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Direct-to-consumer company 23andMe is best known for its mail-order genetic testing kits that provide detailed family histories, but in parallel with that business, the biotech company is also using its vast database of genomic information to develop medicines, bringing it closer to its own cancer cure.
Dr. Jennifer Lo, Head of Therapeutics Development at 23andMe
With permission from 23andMe
23andMe is building on the success of immunotherapies such as Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo. Those are checkpoint inhibitors that block pathways between tumors and the immune system, allowing the body to fight cancer. But using their vast knowledge, 23andMe researchers have found a new pathway that could be similarly effective and add to the cancer-fighting arsenal, said Dr. Jennifer Lo, the company’s therapeutics chief.
23andMe identified genetic mutations from the world’s largest database and discovered a target biomarker in the CD200 pathway that, when inhibited with the therapeutic drug 23ME-00610, Preliminary Clinical Benefits As the first antibody to target this pathway in mid-stage studies of patients with neuroendocrine and ovarian cancer, Dr. Lo and her team hope this will be a foray into precision medicine. This has been a topic of discussion in the industry for years..
And 23andMe needs a win. The company has been embroiled in controversy. ethics Using genetic information for research High-profile data breachesLast year, the treatment department Cut jobs Investment in biotechnology has declined, and the company Stock prices are on a downward trend.
But Lo is optimistic about the company’s foothold in the pharmaceutical industry. We spoke to its therapeutic head about the role genetic databases play in discovering and developing new treatments for diseases like cancer, how understanding demographics can help improve diversity in clinical trials, and the possibility of collaborating with traditional pharmaceutical companies in the future.
This interview has been edited for clarity and style.
PHARMAVOICE: How has 23andMe’s vast customer database helped the company develop its tumor checkpoint inhibitors?
Dr. Jennifer Law: One of the biggest challenges throughout the pharmaceutical industry is that we use animal models to try to understand human biology, but they have very limited practical applications. Animal models can’t replicate what’s going on inside the human body. So the big advantage of the 23andMe database is that this is human data – human genetics. We have over 15 million genotyped individuals in our customer database, and we’re able to find statistical associations between genetics and what people are experiencing biologically. We don’t just ask about family history and diseases, we also ask a lot of other things, like how susceptible you are to onychomycosis, or are you the type that always gets bitten by mosquitoes, and so on. This gives us nuanced information about your biology that you can’t get from medical records.
“This gives us a wealth of information, including nuances in immune function and how they relate to a person’s propensity to develop cancer. Combining this information can help us understand which parts of immune biology are important for a person’s immune system to find and attack cancer, and it can also help us fine-tune drugs in development to recalibrate the immune system so it doesn’t miss cancer.”
When you look at the success of immunotherapies like Keytruda, they’re still limited by a patient’s genetics, so how can 23andMe improve on that to create what could be the next wave of checkpoint inhibitors?
Checkpoint inhibitors were a big breakthrough. Initially, immunotherapies like interferon and IL-2 were very difficult for patients to take and had low long-term survival. Then we got to over 20% with PD-1 and PD-L1 immunotherapy. That’s phenomenal, but 70% to 80% of people still don’t get long-term benefit. And maybe other checkpoints are important. So our first program, the CD200R1 program, affects another checkpoint that’s independent of PD-1 and PD-L1. We need different options to get the right effect, and we need to understand more about the immune system that we’re trying to activate. Because 23andMe has a broader understanding of the variability of the immune system, we’re finding targets that we can explore different ways of approaching. We’re very excited about the potential of these agents.
23andMe has several Ethical issues Dealing with demographics in genetic research. How can databases help bring diversity to clinical trials?
The FDA is very concerned about the lack of breadth that we see in a lot of clinical trials, and they want to see diversity because the U.S. population is very diverse and the FDA needs a broader understanding. With our experience with genetics and our growing knowledge of the differences, I think other companies in the industry will recognize the importance of having that additional information. The U.S. only represents 30% of the global market for most drugs, so this is a really important thing to think about.
As precision medicine advances, expanding biomarkers will be important. How do you think 23andMe’s database will help in the future?
We’ve been talking about personalized medicine for a long time, because for an individual, even if you have a disease as broad as lung cancer or breast cancer, the tumor and the immune system have a huge impact on how the drugs work and how you ultimately get the tumor under control. In oncology, we tend to focus on the tumor itself, but we already know that the tumor is much bigger than that. We’re trying to understand these nuances and understand the biological processes. That’s why 23andMe is doing a lot of research to look at polygenic causes and polygenic risk for the propensity to develop disease. I think 23andMe is making an important contribution to thinking about these big questions, and we would love to partner with any company that wants to understand some of these aspects. That’s one of the mechanisms that allows us to extend our impact much more.
What are the biggest challenges for 23andMe moving forward in the therapeutic space?
This is a tough market for us as a small biotech company right now. As a result, we have had to make some tough decisions regarding our priorities and focus. We announced that we needed to scale back our activities and have made the very tough decision to lay off several employees in our therapeutics division. While we wish we could have done it all, we are confident that we are a leaner, stronger organization and better equipped to accomplish a lot more with great efficiency.
