. The Phase I trial will be run at two Australian sites initially: the SAN Hospital under clinical advocate A/Prof. Gavin Marx and the Northern Cancer Institute under clinical advocate A/Prof. Nick Pavlakis of the Royal North Shore Hospital.

Biosceptre CEO Gavin Currie said, “We are very pleased to have Professor de Souza join our executive team to take on the role of Chief Medical Officer; he brings to the company deep experience of oncology trials that will be critical to the success of our upcoming Phase 1 trial for BIL06v. We will also look to his expertise as we bring trials of our other clinical candidates online as well. We welcome Paul and look forward to a productive partnership with him and his practice.”

Professor de Souza said, “The BIL06v trial is an opportunity to investigate potential of therapies targeting a new and very promising oncology marker – nfP2X7 – discovered by Biosceptre. If the trials are able to replicate the safety and efficacy that have been indicated by results produced in preclinical studies of BIL06v, and in compassionate access patient treatments, this cancer vaccine therapy has potential to make a significant contribution to the successful treatment of many cancers.”

About Professor Paul De Souza:

Professor de Souza is Foundation Chair of Medical Oncology at Western Sydney University and is a practicing medical oncologist at Liverpool Hospital, St George Private Hospital, and Southside Cancer Care Centre. He runs a research laboratory at the Ingham Institute in Sydney, and is dedicated to developing new drugs for cancer patients and innovative methodologies for monitoring of cancers, and running many clinical trials.

After completion of his medical oncology training in Sydney, Paul was appointed as a Research Associate and later an Assistant Professor of Medicine at the University of Virginia where he developed his clinical and research interests in cancer drug development.

Professor de Souza’s Qualifications:

BScMed MB BS MPH Syd, PhD UNSW, FRACP
Professor de Souza’s Society Memberships & Professional Activities:
ASCO, AACR, SNO, MOG, COSA

About Biosceptre:

Biosceptre is a Cambridge, UK headquartered biotechnology company focused on developing next generation cancer treatments targeting nfP2X7. Biosceptre’s programs include topical products, as well as systemic antibody-based therapeutics and vaccines, intended to treat a range of cancer types. With one successful phase I trial completed, Biosceptre seeks to progress three products through the clinic:

– BIL03s, a systemic human domain antibody for treatment of solid tumours (Phase 1)

– BIL06v, a therapeutic vaccine for treatment of solid tumours (Phase 1)

– BIL010t, a topical antibody treatment for Basal Cell Carcinoma (Phase 2)

These trials will further advance the exploitation of nfP2X7 as a new and important target for the successful treatment of a range of human cancers.

About Western Sydney University (WSU):

Ranked in the Top 100 Young Universities in the World by Times Higher Education, WSU is a vibrant research institution committed to achieving excellence and impact by its research. Eleven of the University’s research disciplines, including Oncology and Carcinogenesis, were rated at Excellence in Research for Australia (ERA) level 5 in 2015, meaning that they ranked “well above world standard” – the highest ranking possible. 80 per cent of WSU’s research is now ranked world standard or above.

Further information on WSU can be found at https://www.westernsydney.edu.au/research/research.

Biosceptre’s proposed Phase I clinical trial for BIL03s (anti-cancer monoclonal antibody therapy) was granted conditional approval by the Bellberry Ethics committee. Biosceptre is now seeking partners and external funding to progress BIL03s into the clinic.

Biosceptre has high confidence in the safety of BIL03s, in part as a result of pre-clinical toxicology studies and compassionate access patients treated in Australia under the TGA’s Special Access Scheme.

The planned clinical trial, approved on 5^th of January, would recruit between 12 and 42 patients with a range of late stage cancers and seek in a Phase I clinical trial to confirm safety and tolerability of BIL03s and provide indications of efficacy in humans.

CEO Gavin Currie said “We are pleased that this clinical trial, building on significant preclinical data, has been conditionally approved, and believe that a successful clinical trial, our first for a systemic therapeutic product targeting nfP2X₇, would provide further validation of our oncology therapy target. We are now seeking partners and external funding to progress BIL03s into clinic.

Biosceptre has published a clinical study demonstrating that its topical drug BIL010t provides a novel, safe and tolerable topical therapy for BCC in the British Journal of Dermatology (BJD).

Basal cell carcinoma (BCC) is the most common type of cancer, and its incidence is increasing. Biosceptre has discovered a variant of an important signalling protein P2X₇, termed nfP2X₇, that occurs in the cancer cell membrane and is present in BCC. In nfP2X₇, a critical function involved in cell death is lost. Loss of this function is believed to play an important role in cancer. The nfP2X₇ receptor is uniquely targeted by Biosceptre therapies without significant off-target safety issues. Biosceptre has developed three therapeutic candidates targeting nfP2X₇. BIL010t, the subject of the BJD paper, is the most clinically advanced, and has the potential to provide a first in class therapy for BCC. Our article on BIL010t provides an overview of preclinical and clinical development activities to date for BIL010t.

(http://onlinelibrary.wiley.com/doi/10.1111/bjd.15364/abstract)

The data presented in the paper demonstrates high patient compliance for BIL010t, with treatment being well-tolerated. Efficacy was also investigated with lesion size measured prior to and after 28 days treatment, with 65% of patients showing a reduction in lesion area and 20% no change in area. Histopathology of post-treatment excision of lesion sites showed 8 patients with stable disease, 9 with partial response and 3 with complete response. The conclusions from this study show that antibodies against nfP2X₇ (BIL010t) have the potential to provide a novel, safe and well tolerated treatment for BCC.

Biosceptre is pleased to announce the appointment of Sir Greg Winter as interim Chairman of the Biosceptre Board. Sir Greg has led the Science Advisory Board of Biosceptre for over 4 years and also joined the Board of Directors as a non-executive director in May 2016.

Sir Greg said: “My interest in Biosceptre began when Domantis was involved in developing a domain antibody against nfP2X7 – a promising new target for immuno-oncology. Having served on the SAB for some years and on the the board for a short time, I am pleased to take the role of interim Chairman of the Board of Directors as the Biosceptre programme advances towards clinical trials.”

Gavin Currie, CEO of Biosceptre, said “We are grateful that Sir Greg has taken this further role at Biosceptre, increasing again his thought leadership and support for the business. I also take this opportunity to thank the outgoing Chair Peter Newton for his long support and service to Biosceptre”.

28th September, 2016

Daniel Barton spoke with Fintan Walton of Pharmaventures about the Biosceptre portfolio while attending the Sachs Associates 16th Annual Biotech in Europe Conference in Basel Switzerland.

Biosceptre represented at the 2nd Annual Immuno-Oncology: BD&L and Investment Forum

CHICAGO, USA, June 3, 2016 – Biosceptre, the therapeutic antibody company targeting the nfP2X₇ receptor across a broad range of cancers, was in attendance at the leading Immuno-oncology investment forum in Chicago last week in parallel with the ASCO convention.

Biosceptre delivered a 20 minute Investors’ Presentation – Biosceptre – Investor Deck Sachs June 2016 – including new preclinical data on the prevalence of the nfP2X₇ target and its’ role in cancer, and met with a number of major pharmas and biotech specialists.

As well as making a corporate presentation, Biosceptre also participated in one of the panels at the conference; Dr Shaun McNulty (Biosceptre CSO) represented on the IO Direct Therapeutic Strategies Panel which was co-chaired by James Mulé, Associate Center Director for Translational Research at the H. Lee Moffitt Cancer Center & Research Institute and Paul Rennert, Founder & Principal, SugarCone Biotech LLC, President and CSO, Aleta Biotherapeutics.

Fellow panelists included Francis Kern, Senior Director, External Scientific Affairs, Daiichi Sankyo, Inc., John Haurum, CEO, F-star Biotechnology Ltd., and Juergen Gamer, VP Business Development, APOGENIX AG

Biosceptre announces today that Sir Gregory Winter, founder of Cambridge Antibody Technology, Domantis and a co-founder of Bicycle Therapeutics Limited has joined the Board as a non-executive Director.

CAMBRIDGE, UK, May 31, 2016 -Biosceptre, the therapeutic antibody company targeting the nfP2X₇ receptor across a broad range of cancers, announced today that Sir Gregory Winter has taken a board position as non-executive Director. Sir Gregory has been strongly associated with Biosceptre since 2011 as chair of its Scientific Advisory Board.

In this role, he provided invaluable guidance driving a better understanding of Biosceptre’s novel nfP2X₇ oncology target and translation of the science to enable development of three promising therapeutic candidates. Based on this significant progress to date, Sir Gregory will now take on a broader role within Biosceptre.

Sir Gregory said: “I have taken an interest in Biosceptre since Domantis was involved in developing a domain antibody against nfP2X₇. Not only is nfP2X₇ an exciting target for the development of antibodies but also vaccines. I am therefore delighted that the Biosceptre programme is now at the stage that it can enter further clinical trials. I look forward to increasing my involvement in Biosceptre by providing guidance as a member of the Board.”

Gavin Currie, Biosceptre’s CEO, said: “I am delighted that Sir Gregory has agreed to join the board of Biosceptre at this exciting time for the company. We have characterised nfP2X₇ and its relationship with cancer, leading to the development of a broad therapeutic portfolio. With a successful clinical trial completed, demonstrating safety and a strong indication of efficacy, we have a further three clinical trials planned for 2016. The contribution that Sir Gregory has made as Chair of our Scientific Advisory Board has been invaluable to our progress and his new role as Board Director will help drive our advance into phase I and II trials this year.”

About Sir Gregory Winter:

Sir Gregory Winter is Master of Trinity College Cambridge, and until recently was a member of the Medical Research Council’s Laboratory of Molecular Biology (LMB), serving as both a Head of Division, and as Deputy (and Acting) Director.

Sir Gregory developed technology for making humanised antibodies and human antibodies in bacteria. Many of the therapeutic antibodies on the market now were developed using methods devised by Sir Gregory. As a Founder and Director of Cambridge Antibody Technology (acquired by AstraZeneca), of Domantis (acquired by GSK) and currently of Bicycle Therapeutics Limited, he has unique biotechnology industry experience.

Sir Gregory was elected a Fellow of the Royal Society (FRS) in 1990 and awarded the Royal Medal by the society in 2011 “for his pioneering work in protein engineering and therapeutic monoclonal antibodies, and his contributions as an inventor and entrepreneur”. Sir Gregory has also won several international awards including the King Faisal International Prize for Medicine, the Cancer Research Institute William B. Coley Award and the Canada Gairdner International Award. Sir Gregory was appointed Knight Bachelor in 2004.

About Biosceptre:

Biosceptre is a Cambridge, UK headquartered biotechnology company focused on developing next generation cancer treatments targeting nfP2X₇ including topical products, systemic antibody-based therapeutics and vaccines, to treat a range of cancer types. With one successful phase I trial completed, Biosceptre will undertake three additional clinical trials in 2016, to progress the following candidates to market:

•      BIL03s, a systemic human domain antibody for treatment of solid tumors (phase 1)

•      BIL06v, a therapeutic vaccine for treatment of solid tumors (phase 1)

•      BIL010t, a topical antibody treatment for Basal Cell Carcinoma (phase 2)

These trials will further advance the use of nfP2X₇ as a new and important target for the successful treatment of a range of human cancers.

Biosceptre will give a presentation on the science of nfP2X₇ in Chicago on the 3rd of June 2016 at the Sachs’ Associates 2nd Annual Immuno-Oncology: BD&L and Investment Forum.  For more information please visit

Daniel Barton
Biosceptre
media@biosceptre.com
+61 412 548 824
+1 650 249 4977

10^th March 2016

Cambridge, UK, 8^th February 2016 – Biosceptre, a biopharmaceutical company developing innovative diagnostic and therapeutic approaches to cancer, today announced that the UK government-backed Innovate UK SMART award scheme, has awarded the company £100,000 to support pre-clinical development of diagnostic approaches and antibodies to target Kidney and Lung cancers. This project will enable Biosceptre to obtain efficacy data and support the development of a companion diagnostic for the Company’s lead therapeutic candidate BIL03s. Biosceptre will also undertake business development activities to establish the commercial and clinical pathways for BIL03s development.

Biosceptre’s diagnostic and therapeutic candidates are based on its proprietary nfP2X₇ platform. This platform utilises antibody- and peptide-based approaches to target nfP2X_7, a unique variant of the P2X₇ receptor present on the surface of cancerous but not normal cells. Biosceptre has established freedom to operate and a strong global patent portfolio. Antibodies targeting nf-P2X₇ have shown specificity, safety and efficacy in pre-clinical studies. A phase I trial has confirmed safety and provided a strong indication of efficacy against basal cell carcinoma. Hence, nf-P2X₇ can be targeted safely and effectively.

Gavin Currie, Biosceptre’s CEO said; “Biosceptre is delighted to receive funding from the UK’s innovation agency to progress the development of our novel diagnostics and therapeutics targeting cancer. Successfully winning funding represents a major vote of confidence in our approaches to target cancer through nf-P2X₇. This award recognises the need for effective new diagnostic and therapeutic approaches against cancer, and the potential of our technology to protect against a wide range of disease-causing strains.”

Media contact:

Daniel Barton
Biosceptre
media@biosceptre.com
+61 412 548 824
+1 650 249 4977