Combining their Human-on-a-Chip® technology with the expertise of biologists, surface chemists and engineers, co-founders Dr. James Hickman and Dr. Michael Shuler are at the forefront of cutting-edge science and medicine. Hesperos, founded in the US in 2015, enables real-time, non-invasive monitoring of ‘organ’ activity to detect changes as new drugs are administered and measured. It’s a pre-clinical insight that hasn’t previously been possible without testing on animals or humans.
They aim for a world where every disease has a treatment and every patient has hope, without the need for testing on living species for life-changing drug discovery.
We sit down with Co-Founder – and Chief Scientist – James Hickman for a science lesson.
As the Chief Scientist, can you tell us your story, from conception to launch, and where you currently are in your journey?
“Michael and I started Hesperos with some commercial funding and a direct to Phase II grant through the NCATS Tissue Chips program where we validated our Human-on-a-Chip® technology for drug discovery. That initial award was followed by a Phase IIB grant that has been instrumental in increasing our technical capabilities, capacity and throughput. Thanks to their support, Hesperos is now well-positioned as a leader in the field of human-based, microphysiological systems (an interconnected set of two- or three-dimensional cellular constructs that are frequently referred to as ‘organs-on-chips’). All while eliminating the need for animal testing and enabling research into rare diseases previously considered untreatable.”
For those who haven’t heard about Hesperos before, can you please give us a bit of background on the business?
“The company was founded by Dr. Michael Shuler and I after spending 25 years developing a pharmaceutical testing platform that could accurately predict how new drugs would impact the human body.
We developed many of the foundational technical breakthroughs in university research labs dating back to the early 1990s. We realised that the conventional road to getting a therapeutic drug approved and into patients was incredibly flawed and inefficient.
It takes $2-3 Billion and more than 10 years to bring a single drug to market. After developing a drug, the standard procedure is to test it in a series of animals first, and then in humans. The problem is that not only are humans very different from animals, but all humans are different from each other. As a result, more than 90% of all drugs that prove safe and effective in animals ultimately fail in human trials. That failure rate is what drives the cost of drug discovery and limits the therapeutics available, especially for those battling rare diseases.
To solve this problem, we have produced a platform that reproduces human biology that can accurately replicate the safety and efficacy of a therapeutic. The result is Human-on-a-Chip® – an integrated, multi-organ cellular platform that reproduces the functional aspects of key organs specifically to understand diseases and the human response to therapeutics.”
What is Human-on-a-Chip®?
“It’s a device about the size of your phone that reproduces human biology for the purposes of understanding specific disease states and whether a potential treatment is safe and effective.
The devices are equipped with sensors that monitor real-time changes to organ function. For example, when a drug is metabolised by the liver, you might see the heartbeat get weaker in response, but then recover as the drug clears. Being able to reproduce, damage and recover that signal within our system provides the first platform capable of evaluating a range of potential treatments prior to animal or human trials.”
How are you pioneering Human-on-a-Chip® technology?
“The Human-on-a-Chip® developed by Michael and I has given researchers visibility and insight into disease states not previously possible. This has significant implications both ethically and economically as we’re now able to investigate a range of human diseases, including rare varieties, where no existing models or treatments exist. Today, there are 7,000 rare diseases with only 400 active research programs. Moving forward, we intend to accelerate the testing and development of therapeutics for this underserved population.”
Is there a barrier to overcome in terms of explaining such innovative technology to the world before adoption?
“The major hurdle has to do with earning the trust from clients and regulators that our systems accurately predict human outcomes. As we continue earning that trust through practice, we are seeing accelerated adoption with clear and extraordinary value for drug discovery and personalised medicine.
A significant step along the path of widespread adoption can be found in President Biden signing into law the FDA Modernization Act 2.0 in December 2022. This removed the longstanding mandate for animal studies to be involved in a new drug application to allow for alternative paths to approval with new, relevant technologies, including microphysiological systems.”
Would you say it’s the future and how can it evolve from here?
“We’re just getting started. As we evolve, it will become more widely adopted and enable research into other areas, while we aim to model every human disease, which will naturally reduce the amount of animals involved in the process and enable development of more targeted, even personalised, therapies. Currently, we focus on the pre-clinical phase of drug discovery, which means we’re able to inform decisions. As we move forward, this infrastructure-like technology will expand to directly support clinical trials and personalised medicine, amongst other applications.
Ultimately, the objective is to have a human-relevant test platform that becomes the primary test platform for drug development.”
“Our vision is to enable a world where every disease has a treatment and animals are no longer required for drug discovery.”
Why did you choose BTV as your strategic partner?
“BTV has been an exceptional partner enabling a rapid expansion of our technical capabilities that will allow us to provide a wider range of services as we continue the pursuit of modelling all key aspects of the human body. This relationship is opening doors for us in several key areas that will enable us to benefit patients on a global scale much faster than we could have otherwise.”
What does 2024 look like for Hesperos?
“As the technology continues to gain industry adoption as a more reliable testing platform for understanding new drugs, it’s more likely to be the primary path to drug approval. Our goal is to enable the development of therapeutics for all rare diseases, particularly because this is such an underserved population.
Areas of growth will centre around both. While we operate on the cutting-edge of this space, our goal is to continue expanding capabilities to ultimately serve more patients.
In general, the economics for research into rare diseases is unattractive to pharmaceutical companies. Because of the considerable effort involved and the small number of patients affected, the costs and benefits for the companies are simply not in proportion. In addition, there’s little funding available for research – and little or no so-called animal models on which to study them. For this reason, the research area of rare diseases is an ideal example to show the advantages that complex animal-free methods, such as Human-on-a-Chip® technology, offer.”
To find out more about Hesperos, visit www.hesperosinc.com.
