The oncology market has seen a significant transformation away from cytotoxic and anti-hormonal therapies toward more targeted therapies. Targeted cancer therapies are drugs or other substances that block the growth and spread of cancer by interfering with specific molecules involved in tumor growth and progression—Biosceptre’s products fall into this class. In 2013, IMS Health, Inc. estimated that targeted therapies represented 46% of global oncology sales, up from 11% a decade ago. In clinical development, the oncology drug pipeline has expanded by over 60% during the past decade, with approximately 90% of the focus on targeted agents.
The nfP2X7 receptor is a broadly occurring cancer target that has been identified on the surface of 20+ human cancer types, including lung, breast, colorectal, and prostate cancers. nfP2X7 has a significant positive attribute among cancer targets in that it is not expressed on the cell surface of normal, healthy tissue, minimizing the potential for side effects.
Biosceptre is developing three proprietary clinical candidates addressing the nfP2X7 target: (1) BIL03s, a domain antibody (dAb) for systemic treatment of solid and blood-based cancers; (2) BIL06v, a peptide-protein conjugate vaccine therapeutic that stimulates the patient’s own immune system to target nfP2X7 in cancers; and (3) BIL010t, a topical antibody (Ab) treatment targeting nfP2X7 in non-melanoma skin cancers. The Company has completed one clinical trial for BIL010t that has demonstrated favorable human safety data and indicative efficacy data that supports BIL010t and other products in the Company’s pipeline.
While BIL010t represents the most advanced-stage candidate in the Company’s pipeline (Phase I complete), Biosceptre believes that the other candidates in its pipeline (BIL03s and BIL06v) hold greater market potential.
In parallel, through a series of collaborations, Biosceptre has a pipeline of external development programs where the Company seeks out-licensing agreements to develop cancer diagnostics and imaging technologies, as well as veterinary programs, which can benefit from the Company’s proprietary position with nfP2X7.
The Company holds broad intellectual property (IP), with 13 granted U.S. patents and a global portfolio with protection through 2032. Biosceptre has secured IP protection on the nfP2X7 target until 2022 with additional protection covering therapeutic intervention until at least 2035 (with further patents in development).
The Company’s scientific team is highly experienced in product development. Its scientific advisory board is led by Sir Gregory Winter, a founder of Cambridge Antibody Technology, Domantis, and cofounder of Bicycle Therapeutics; and Professor Terrence Rabbitts, a professor of molecular biology at the University of Oxford. Sir Gregory Winter has also recently agreed to join the Company’s Board of Directors. The Company’s CSO, Dr. Shaun McNulty, has over 20 years of experience in major pharma and biotech drug discovery. Clinicians supporting the Company’s trials include Professor Gavin Marx (chair of the Section of Oncology at the Sydney Adventist Hospital [Aus.]), Professor Nick Pavlakis (head of medical oncology, Royal North Shore [Aus.]), and Dr. Bob Li (attending physician at Memorial Sloan Kettering [U.S.]).
Biosceptre seeks funding of £25 million (~US$32.8 million) for continued development of its oncology products. Funds are intended to cover the costs of Phase I trials for both BIL03s and BIL06v, with data collected in these two trials to include indicative efficacy signals. Funds are also earmarked to cover the costs of a Phase II trial for BIL010t, the planning work for Phase II trials for BIL03s and BIL06v, and the costs of advancing the preclinical portfolio to the selection of one or more further clinical candidates for development (approximately 8% [£2 million] of the funds sought are intended for this purpose). Lastly, funding may support an increase in infrastructure ahead of any potential initial public offering ([IPO] currently planned for the second half of 2017) and out-licensing activity for diagnostic and veterinary programs.