Personalized therapy simulation company Cellworks announced on Monday the launch of two separate business units that will take an in silico approach to testing potential new precision oncology drugs in both pre-clinical and clinical stages. The services, the company said, will both accelerate the development of promising therapies in a pharma company’s pipeline and can also be applied to reviving previously studied but unapproved therapy candidates.
The new business units will employ Cellworks’ biosimulation and computational biosimulation model (CBM) to streamline clinical trials by predicting patient response more quickly, and identifying the right patients to enroll in trials, thereby saving drug development time and money.
“Drug development today is a time-consuming and expensive process—it can take a decade or longer to take a new drug to market and cost hundreds of millions of dollars. But in many instances, the Cellworks platform has the ability to predict the human clinical response to drug candidates years earlier than traditional development pipelines,” said Brian Battey, COO of Cellworks Group. “By predicting human clinical response much earlier in the drug development cycle, we can help pharmaceutical companies shave years off drug development timelines, expand the diseases explored, reduce the cost of thoroughly investigating pharmaceutical assets and get new therapies to patients faster.”
Applying its approach to pre-clinical work can aid in a number of distinct areas, Cellworks noted in a press release: biomarker development, companion molecule identification and development, indication expansion of the drug candidate, clinical trial biosimulation, and drug revival and repurposing.
For biomarker development, the company will use retrospective patient data to help predict response or non-response to investigational therapy candidates based on a patient’s molecular profile and employing either single-gene or multi-gene signatures. It’s in silico approach can also potentially identify other agents that may work successfully with the candidate as a combination therapy. The plan is to also leverage the company’s data of more than 100,000 patient molecular profiles against more than 1,800 cancer cell lines to help identify the potential to apply the candidate against other indications.
“Ninety percent of drug candidates fail to make it to the marketplace because of failed clinical development strategies,” said Michael Castro, MD, chief medical officer of Cellworks. “Low efficacy is often not because the drug fails to hit its target, but is more often a consequence of a molecularly naïve approach to a heterogenous and complex disease. Biosimulation stratifies treatment options according to therapeutic impact and enables precision clinical trials that promises to transform the drug development process with fewer failures.”
For service focused on clinical trial candidates, Cellworks believes its approach could reduce the time to determine human clinical response to mere weeks via biosimulation versus what can be years via in-human testing of current trials.
For drug revival or repurposing, the company said it will seek to determine why a drug caused either a response, or non-response in patients—information that could be used to revive a suspended program by more precise selection of patients or by uncovering other, previously unidentified indications for the drug. In these cases, Cellworks will either collaborate with pharma and biotech partners to enhance development efforts and accelerate commercialization or will in-license assets that allows Cellworks to take on the clinical development and financial responsibilities.