23andMe Announces Presentation of Phase 1 Clinical Data for 23ME-00610, an Investigational Antibody Targeting CD200R1, at the American Association for Cancer Research (AACR) Annual Meeting 2023

Rhea-AI Summary

23andMe Holding Co. (Nasdaq: ME) has announced the presentation of clinical data from the Phase 1 portion of the 23ME-00610 study at the AACR Annual Meeting on April 18, 2023. This study investigates 23ME-00610, an investigational antibody targeting CD200R1 for treating advanced solid tumors. Key data will focus on safety, tolerability, and pharmacokinetics. The study aims to understand the antibody's potential to restore immune function against tumors. A successful presentation could impact investor sentiment positively as the company transitions into Phase 2a for assessing anti-cancer efficacy in specific tumor types.

Positive

• Data on safety and tolerability for 23ME-00610 presented at AACR Annual Meeting.
• Successful dosing of the first patient in the Phase 2a study of 23ME-00610.
• Potential to restore immune function, enhancing treatment options for cancer patients.

Negative

• None.

Data from the Phase 1 portion of the 23ME-00610 Phase 1/2a study, including safety, pharmacokinetics, and the recommended Phase 2a dose to be presented

SOUTH SAN FRANCISCO, Calif., March 14, 2023 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (23andMe) announced that clinical data from the Phase 1 portion of the Phase 1/2a study of 23ME-00610 has been selected for a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting being held in Orlando, Florida, April 14-19, 2023.

The poster presentation will provide data on the safety and tolerability of 23ME-00610, an investigational antibody targeting CD200R1 in patients with advanced solid malignancies, and the rationale for the dose selected for the Phase 2a portion of the study. Additional data on the pharmacodynamics and pharmacokinetics of 23ME-00610 will also be presented. The abstract is embargoed by AACR until April 14, 2023, 12:00 PM ET.

Poster Presentation Details:

• Poster Title: First-in-class anti-CD200R1 antibody 23ME-00610 in patients with advanced solid malignancies: Phase 1 results
• Session Title: First-in-Human Phase I Clinical Trials 2
• Session Date and Time: Tuesday, April 18, 2023, 9:00 AM - 12:30 PM ET
• Location: Poster Section 45
• Poster Board Number: 6
• Abstract Presentation Number: CT174

23andMe, a leading human genetics and biopharmaceutical company with a mission to help people access, understand, and benefit from the human genome, recently announced the first patient dosed in the Phase 2a portion of the 23ME-00610 study. The expansion portion of the study will evaluate the anti-cancer activity of 23ME-00610 in specific tumor indications, and will further characterize the safety, tolerability, pharmacokinetic and pharmacodynamic profile of 23ME-00610.

About 23ME-00610
23ME-00610 is a high-affinity, fully humanized monoclonal antibody that 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. 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.

The Phase 1/2a study is an open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of 23ME-00610 in patients with advanced solid malignancies who have progressed on all available standard therapies. 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 the future performance of 23andMe’s businesses in consumer genetics and therapeutics and the growth and potential of its proprietary research platform. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding 23andMe’s strategy, financial position, funding for continued operations, cash reserves, projected costs, plans, 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.

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

FAQ

What is the purpose of the 23ME-00610 study?

The study aims to evaluate the safety, tolerability, and efficacy of the investigational antibody 23ME-00610 in patients with advanced solid malignancies.

When will the clinical data for 23ME-00610 be presented?

The clinical data will be presented on April 18, 2023, at the AACR Annual Meeting.

What are the next steps for the 23ME-00610 study?

After the Phase 1 results, the study will transition to Phase 2a to evaluate anti-cancer activity in specific tumor indications.

How does 23ME-00610 work?

23ME-00610 is designed to prevent the interaction of CD200R1 with CD200, aiming to restore immune activity against cancer cells.

What is the significance of the AACR Annual Meeting for 23andMe?

The AACR Annual Meeting provides a platform to present pivotal clinical data, which may influence investor confidence and future funding opportunities.