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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

Biosceptre closes AUD5m financing from existing investors

Funds to progress Phase I development of oncology product BIL-03s

Cambridge, UK, 9th July 2014. Biosceptre International Limited, the oncology company developing antibody products that target the nf-P2X7 receptor, today announced that it has raised AUD5m through a syndicate of existing investors. The funds raised will enable the Company to progress the lead systemic programme, BIL-03s through Phase I development.

This latest investment will start a 20 patient, multicentre, safety and efficacy, dose-escalation, Phase I study of BIL-03s. The primary endpoint of the study will be safety, however Biosceptre expects to also obtain preliminary data on pharmacokinetics and efficacy. The Company plans to start the trial in Q4 2014.

BIL-03s is a fully human monoclonal antibody that targets nf-P2X7, a non-functional form of P2X7, (a transmembrane ion channel receptor expressed on cell surfaces of many tumours). Targeting nf-P2X7 has the potential to treat a wide range of cancers.

“This latest financing shows the ongoing support Biosceptre has from its highly committed investors. The funds are central to the development of BIL-03s, a key asset in our internal product development portfolio,” said Gavin Currie, CEO of Biosceptre. “The Company strategy is to focus on the development of an internal pipeline of both topical and systemic antibody products in the therapeutics space. Concurrently, we have an external pipeline of cancer vaccines in development, through a series of collaborations. We are also seeking out-licensing agreements to develop cancer diagnostics and imaging technologies that take advantage of our proprietary position with nf-P2X7.”

Media contact:

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

Biosceptre moves corporate headquarters to the UK from Australia

Move provides greater access to investors, grants, partners and expertise

Cambridge, UK, 21st February 2014. Biosceptre International Limited, the oncology company developing antibodies to target the nf-P2X7 receptor, today announced that has moved operations to the UK, from Australia.

The move comes as Biosceptre enters the next phase of its development. The Company is currently progressing the applications of its unique intellectual property and knowledge of nf-P2X7, including systemic and topical applications for human and veterinary use, across therapeutics, diagnostics and imaging, and immuno-oncology vaccines.

“The move to the UK, in particular Cambridge, gives Biosceptre access to some of the greatest expertise in antibody engineering in the world. This, combined with greater access to capital, European grants, the favourable taxation position for R&D companies, and potential developmental partners on our doorstep, will provide Biosceptre with the greatest chance of commercial success,” said Gavin Currie, CEO of Biosceptre.

Following the move to the UK, Biosceptre will have its headquarters and main research facility in Cambridge, but will also maintain the existing facilities in Sydney, Australia.

Media contact:

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