ADC Biotechnology Limited
ADC Biotechnology Limited
ADC Biotech’s patented ‘Lock-Release’ platform addresses problems with the development of ADCs – the Next Generation of Blockbuster Cancer Therapeutics
ADC Biotechnology provides specialist drug manufacturing services based on its own patented Lock-Release™ processing technology, focused on a new wave of oncology therapeutics called antibody-drug conjugates (“ADCs”) being developed by pharmaceutical companies worldwide. ADC is already achieving revenues of £1.4m and has recently won its 90th project.
The remit of the Company is to develop a technology platform for the efficient development & manufacture of new ‘Magic Bullet’ cancer therapies, ADCs. Application of its core Lock-Release™ technology enables maximum therapeutic effect with better patient outcomes; it considerably shortens the development timeline to clinical testing and can significantly reduce supply chain costs by maximising manufacturing yield & productivity.
The Company was co-founded by sector specialists Dr Pete Jackson, Charlie Johnson and Dr Dave Evans. In September 2010, the Company secured £40k of seed funding from the founders and an additional £15k grant support from the Welsh Government to undertake a techno-commercial feasibility study and commence proof-of-concept laboratory work.
Subsequent equity rounds and R&D grant funding, totalling £1.03m enabled the company to develop operations within the OPTIC Incubator, expand the technical services group and dedicated R&D laboratory and to develop the technology platform to a commercial position.
The Company achieved profitability during FY2015 and at the financial year-end recorded a small profit. Accumulated technology service profits across FY2016 to FY2018 will be used to partly fund the planned expansion into clinical manufacturing.
The Company has secured a mid-term contract with a European biotech customer. This contract together with other contracts already secured provides significant revenue contracted for FY2017.
The Company is targeting R&D technical service growth to £2m by FY2018. This additional growth will be facilitated by communication of the Company’s investment in manufacturing services for clinical trial materials.
The Directors believe the Company is in an exceptional position to exploit the significant commercial traction it has built through its technical services business over the last 3 years, and importantly the inroads it has made in positioning its maturing Lock-Release™ technology platform with key ADC developers.
The Company intends to move in to a manufacturing facility for the production of ADCs for testing in human clinical trials, which will be brought in line with the current cGMP standards for the manufacture of ADCs, approved by the UK medicines regulator (MHRA). The initial facility will provide capability for 2 segregated, parallel manufacturing streams that can be combined in a flexible configuration as required. The facility will be approx. 4,000m2 with expansion as required to 4,000m2 for build on of a commercial manufacturing facility. The estimated capital cost of the project will require an investment of £2.9m.
The Company intends to proactively pursue a strategy of embedding Lock-Release™ technology into as many early stage customer ADC programmes as possible, with the intention of locking in the Company’s technology and maximizing future license revenues.
R&D Technical Services
Technical Services (discovery and pre-clinical) revenues are currently in excess of £1.4m and are growing strongly.
To date, ADC Biotech has completed more than 90 R&D projects, many of which are repeat business from a core number of clients. The Company has some 10 key clients, with which they work on a semi-continuous basis. In addition, ADC Biotech has a number of one-off clients, including UK universities and EU biotechs.
Two other important trends in terms of the Company’s existing technology services projects are: (i) increasingly they are using Lock-Release™ technology as an R&D enabling tool and, (ii) its project portfolio is maturing. The latter is resulting in an increasing involvement in pre-clinical candidate development work, where the endpoint is either investigational toxic materials or pivotal toxic materials.
Clinical Manufacturing Services
The Company anticipates that its existing clients and prospective clients are more likely to place their key pre-clinical development projects with the Company if they are confident that the Company can progress its services into pivotal clinical manufacturing services.
Based on this established project pipeline and high value established customer relationships, the Company forecasts a significant increase in clinical manufacturing projects.
The Company’s Lock-Release™ technology has been developed to a point where it can now be applied in pre-clinical manufacturing and transferred to GMP manufacturing.
Any conjugation process which uses Lock-Release™ gains a key advantage over conventional solution based processing, where scale and hence productivity can be compromised by complicated equipment layouts and higher risks in manufacturing.
Scale up of the Lock-Release™ technology to 100’s mg in flow processing has demonstrated the scalability of the concept for ADC synthesis. Demonstrating the linear scalability of the Lock-Release™ concept will be key to clients wishing to employ the platform in a manufacturing setting.
Analysis of Lock-Release™ ADC product and conventional ADC product based on advanced structural analysis at Covance and Avacta analytical and functional assay at NDA analytics have demonstrated consistent bio-equivalence between conventional solution phase means and Lock-Release™. These results provide a compelling and necessary data set to convince ADC developers to adopt the Lock-Release™ technology for clinical and commercial manufacturing applications.
The Company has not built any licensing revenues into its forecasts. However, the Company anticipates that it will continue to extract premium service value (above industry standard FTE rates) by application of the Lock-Release™ platform within its technical services offer.