GSK, 23andMe Partnership Offers Opportunity for Development of Alzheimer, Parkinson Treatments

Hal Barron, MD, GSK chief scientific officer and president of R&D

Hal Barron, MD

In July, GlaxoSmithKline (GSK), a prominent player in the drug development space, announced an exclusive multi-year partnership with popular direct-to-consumer genetic testing company 23andMe. The partnership is aimed at identifying novel drug targets, addressing new disease subsets, and increasing the speed of clinical program progression.

The partnership includes a 50-50 split of funding responsibilities but also included a $300M equity investment from GSK. Both GSK and 23andMe will share in the proceeds from any new treatments and medicines arising from the collaboration.¹

More so than that, though, the partnership has opened the door to an otherwise difficult to attain vault of genetic data from individuals around the world—which leaves many asking how the 2 giants will utilize the goldmine of genetic information.

This isn’t the first time a company on the development side has partnered with a direct-to-consumer DNA collector. In 2015, AncestryDNA announced a partnership to investigate the human heredity of lifespan, with the ultimate goal of developing and commercializing potential therapeutics.² Similarly, in 2012, Amgen announced it had acquired deCODE genetics, an Icelandic genetic company, and Regeneron partnered with Biobank and Geisinger Health with similar ideas in mind.^3-4

However, privacy worry surrounded the agreement. According to GSK, the pharma company will “have the right to work with 23andMe to analyze 23andMe’s database for validation of GSK’s existing therapeutic portfolio as well as leverage 23andMe’s capabilities for clinical trial recruitment.” Following the backlash from user’s who feared their genetic data would be shared without permission, 23andMe, along with a group of others in the space, pledged to protect their customer’s privacy by obtaining “express consent” from the consumer before sharing the data.⁵ As of now, 23andMe has nearly 5 million customers—80% of which have consented to participate, with the average participant aiding 200 different studies.

Nevertheless, the partnership poses a significant opportunity for the scientific community to develop more effective therapies for Alzheimer disease and Parkinson disease, among other difficult-to-treat conditions.

“We are excited about this unique collaboration as we know that drug targets with genetic validation have a significantly higher chance of ultimately demonstrating [a] benefit for patients and becoming medicines,” said Hal Barron, MD, GSK’s chief scientific officer and president of R&D. “Partnering with 23andMe, an organization whose vision and capabilities are transforming the understanding of how genes influence health, will help to shift our research and development organization to be ‘driven by genetics,’ and increase the impact GSK can have on patients.”

Gregory Day, MD, MSc, assistant professor, Washington University School of Medicine, Knight Alzheimer Disease Research Center, in St. Louis, told NeurologyLive’s sister publication, MD Mag, that the success of the partnership—specifically for 23andMe—lies in the quality of the data being reported. The genealogy company collects and processes tissue samples which it analyzes to provide its customers with information based on a limited set of common genes and their variants. “One of these includes APOE allele status. APOE4 allele carriers are known to be at an increased risk of developing symptomatic Alzheimer disease, and this information is communicated to the client,” Day said.

While he acknowledged the potential of the partnership, Day also exercised caution in getting too far ahead. Customers who use 23andMe’s service are also asked to take a survey in addition to their DNA sample, which leaves a large space for self-reported inaccuracies. However, if the company wished to make a real impact in the Alzheimer space, Day said, it should partner with companies or institutions “who are actively recruiting participants into longitudinal studies of evaluating the factors that contribute to changes in memory and thinking or developing and testing medications and/or other forms of treatment that are meant to prevent Alzheimer’s disease in at-risk individuals.”

These at-risk individuals, according to Lutz Frölich, MD, PhD, the head of the Department for Geriatric Psychiatry, Central Institute of Mental Health, could be ideal candidates for clinical trials, as these patients are not yet affected by the degeneration that Alzheimer causes. They don’t have symptoms and may just feel that their cognitive function is off, he said, which makes them difficult to enroll in trials, despite the need to treat them.

“In the end, we will have to deal with patients who feel [this way] and don’t show symptoms, and not just patients who have a change in their biology,” Frölich told NeurologyLive. “Those patients still have a hard time getting access to the medical care system unless they do have symptoms.”

Day noted that enrolling at-risk patients in clinical trials for preventative therapies is essential to the process of developing therapies to treat Alzheimer, as they evaluate the effects of medications or lifestyle adjustments in preventing the development of dementia. “Currently there are several clinical trials doing just that. There are other studies that specifically wish to enroll individuals who have 2 copies of the APOE4 allele. These individuals are at a much higher risk of developing Alzheimer,” Day said.

Patients with 2 APOE4 allele copies are a rarity, though, and in order to identify them drug companies need to screen thousands of patients at once, Day explained. This is where 23andMe comes into play. It offers clients for the drug developers.

“Such a partnership would potentially allow 23andMe to share information from relevant, vetted institutions [and] companies concerning available opportunities, or treatment trials with their clients who screen positive for gene variants associated with an increased risk,” Day told NeurologyLive’s sister publication, MD Mag.

Day added that this process could be completed without violating client trust. “No client information would be shared with corporations or academic institutions—and would have the added benefit of providing their clients with options that they could then choose to act on should they wish to learn more about active research into these areas,” he said.

In addition to 23andMe’s pledge of protecting the privacy of its clientele, GSK stated that even the customers that do choose to participate will have identifying information removed from the data submitted to the pharma company. “If done well, and if done ethically, this could be a win for their clients, a win for researchers, a win for society in general, and even a win for their shareholders,” Day said.

“This collaboration will enable us to deliver on what many customers have been asking for—cures or treatments for diseases," Anne Wojcicki, BS, CEO and co-Founder of 23andMe, said. "By leveraging the genetic and phenotypic information provided by consenting 23andMe customers and combining it with GSK’s incredible expertise and resources in drug discovery, we believe we can more quickly make treating and curing diseases a reality.”

REFERENCES

1. GSK and 23andMe sign agreement to leverage genetic insights for the development of novel medicines [press release]. London, UK: GlaxoSmithKline; Mountain View, CA: 23andMe; July 25, 2018. gsk.com/en-gb/media/press-releases/gsk-and-23andme-sign-agreement-to-leverage-genetic-insights-for-the-development-of-novel-medicines. Accessed August 14, 2018.

2. AncestryDNA and Calico to Research the Genetics of Human Lifespan [press release]. Provo, UT: AncestryDNA; South San Francisco, CA: Calico; July 21, 2015. ancestry.com/corporate/newsroom/press-releases/ancestrydna-and-calico-to-research-the-genetics-of-human-lifespan. Accessed August 14, 2018.

3. Hirschler B. Amgen buys Icelandic gene hunter Decode for $415 million. Reuters. reuters.com/article/us-amgen-decode/amgen-buys-icelandic-gene-hunter-decode-for-415-million-idUSBRE8B90IU20121210. Published December 12, 2012. Accessed August 14, 2018.

4. Regeneron announces major collaboration to exome sequence UK Biobank genetic data more quickly [press release]. UK: Biobank; January 8, 2018.

ukbiobank

.ac.uk/2018/01/regeneron-announces-major-collaboration-to-exome-sequence-

uk

-biobank-genetic-data-more-quickly. Accessed August 14, 2018.

5. Privacy Best Practices for Consumer Genetic Testing Services. Future of Privacy Forum. fpf.org/wp-content/uploads/2018/07/Privacy-Best-Practices-for-Consumer-Genetic-Testing-Services-FINAL.pdf. Published July 31, 2018. Accessed August 14, 2018.

*A version of this story originally appeared in MD Magazine.