The PGx substudy “helps the company better design [its] drug, [determine] the subset of the population that would benefit from receiving this drug, [and identify] any toxicities that we could predict for this subset,”
Génome Québec Builds PGx Platform for Clinical Trials with VIA, Omics Tool Shops
Génome Québec is teaming with several industry partners to create a pharmacogenomics technology platform that will initially be used to detect the toxicity and efficacy of an investigational drug in an acute coronary syndrome trial, but is expected to have broader applicability for PGx-focused clinical trials.
Earlier this month, Génome Québec tapped the Montreal Heart Institute, VIA Pharmaceuticals, Illumina, Invitrogen, and ABI’s Agencourt BioScience for the CAN$4.9 million (US $5 million) project, “Quebec Cardiovascular Pharmacogenomics Research Initiative,” which aims to “accelerate the development of the platforms needed for clinical pharmacogenomics testing in the treatment of cardiovascular diseases,” VIA said in a statement.
The award was one of three the non-profit genomic funding agency awarded in early October under its so-called PRIVAC, or “Private/Academic” program, which promotes academic/industry collaborations in applied genomics research.
James Stewart, VIA Pharmaceuticals’ chief financial officer, told Pharmacogenomics Reporter last week that the company will work with Génome Québec and the Montreal Heart Institute to learn more about its investigational drug, VIA-2291, in a PGx substudy of a larger trial for acute coronary syndrome.
According to VIA Pharmaceuticals, Génome Québec will develop a 5-lipoxygenase genotyping panel for VIA-2291 and another “next-generation” panel for absorption, distribution, metabolism, excretion, and toxicity. The company expects these panels to be useful not only in the VIA-2291 PGx substudy, but also in future clinical trials for other products.
VIA Pharmaceuticals will spend approximately CAN$2.4 million to fund the ACS clinical trial, and approximately CAN$200,000 to finance the pharmacogenomics portion of the study. Génome Québec is contributing CAN$1,648,388, and Illumina, Invitrogen, Agencourt BioScience, and other industry partners will contribute the remaining CAN$696,777.
Industry observers have said that pharma will eventually warm up to pharmacogenomics — often vilified as the science that could kill big pharma’s profitable blockbuster model — as a strategy that will help the industry run cheaper, safer, and more efficient clinical trials. Several large drug companies, including Pfizer, Lilly, and Bristol-Myers Squibb, have said that pharmacogenomics is fast becoming an integral part of their drug development programs. VIA Pharmaceuticals, in partnering with Génome Québec to conduct this PGx substudy for VIA-2291, appears to be falling in step with this industry trend.
Stewart said the objective of the PGx substudy is not to develop a companion diagnostic for the ACS drug, but to use Génome Québec’s platform to identify potential toxicities that patients might experience with the drug, as well as test the drug’s efficacy at a clinical level.
The PGx substudy “helps the company better design [its] drug, [determine] the subset of the population that would benefit from receiving this drug, [and identify] any toxicities that we could predict for this subset,” Carole Jabet, Génome Québec’s VP of scientific affairs, told Pharmacogenomics Reporter last week.
Génome Québec’s Other Mission
Génome Québec’s primary goal is to fund research projects both within and outside Quebec. “But we also have another mission,” Jabet said. “We operate some platforms, like sequencing, genotyping, and microarrays.”
She said that the organization is currently working with the Montreal Heart Institute to develop a pharmacogenomics technology platform that will be used in the VIA study.
“So our interest in the VIA Pharmaceutical project is double,” she said. “Not only do we fund a research project in an area which is very strategic for us, but also it permits us to develop our own platforms, which deal with pharmacogenomics testing.”
According to Jabet, Génome Québec’s technology arm functions much like a contract research organization in that pharmaceutical companies may hire the group to conduct a portion of their clinical trials using PGx strategies.
Génome Québec and the Montreal Heart Institute currently operate a pharmacogenomics center that provides toxicity panels to test for several cytochrome P450 variances, as well as UGT1A1, and VKORC1, among others. The center also provides cardiovascular disease risk panels for ApoA1, ApoA4, ApoB, ApoC locus, ApoE, ABCA1, hepatic lipase, LDL receptor, LPL, and cholesteryl ester transfer protein.
Génome Québec has a portfolio of 30 projects currently comprising $400 million in funding. The non-profit’s business strategy involves aligning with pharmaceutical companies to better understand drugs and how patients respond to them.
“These associations with pharma partners like VIA are really important to us because we get access to patients, and it’s easier for us to not only develop the content of a panel, but also the technology,” Jabet said.
Génome Québec is also partnering with companies like Invitrogen, Illumina, and Agencourt to address the technological aspects of developing the PGx platform.
According to the abstract for the PRIVAC project, Agencourt will develop “rapid clinical methods” for DNA isolation, Invitrogen will provide “technological improvements” for genotyping and medical re-sequencing, and Illumina will offer “excellent opportunities of knowledge transfer and commercialization of standardized pharmacogenomic tests developed through this project and which will have broad applicability across the pharmaceutical industry.”
“When we provide a service to develop a panel to better know the response to a drug, we also need to improve the technology we’re working with,” Jabet said. “Right now we’re really focused on genotyping, but there are several platforms to run genotypes and so really we want to test this. We’re also looking at sequencing, gene expressions.”
“To be able to answer VIA Pharmaceutical’s questions we really need to be at the cutting edge from a technological standpoint,” she added. “That’s why companies like Invitrogen are very important for us to be associated with.”
Génome Québec could not provide any further details regarding the technologies it is investigating with industry partners to expand its PGx platform. However, Jabet added that Génome Québec’s platform “can run pharmacogenomics assays in GLP conditions” and is already providing services to some customers.
The PRIVAC Program
The PGx platform is one of three PRIVAC grants Génome Québec awarded earlier this month totaling CAN$21.3 million.
The other projects involve the use of genomics to develop immunotherapies and vaccines, and the development of a genomic platform to identify signaling pathways in cancer. The projects were selected by an international committee of research scientists and industry representatives.
The first study, operating on a CAN$8.2 million budget, involves scientists from the Université de Montréal and the Centre Hospitalier Universitaire de Montréal, Génome Québec, and pharma companies Argos Therapeutics and MDS Pharma Services, as well as the bioinformatics company Biosystemix. This project will create a high-throughput platform to monitor immune response and optimize therapy in various diseases and infections, such as cancer, AIDS, and viral hepatitis.
The second project will receive CAN$8.2 million in funding to develop a platform for RNA interference screening in cancer. It involves researchers from the Institut de Recherche en Immunologie et en Cancérologie (IRIC), Génome Québec, and Sigma-Aldrich. The project aims to create a high-throughput screening platform for use by academic and private laboratories for identifying therapeutic targets and accelerating the development of new classes of cancer treatments.
Génome Québec established the PRIVAC program with a $10 million contribution from the Ministère du Développement Économique, de l’Innovation et de l’Exportation. Under the financing rules for the program, private and institutional partners must invest at least two dollars for every dollar invested by Génome Québec. Of the CAN$21.3 million dedicated to funding the PRIVAC project, CAN$15.1 million is from private and institutional investors and CAN$6.2 million is from the MDEIE.
“If a discovery results, the contracts binding the private and institutional partners to Génome Québec provide for Génome Québec’s sharing in the benefits,” the non-profit said in a statement. “All profits will eventually be reinvested in other structuring research initiatives.”