Biosceptre has initiated its Phase I clinical trial of the peptide vaccine BIL06v, with the first patient treated at the initial trial site on 16th of August 2018. The first patient was recruited at the Sydney Adventist Hospital in Sydney, Australia, under treating physician and Principal Investigator Associate Professor Gavin Marx. Other clinical sites will be added to the trial in the coming months, and competitive recruitment for the minimum 6 month treatment is anticipated to proceed to the full cohort (20-30) within 12 months.

The trial will accept broad cancer indications with primary focus on prostate and lung cancer patients who are refractory to, or have refused, standard of care treatment. Breast, colorectal and other cancer patients will also be accepted.

The trial has been designed by Dr Bob Li, attending oncologist at the Memorial Sloan Kettering Cancer Center in New York. Dr. Li is a recipient of the American Society of Clinical Oncology (ASCO) Young Investigator Award, and the American Association for Cancer Research (AACR) Young Investigator Translational Cancer Research Award.

The trial will be overseen by Biosceptre’s Chief Medical Officer Professor Paul De Souza, who is Foundation Chair of Medical Oncology, School of Medicine, at Western Sydney University, and Honorary Professor of the NHMRC Clinical Trials Centre, University of Sydney.

Biosceptre’s BIL06v therapy is a peptide protein conjugate vaccine, administered in the presence of an adjuvant. Primary endpoints include evaluation of safety and immunogenicity, with secondary endpoints including dose limiting toxicity and/or maximum tolerated dose as well as recommended Phase II dose. Disease control rate at 12 weeks as well as progression free survival will also be examined.

Exploratory endpoints will include quality of life and overall survival, as well as serum tumour biomarkers and cellular immunogenicity. Archived tissue will be screened for expression of the nfP2X₇ target.

Biosceptre Acting Chairman Sir Gregory Winter said “The relationship between P2X₇ and cancer is a field of increasing research interest, and supports the potential of targeting nfP2X₇ in human cancer in the clinic.”

Chief Executive Officer Gavin Currie said “It is a long journey from discovery of a novel target like nfP2X₇ in oncology to eventually putting a first-in-class drug into the clinical setting, and I am delighted that all the hard work has come to fruition. We are very optimistic that this trial will meet its primary endpoints, a critical inflection point for value for our shareholders.”

Chief Medical Officer Paul de Souza said “I am delighted that the first patient has been treated on our Phase I trial. I look forward to reviewing the data and to taking BIL06v into further clinical studies”.

About Biosceptre

Biosceptre is a Cambridge UK headquartered biotechnology company focused on developing next generation cancer treatments targeting nfP2X_7. Biosceptre’s product pipeline includes a range of biologic therapeutics to treat a range of cancer types. For more information visit www.biosceptre.com.

About nP2X₇

Biosceptres’ pipeline, including clinical stage peptide vaccine BIL06v, all target nfP2X₇, a “non-functional” form of the P2X₇ receptor in which cell death signalling (pore functionality) is absent, but ability to sustain ion channel driven proliferation signalling remains.

Expression of nfP2X₇ is important in the avoidance of cell death by cancer cells. The target allows cells to avoid programmed cell death signals in the tumour micro-environment, and provides growth and metastatic advantages to cancer cells.

Biosceptre’s focus is on validation and exploitation of this novel immuno-oncology target by multiple therapeutic modalities including vaccine, antibody, and cell therapy (Car-T).

A paper describing Biosceptres’ recent discoveries of the relationship between nfP2X₇ and the tumour microenvironment, and confirming the role of nfP2X₇ in cancer cell biology has been published by the journal Oncogene.

A paper describing Biosceptres’ recent discoveries of the relationship between nfP2X₇ and the tumour microenvironment, and confirming the role of nfP2X7 in cancer cell biology has been accepted for publication by the journal Oncogene. This study demonstrates that

1. nfP2X₇ is essential for tumour cell survival
2. exposure to a high ATP concentration, similar to those found in the tumour microenvironment, increases nfP2X₇ levels on cells, and
3. nfP2X₇ is broadly expressed in patient-derived tumour sections from a wide range of cancers, confirming earlier studies

The published findings confirm that nfP2X₇ provides a novel therapeutic cancer target against multiple malignancies.

CSO Shaun McNulty said “This publication highlights the significant work that Biosceptres’ Research and Development team has undertaken to characterise nfP2X₇, an important new cancer target.  It also provides further confidence in our decision to progress BIL06v, our therapeutic vaccine candidate, into the clinic and justifies the development of additional therapeutics against nfP2X₇.”

This paper can be viewed online here https://www.nature.com/articles/s41388-018-0426-6

Biosceptre will be attending ASCO 2018 in Chicago. Please contact info@biosceptre.com if you would like to arrange a meeting,

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 nfP2X_7.

On the 21^st 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 nfP2X_7.  Biosceptre will close the series A on the 21^st 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+.

About Biosceptre:

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 and Tuspark S & T team celebrating Tuspark’s decision to invest in Biosceptre

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.