Biosceptre will be presenting a poster at the American Association for Cancer Research Annual Meeting (AACR) in Chicago this year, please find the time to come and talk about our understanding and exploitation of oncology target nfP2X7.
On the 21st of February Biosceptre’s proposed Phase I clinical trial for BIL06v (anti-cancer vaccine) was granted conditional approval by the Bellberry Ethics committee. Biosceptre is now proceeding to take BIL06v into a Phase I trial in late Q2 or early Q3 2018.
Biosceptre has high confidence in the safety of BIL06v, in part as a result of pre-clinical studies and compassionate access patients treated in Australia under the TGA’s Special Access Scheme.
The planned clinical trial will recruit between 20 and 30 patients from a basket of late stage cancers and seeks to confirm safety, tolerability and immunogenicity of BIL06v. The planned clinical trial will also seek to identify early indications of efficacy in humans.
CEO Gavin Currie said “Having recently closed entry to our Series A fund raising round, we are pleased that this fully funded clinical trial, building on significant preclinical data, has been conditionally approved. We consider that a successful clinical trial, our first for a systemic therapeutic product targeting nfP2X7, will provide further validation of nfP2X7. We are hopeful for first patient recruitment in Q2 2018.”
Biosceptre has received over £8M into its’ series A raise which will be used to resource the next stage of the companies’ development; progression into the clinic of Biosceptre’s first systemic products against novel oncology target nfP2X7. Biosceptre will close the series A on the 21st December, 2017.
The major portion of the raise received to date was led by Tuspark Science and Technology Service Group, the venture arm of Tsinghua University, Beijing, and was made through through its investment vehicle, Bluesky Partnership II L.P.
Biosceptre CEO Gavin Currie said “After a period of extensive preclinical work to establish the validity of the novel oncology target nfP2X7 for systemic therapies, the Biosceptre board is very pleased to see the company achieve this significant milestone. The work we have done to date on exploitation of nfP2X7 as a therapeutic target has shown incredible promise, and we are now very eager to generate in-human formal clinical trial results that bear out that promise.”
“We welcome Tuspark as they become a strategic shareholder, and look forward to working closely with them. We also thank other participants in this round for their support.”
At the boards’ direction, Biosceptre will apply the funding to progression of the companies’ highest priority clinical assets into Phase I and II trials in Australia. A Phase I trial of the peptide vaccine BIL06v is scheduled to start at three sites in Sydney Australia in 2018. Ethics approval has also been granted for a Phase I clinical trial for Biosceptre’s lead antibody BIL03s, however the company is currently reviewing improvements to this lead. In addition to these plans, a number of Investigator Initiated Trials at research centres are also in planning. Biosceptre anticipates announcing clinical milestones and results over the next 18 months, which would, if favourable, facilitate an IPO or trade sale as early as 2019.
About Tuspark S & T:
Tus Science & Technology Service Group is the leading S&T Service Platform by Tus-Holdings. It was jointly founded by Tus-Holdings and Tsinghua Holdings in 2014, with strategic investment from CCB and ICBC. It is a platform committed to helping customers with complex challenges and improving quality of life through S&T innovations. It is the first S&T service provider in China devoted to building an integrated platform for innovation and entrepreneurship and has total assets of RMB 50B+.
Biosceptre is a Cambridge, UK headquartered biotechnology company focused on developing next generation cancer treatments targeting nfP2X7. Sir Greg Winter, founder of Cambridge Antibody Technology and Domantis is acting chairman of the Biosceptre Board of Directors and also chairs the Science Advisory Board.
Biosceptre’s clinical programs include 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 number of clinical trials across a range of cancer indications. 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 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
- 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
- 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.
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
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 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 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.
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.
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 antibody 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.
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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