Fusion Antibodies are working with a number of clients on pilot projects for their latest technology – RAMP™ – Rational Affinity Maturation Platform.

RAMP™ was launched at the end of 2018 and clients have been coming on board to benefit from the innovative in silico approach to Affinity Maturation, particularly for time sensitive projects.

The range of clients includes one of the world’s top ten pharmaceutical companies, multiple biotech companies in Asia and Europe, and a UK based academic research institution.

Dr. Paul Kerr, CEO, Fusion Antibodies, said, “Having presented the technology platform at Antibody Engineering and Therapeutics, San Diego at the end of 2018, we are delighted that a number of projects have now commenced with us. We welcome the opportunity to help these clients address difficult roadblocks in their antibody development projects.”

Chief Technology Officer, Dr. Richard Buick commented, “We have already tested the power of our platform on one of the world’s bestselling drugs, Trastuzumab, and significantly improved its affinity. We are excited for the opportunity to demonstrate the power that lies in our approach.”

RAMP™, a Rational Affinity Maturation Platform, is designed to improve the ability of an antibody to bind without damaging the overall profile, has delivered results beyond affinity maturation. Factors that can be improved using the platform include stability, aggregation, yield, specificity and cross-reactivity, which are key considerations for clients who want to get their antibody to the clinic and market approval.

Paul Kerr, CEO, Fusion Antibodies
by Paul Kerr, CEO, Fusion Antibodies

Why investing in pre-clinical activity is crucial to maximise the chance of success in clinical trials

Most investigators & all investors in pharmaceutical development dream of creating a blockbuster—a drug so effective, useful and high-profile that it generates sales of at least $1 billion per year. However, even getting a new drug to market is a gruelling long-distance race, with many hurdles to surmount. At each of the three phases of clinical trials, the scale and cost of development increases—and a failure during the later phases can write ofhundreds of millions of dollars in investment.

With the advent of drugs based on monoclonal antibodies, the game is changing. Advances in this field have opened the door to new therapeutic possibilities, such as the safe engagement of the immune system in cancer treatment; research in this area led to James P Allison and Tasuku Honjo winning the Nobel Prize in 2018.

Now well beyond the early days of ‘vanilla IgG’ antibody approvals, the development of antibody-based drugs has become highly sophisticated, and competition is fierce. As ever-larger numbers of pharmaceuticals companies invest in antibody development, the number of approvals is increasing year-on-year—in fact, just as I’m writing this, the Antibody Society has announced that four new drugs have entered regulatory review.

Antibody-based drugs tend to be much more successful in the clinic than traditional small-molecule drugs, due to higher specificity and fewer side effects. However, these more sophisticated technologies also create greater manufacturing challenges, and drug developers must prove a clear differentiation of their molecule to achieve success and approval in the long run. Many big challenges remain, which is why it’s important to work with the experts in antibody development.

De-risking projects to boost success rates

At Fusion Antibodies, we have worked in antibody development for almost 20 years. We have completed more than 150 antibody humanization campaigns, and of our first 15 projects, more than half have now entered clinical trials.  This impressive success rate, in particular compared to our competitors in the antibody engineering field, indicates that Fusion’s unique approaches and expertise can make a significant difference.

Our clients are successful because they see the value of de-risking their projects at the earliest possible stage. When they have a promising candidate, we help them evaluate its biophysical characteristics, detect and address problems quickly, and ultimately increase their chance of success in the clinic.

Combining hard science with commercial sense

When developing a therapeutic antibody, it’s important to think about the big picture and consider commercial success. By considering manufacturability at the early stage of drug development you’ll be more likely to produce an antibody that not only does what you want it to do, but that will also be commercially viable.

For example, your complex bi- or tri-specific antibody may be wonderful at binding to its target, but if it’s impossible to manufacture cost-effectively or at scale, that’s a red flag for investors.

We can help you make the right decisions to find an optimal balance between specificity and yield, improving efficiencies in the drug development journey, and potentially saving millions of dollars in manufacturing costs during the clinical trials stage and beyond.

Avoiding expensive failures with preclinical preparation

As a quick example: I recently spoke to a venture capital investor who specialises in re-engineering antibodies. In the past, he had several times made the mistake of entrusting preclinical development activities to low-cost outsourcing companies. As a result, he had ended up with products whose expressibility, stability and yield were well below par.

Since first engaging with Fusion, he has recognised the value of working with a team that can help him make the right decisions throughout the discovery, development and manufacturing process.

Building a partnership for end-to-end development

At Fusion Antibodies, we pride ourselves on being a true business partner to our clients. We’re an antibody discovery and development partner dedicated to delivering the best results for our clients. Frequently, we’ve helped clients improve the performance of their antibodies so much that they have gained new intellectual property, adding five or more years to the life of their patents.

Above all, our services give our clients the best possible shot at preparing their antibodies for successful clinical trials, eliminating avoidable risks on the road to FDA approval, and making their IP more attractive to big pharma partnering.

If you’d like to learn more about how Fusion Antibodies can help you increase your chances of success at clinical trial, reach out to us today.

CIR Approved

Fusion Antibodies has been granted approval to participate in the Crédit Impôt Recherche (CIR) scheme, meaning our French clients can enjoy a significant tax break by partnering with us for pre-clinical antibody research.

Based on Article 244 quarter B of the French Fiscal code, French Partners can benefit from a tax credit of 30% of the cost for R&D services. The tax credit covers costs including salaries, social security contributions, amortization and depreciation allowances, operating costs, subcontracting, patents and monitoring. For further details on the CIR tax credit, click here.

Julie Gormley, Sales Director for Fusion Antibodies, commented: “We are delighted to secure CIR approval to be able to offer our French customers access to this substantial tax break. Successful antibody development depends on getting things right from the outset and at Fusion Antibodies we have vast experience in the pre-clinical stages which will ultimately contribute towards a more successful outcome at clinical trial”.

To learn more about partnering with Fusion Antibodies for pre-clinical research, click below. 

150th Antibody Humanization project

Fusion Antibodies, a world leading CRO, has today announced that they have successfully completed their 150th Antibody Humanization project as part of their Antibody Engineering offering.

Humanization is a critical process in the development of therapeutic drugs where the antibody has been derived from a non-human source.

Paul Kerr, CEO of Fusion Antibodies said, “We developed the multiplex and standard CDRx™ platforms in 2012 and have been humanizing antibodies from multiple species since then. We are proud to have reached our 150th Humanization project.

“I am delighted to see more than half of our first 15 clients advancing to clinical stages some as far as Phase 2. The importance of Antibody Humanization cannot be underestimated to ensure manufacturability and increasing success at later stages.”

CDRx™  was launched by Fusion Antibodies in 2012. It generates a matrix of humanized variants from the parental antibody increasing the likelihood of selecting the optimal candidate and thereby accelerating the project to clinical trials. Fusion Antibodies are experienced in delivering successful humanization projects. These projects can range from one single sequence to humanizing hundreds of molecules from B-Cell repertoires.

The life science sector is a key sector and jewel in the crown for the UK economy. The sector contributes a massive annual turnover of £50 Billion, comprises of over 5,000 companies and employs an estimated 175,000 people.

The life science sector is a key sector and jewel in the crown for the UK economy. The sector contributes a massive annual turnover of £50 Billion, comprises of over 5,000 companies and employs an estimated 175,000 people.

Back in 2011, the ‘Strategy for UK Life Sciences’ was launched by then Prime Minister David Cameron in a long term aim of making the UK the global hub for life sciences in the future. The strategy set out a vision where academia, NHS, charities and industry would come together to create an unrivalled ecosystem. The strategy was designed around 3 main principles:

  1. Building a life science ecosystem
  2. Attracting, developing and rewarding best talent
  3. Overcoming barriers and creating incentives for the promotion of health care innovation

A report (From vision to action: delivery of the Strategy for the UK Life Sciences) released by LIfeScience UK in 2014 evaluated the ‘Strategy for UK Life Sciences’ was of mixed success so far. Projects as the ‘Biomedical Catalyst Fund’ which is £180 million fund jointly managed by the Medical Research Council and the Technology Strategy Board matched private funding to support medical research and innovation was successful as of 2014. Almost £125 million has been committed to accelerate numerous medical research projects, including over 100 business led projects.

However, some projects have been slow to come to action and deliver anything close to their objectives. For example, the ‘Innovation Scoreboard’ was designed to track the adoption of NICE Technology Appraisals (recommendations on the use of new and existing medicines and treatments within the NHS) at a local level. These are useful tools to enable NHS staff to understand their organisation’s performance in adopting innovation and for patients / public to exercise choice about their service provider. So far the Innovation Scorecard has become stagnant and is not yet detailed enough or aligned with the latest National Institute for Health and Care Excellence technology appraisals to inform patients and public about the availability of innovative treatments in the NHS. There is a long way to go before patients and NHS stakeholders will be able to understand the Innovation Scorecard.

The Clinical Practice Research Datalink (CPRD) is another success of the strategy, the CPRD is the observational data and interventional research service for NHS in England. The CPRD can link anonymised NHS clinical data to observation research beneficial to safeguarding and improving public health. The CPRD now holds a range of over-arching governance approvals that make under undertaking research on NHS databases far simpler. It connects patient information from GPs and hospitals to other records, such as registries and audit datasets, these combined datasets can be used to answer medical research questions.

Fusion Antibodies like other SME’s can also benefit from the Strategy. Life Science SME’s are increasingly taking a lead role in driving growth and innovation which the government recognises. SME’s can benefit from The Seed Enterprise Investment Scheme (SEIS) which offers tax relief at 50% of the cost of shares in qualifying companies, up to a maximum annual investment limit of £100,000. This allows smaller Life Science companies to gain investment more easily from private investors.

Fusion Antibodies applauds the positive developments undertaken since the start of the strategy such as the Biomedical Catalyst and the Clinical Practice Research Datalink, and also the increased collaboration between the NHS, academia, industry and the voluntary sector. Implementation of some government commitments has been inconsistent and yet to meet anything remotely near their goals so it is therefore essential that the government renew their efforts and get it right in order for the UK to remain at the pinnacle of scientific and medical advances.

To read more about the ‘Strategy for UK Life Sciences’ by the Department of Business Innovation & Skills, please visit here

To read more about the ‘From vision to action: delivery of the Strategy for the UK Life Science’  by the LifeSciences UK, please visit here

The Fusion Antibodies Team will be attending BioJapan 2016 held in Pacifico Yokohama, Japan this October.

BioJapan is Asia’s Leading Bio, Pharma R&D Event (Exhibition, Partnering, Conference) specialised in Biotechnology, Drug Discovery, Pharmaceutical Development, Regenerative Medicine and Personalised Medicine. Japan is the world’s 2nd largest pharmaceuticals and medical devices market. Japan is also recognised as leading the world in the regenerative medicine and cell therapy sector by easing regulations to allow early access to the market.

BioJapan has played a vital role in facilitating interaction between companies and organizations from Japan and abroad for almost 20 years. BioJapan 2016 is expected to feature 8000 partnering meetings, 15000 visitors and 800 participating companies.

 The Fusion Team (Dr Paul Kerr and Dr Richard Buick) will be attending from October 12th to 14th.

“I am looking forward to visiting Japan as it’s researchers are at the forefront of many new exciting immunotherapy treatments. Fusion has many collaborators in Japan and I am looking forward to meeting them in person and build on our relationship with Japanese researchers at BioJapan”

Paul Kerr. Managing Director at Fusion Antibodies

To find out more information about BioJapan, please visit http://www.ics-expo.jp/biojapan/index.html

To find out more information about Fusion Antibodies, please visit https://www.fusionantibodies.com/