Troubled Biotech Company's Investigational Cancer Drug Gets Greenlighted By FDA

In a recent announcement, 23andMe Holding Co. ME has disclosed that the U.S. Food and Drug Administration (FDA) has given the green light to its investigational new drug application for 23ME-01473 (‘1473), a natural killer (NK) cell activator designed to combat cancer.

What Happened: As per the company’s press release, ‘1473 is set to be evaluated in a Phase 1 clinical study commencing in the first half of 2024. The study will focus on participants with advanced solid tumors.

The drug targets ULBP6, a protein found on the surface of cancer cells, and aims to restore the immune system’s ability to recognize and destroy these cells. ‘1473 is also Fc-effector enhanced, providing another method for NK cells to induce cell death of ULBP6-expressing cancer cells.

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Furthermore, the drug has the potential to address a significant gap in cancer treatment by targeting patients who may develop resistance to checkpoint inhibitors.

Jennifer Low, head of Therapeutics Development at 23andMe, commented, “This program further validates the 23andMe database as a proven resource for identifying novel therapeutic targets.”

Why It Matters: This development marks a significant milestone for 23andMe, a company that has been in the spotlight for security breaches in the past. In October 2023, an unidentified hacker reportedly stole personal genetic data from millions of 23andMe customer accounts, raising concerns over privacy and security. Later in December, the company confirmed that hackers had accessed the ancestry data of a significant number of users in a security breach that affected around 0.1% of its customer base.

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