CD200

23andMe to give an oral presentation on the genetic signature of ULBP6, the target of 23ME-01473, along with poster presentations of the biology of ULBP6 and mechanism of 23ME-01473, and new non-clinical insights for 23ME-00610, targeting the CD200R1 pathwaySOUTH SAN FRANCISCO, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, today announced an oral presentation and two poster presentations on two of the Company’s immuno-oncology programs that will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place in San Diego, CA, April 5-10, 2024. The oral presentation will detail the use of the 23andMe genetic and health survey database to discover ULBP6, the highest affinity ligand of the NK and T-cell activation receptor, NKG2D. ULBP6 is the primary target for 23ME-01473 (‘1473), a dual mechanism monoclonal antibody. The Company will also present a poster on the biology of ULBP6, and how ‘1473 reinvigorates anti-tumor NK cell function through NKG2D and FcγRIIIa activation. These presentations will be the first scientific communications the Company has prepared on ‘1473 since announcing its pursuit of this novel, genetically-validated target. The FDA recently cleared the IND application for ‘1473, which targets ULBP6. Cancers escape immune cell recognition by shedding ULBP ligands from their cell surface, which act as immunosuppressive molecular decoys. Blocking the binding of soluble ULBP6 to NKG2D with ‘1473 may restore immune cell recognition and killing of cancers. Further, ‘1473 is Fc-effector enhanced, which provides an additional mechanism for NK cells to induce cell death of ULBP6-expressing cancer cells. 23andMe will also present a non-clinical poster on 23ME-00610, an inhibitor of the CD200R1 receptor, which will include new insights into targeting the CD200R1 pathway in T and NK cells using 23ME-00610 as a single agent or in combination with other anti-tumor therapies. 23ME-00610 is currently in Phase 2a of a Phase 1/2a clinical study. The presentations will be available on the 23andMe Investor Relations and Therapeutics websites on April 5, 2024. Presentation details - 23ME-01473: Oral presentation Title: Discovery of ULBP6 as a novel immuno-oncology target using pleiotropic signals from 23andMeʼs genetic and health survey databaseSession Type: MinisymposiumSession Category: Experimental and Molecular TherapeuticsSession Title: Drug Discovery 1: New Targets and ApproachesSession Date and Time: Monday, April 8, 2024, 2:30 - 4:30 PM PTPublished Abstract Number: 3903 Poster presentation Title: 23ME-01473, a novel anti-ULBP6/2/5 monoclonal antibody, reinvigorates anti-tumor NK cell function through NKG2D and FcγRIIIa activationSession Category: Clinical ResearchSession Title: Antibodies 1Session Date and Time: Monday, April 8, 2024, 9:00 AM - 12:30 PM PTLocation: Poster Section 38Poster Board Number: 21Published Abstract Number: 2375 Presentation Details: 23ME-00610: Poster presentation Title: New insights into targeting the CD200R1 pathway in T and NK cells using 23ME-00610 as a single agent or in combinationSession Category: Clinical ResearchSession Title: Antibodies 1Session Date and Time: Monday, April 8, 2024, 9:00 AM - 12:30 PM PTLocation: Poster Section 38Poster Board Number: 5Published Abstract Number: 2359 About 23ME-01473 (‘1473)‘1473 targets ULBP6 to restore anti-tumor immunity through NK and T cells. ULBPs are stress-induced ligands found on the surface of cancer cells that bind to their receptor, NKG2D, on NK and T cells. Cancers escape immune cell recognition by shedding ULBP ligands from their cell surface, which act as immunosuppressive molecular decoys. Blocking the binding of soluble ULBP6 to NKG2D may restore immune cell recognition and killing of cancers. Further, ‘1473 is Fc-effector enhanced, which provides an additional mechanism for NK cells to induce cell death of ULBP6-expressing cancer cells. 23andMe plans to evaluate ‘1473 in participants with advanced solid tumors in a Phase 1 clinical study beginning in the first half of 2024. Clinical trials registry (clinicaltrials.gov): NCT06290388. About 23ME-0061023ME-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. 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 23andMe23andMe is a genetics-led consumer healthcare and biopharmaceutical company empowering a healthier future. For more information, please visit www.23andMe.com. Forward-Looking StatementsThis 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 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. Contacts: Investor Relations Contact: investors@23andMe.comMedia Contact: press@23andMe.com

Thirty additional patients with advanced neuroendocrine and advanced ovarian cancer will be enrolled in the study of 23ME-00610, an investigational antibody targeting CD200R1 A second potentially efficacious dose level to characterize safety and efficacy will be evaluated to identify the optimal dose in alignment with recently published regulatory guidance SOUTH SAN FRANCISCO, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company, announced the further expansion of the ongoing 23ME-00610 Phase 1/2a study to include an additional 30 patients with advanced neuroendocrine and ovarian cancers, above the original enrollment goals. The ongoing study has been enrolling the Phase 2a portion of the Phase 1/2a clinical trial evaluating the anti-CD200R1 monoclonal antibody since February 2023. As previously presented at a scientific conference in November 2023, 23ME-00610 has an appropriate safety profile in the highest doses tested, and met pharmacodynamic biomarker and pharmacokinetic objectives, while not reaching a maximum tolerated dose in the Phase 1 study. The Phase 2a portion of the study is being conducted with the highest tested dose from the Phase 1, 1400 mg intravenously every 3 weeks. In order to characterize potential optimal dosing of 23ME-00610, and aligned with recent regulatory guidelines, 23andMe is utilizing this clinical trial to further characterize safety and efficacy of a second potentially efficacious dose of 600 mg intravenously every 3 weeks in these additional patients. “23ME-00610 has been well-tolerated with a very manageable side effect profile and we've also seen some encouraging signs of activity, particularly in neuroendocrine cancers that we've previously presented,” said Drew W. Rasco, MD, Associate Director of Clinical Research at the START Center for Cancer Care, and a principal investigator for the 23ME-00610 study. “CD200R1 is an exciting new target in the immuno-oncology landscape, and we are looking forward to enrolling additional patients in the neuroendocrine and ovarian cancer expansion cohorts.” “We are gratified by the patient and investigator enthusiasm with this clinical trial, that allows us to continue enrolling additional patients to better understand the potential for our anti-CD200R1 program,” said Jennifer Low, MD, PhD, Head of Therapeutics Development, 23andMe. “We look forward to evaluating this new data as it emerges, in order to plan for the future of this program.” 23andMe and the investigators for this clinical trial plan to share Phase 2a data from the ongoing Phase 1/2a study at scientific conferences in 2024. About 23ME-0061023ME-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 monotherapy in patients with advanced solid malignancies who have progressed on all available standard therapies. Clinical trials registry (clinicaltrials.gov): NCT05199272. About 23andMe23andMe is a genetics-led consumer healthcare and biopharmaceutical company empowering a healthier future. For more information, please visit www.23andMe.com. Forward looking statementsThis 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, the results of its clinical trials, 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.comMedia Contact: press@23andMe.com

23andMe presented data from the now completed dose escalation phase, and pharmacokinetic / pharmacodynamic (PK/PD) cohorts at the Society for Immunotherapy of Cancer Annual Meeting 2023 Dosing with 23ME-00610 monotherapy in 28 patients with advanced solid tumors up to 1400 mg every three weeks (Q3W) showed tolerability consistent with expectation for on-target effects Peripheral pharmacodynamic data demonstrate that 23ME-00610 maximally inhibits signaling through CD200R1 on immune cells, which correlated with the presence of expected immune-related adverse events, at pharmacologically relevant doses Preliminary efficacy data from the Phase 1 dose escalation portion showed signs of clinical activity and a stable disease rate of 52% The PK, PD, safety, and preliminary efficacy data continue to support the ongoing Phase 2a study of 23ME-00610 in tumor-specific expansion cohorts at the preliminary recommended Phase 2a expansion dose (RP2D) of 1400 mg Q3W SOUTH SAN FRANCISCO, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company, announced data from its ongoing first-in-human Phase 1/2a clinical trial evaluating the safety and efficacy of 23ME-00610, an investigational antibody targeting CD200R1. Updated data from the now completed dose escalation phase continue to showcase the manageable safety profile of 23ME-00610 at the dose levels tested, and highlight preliminary efficacy results in patients with advanced solid tumors. The data was presented in two posters at the Society of Immunotherapy in Cancer Annual Meeting 2023 on Friday, November 3, 2023. The poster presentations are available on the 23andMe Therapeutics and Investor websites. The presentations include pharmacokinetic (PK), pharmacodynamic (PD), safety, and efficacy data from 28 patients that enrolled between January 5, 2022 and May 15, 2023 in the dose escalation portion of the 23ME-00610 Phase 1/2a clinical trial who had received a median of 3 prior anticancer treatment regimens, 54% of whom had prior immunotherapy. Of the phase 1 patients enrolled across all doses of the dose escalation, there was a 52% stable disease rate. One patient with pancreatic neuroendocrine cancer had a maximum reduction in sum of longest target lesion diameters of 19% and remained on treatment with stable disease at 40 weeks on study at the time of data cut off. One of the tumor lesions in this patient had a sustained 58% reduction in the longest diameter of the tumor on imaging scan. 23ME-00610 monotherapy was well-tolerated, with no dose-limiting toxicities or serious adverse events related to 23ME-00610, and no maximum tolerated dose (MTD) was reached up to the maximum tested dose of 1400 mg every 3 weeks. Immune-related adverse events (AE) were observed at pharmacologically relevant doses (≥ 60 mg), consistent with expected 23ME-00610-mediated immune modulation. Preliminary immunogenicity assessments showed no evidence of treatment-induced anti-drug antibodies (ADA). One treatment-related AE (600 mg dose) leading to discontinuation was observed: a non-serious grade 3 adverse event, maculopapular rash in Cycle 1, which resolved to baseline after treatment with oral and topical steroids. Preliminary PK data support dosing 23ME-00610 every three weeks (Q3W). 23ME-00610 has a favorable PK and PD profile, with median half-life of 11 to 13 days for doses ≥ 200 mg, and saturated peripheral PD and dose-proportional exposure for doses greater than 60 mg. The combined safety, PK, PD, and preliminary efficacy data continue to support the evaluation of 23ME-00610 at the preliminary recommended Phase 2a expansion dose (RP2D) of 1400 mg every three weeks (Q3W), which is the dose expected to maximize CD200R1 inhibition in participants with cancer, based on the Cycle 1 predicted tumor concentration of 23ME-00610 that is above the tumor cell-killing EC90 for all participants with evaluable data. “In this Phase 1 study, 23ME-00610 was well-tolerated with a very manageable side effect profile,” said Drew W. Rasco, MD, Associate Director of Clinical Research at the START Center for Cancer Care, and a principal investigator for the 23ME-00610 study. “We also saw some encouraging signs of activity, particularly in neuroendocrine cancers. CD200R1 is an exciting new target in the immuno-oncology landscape, and we look forward to seeing more results from the ongoing enrollment in disease-specific expansion cohorts.” “The Phase 1 data from our first 23andMe-sponsored clinical trial in patients with cancer continues to be encouraging,” said Jennifer Low, MD, PhD, Head of Therapeutics Development at 23andMe. “Our data demonstrate that 23ME-00610 is able to be dosed in our participants over extended periods of time at the dose that should inhibit this pathway in tumors.” 23ME-00610 Phase 2:The Phase 2a portion of the Phase 1/2a study is currently enrolling, evaluating the anti-tumor activity of the 23ME-00610 monotherapy in a number of expansion cohorts, and further characterizing the safety, tolerability, PK and PD profile of 23ME-00610. The Phase 2a portion will include assessment of objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in the expansion cohorts. The expansion cohorts will enroll patients with clear cell renal cell carcinoma; epithelial ovarian, fallopian tube or primary peritoneal carcinoma; neuroendocrine cancers; 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. About 23ME-0061023ME-00610 is a first-in-class anti-CD200R1 monoclonal antibody in Phase 2 clinical development for advanced solid malignancies that has been shown to rescue T cell function in preclinical studies. 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. 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 23andMe23andMe is a genetics-led consumer healthcare and biopharmaceutical company empowering a healthier future. For more information, please visit www.23andMe.com. Forward looking statementsThis 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, the growth and potential of its proprietary research platform and its future clinical trial results. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding 23andMe’s plans, strategy, therapeutics development, clinical trials, projected costs, product development and launches, the successful commercialization and market acceptance of new products 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.comMedia Contact: press@23andMe.com