NEW YORK – Hoping to strengthen its pharmaceutical research business, genomics firm Personalis recently launched a dedicated pharma services program, which it is hoping to market for a wider range of research goals and disease areas than the translational and clinical cancer research that have been its mainstay thus far.
The core of the service, which the firm has dubbed its Pharma Research Solutions, is a menu of flexible genomic analyses spanning from narrow gene panels to whole-genome and transcriptome sequencing, supported by the company's large sample capacity as well as other unique expertise in areas like immune profiling.
Although it has historically drawn most of its revenue from population genomic sequencing services for the Department of Veterans Affairs Million Veteran Program (VA MVP), biopharma services have been another mainstay for Personalis over the last several years. According to the company's most recent earnings reports, orders from pharma clients outstripped the company's expectations throughout the second half of 2019 and were projected to do the same in Q1 of this year.
Personalis CEO John West has said in recent calls with investors that the firm made several new deals with multinational pharma companies in recent months, at least two of whom were not existing customers.
In an interview this week, West said that some of what the company will be providing through its Pharma Research Solutions offering was already available informally — essentially, customized aspects of its technology platform to serve more specific needs across different areas of drug development.
While the existing ImmunoID NeXT platform might provide signatures predictive of drug response in a retrospective clinical trial dataset, for example, pharma firms might want to pick and choose more bespoke or narrow analyses to support other aspects of the drug development process, like early drug discovery and preclinical development.
But the idea behind forming a dedicated research solutions product was also to try to better serve — or attract — interest in other disease areas beyond cancer, West added.
"We think that just as there's been a broadening across cancers, with [more pan-cancer approaches] or people tending to do less and less that's just specific to one type of cancer … we also see that these technologies can span from cancer across to a number of other disease areas. That's what we're highlighting here," he said.
"Our commercial efforts have really been focused on advanced oncology therapeutics development. But as we work with those kinds of partners, we often found that that they said, you know, actually have a colleague who was working on, for example, autoimmune disease and they could really use what you're doing as well."
Personalis described the capabilities it plans to offer under the umbrella of its Pharma Research Solutions as a broad suite of both proprietary and standard assays ranging from targeted DNA and RNA panels to whole-genome, whole-exome, and transcriptome services. These will be aligned to support the identification of novel drug targets, as well as the generation of deeper insights into drug candidates’ activity and resistance mechanisms in human and non-human models.
According to West, the firm believes its large sequencing capacity, built up through its support of the VA MVP, will be a differentiator for Personalis relative to other companies that market genomics services for drug/biomarker development, both in terms of cost effectiveness and scalability.
"We've now sequenced over 50,000 human genomes, so that makes us one of the largest commercial providers of human whole-genome sequencing in the United States," he said. "We [can work at] a scale that very few other groups would be in a position to offer."
West also highlighted the firm's proprietary analytics methods and the expertise it has developed in regard to profiling the immune system through its NeXT platform.
With the current coronavirus pandemic and resulting proscriptions on travel and medical services significantly affecting researchers' ability to conduct human studies, Personalis, like any company working in this area, faces significant uncertainty.
But West said that the company may be buffered by the fact that a lot of its previous and current biopharma work — as well as the kind of contracts it is hoping to attract through its new pharma research solutions — involve retrospective samples.
"These are trials that have already been run [and] samples already exist, so with a delay in [new] trials today, [it may] slow down the growth of the pool of samples that could be used retrospectively in the future," he said. "But it's a pretty large pool already, and so I think that's likely to be a relatively modest effect and perhaps [will] spread out over an extended period of time."
Although a variety of companies now perform genomic analyses for both clinical and research use, Personalis has distinguished itself in embracing a comprehensive platform, rather than developing narrower tests that might be more immediately applicable to the clinic.
"In some cases, companies start on the diagnostics side: they develop a product as a diagnostic and then they ultimately find ways to sell that also to the pharma world. But in our case, we've been focused on pretty high-end solutions and those end up often corresponding better, at least initially, to advance drugs that are in development," West said.
The company's hope, though, is that by providing these more comprehensive services for pharma research a groundwork can be laid for various clinical use cases that emerge.
For example, he said that the firm's primary platform, ImmunoID NeXT, covers all 20,000 human genes, a breadth of sequencing for which clinical utility still needs to be established. However, as drugs are being developed where a broad content becomes required in order to select the appropriate patients, there might be a larger market for such platforms as a diagnostic.
Along these lines, the company has already made available a diagnostic version of its ImmunoID NeXT platform, which it calls NeXT Dx, which West said was developed in response to pharmaceutical customers wanting to return results to trial participants.
"It'll take time," West said, "but certainly a lot of the efforts at the company are aimed at working with pharma and increasingly moving towards companion diagnostic kinds of capabilities."