Biosceptre appoints Sir Greg Winter as Chairman of the Board

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”.

Professor Francesco Di Virgilio joins Biosceptre Scientific Advisory Board

Press Release – Biosceptre announces today that Professor Francesco Di Virgilio, an international expert on the role of P2X7 in cancer, has joined the Scientific Advisory Board alongside its existing members, Sir Gregory Winter and Professor Terence Rabbitts.

Cambridge, UK, 28th July 2016  – Biosceptre, the therapeutic aFrancescoDiVirgiliontibody and immunotherapy company targeting the non-functional form of the P2X7 receptor (nfP2X7) across a broad range of cancers, announced today that Professor Francesco Di Virgilio, an expert in the role of P2X7 in cancer based at the University of Ferrara, has taken a position on the Biosceptre Scientific Advisory Board.

Professor Di Virgilio said: “I am impressed by Biosceptre’s progress in validating the “non-functional” form of P2X7 as a cancer target. Far from being “non-functional” nfP2X7 in fact has been shown to have a significant role in cancer cells. I think that the work that is being carried out is really exciting and the clinical applications potentially enormous. Biosceptre has generated a persuasive body of scientific and clinical evidence ranging from molecular biology through to clinical studies that suggests this receptor can be successfully targeted in cancer. This is of the utmost importance to me and therefore I am very pleased to be advising the science team directly and also through the SAB.”

Sir Gregory Winter said: “In recent years, work at Biosceptre has focused on establishing the role of nfP2X7 as a novel cancer target. I am therefore delighted that Professor Di Virgilio as a world expert on P2X7 and cancer will be joining the SAB.”

Gavin Currie, CEO, said: “We have characterised nfP2X7 and its relationship with cancer, leading to the development of a broad therapeutic portfolio. With one successful clinical trial already completed, we now have a further three clinical trials planned for 2016. Professor Di Virgilio will help with our ongoing investigations into the mechanism of action and our therapeutic validation studies, as well as supporting our progress into clinical trials.”

About Professor Di Virgilio:

Professor Francesco Di Virgilio is Professor of Clinical Pathology, University of Ferrara, Head of the Postgraduate School in Clinical Pathology and of the PhD School in Molecular Medicine and Pharmacology. He has published over 230 scientific papers, of which over 200 on purinergic receptor signaling, and his corporate experience includes being on the Scientific Advisory Board of Duska Therapeutics Inc and Affectis Pharmaceuticals AG.

He obtained a Medical Degree (MD) from the University of Padova. In 1982-3 he was Honorary Research Assistant at the University College (London) and in 1986-7 a Visiting Fellow, Department of Physiology and Cellular Biophysics, Columbia University, New York, before becoming Associate Professor of Molecular Pathology at the University of Padova in 1988, and Professor of General Pathology at the University of Ferrara in 1992. He was Chairman of the Center of Excellence for the Study of Inflammation (2001-2010), and Deputy-Rector for Research and Technology Transfer of the University of Ferrara (2011-2015). He is a member of the Faculty of 1000, Cell Biology Section, and an Academic Member of European Academy of Tumor Immunology.

About Biosceptre:

Biosceptre, a UK-based clinical-stage immuno-oncology company, has identified a novel and valuable target (nfP2X7), that is present in many cancers including lung, breast, colorectal and prostate, but absent from healthy tissue. Drugs targeting nfP2X7 have the potential to treat a wide variety of cancers, with minimal side effects, and in so doing win a significant place in an expected US$41 billion p.a. market. Biosceptre is set to enter pivotal clinical trials in 2016.

Each of the next-generation products in Biosceptre’s therapeutic pipeline is designed to target nfP2X7, a variant of the P2X7 transmembrane pore which has roles in healthy tissues, including cell proliferation signaling and also in apoptosis. The nfP2X7variant was originally identified as an oncology target by research undertaken at the University of Sydney in Australia by Dr Julian Barden. The ability to distinguish the non-functional form as it occurs in cancer, from the functional form, as it occurs in normal tissues, is key to the very high safety profile that Biosceptre’s products have demonstrated in preclinical studies.

A pivotal milestone for the industries’ adoption of the nfP2X7 target is a clinical Proof of Concept (PoC) in man. In order to expedite delivery of this milestone, Biosceptre has chosen to progress 3 different therapeutics, employing three different treatment modalities.

The first clinical candidate, BIL010t, is a topical treatment for skin cancers using a polyclonal antibody formulation. The second, BIL03s is a monoclonal antibody targeting solid tumours systemically (via injection or infusion) and the third, BIL06v, is a vaccine therapeutic that elicits an internal immune response in the patient, which then targets solid tumours.

With one successful phase I trial completed, Biosceptre will undertake three additional clinical trials in 2017:

·      BIL010t, – topical antibody treatment targeting Basal Cell Carcinoma (Phase II)

·      BIL03s, – systemic human domain antibody –  targeting solid tumors (Phase I)

·      BIL06v, – therapeutic peptide protein conjugate vaccine – targeting solid tumors (Phase I)

These trials will advance the awareness and exploitation of nfP2X7 as an important new approach to the treatment of a range of human cancers.

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Daniel Barton
Biosceptre
+ 44 1223 496 090
+61 412 548 824

Biosceptre presents at leading Immuno-oncology Investment Conference in Chicago

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

Sir Gregory Winter joins Biosceptre Board

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

Biosceptre Wins Funding from the UK Government-Backed, SMART Award to Develop Novel Cancer Diagnostic and Therapeutic Targets

10th March 2016

Cambridge, UK, 8th 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 nfP2X7, 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

Biosceptre appoints new Chief Scientific Officer

Appointment to accelerate commercialisation of lead products

Cambridge, UK, 20 October 2014. Biosceptre, the oncology company developing antibody products that target the nf-P2X7 receptor announces the appointment of Dr Shaun McNulty as Chief Scientific Officer (CSO).

Shaun’s appointment follows an organisational change as the Company progresses from product development to the next phase of product commercialisation. Shaun’s primary function will be to ensure that Biosceptre delivers successful clinical trials for BIL-010t (topical) and BIL-03s (systemic) anti-cancer programmes. The Directors of Biosceptre are pleased to announce the appointment of Shaun as CSO with immediate effect.

Shaun has a wealth of relevant leadership experience including over 18 years of managing development projects and teams within the Pharmaceutical and Biotechnology sectors. Shaun has held leadership positions at GSK, Syntaxin, and Pfizer, where he helped develop Lyrica pregabalin, to treat neuropathic pain and partial seizures. He has consulted for the Biotechnology sector over a 12 year period and has published broadly.

Shaun said: “I am pleased to become CSO at this exciting stage for Biosceptre, with the opportunity to progress human clinical trials to validate our positive findings from preclinical and clinical studies.”

Gavin Currie CEO, added: “I am delighted that Shaun has agreed to become CSO of Biosceptre. His wealth of experience will be enormously beneficial in taking Biosceptre’s programmes forward into the clinic and beyond.”

Media contact:

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

Biosceptre announces positive Phase I results for BIL-010t to treat Basal Cell Carcinoma

Trial further validates the nfP2X7 target in cancer

Cambridge, UK, 23rd July 2014. Biosceptre, the oncology company developing antibody products that target the nf-P2X7 receptor, announces positive results from its Phase I trial to assess the safety and tolerability of BIL-010t (formerly known as BSCT (Anti-nf-P2X7) 10% Ointment), a topically administered, highly purified sheep antibody therapy, to treat Basal Cell Carcinoma (BCC).

The Phase I trial, conducted in the US, was an open-label, single-arm, multicentre study, to assess safety, tolerability, and levels of anti-drug antibodies in the patients’ serum. The study enrolled 21 male and female patients, with a BCC lesion histologically confirmed within the previous four weeks, who self-applied the BIL-010t ointment for 28 days.

The results showed that BIL-010t was both safe and well tolerated, with very high levels of patient compliance. The only reported side effect, associated with treatment, was mild to moderate localised skin reactions. Levels of BIL-010t were generally undetectable in patients’ blood serum, and gave no evidence of immunogenicity in the majority of patients.

Although efficacy was not a prescribed endpoint of the trial, it was noted that 65% of patients (13 out of 20) who completed the study had decreases in the size of their BCC lesions. The reductions ranged from 10% to 56% reduction in the size of the BCC during the course of treatment.

“The results from this trial are extremely encouraging for the potential of nf-P2X7 as an entirely new target to treat cancer,” said Gavin Currie, CEO of Biosceptre. “BIL-010t is our lead topical programme for BCC, a form of cancer that results in between 2 and 3 million new cases in the US each year. This therapy has the potential in many cases to replace expensive, and often disfiguring, surgery.”

Media contact:

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

Biosceptre publishes preclinical data on nf-P2X7 in the Journal of Clinical and Cellular Immunology

Paper concludes Biosceptre’s target nf-P2X7 is ubiquitous to all cancer types

Cambridge, UK, 18 July 2014. Biosceptre, the oncology company developing antibody products that target the nf-P2X7 receptor, announces it has published preclinical research on its fully IP-protected cancer target.

For full text of the paper, click here: Non-Functional P2X7: A Novel and Ubiquitous Target in Human Cancer

The paper proposes that a key hurdle to the development of cancer therapies is identifying a target that is common to all cancers, but not found in healthy tissue. Using histological and staining techniques, the researchers tested many different cases and forms of prostate, skin, breast, bowel, ovarian, cervical, uterine, lung, liver, stomach, bladder, head and neck, testicular, and pancreatic cancer tissues for the presence of nf-P2X7.

The results showed nf-P2X7 to be present in all of these cancers; and importantly not present in comparitive healthy tissues. As such the researchers concluded that nf-P2X7 has the potential to provide a novel and broad therapeutic cancer target.

“In our minds, the results from this research couldn’t be clearer,” said Gavin Currie, CEO of Biosceptre. “This is significant data showing our proprietary target to be present in a wide range of cancer types, and is a commercially viable therapeutic target as it is not present in healthy tissues. We look forward to reporting on our topical and systemic clinical programmes that are already underway.”

Media contact:

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

Biosceptre secures Technology Strategy Board Award

Award to develop new therapeutic antibodies targeting nf-P2X7 to treat cancer

Cambridge, UK, 16th July 2014. Biosceptre International Limited, the oncology company developing antibody products that target the nf-P2X7 receptor, today announced it has secured a Technology Strategy Board Feasibility Study Award of £150k. This grant will allow Biosceptre to undertake a feasibility study to expand its pipeline of monoclonal antibodies (mAbs) to bind the nf-P2X7 receptor, a non-functioning conformation of the P2X7 receptor, for the treatment of cancer. This is the first Technology Strategy Board award that Biosceptre has secured since relocating to the UK in February 2014.

The project aims are to develop a series of mAbs, confirm their ability to bind nf-P2X7, and demonstrate in vitro cytotoxicity. Work is due to start on the project in July 2014.

Shaun McNulty, Commercial Manager, who secured the grant application said: “Feedback from the Technology Strategy Board reviewers highlighted Biosceptre’s strength of scientific approach, the fundamental technology, and potential for commercialisation as key factors in selecting us for the award.”

“We are delighted to have secured this funding through the Technology Strategy Board,” said Gavin Currie, CEO of Biosceptre. “This grant will enable the Company to further explore and develop new potential products to diagnose and treat cancer, taking advantage of our unique intellectual property position and proprietary knowledge of the nf-P2X7 receptor.”

Media contact:

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