23andMe Trials-in-Progress Poster Details Expansion Cohorts for 23ME-00610, an Investigational Antibody Targeting CD200R1, at The Society for Immunotherapy of Cancer’s (SITC) 2022 Annual Meeting
23andMe Holding Co. (Nasdaq: ME) presented a trials-in-progress poster at the SITC 37th Annual Meeting detailing the expansion phase of its Phase 1 study for 23ME-00610, an investigational antibody targeting CD200R1 in advanced solid malignancies. Targeted tumor types include clear cell renal cell carcinoma, epithelial ovarian carcinoma, and neuroendocrine cancers, among others. The study aims to evaluate the monotherapy activity of 23ME-00610 across various cohorts. The poster emphasizes the genetic basis for selecting these tumor types and the potential benefits of targeting CD200R1 to enhance immune response against cancer.
- 23ME-00610 targets a novel pathway (CD200R1) with potential to restore T-cell activity against tumors.
- The study includes diverse tumor types, increasing the potential market impact if successful.
- 23andMe's vast genetic database supports the scientific rationale behind the drug's development.
- The Phase 1 study is still ongoing, with no confirmed results or approvals yet.
- Risk of clinical trial failures which could delay or halt development of 23ME-00610.
The presentation outlines plans for the expansion phase of the study (part B), including the specific tumor indications where 23ME-00610 will be tested for anticancer activity
SOUTH SAN FRANCISCO, Calif., Nov. 07, 2022 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company with a mission to help people access, understand, and benefit from the human genome, is presenting a trials-in-progress poster detailing tumor types being evaluated in the expansion phase of its ongoing Phase 1 study for 23ME-00610, an investigational antibody targeting CD200R1 in patients with advanced solid malignancies, at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting, November 8-12, 2022 in Boston, Massachusetts.
The poster includes details on how the monotherapy activity of 23ME-00610 will be evaluated in tumor indication-specific expansion cohorts (N~15/cohort), which include clear cell renal cell carcinoma; epithelial ovarian, fallopian tube or primary peritoneal carcinoma; neuroendocrine cancers including small cell lung cancer; and microsatellite instability-high (MSI-H) or tumor mutational burden-high (TMB-H) cancers that have progressed on standard therapies. A cohort of adolescents with locally advanced unresectable, or metastatic solid malignancies will also be enrolled.
The tumor indications for the expansion phase were selected based on pre-clinical and published data of the activity and expression of CD200R1 and its ligand, CD200, together with immune cell and tumor characteristics that have the potential to increase the likelihood of a response to CD200R1 inhibition.
23andMe has more than 13 million genotyped customers, over
“Our hypothesis, backed by published research, is that drug targets based on human genetics are more likely to prove successful than those with no underlying human genetic evidence,'' said Jennifer Low, MD, PhD, Head of Therapeutics Development at 23andMe. “We are testing if our antibody has activity in a variety of tumor types including those that traditionally don't respond to anti-PD(L)-1 treatment. We hope that 23ME-00610 will ultimately provide clinical benefit to patients with cancer.”
Poster Details
Title: A Phase 1 Dose Escalation and Expansion Study of the anti-CD200R1 Antibody 23ME-00610 in Patients with Advanced Solid Malignancies.
Session: Annual Meeting Regular Poster Abstract Presenter
Abstract/Poster Number: 758
Location: Hall C
Date and Time: Friday, November 11, 2022 - 9:00 a.m. – 8:30 p.m. ET
About 23ME-00610
23ME-00610 is a high-affinity humanized monoclonal antibody that is designed to bind to the CD200R1 receptor and prevent the interaction of CD200 and CD200R1. 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 study is an open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary 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.
Reference, drug targets based on human genetics: Nelson et al., 2015 (Nature Genetics), King et al., 2019 (PLOS Genetics)
About 23andMe
23andMe is a genetics-led consumer healthcare and therapeutics 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 23ME-00610 and its purpose?
When and where was the 23andMe trial poster presented?
What tumor types are being targeted in the 23ME-00610 study?
What is the significance of CD200R1 in the study?
What are the expected outcomes of the Phase 1 study for 23ME-00610?
