DNAPrint Genomics and BioServe will provide researchers with a large repository of clinical DNA samples tagged with genetic ancestry data in hopes of helping pharma and diagnostics companies develop drugs and assays that can be used by the broadest population.
“With the added dimension of ancestry information to clinical samples, medical researchers will be able to determine whether certain biological markers are artifacts of genetic ancestry or are true markers for a disease or drug response in a disease,” BioServe said in a release this week.
DNAPrint Genomics will use its ANCESTRYbyDNA test to analyze and categorize BioServe’s global repository of nearly 600,000 human biological samples. According to Beltsville, Md.-based BioServe, it has the largest commercial repository of human DNA samples in the world, and makes these samples available to researchers at industry, academia, and government labs through Genomics Collaborative, a company BioServe acquired in April.
Patients’ genetic ancestry can sometimes significantly determine how well or how poorly they respond to a drug. Having a large repository of clinical samples defined with such data might help researchers at pharma and diagnostics companies run more efficient clinical trials, the companies claimed.
“We have presumably an underlying ethnic consideration with the biology of these patients that predisposes them to either respond or not respond to drugs,” BioServe CEO Kevin Krenitsky told Pharmacogenomics Reporter this week. “So, if you’re going to go and spend $600 million to $700 million developing a drug, it behooves you, if you’re using human biological samples for target identification, target validation, or even diagnostics, that you utilize the appropriate genetic panels using genetic ancestry tagging.”
According to Krenitsky, the “goal … is not necessarily to come up with a drug or a target that may be suited for a particular ethnic group, but to come up with a target that works independently of the ethnic groups, so you can find a true marker that is indicative of the population as a whole without regard to the ethnic group.
“The goal would be to find tests and drugs that would work in everyone,” he said.
A draft report released by the HHS Secretary’s Advisory Committee on Genetics, Health, and Society earlier this year found that “although genetic characteristics may vary according to racial or ethnic origin … these divisions between subpopulations often are determined using ethnic or racial or other demographic information as a proxy for more precise selection criteria.”
The report cites the example of NitroMed’s heart failure drug BiDil – often held as the first marketed race-based drug – to note that the drug’s label is “ambiguous and clinically sub-optimal.” The report concludes that the US Food and Drug Administration should encourage gene-based studies over race-specific ones.
In the report HHS contends that “while [BiDil] may benefit some patients who self-identify as black, it may not benefit others and could be effective for some non-black patients.”
Still, given the soaring cost of drug development and the high rate of attrition in late-stage clinical trails, genetic differentiation of ancestry is growing in prominence among drug and diagnostic developers looking to run safer clinical trials and learn more about investigational products earlier in the development process.
“The legislation and the push for pharmacogenomic testing now is so great that pharma companies don’t really have a choice. It’s a situation now where, as we get into more niche drugs, the pharmaceutical companies are being forced to respond to this issue upfront,” Krenitsky said.
“If you look at the pipelines at the pharma companies and how they have been stretched thin over the last few years, and there is a move to outsourcing to innovating biotech companies, they can’t afford to spend several hundred million dollars before they find out that drug A or B failed because it has minimal response in a certain segment of the population. So they’re being forced to really embrace pharmacogenomics.”
DNAPrint Genomics CEO Richard Gabriel said in a statement that the collaboration with BioServe will help its industry partners “remove the question of ancestry from a clinical sample” so “researchers can more readily evaluate which medicines will produce side effects within certain ethnic groups, and which medicines will work for the widest spectrum of a population.”
“If you look at the pipelines at the pharma companies and how they have been stretched thin over the last few years … they can’t afford to spend several hundred million dollars before they find out that drug A or B failed because it has minimal response in a certain segment of the population. So, they’re being forced to really embrace pharmacogenomics.”
“A big part of these samples is the ethnic makeup of them,” Krenitsky said. "Obviously, if you’re involved in any type of biomarker discovery, whether it’s drug discovery, diagnostic discovery, whatever the case might be, there [are] varied markers that are predicated on ethnicity of patients and groups.”
He said that clinical evidence going back 30 years show that “different ethnic groups respond to different medications in different ways. You can look at clear-cut examples of hypertension in Caucasian populations and hypertension in African American populations, there are clearly drugs that work in African Americans better than other drugs, and vice versa.”
Krenitsky noted that although BioServe tries to capture ethnicity by getting three generations of self-reported ethnicity with linguistics and place of birth, “there is just no way to truly accurately do it with the exception of genetic ancestry tagging.”
DNAPrint Genomics offers computational biology and pharmacogenomics services to biopharmaceutical companies, a service that may benefit with a more detailed biological sample repository. BioServe’s global repository also facilitates its collaborations with pharma, biotech, and diagnostic firms to identify and validate disease-causing biomarkers, and to correlate clinical and molecular data to develop diagnostic tests.
In addition to providing researchers in industry, academia, and government better defined samples for clinical trials, DNAPrint Genomics and BioServe also assist customers with sample extraction and preparation, genotyping, and gene-expression analysis. To perform the genotyping services, the two companies will use Beckman Coulter’s ultra-high-throughoutGenomeLab SNPstream instrument, Illumina’s SNP Golden Gate technology, and Sequenom’s iPLEX platform.
BioServe’s sample repository may also help DNAPrint Pharmaceuticals, a subsidiary of DNAPrint Genomics that is currently developing its first theranostic product, PT-401, an erythropoietin dimer protein drug for treatment of anemia in renal dialysis patients with late-stage renal disease.
“Preclinical and clinical development of all the company's drug candidates will benefit from simulated pre-trials to design actual trials better that are targeted to patients with genetic profiles indicating their propensity to have the best clinical responses,” DNAPrint Genomics said in a statement.
BioServe will perform genetic ancestry tagging for clients on an on-demand basis, Krenitsky said. In addition, the company in the coming weeks and months will release a number of “off-the-shelf” packages of biological samples tagged with genetic ancestry information.