Thursday, April 20, 2023

Spit takes

23andMe is coming for pharma.

Hi folks, it's Kristen in NYC. You've probably gotten one of their spit kits for Christmas, now 23andMe has some news on a tumor-fighting drug. But first… 

Today's must-reads

  • Secondhand clothing sellers have a looming problem with toxic chemicals found in rain jackets and other garments.
  • Mental health is getting more attention in the workplace, but many managers don't know how to handle workers' concerns.
  • India's people are becoming more vulnerable to hunger and illness due to heat waves.

23andMe's big pharma ambitions 

It was not long ago that 23andMe made what seemed like a pivot — even though it had really been part of CEO Anne Wojcicki's big plan all along

The company is probably best known for its consumer DNA testing kits that, with the aid of a fairly large amount of spit, reveal to its customers information about their ancestry and health. But Wojcicki's goal was never to inform people about their genetic aversion to cilantro. It was to use the power of genetics at scale to transform health. The idea is to comb its database of more than 13.6 million users for hints as to what genetic pathways might be at the root of disease. 

Now, early results are in on the first drug the company sought to develop fully in house. The drug, 23ME-00610, is a monoclonal antibody that came from a discovery by 23andMe scientists of a biological pathway strongly associated with the way immune cells attack a certain kind of tumor. The drug is designed to reactivate the immune system's response to tumors by restoring the ability of both T-cells and myeloid cells to fight them.

Early human clinical trials are mostly about safety — once it's determined that a drug seems safe in a small number of people, larger trials further evaluate how effective the drugs are. 

In this case, 27 people with treatment-resistant tumors were given doses of the drug every three weeks. The drug appeared to have a tolerable safety profile. There were also some early signals of the drugs efficacy, with a nearly 20% reduction in the size of tumors after several months for one patient, who remains in the trial.  (You can see more details in this poster on the trial that the company presented at the annual meeting for the American Association for Cancer Research.)

"We are very proud of this program," says Jennifer Low, 23andMe's head of therapeutic development, via email. "The program is exceeding our expectations at this stage. We are busy with the next stage of our program!"

Now, the drug will be tested in larger numbers of patients with specific cancers likely to respond best to the drug at the dose identified as potentially effective in earlier trials. 

23andMe's other pharmaceutical efforts to make it to human trials have been through partnerships with drugmakers like GSK. Its effort is still years away from market, if it does prove successful. And the company has plenty of skeptics.  

Drug development is in large part a crapshoot. An estimated 13% of all global drug development programs end in approvals. Sometimes we don't really understand the molecular mechanism underpinning the success of a drug at all. Genetics holds the promise to winnow down the randomness, and get more drugs to market, faster. 

So far, though, genetics has not played a huge role in very many new drugs. For 23andMe, the next few years will mark a major test. — Kristen V. Brown
 

What we're reading

Mindpath is a cautionary tale for private equity in mental health, reports STAT

The pregnancy risks of new weight loss drugs, from Vox.

Social media is fueling interest in weight loss drugs, but are regulators paying attention? By Kaiser Health News.

Ask Prognosis

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