NEW YORK (GenomeWeb) – Originally founded as a pharmacogenomics firm to help guide clinicians in deciding which cancer drugs to prescribe to their patients, Precision Therapeutics is embarking on a new approach to leverage what its new CEO said were under-utilized assets.
In November, the Pittsburgh-based firm announced a $60 million investment from healthcare investment firm HealthCare Royalty Partners, as well as a new management team led by President and CEO Neil Campbell, and a new board. Topping it all off was a name change to Helomics.
According to Campbell, the changes amount to a reorientation of Helomics' technologies to encompass "more holistic elements of personalized medicine." While the company remains focused on a personalized medicine-based approach to cancer, Helomics aims to expand it to a personalized healthcare approach that essentially creates an ecosystem to include wellness, disease prevention, treatment, and management in order to tackle cancer, Campbell said.
"Forming Helomics was predicated on understanding a tumor cell and having a profile of the tumor cell," he told GenomeWeb recently on the sidelines of the 33rd Annual JP Morgan Healthcare Conference in San Francisco. Using its testing services, the company analyzes patient samples to see the effect of different drugs. Simultaneously, "we're looking at that cell [and asking], 'Why is that cell more aggressively growing; why is its morphology different; what was its gene signature; what was its transcription; and what structural variants were in that tumor based upon the live cell analysis?'"
In his vision, Helomics' role as a personalize healthcare shop would encompass genetic testing to elucidate a person's predisposition to disease, specifically cancer; intervention to prevent disease; early detection of disease at the molecular level; diagnosis of disease to enable individualized treatments; helping design such treatments; and monitoring the patient.
All of this would be achieved through big data analysis of the patient's tumor.
While Helomics had always had the capabilities to do all of that, Campbell said, "That was never fully pulled together for Precision. We've been putting those pieces in place quietly since September."
Helomics' flagship technology remains a live cell method dubbed Precision Cellular Analytical Platform (PCAP), which the company has been using, and continually developing, for the past 14 years. Helomics is now looking at the full live cell to analyze its morphology, the way the cells divide, and what makes that specific tumor unique compared to another patient's tumor.
Additionally, it is performing more traditional fixed-cell analysis, including investigations into genetic sequences and expression, as well as protein sequences and expression. "But we're making a multilayer profile of genomics, proteomics, and epigenomics, and then building what the signatures look like, and comparing it to the live cell and bringing the two together to try to mimic as close as possible [to] what's happening in the tumor cell in the body in vivo," Campbell said.
He added that Helomics is creating a database that, in time, will be used to analyze disease patterns and discover new biomarkers.
Campbell refers to Helomics today as a "reverse startup." While the firm is in some ways starting anew and has "the leanness and aggression and the passion" of a startup, it has a sizeable war chest, thanks to the $60 million investment, and is generating revenues "in the tens of millions," he said, declining to provide further details or to say whether the company is profitable.
"We have current capabilities that weren't fully utilized, and that excess capacity is being used now and will be for the first half of 2015," Campbell said. "Precision had a lot of well-considered assets that were not probably monetized, so we're taking a lot of what was there and actually utilizing it [on] a more commercial basis."
In addition to the PCAP technology, those assets include data from several hundred thousand patients that were archived, as well as specimen banks, Helomics CFO Dane Saglio said.
Campbell also pointed to the company's ChemoFx assay for helping clinicians select treatments for women with gynecological cancer. While the product has been on the market for some time, underlying the technology is the ability to grow, analyze, and eventually harvest the cancer cells for additional analysis "and that was something that was not done" until recent months, he said.
Toward the spring, he added, Helomics plans to expand its business to include acquisitions and licensing deals "and creative ways to get into other markets." Technologies in which it is interested include anything dealing with big data, bioinformatics, and high-performance computing, as well as omics, such as next-generation sequencing, proteomics, and new PCR approaches.
With the changes, Helomics has shifted the business to be more research-oriented and to do contract research services, such as biobanking, as "a precursor to the clinical utility products," Campbell said.
Helomics' assays are offered as laboratory-developed tests that are run in its two CLIA laboratories in Pittsburgh, and during the next few years, it plans to add additional CLIA facilities elsewhere, Campbell said. Helomics does not have plans currently to offer its assays as kits, which would be too expensive and time-consuming, he added.
According to Campbell, the firm's focus is not in the US – although one of its goals is to increase its US customer base – but rather in the UK and potentially Canada, two countries that are taking a more holistic approach to personalized healthcare than the US, where obstacles such as the Health Insurance Portability and Accountability Act and FDA regulations limit access to patient data, he said.
The UK, by comparison, allows a firm such as Helomics greater access to patient data, Campbell said, which it can then use for research. And earlier this month, Helomics joined the UK Personalised Healthcare Alliance as a founding member.
According to the alliance's LinkedIn page, its objectives are to collaborate with stakeholders "to build better alignment"; advocate for personalized healthcare; promote the UK in the personalized healthcare space; and educate stakeholders about the space "to inform dialogue, build political support, and improve patient outcomes." Additional members of the alliance include AstraZeneca, Biogen Idec, Cancer Research UK, Epistem, Horizon Discovery, and others.
As part of its involvement, Helomics will provide funding for the effort and will work collaboratively with other members on projects. In addition to being able to access data, Helomics will have access to clinical samples in the UK, Campbell said.
In Canada, the firm has started relationships to offer services similar to what it offers in the US and Helomics is exploring potentially partnering on CLIA-equivalent labs in the UK and Canada, Campbell said.
Also in Helomics' plans is an expansion of its companion diagnostic business. The firm currently has six CDx deals with pharmaceutical firms in the very early stages, though Campbell declined to identify them.
Meanwhile, diagnostics remains very much on Helomics' radar, and as it progresses on its new business model, it intends to launch new products in the first half of 2015, including GeneFx Colon, a 634-transcript DNA gene signature microarray-based assay for stage II and III colon cancer risk assessment. The technology is licensed from Almac Diagnostics, a division of the Almac Group.
Also planned is a launch of GeneFx Lung, a 15-gene assay for non-small cell lung cancer. The company plans to launch the product to the research market in the first quarter of 2015 and then as an LDT in the second quarter. The test is licensed from Med BioGene.