SOUTH SAN FRANCISCO, Calif. - The U.S. Food and Drug Administration (FDA) has approved the investigational new drug application for 23andMe Holding Co.'s (NASDAQ:ME) cancer treatment candidate, 23ME-01473, the company announced. The drug is designed to activate natural killer (NK) cells and T cells to restore anti-tumor immunity and is set to enter Phase 1 clinical trials in the first half of 2024.
The investigational drug, referred to as '1473, targets ULBP6, a molecule found on the surface of cancer cells. By blocking the immunosuppressive effects of soluble ULBP6 and inducing Fc receptor-mediated killing of ULBP6-expressing cancer cells, '1473 aims to enhance the immune system's ability to recognize and eliminate cancer cells. This could be particularly beneficial for patients with advanced solid tumors who may have or develop resistance to existing checkpoint inhibitors.
Jennifer Low, Head of Therapeutics Development at 23andMe, highlighted the potential of '1473 to initiate a more comprehensive immune response and possibly delay tumor resistance, a significant issue in current cancer treatments. The therapeutic candidate was discovered using 23andMe's proprietary research platform, which leverages a vast database of de-identified human genetic and phenotypic information.
23andMe, primarily known for its consumer genetics testing services, has been expanding its biopharmaceutical division, aiming to utilize its genetic database to identify and develop novel therapeutic targets.
This announcement is based on a press release statement from 23andMe.
InvestingPro Insights
As 23andMe (NASDAQ:ME) embarks on clinical trials for its new cancer treatment candidate, investors are closely monitoring the company's financial health and market performance. According to real-time data from InvestingPro, the company holds a market capitalization of 356.02 million USD and has experienced a revenue decline of 9.22% over the last twelve months as of Q2 2024. Despite these challenges, 23andMe has a notable gross profit margin of 45.58% for the same period, indicating a strong ability to control costs relative to revenue.
InvestingPro Tips suggest that while the company has more liquid assets than short-term obligations, indicating a degree of financial stability, it is quickly burning through cash and analysts do not expect it to be profitable this year. Additionally, the stock has seen a significant price drop of 61.3% over the last six months, reflecting investor concerns and market reactions to the company's performance. Nevertheless, these financial metrics and analyst insights could offer valuable context for investors considering the potential risks and rewards associated with 23andMe's venture into therapeutic development.
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