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

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

23andMe将在2024年美国临床肿瘤学会(ASCO)年会上公布23ME-00610的初步疗效和生物标志物数据
24andMe ·  04/24 12:00

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

23ME-00610的1/2a期临床试验中神经内分泌和卵巢癌患者群组的数据将公布

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.

加利福尼亚州南旧金山,2024 年 4 月 24 日(GLOBE NEWSWIRE)— 23andMe Holding Co.领先的人类遗传学和生物制药公司纳斯达克股票代码:ME)(“23andMe”)今天宣布,关于同类首创抗CD200R1抗体23ME-00610的两份摘要已获准在5月31日至6月4日在芝加哥举行的2024年ASCO年会上作海报展示。23andMe将提供临床数据,包括初步疗效和探索性神经标志物分析内分泌和卵巢癌患者群组处于其正在进行的1/2a期临床试验的2a期部分。

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.

23andMe的科学家通过该公司专有的人类遗传和健康信息数据库发现了23ME-00610的目标。23andMe拥有超过1500万基因型客户,其中约80%同意参与研究。通过分析来自同意的研究参与者的去识别化聚合遗传和健康数据,23andMe确定了下游信号蛋白 CD200R1、CD200 和DOK2的遗传变异,这些变异与更高的免疫疾病风险和较低的癌症风险有关,并将 CD200R1 确定为有前景的免疫肿瘤学靶标。

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.

其他临床前数据证实,CD200-CD200R1 途径是免疫检查点,以及作为单一疗法或与其他疗法联合使用可逆转癌症免疫耐受性的潜在靶标。来自晚期实体瘤患者剂量递增队列的临床数据显示,23ME-00610具有良好的药代动力学(PK),每三周给药一次,具有预期的靶向药理活性,并且在初步推荐的2期剂量1400 mg时具有良好的安全性和耐受性。

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

海报的详细信息如下。海报将在 23andMe 上发布 治疗的投资者 演讲之后的网站。

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

摘要:4129
标题:23ME-00610(同类首创的抗CD200R1抗体)在晚期神经内分泌癌患者中的安全性、有效性和PKPD:来自多中心多国1/2a期扩张队列的结果。
会议类型:海报会议 — 胃肠道癌 — 胃食管、胰腺和肝胆癌
日期和时间:中部夏令时间 6 月 1 日下午 1:30-4:30

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

摘要:5575
标题:23ME-00610(同类首创的抗CD200R1抗体)在晚期或转移性卵巢癌患者中的安全性、有效性和PKPD:来自多中心多国1/2a期扩张队列的结果。
会议类型:海报会议 — 妇科癌症
日期和时间:中部夏令时间 6 月 3 日上午 9:00-下午 12:00

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.

关于 23ME-00610
23ME-00610是同类首款抗CD200R1单克隆抗体,处于晚期实体恶性肿瘤1/2a期临床开发的2a期阶段。CD200R1 被确定为 23andMe 数据库中的免疫肿瘤学 (IO) 靶标,在该途径的三种成分中观察到对癌症和免疫疾病风险产生相反影响的多效因果变异被称为 IO 特征。

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.

23ME-00610 旨在与 CD200R1 结合并防止 CD200R1 与 CD200 的相互作用。CD200—CD200R1 轴是一个免疫学检查点,在维持免疫耐受性方面起着关键作用。CD200R1 是一种在 T 细胞和骨髓细胞上表达的抑制性受体,而 CD200R1 的配体 CD200 在某些肿瘤上高度表达。在临床前研究中,肿瘤相关的 CD200 与 CD200R1 的结合会导致免疫抑制,减少对癌细胞的免疫细胞杀伤。临床前数据表明,这种机制有可能恢复T细胞和骨髓细胞杀死癌细胞的能力。临床试验注册表(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.

关于 23andMe
23andMe是一家以基因为主导的消费者医疗保健和生物制药公司,致力于打造更健康的未来。欲了解更多信息,请访问 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.

前瞻性陈述
本新闻稿包含经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条所指的前瞻性陈述,包括但不限于有关其未来临床试验和23andMe治疗业务计划的声明。本新闻稿中包含或纳入的所有陈述,除历史事实陈述外,包括有关23andMe的战略、临床试验计划和结果以及管理目标的声明,均为前瞻性陈述。“相信”、“预期”、“估计”、“计划”、“预期”、“打算”、“可能”、“应该”、“潜在”、“可能”、“项目”、“预测”、“继续”、“将”、“计划” 和 “将”,或者,在每种情况下,它们的负面或其他变体或可比术语旨在识别前瞻性陈述,尽管不是所有前瞻性陈述都包含这些识别词。这些前瞻性陈述是基于23andMe当前对未来事件的预期和预测以及各种假设的预测。23andMe无法保证它会真正实现其前瞻性陈述中披露的计划、意图或预期,您不应过分依赖23andMe的前瞻性陈述。这些前瞻性陈述涉及许多风险、不确定性(其中许多是23andMe无法控制的)或其他假设,这些假设可能导致实际业绩或业绩与这些前瞻性陈述所表达或暗示的业绩存在重大差异。此处包含的前瞻性陈述通常还受公司向美国证券交易委员会提交的文件中不时描述的其他风险和不确定性的影响,包括1A项下的公司向美国证券交易委员会提交的最新10-K表年度报告中的 “风险因素”,以及我们的10-Q表季度报告和8-K表最新报告的修订和更新。此处发表的声明是截至本新闻稿发布之日发表的,除非法律要求,否则23andMe没有义务对其进行更新,无论是由于新信息、事态发展还是其他原因。

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

联系人:
投资者关系联系人: investors@23andMe.com
媒体联系人: press@23andMe.com

译文内容由第三方软件翻译。


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