NEW YORK – A new joint venture between cancer diagnostic firm SEngine Precision Medicine and French cancer center Institute Gustave Roussy intends to broaden access to cancer diagnostic testing across Europe by bringing SEngine's flagship test to market.
Called PARIS, the test from Seattle-based SEngine combines DNA sequencing of cancer tissue with phenotypic drug testing in patient-derived tumor cells to determine a ranked list of oncology drugs that are most likely to work for a particular patient.
SEngine originally inked a deal with the Fred Hutchinson Cancer Research Center in 2017 to market the laboratory-developed test, which is currently available only in the US and performed at the firm's CLIA-certified lab, SEngine CEO Carla Grandori said.
SEngine established a three-dimensional patient organoid culture system and uses personalized high-throughput drug screening, along with genomic analysis, to stratify and identify effective drugs or drug combinations for each patient.
With its technology, SEngine has "the power to use laboratory robotics and new computational approaches to measure drug response in patient-derived organoids," Grandori said.
The PARIS test can be used for all cancers, but the lab has been mostly focused on colorectal cancer. PARIS has been tested on "over 32 more [cancer] types," Grandori said, and the company has "established general principles that allow us, even if we have never tested a tumor, to … keep the tumor alive long enough to do the test."
The as-yet-unnamed joint venture between SEngine and Gustave Roussy began with the institute, Grandori said, after an oncologist at the institute saw a paper about the PARIS test published in Cancer Discovery in 2017 and reached out to Grandori to invite her to give a talk on the technology in Paris in 2019.
That meeting served as a jumping-off point for a collaboration — while scientists at the institute were working with organoids, they didn't have the methodology or computational tools to measure drug response, Grandori said.
Fanny Jaulin, head of the gastrointestinal oncology unit at Gustave Roussy, added that the institute had been interested in organoid technology and was using organoids in her laboratory for drug testing, but that the process wasn't automated. When her team saw that SEngine was using the same approach, a partnership seemed potentially fruitful.
Jaulin's team had designed a clinical trial using organoids for colorectal cancer and had prepared a grant application for it, and SEngine joined as a collaborator "at the last minute" to provide its broader, high-throughput assay and its CLIA-certified lab, Grandori said.
What the field of patient-derived organoids was missing, Jaulin added, was a large-scale trial to prove its utility in the clinic.
In 2020, with new leadership at Gustave Roussy, the institute inquired about forming a joint venture with SEngine to commercialize its intellectual property throughout Europe, and SEngine's team "welcomed this proposal quite enthusiastically," Grandori said.
"It would be very difficult for an American solely owned company to operate in France and to adjust also to all the regulatory requirements there," she said.
SEngine had thought about commercializing the PARIS test outside the US before — Grandori is from Italy — but decided against doing so without a partner, Grandori said. When an established institution came calling, SEngine "felt it was an opportunity that we had to pursue," she noted.
"Functional precision medicine [is] a new field, and it would require an entire institution to embrace this process to move it forward," she added.
The joint venture, which is a 50-50 split between SEngine and Gustave Roussy, is getting started with a clinical trial for the PARIS test in France. SEngine is providing its IP to the joint venture through a licensing agreement, while Gustave Roussy has provided financing and will perform the trial. Both organizations declined to specify the exact funding amount.
Gustave Roussy has also reached out to venture capital firms in France for potential additional funding for the JV and has applied for a $10 million grant from the French government, Grandori said. Jaulin added she is applying for several grants to support the clinical trial, although both declined to provide the exact amount of funding they're seeking.
Although the JV is based in France, the plan is to make the PARIS test available across the EU, and SEngine will work with Gustave Roussy and use its expertise to seek regulatory approval in the EU for the test, Grandori said.
She added that the company would "ensure adherence to all applicable EU and French regulations," including the forthcoming In Vitro Diagnostic Regulation, but noted that there is currently "no clear consensus on the definition of the scope of the IVDR requirements for self-developed testing systems."
Meantime, in the US, SEngine is pursuing private payor and Medicare reimbursement for the test, which costs $5,000 for the basic drug panel and $7,500 for a custom panel at the list price. The company is in the middle of a Series A2 funding round that hasn't closed yet.
SEngine plans to embark on a Series B round in about 18 months, she added, which will partially be used to support reimbursement efforts, Grandori said.
While commercialization and regulatory approval are key focuses for SEngine, Jaulin said the first priority is completing the clinical validation.
The multicenter trial is expected to begin at the end of this year, as the team is waiting for final committee approval. The plan is to enroll approximately 60 patients with colorectal carcinoma for Phase I of the study across eight cancer centers in France, Jaulin said. The clinical trial team also intends to include patients with "all sorts of solid tumors" down the line, she added.
The trial has a drug library comprised of chemotherapies and targeted agents developed primarily by oncologists at Gustave Roussy that will be prioritized, Grandori said.
An additional library of more than 20 drugs was provided by SEngine that will also be tested with the PARIS test. Those drugs were derived from three approaches, Grandori said: large drug libraries, functional genomic screens, and "in-depth bioinformatics analysis of the druggable landscape of colorectal cancer that implicates drugs" approved by the US Food and Drug Administration for other cancer types.
The Gustave Roussy team hasn't considered whether to expand the trial beyond France yet, Jaulin said.
For the trial, the institute's researchers will perform biopsies at the beginning of the last line of each treatment and send the samples to the US for SEngine to test. They hope to provide results within 10 weeks, ensuring the organoid has enough time to grow but making sure the patient receives appropriate treatment, Jaulin said.
The institute is working on getting an organoid facility up and running in France to "develop the organoids from their patients in close proximity to their hospital," Grandori said. That facility, which will enable the testing to be performed in France, will likely be ready to open in a year to 18 months, she added.
The joint venture will also aim to broaden applications of the test for use in immunoncology, and there are plans to develop different tests based on organoids, Grandori and Jaulin said. Some of those other types of assays are ones including co-culture with immune cells to measure response to immunoncology drugs and ones implementing microfluidics or high content imaging, Grandori said.