23andMe Therapeutics presented encouraging Phase 2 clinical data for its novel cancer therapies, 23ME-01473 and 23ME-00610, at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona. The data highlight the potential of these first-in-class antibodies to address unmet needs in various solid tumors.
23ME-01473: Targeting ULBP6 in Solid Tumors
23ME-01473, a first-in-class antibody targeting the NKG2D ligand ULBP6, demonstrated significant anti-tumor activity in a patient-derived xenograft mouse model of non-small cell lung cancer (NSCLC). The preclinical data, presented in a poster session, showed that 23ME-01473 effectively inhibited tumor growth. Furthermore, the presentation included data showing elevated plasma soluble and tumor expression levels of ULBP6 in squamous cell carcinomas and a subset of adenocarcinomas.
"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 at 23andMe. "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."
23ME-01473 is currently being evaluated in a Phase 1/2a clinical trial (NCT06290388) in patients with locally advanced or metastatic solid malignancies that have progressed after standard therapy. The trial's Phase 2a dose expansion portion will prioritize four cancer types for further investigation: head and neck squamous cell carcinoma, squamous non-small cell lung cancer, colorectal cancer, and triple-negative breast cancer. The first patient was dosed in March 2024.
23ME-00610: Inhibiting CD200R1 in Clear-Cell Renal-Cell Carcinoma and Other Tumors
23andMe also announced positive preliminary Phase 2 safety and efficacy data from its Phase 1/2a clinical trial for 23ME-00610, a first-in-class anti-CD200R1 antibody. The data, presented in posters, covered two new patient cohorts: clear-cell renal-cell carcinoma (ccRCC) and tumor mutational burden-high (TMB-H) or microsatellite instability-high (MSI-H) cancers.
In the ccRCC cohort, one patient with refractory disease experienced a confirmed partial response, with a 38% decrease in measured tumor burden after more than 11 cycles of treatment. The 23ME-00610 monotherapy continued to demonstrate acceptable safety and tolerability, achieving the pre-specified targets for maximal pharmacology at 1400 mg dosed every three weeks.
"We continue to be encouraged by evidence for therapeutic potential, in the form of multiple patients with durable clinical benefit from '610," said Jennifer Low, M.D., Ph.D., Head of Therapeutics Development, 23andMe. "Furthermore, the emergence of CD200 expression as a candidate biomarker has the potential to give us a powerful tool for patient selection."
Notably, higher tumor expression of CD200 may be associated with clinical benefit in some patient groups treated with 23ME-00610, warranting further exploration of this biomarker. Histology data also suggest that immunosuppressed ("cold") tumors may be more likely to exhibit disease control with 23ME-00610, offering a potential treatment option for patients who have progressed after multiple lines of treatment, including existing checkpoint inhibitors.
In the TMB-H/MSI-H cohort, 13 adult patients with locally advanced or metastatic solid cancers who received a median of five prior treatments were enrolled and received a median of three cycles of 23ME-00610. One patient remained on the study at the July 1, 2024, data cutoff.
About 23ME-00610
23ME-00610 is a monoclonal antibody that binds to CD200R1 to prevent the interaction of CD200R1 with CD200. Using the world’s largest proprietary database of health and genetic information, 23andMe identified genetic variants of CD200R1, CD200, and DOK2, the downstream signaling protein, associated with higher risks of immune disease and lower risks of cancer, pinpointing CD200R1 as a promising immuno-oncology target.
