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.