Category Archives: News

Biosceptre’s Phase 1 Clinical Trial for anti-cancer antibody BIL03s approved by Ethics Committee

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 5th 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 publishes a clinical study of topical drug BIL010t as therapy for BCC

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 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.

Media Contact

media@biosceptre.com

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