The FDA cleared 23andMe Therapeutics to begin dosing patients with advanced solid tumors as part of a Phase I clinical trial for a new investigational cancer drug.
This clinical trial, to begin later this year, will be the Company’s second clinical trial for a cancer drug. The first, 23ME-00610, begun in early 2022, is now enrolling patients in the Phase 2a portion of its Phase 1/2a clinical trial.
The New Investigational Cancer Treatment
The new drug, 23ME-01473, or ‘1473, is designed to restore anti-tumor immunity by activating two types of immune cells — Natural Killer (NK) cells and T cells. It binds to ULBP6, a protein that binds to the immune-activating receptor NKG2D on NK and T cells.
“The team is excited to initiate our next immuno-oncology program, ‘1473, which is particularly interesting given its two mechanisms of action, which may synergize to enhance NK and T cell immunity against certain tumors,” said Jennifer Low, MD, Ph.D., Head of Therapeutics Development at 23andMe.
Typically, cells express ULBPs on their surface in response to a stressor such as an infection or cancer to signal to NKG2D on immune cells that there is an abnormality. However, some cancers shed ULBP6 from the cell surface, which acts as a decoy to evade immune cell recognition through NKG2D.
Immune Activation
By binding the shed ULBP6, immune activation through NKG2D activation may restore the immune cells’ ability to recognize and fight cancer.
Additionally, the fragment crystallizable (Fc) region of ‘1473 is designed to further promote cancer cell killing by immune cells, offering another mechanism for anti-tumor activity.
Part of 23andMe Therapeutics’ mission is to create new treatments to address unmet needs. The hope is that ‘1473 could help cancer patients with tumors resistant to other therapies. Combining NK and T cell activation as part of this process could initiate a broader and deeper immune system response and delay tumor resistance, often seen with traditional checkpoint inhibitor treatments for these cancers.
As with other Phase 1 clinical trials, this one will assess safety and identify a safe and efficacious dose level and frequency for this newly developed drug in a small group of cancer patients.
Learn More
Learn more about 23andMe Therapeutics, its pipeline, and programs at the updated website here.