23andMe Reports Positive Phase 2 Results for 23ME-00610 at 2024 ASCO Annual Meeting

South San Francisco, Calif., June 03, 2024 – 23andMe Holding Co., a pioneering company in human genetics and biopharmaceuticals, announced promising preliminary findings from its Phase 2 clinical trials of 23ME-00610, an innovative anti-CD200R1 antibody. The data was showcased at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Clinical Outcomes and Safety

The trials, which involved patients with neuroendocrine and ovarian cancers, revealed encouraging safety and efficacy results. Notably, a patient with well-differentiated pancreatic neuroendocrine cancer (pNET) exhibited a confirmed partial response (PR) after more than 24 cycles of treatment. Another patient with mesonephric adenocarcinoma, a type of ovarian cancer, showed significant clinical improvement, including tumor shrinkage.

23ME-00610 has met the safety and tolerability benchmarks, achieving the pre-set pharmacological targets at a dose of 1400 mg administered every three weeks. The treatment showed over 70% of patients had detectable CD200 in tumor cells, with a higher expression correlating with better clinical outcomes. Additionally, tumors with an immunosuppressed profile appeared more responsive to the therapy.

Additional Findings

Emerging data suggest that 23ME-00610 provides clinical benefits with a lower risk of chronic immune-mediated diseases but may heighten the risk of acute immune reactions and cancer. This aligns with the 23andMe Immuno-oncology Signature, which identifies genomic regions associated with varying risks for autoimmune diseases and cancer.

Neuroendocrine Cancer Cohort

Between February 2023 and April 2024, 16 patients with advanced neuroendocrine tumors, having undergone a median of 3.5 prior treatments, participated in the trial. A patient with pNET and high tumor CD200 expression maintained a partial response for over 21 months. The overall disease control rate was 50%, with 25.3% of patients free from clinical progression at six months. The treatment exhibited a favorable safety profile, with no adverse events leading to discontinuation. The most common treatment-related side effects were mild to moderate skin rashes and fatigue.

Ovarian Cancer Cohort

In a parallel trial conducted from March 2023 to April 2024, 16 ovarian cancer patients who had a median of four prior treatments were enrolled. The safety profile was consistent with the neuroendocrine cohort, with no severe adverse events reported. A patient with mesonephric adenocarcinoma demonstrated significant clinical improvement and reduced tumor markers and malignant ascites over more than 12 treatment cycles.

Biomarker and Treatment Insights

Eligible patients had advanced or metastatic neuroendocrine or ovarian cancers that had progressed despite standard treatments. Exploratory biomarkers included CD200R1 and CD200 tumor expression, genetic profiling, and risk scores for immune and cancer phenotypes. Patients received 1400 mg doses intravenously every three weeks, with imaging studies conducted approximately every eight weeks.

About 23ME-00610

23ME-00610 targets CD200R1 to inhibit its interaction with CD200. Leveraging a vast proprietary health and genetic database, 23andMe identified genetic variants linked to immune diseases and cancer, pinpointing CD200R1 as a critical immuno-oncology target. Preclinical data confirmed the potential of the CD200-CD200R1 pathway as an immune checkpoint. Clinical results indicate that 23ME-00610 has promising pharmacokinetics and a favorable safety profile at the recommended Phase 2 dose.

About 23andMe

23andMe is a genetics-led consumer healthcare and biopharmaceutical company committed to promoting a healthier future. The company uses genetic insights to develop innovative treatments and empower consumers with health information.

Conclusion

The preliminary Phase 2 data for 23ME-00610 highlights its potential as a monotherapy for certain cancers, demonstrating notable safety, tolerability, and clinical benefit. With continuing research, 23andMe aims to further explore combination therapies to enhance patient outcomes.

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