23andMe Therapeutics Announces Positive Preliminary Phase 2 Safety and Efficacy Results for 23ME-00610, Targeting CD200R1, at the 2024 ASCO Annual Meeting
23andMe Therapeutics Announces Positive Preliminary Phase 2 Safety and Efficacy Results for 23ME-00610, Targeting CD200R1, at the 2024 ASCO Annual Meeting
– 23ME-00610 monotherapy demonstrates preliminary evidence of clinical benefit, including one confirmed partial response
23ME-00610的单药疗法显示出初步的临床效益,包括一个确诊的部分反应。
– 23ME-00610 monotherapy continues to demonstrate acceptable safety and tolerability, and achieves the prespecified targets for maximal pharmacology at 1400 mg dosed Q3W
23ME-00610的单药疗法继续表现出可接受的安全性和耐受性,并在每3周给药的1400毫克最大药效学预定目标的实现。
– Tumor CD200 is emerging as a potential biomarker associated with 23ME-00610 monotherapy efficacy
肿瘤CD200正在成为与23ME-00610单药疗法疗效相关性的潜在生物标志物。 是 出现初步的临床效益数据,与23ME-00610治疗相关的低慢性免疫介导疾病风险较低,但急性免疫反应和癌症风险较高。这与23andMe免疫肿瘤学签名相一致,通过确定与自身免疫疾病和癌症风险相对应的基因组区域来确定有前途的免疫学靶点。
SOUTH SAN FRANCISCO, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) ("23andMe"), a leading human genetics and biopharmaceutical company, announced positive preliminary Phase 2 safety and efficacy data from 23ME-00610, a first-in-class anti-CD200R1 antibody, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31-June 4.
2024年5月31日至6月4日在芝加哥召开的美国临床肿瘤学会年会上23andMe Holding Co. (Nasdaq: ME)(“23andMe”)作为领先的人类遗传学和生物制药公司,宣布23ME-00610的积极初步2期安全性和疗效数据,这是一款第一类抗CD200R1抗体。
23andMe presented two posters on 23ME-00610, one each from neuroendocrine and ovarian cancer patient cohorts in its ongoing Phase 1/2a clinical trial.
23andMe在正在进行的1/2a期临床试验中,针对神经内分泌和卵巢癌患者队列分别展示了两篇关于23ME-00610的海报。
Key takeaways:
要点:
- Confirmed partial response (PR) in patient with well-differentiated pancreatic neuroendocrine cancer (pNET) (> 24 cycles at data cut-off) and qualitative clinical benefit with durable treatment duration (> 12 cycles at data cut-off) and tumor shrinkage in patient with mesonephric adenocarcinoma (a form of ovarian cancer).
- 23ME-00610 monotherapy demonstrates acceptable safety and tolerability, and achieves the prespecified targets for maximal pharmacology at 1400 mg dosed every three weeks.
- From archival tumor immunohistochemistry (IHC) analyses, over 70% of patients had detectable tumor cell CD200, and higher expression tended to trend with clinical benefit.
- In addition to CD200, histology data suggest that immunosuppressed ("cold") tumors may be more likely to exhibit disease control with 23ME-00610.
- Emerging data shows preliminary evidence of clinical benefit from 23ME-00610 treatment associated with lower risk for chronic immune-mediated diseases (e.g., psoriasis, asthma, eczema), yet higher risk for acute immune reactivity and cancer. This aligns with the 23andMe Immuno-oncology Signature, which identifies promising IO targets by pinpointing areas of the genome associated with opposing risk for auto-immune disease and cancer.
- 在数据剪切时,患有良性胰腺神经内分泌肿瘤(pNET)的患者(> 24个周期)确认部分反应(PR),并获得持久的治疗效果(>12个周期),以及在含有卵巢癌的间质腺癌(一种卵巢癌)患者中出现肿瘤萎缩。
- 23ME-00610单药疗法显示出可接受的安全性和耐受性,并在每3周给药的1400毫克最大药效学预定目标的实现。
- 通过档案肿瘤免疫组化(IHC)分析,超过70%的患者检测到肿瘤细胞CD200,并且CD200的更高表达倾向于与临床效益相关。
- 除了CD200外,组织学数据表明免疫抑制(“冷”)的肿瘤可能更可能表现出与23ME-00610的疾病控制。
- 初步数据显示,23ME-00610治疗具有与慢性免疫介导疾病(例如牛皮癣,哮喘,湿疹)风险降低相关的临床效益,但具有更高的急性免疫反应和癌症风险。这与23andMe免疫肿瘤学签名相一致,通过确定与自身免疫疾病和癌症风险相对应的基因组区域来确定有前途的免疫学靶点。
"We continue to be pleased with the progress of 23ME-00610 as monotherapy, which continues to demonstrate therapeutic potential for inhibiting CD200R1 in cancer patients," said Jennifer Low, M.D., Ph.D, Head of Therapeutics Development. "We are also seeing evidence of CD200 emerging as a potential biomarker associated with 23ME-00610 monotherapy efficacy. Further, we are encouraged by the continued safety and tolerability profile of 23ME-00610 which, as presented at AACR earlier this year, points to potential combination strategies for added therapeutic benefit in cancer patients."
“23ME-00610作为单药疗法继续展现出抑制癌症患者CD200R1的治疗潜力,我们对其进展感到满意。”治疗研发部门负责人Jennifer Low博士说,“我们还看到CD200正在成为与23ME-00610单药疗法疗效相关的潜在生物标志物。 此外,我们对23ME-00610持续的安全性和耐受性很有信心,正如今年早些时候在AACR上展示的那样,这指向了潜在的联合治疗策略,为癌症患者带来更多的治疗益处。”
Further details - neuroendocrine cancers cohort
神经内分泌癌队列的详细信息:
- Between February 23, 2023 and April 1, 2024, 16 adult patients with advanced neuroendocrine neoplasms who received a median of 3.5 prior treatment lines (range: 1 to 10), were enrolled and received ≥ 1 dose of 23ME-00610.
- A patient from the Phase 1 portion of the Phase 1/2a trial with well-differentiated pancreatic neuroendocrine cancer (pNET) and high tumor CD200 expression has a confirmed partial response (PR) and remains on treatment (> 21 months).
- Among the N=16 expansion cohort, the disease control rate was 50% (n=8), and 25.3% of patients were free from clinical progression at 6 months, per RECIST v1.1.
- The safety and tolerability profile remains acceptable and promising for potential anti-cancer combinations in neuroendocrine patients.
- No treatment-emergent adverse events (TEAEs) leading to 23ME-00610 discontinuation were reported.
- Related treatment-emergent adverse events (TRAEs) occurred in 8 patients (50%); all were G1/G2, and the most common were maculopapular rash (18.8%), pruritus (18.8%), nausea (12.5%), and fatigue (12.5%).
- Patients with moderate to high tumor CD200 expression tended to be more likely to derive clinical benefit (PR or durable SD) relative to patients with low or undetectable tumor CD200.
- 2024年2月23日至2024年4月1日,16名成年晚期神经内分泌肿瘤患者接受了平均3.5次(范围:1到10)预先治疗,并接受了≥处23ME-00610的剂量。
- 来自该阶段1/2a试验的一名患有良性胰腺神经内分泌癌(pNET)和高肿瘤CD200表达的患者有一个确定的部分反应(PR),并继续接受治疗(> 21个月)。
- 在扩展队列中,N = 16中,疾病控制率为50%(n = 8),在6个月内有25.3%的患者不受临床进展的影响,根据RECIST v1.1。
- 对于神经内分泌患者的潜在抗癌联合治疗,安全性和耐受性显著并且有望。
- 没有报道由于治疗引发的不良事件(TEAEs)导致23ME-00610停用。
- 与治疗相关的不良事件(TRAEs)发生在8名患者(50%)中;所有不良事件均为G1 / G2,最常见的是斑疹(18.8%),瘙痒(18.8%),恶心(12.5%)和疲劳(12.5%)。
- CD200表达量中等至高的肿瘤患者相对于CD200低或无表达的患者更有可能获得临床效益(部分缓解或持久稳定)。
Further details - ovarian cancer cohort
更多细节 - 卵巢癌队列
- Between March 27, 2023 and April 1, 2024, 16 adult patients with advanced ovarian cancer who received a median of 4 prior treatment lines (range: 1 to 12), were enrolled and received ≥ 1 dose of 23ME-00610.
- The safety and tolerability profile remains acceptable and promising for potential anti-cancer combinations in ovarian cancer patients.
- No TRAEs ≥ G4 or AEs leading to 23ME-00610 discontinuation or death were reported.
- Related TEAEs occurred in 7 patients (43.8%); most were G1 (12.5%) and G2 (25.0%), and the most common were maculo-papular rash (12.5%) and pruritus (12.5%). Immune-related AEs (irAEs) were ≤ G2 in severity and generally dermatologic and thyroid in nature.
- A patient with well-differentiated mesonephric adenocarcinoma progressing prior to study enrollment has shown qualitative clinical benefit and durable treatment duration (> 12 cycles), including decreasing CA-125, substantial decreases in malignant ascites, and tumor reduction while on 23ME-00610 treatment.
- 2023年3月27日至2024年4月1日,招募了16名晚期卵巢癌成人患者,这些患者接受了中位数为4的前治疗线路(范围:1至12条),并接受了至少1次23ME-00610的剂量。
- 对于潜在的抗癌联合治疗,卵巢癌患者的安全性和耐受性良好且有前途。
- 没有上报TRAE≥G4或因AEs导致23ME-00610停药或死亡。
- 7名患者(43.8%)出现了相关TEAEs;大多数为G1(12.5%)和G2(25.0%),最常见的是斑疹和瘙痒症(各12.5%)。免疫相关的AEs(irAEs)在严重程度上≤G2,通常是皮肤和甲状腺病变。
- 一名在研究入组之前出现进展的中分化间质性腺癌患者显示了定性的临床效益和持续治疗时间(>12个周期),包括降低CA-125、恶性腹水大量减少和接受23ME-00610治疗时的肿瘤缩小。
Additional data from the 23andMe poster presentations at ASCO 2024
更多来自ASCO 2024的23andMe海报展示的数据
- Eligible patients had histologically diagnosed locally advanced (unresectable) or metastatic 1) neuroendocrine cancers who had progressed on standard therapies, or 2) metastatic platinum-resistant epithelial ovarian, fallopian tube, or peritoneal carcinoma who have progressed on standard therapies.
- Exploratory biomarkers included CD200R1 and CD200 tumor expression, germline genotyping, and polygenic risk score calculation for immune-mediated and cancer phenotypes.
- Patients received 1400 mg given IV every 3 weeks until disease progression, and CT/MRI scans were conducted every ~ 8 weeks.
- 符合条件的患者诊断有局部晚期(无法切除)或转移的1)神经内分泌癌,曾接受标准疗法但进展,或者2)转移性铂类耐药性上皮卵巢、输卵管或腹膜癌,曾接受标准疗法但进展。
- 探索性生物标志物包括CD200R1和CD200肿瘤表达、种系基因分型以及免疫介导和癌症表型的多基因风险评估。
- 患者每3周静脉注射1400毫克,直至病情进展,并于约8周进行CT/MRI扫描。
Posters are available on the 23andMe Therapeutics and Investor websites.
About 23ME-00610
23ME-00610 binds to CD200R1 to prevent the interaction of CD200R1 with CD200. Using the world's largest proprietary database of health and genetic information, 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.
关于23ME-00610
23ME-00610结合CD200R1以防止其与CD200的相互作用。利用世界上最大的专有健康和遗传信息数据库,23andMe确定了与免疫性疾病风险更高和癌症风险更低有关的CD200R1、CD200和下游信号蛋白DOK2的遗传变异,将CD200R1确定为一个有前途的免疫治疗靶点。
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.
额外的临床前数据验证了CD200-CD200R1通路作为免疫检查点,并且是单药或与其他治疗组合用于逆转癌症免疫耐受的潜在靶点。来自晚期实体瘤患者剂量递增队列的临床数据表明,23ME-00610在建议的2期安全剂量1400毫克下具有有利的药代动力学(PK)和预期的靶向药理活性。
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是一家以基因为导向的消费者医疗保健和生物制药公司,致力于实现更健康的未来。有关更多信息,请访问www.23andMe.com。
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