23andMe to Present Preliminary Efficacy and Biomarker Data for 23ME-00610 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

April 24, 2024

Data from neuroendocrine and ovarian cancer patient cohorts in the Phase 1/2a clinical trial of 23ME-00610 to be presented

SOUTH SAN FRANCISCO, Calif., April 24, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, today announced that two abstracts on 23ME-00610, a first-in-class anti-CD200R1 antibody, have been accepted for poster presentations at the 2024 ASCO Annual Meeting, taking place May 31 - June 4 in Chicago. 23andMe will present clinical data, including preliminary efficacy and exploratory biomarker analyses, for the neuroendocrine and ovarian cancer patient cohorts in the Phase 2a portion of its ongoing Phase 1/2a clinical trial.

23andMe scientists discovered the target for 23ME-00610 through the Company’s proprietary database of human genetic and health information. 23andMe has more than 15 million genotyped customers, roughly 80 percent of whom consent to participate in research. By analyzing de-identified, aggregate genetic and health data from consented research participants, 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.

Additional preclinical data validated the CD200-CD200R1 pathway as an immune checkpoint, and potential target for reversing immune tolerance in cancer as a monotherapy, or in combination with other therapies. Clinical data from the dose escalation cohort of patients with advanced solid tumors has shown 23ME-00610 has favorable pharmacokinetics (PK) for dosing once every three weeks, expected on-target pharmacologic activity, and a promising safety and tolerability profile at the preliminary recommended phase 2 dose of 1400 mg.

Details on the posters are below. Posters will be available on the 23andMe Therapeutics and Investor websites following the presentations.

Abstract: 4129
Title: Safety, efficacy, and PKPD of 23ME-00610, a first-in-class anti-CD200R1 antibody, in patients with advanced neuroendocrine cancers: Results from a multi-center multi-country phase 1/2a expansion cohort.
Session Type: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Date and Time: June 1, 1:30 - 4:30 PM CDT

Abstract: 5575
Title: Safety, efficacy, and PKPD of 23ME-00610, a first-in-class anti-CD200R1 antibody, in patients with advanced or metastatic ovarian cancer: Results from a multi-center multi-country phase 1/2a expansion cohort.
Session Type: Poster Session – Gynecologic Cancer
Date and Time: June 3, 9:00 AM - 12:00 PM CDT

About 23ME-00610
23ME-00610 is a first-in-class anti-CD200R1 monoclonal antibody in the Phase 2a portion of Phase 1/2a clinical development for advanced solid malignancies. CD200R1 was identified as an immuno-oncology (IO) target from the 23andMe database, with pleiotropic causal variants that have opposing effect on risks for cancer and immune diseases, referred to as an IO signature, observed in 3 components in this pathway.

23ME-00610 is designed to bind to CD200R1 and prevent the interaction of CD200R1 with CD200. The CD200–CD200R1 axis is an immunological checkpoint that plays a pivotal role in maintenance of immune tolerance. CD200R1 is an inhibitory receptor expressed on T cells and myeloid cells while CD200, the ligand for CD200R1, is highly expressed on certain tumors. In preclinical studies, binding of tumor-associated CD200 to CD200R1 leads to immune suppression and decreased immune cell killing of cancer cells. Preclinical data indicate that this mechanism has the potential to restore the ability for both T-cells and myeloid cells to kill cancer cells. Clinical trials registry (clinicaltrials.gov): NCT05199272.

About 23andMe
23andMe is a genetics-led consumer healthcare and biopharmaceutical company empowering a healthier future. For more information, please visit www.23andMe.com

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding its future clinical trials and plans of 23andMe’s therapeutics business. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding 23andMe’s strategy, the plans for and results of its clinical trials and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," “predicts,” "continue," "will," “schedule,” and "would" or, in each case, their negative or other variations or comparable terminology, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on 23andMe’s current expectations and projections about future events and various assumptions. 23andMe cannot guarantee that it will actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements and you should not place undue reliance on 23andMe’s forward-looking statements. These forward-looking statements involve a number of risks, uncertainties (many of which are beyond the control of 23andMe), or other assumptions that may cause actual results or performance to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission, and as revised and updated by our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The statements made herein are made as of the date of this press release and, except as may be required by law, 23andMe undertakes no obligation to update them, whether as a result of new information, developments, or otherwise.

Investor Relations Contact: investors@23andMe.com
Media Contact: press@23andMe.com

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