23andMe Therapeutics Announces Positive In Vivo Results for 23ME-01473, a Dual-Mechanism ULBP6-Targeting Antibody Currently in a Phase 1 Trial

23ME-01473 inhibited tumor growth in a patient-derived xenograft mouse model of non-small cell lung cancer

Elevated levels of soluble and tumor-bound ULBP6 confirmed in squamous cell carcinomas and a subset of adenocarcinomas, offering potential indications to assess clinical activity

Phase 1 trial ongoing with first patient dosed in March 2024

SUNNYVALE, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) — 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, announced nonclinical data supporting the anti-tumor activity of its first-in-class 23ME-01473 (’1473) antibody targeting the NKG2D ligand ULBP6 at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, September 13-17.

In a poster presentation at the 2024 ESMO Congress, 23andMe Therapeutics presented new data showing that 23ME-01473 inhibits growth of non-small cell lung cancer in a patient-derived xenograft mouse model. The presentation also included data showing elevated plasma soluble and tumor expression levels of ULBP6 in squamous cell carcinomas and a subset of adenocarcinomas. These findings have led to the prioritization of four expansion cohort cancer types for potential further investigation during the Phase 2a dose expansion portion of the Phase 1/2a trial, which began in March 2024: head and neck squamous cell carcinoma, squamous non-small cell lung cancer, colorectal cancer and triple-negative breast cancer. The design of this Phase 1/2a trial was presented in a second Trials-In-Progress presentation at the ESMO Congress. (The 23andMe ESMO posters are available on the 23andMe Therapeutics and Investor websites).

“We are excited to share this new preclinical data that support our ongoing clinical trial,” said Jennifer Low, M.D., Ph.D., Head of Therapeutics Development. “This additional data, coupled with our ongoing clinical studies, demonstrates the potential utility of human genetics to identify new targets and develop promising new drugs in the immuno-oncology space.”

About 23ME-01473
’1473 targets ULBP6 to restore anti-tumor immunity through NK and T cells. ULBPs are stress-induced ligands found on the surface of cancer cells that bind to their receptor, NKG2D, on NK and T cells. Cancers escape immune cell recognition by shedding ULBP ligands from their cell surface, which act as immunosuppressive molecular decoys.
Blocking the binding of soluble ULBP6 to NKG2D through ‘1473 may restore immune cell recognition and killing of cancers. Further, ‘1473 is Fc-effector enhanced, which provides an additional mechanism for NK cells to induce cell death of ULBP6-expressing cancer cells.
ULBP6 was identified as a potential cancer drug target using the 23andMe immuno-oncology (I/O) genetic signature, an approach developed by 23andMe to identify evidence for genetic variants that increase immune function while decreasing cancer risk. Using genetic data, 23andMe can identify immune-related genes that are expected to have an impact on cancer biology. Specifically, germline genetics can reveal which of the immune-related genes harbor genetic variants that also alter an individual’s predisposition for developing cancer.

About the Phase 1 ‘1473 Study
The first-in-human, multi-center, open-label clinical trial will determine the safety and tolerability of ‘1473 in people with locally advanced or metastatic solid malignancies that have progressed after standard therapy. This study will also evaluate the pharmacokinetic and pharmacodynamic profile of ‘1473 to identify the optimal dose and schedule for further clinical studies. Clinical trials registry (clinicaltrials.gov): NCT06290388. For information on enrolling on to this clinical trial contact 650-963-8997 or [email protected].

About 23andMe
23andMe is a genetics-led consumer healthcare and therapeutics company empowering a healthier future. For more information, please https://therapeutics.23andme.com.

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