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Y-mAbs Announces Presentation of Naxitamab Data at ASCO

Y-mAbs Announces Presentation of Naxitamab Data at ASCO

Y-mabs 宣布在 ASCO 上发布纳西他抗数据
GlobeNewswire ·  2023/05/26 21:00

NEW YORK, May 26, 2023 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that a poster presentation featuring interim clinical data on naxitamab, a recombinant, humanized anti-GD2 monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF") will be presented at the American Society of Clinical Oncology ("ASCO") Annual Meeting to be held June 2-6, 2023, in Chicago, Illinois.

纽约,2023年5月26日(GLOBE NEWSWIRE)——专注于开发和商业化治疗癌症的新型基于抗体的治疗产品的商业阶段生物制药公司Y-maBs Therapeutics, Inc.(“公司” 或 “Y-mab”)(纳斯达克股票代码:YMAB)今天宣布,一份海报展示了纳西他单抗的中期临床数据,这是一种重组人源化的抗gD2单克隆抗体与粒细胞巨噬细胞集落刺激因子(“GM-CSF”)联合将在美国临床肿瘤学会(”ASCO”) 年会将于2023年6月2日至6日在伊利诺伊州芝加哥举行。

Patients with high-risk neuroblastoma ("HR-NB") commonly develop metastases in the bone and/or bone marrow. Approximately 15% of HR-NB patients are refractory to induction therapy and approximately 50% will relapse. The ongoing Phase 2 Trial 201 (NCT03363373) evaluates naxitamab in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF") in patients with relapsed or refractory HR-NB with residual disease limited to bone and/or bone marrow. Patients with disease in soft tissues or actively progressing disease were excluded from the trial.

高危神经母细胞瘤(“HR-NB”)患者通常会在骨和/或骨髓中发生转移。大约 15% 的 HR-NB 患者对诱导治疗有难治性,大约 50% 会复发。正在进行的二期试验 201(NCT03363373)评估了纳西他单抗与粒细胞巨噬细胞集落刺激因子(“GM-CSF”)联合治疗复发或难治性HR-NB、残留疾病仅限于骨和/或骨髓的患者。软组织疾病或疾病进展活跃的患者被排除在试验之外。

Curie Score ("CS") is a semi-quantitative scoring system used to assess the extent of bone metastases and treatment response. Higher CS indicates more extensive bone involvement and may suggest a poorer prognosis.

居里评分(“CS”)是一种半定量评分系统,用于评估骨转移程度和治疗反应。CS 越高表示骨受累范围越广,可能表明预后较差。

An interim analysis of Trial 201 (data cutoff December 31, 2021) included 52 patients in the efficacy group and 74 patients in the safety group. The efficacy analyses included the overall response rate (ORR; complete response or partial response) and the reduction in CS by baseline disease status, i.e., refractory or relapsed disease. Clinically meaningful ORRs and reductions in CS were seen in patients regardless of baseline disease status. The ORR was 58% in patients with refractory disease and 42% in patients with relapsed disease. Furthermore, from a mean baseline CS of 5.5 and 5.7 in the refractory and relapsed subgroups (range 1-20 across the two subgroups), the mean change to end of naxitamab treatment was -4.2 and -1.2, respectively. Maximum reductions in CS for relapsed and refractory subgroups were -17 and -18, respectively. Overall, the most common naxitamab related serious adverse events were hypotension, pain, urticaria, and bronchospasm. Baseline CS did not affect the safety profile of naxitamab. Patients with refractory disease had a lower frequency of serious naxitamab related adverse events compared to patients with relapsed disease.

201号试验(数据截止日期为2021年12月31日)的中期分析包括疗效组中的52名患者和安全组的74名患者。疗效分析包括总体缓解率(ORR;完全缓解或部分缓解)以及按基线疾病状态(即难治性或复发性疾病)划分的CS降低。无论基线疾病状态如何,患者均可看到具有临床意义的 ORR 和 CS 降低。难治性疾病患者的ORR为58%,复发性疾病患者的ORR为42%。此外,从难治和复发亚组的平均基线CS为5.5和5.7(两个亚组的范围为1-20)来看,纳西他单抗治疗结束的平均变化分别为-4.2和-1.2。复发和难治亚组的CS最大降幅分别为-17和-18。总体而言,最常见的纳西他单抗相关严重不良事件是低血压、疼痛、荨麻疹和支气管痉挛。基线 CS 没有影响纳西他单抗的安全性。与复发性疾病患者相比,难治性疾病患者发生与纳西他单抗相关的严重不良事件的频率较低。

Naxitamab was licensed by the Company from Memorial Sloan Kettering ("MSK"). MSK has institutional financial interests in the compound.

Naxitamab由该公司获得斯隆·凯特琳纪念馆(“MSK”)的许可。MSK 在该大院拥有机构财务利益。

About DANYELZA (naxitamab-gqgk)

关于 DANYELZA(naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved in the United States by the FDA under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information ( for complete Boxed Warning and other important safety information.

DANYELZA(naxitamab-gqgk)适用于与粒细胞-巨噬细胞集落刺激因子(“GM-CSF”)联合用于治疗1岁及以上的儿科患者和骨髓中复发或难治性高危神经母细胞瘤的成年患者,这些患者在先前的治疗中表现出部分反应、轻微反应或病情稳定。该适应症在美国获得美国食品和药物管理局的批准,根据总体反应率和反应持续时间加快了批准速度。该适应症的持续批准取决于确认性试验中对临床益处的验证和描述。DANYELZA 包括针对严重输液相关反应(例如心脏骤停和过敏反应)以及神经毒性(例如严重的神经病理性疼痛和横贯性脊髓炎)的盒装警告。查看完整的处方信息(查看完整的盒装警告和其他重要的安全信息)

About Y-mAbs

关于 Y-mab

Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the Company's technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company's broad and advanced product pipeline includes one FDA-approved product, DANYELZA (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate, omburtamab, which targets tumors that express B7-H3.

Y-mabs是一家处于商业阶段的生物制药公司,专注于基于抗体的新型治疗性癌症产品的开发和商业化。除常规抗体外,该公司的技术还包括使用Y-biclone平台和SADA平台生成的双特异性抗体。该公司广泛而先进的产品线包括一种经美国食品药品管理局批准的产品 DANYELZA(naxitamab-gqgk),该产品靶向表达 GD2 的肿瘤,以及一种靶向表达 B7-H3 的肿瘤的候选产品omburtamab。

Forward-Looking Statements

前瞻性陈述

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements with respect the potential of naxitamab to treat high-risk neuroblastoma, the safety profile of naxitamab, expectations with respect to Trial 201, including with respect to results and timing, the Company's product candidates and pipeline, including with respect to the development of naxitamab, the Company's presentation at ASCO, and other statements that are not historical facts. Words such as ''anticipate,'' ''believe,'' "contemplate," ''continue,'' ''could,'' ''estimate,'' ''expect,'' "hope," ''intend,'' ''may,'' ''might,'' ''plan,'' ''potential,'' ''predict,'' ''project,'' ''should,'' ''target,'' "will", ''would'' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with our financial condition and need for additional capital; the risks that actual results of our restructuring plan and revised business plan will not be as expected; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay in the timing of our regulatory submissions or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock, risks associated with the COVID-19 pandemic; risks associated with the conflict between Russia and Ukraine and sanctions related thereto; including inflation and uncertain global credit and capital markets; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Annual Report on Form 10-K for the year ended December 31, 2022, our Quarterly Report on Form 10-Q for the quarter ending March 31, 2023 and in our other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

本新闻稿中关于未来预期、计划和前景的声明,以及任何其他关于非历史事实的陈述,可能构成1995年《私人证券诉讼改革法》所指的 “前瞻性陈述”。此类陈述包括但不限于关于纳西他单抗治疗高危神经母细胞瘤的潜力的陈述、纳西他单抗的安全状况、对201号试验的预期,包括对结果和时机的预期,公司的候选产品和产品线,包括对纳西他单抗开发的陈述、公司在ASCO的演讲,以及其他非历史事实的陈述。诸如 “预期”、“相信”、“考虑”、“继续”、“可以”、“估计”、“期望”、“希望”、“打算”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“目标”、“将” 等词语旨在识别前瞻性陈述,尽管并非所有前瞻性陈述都包含前瞻性陈述这些识别词。我们的候选产品和相关技术是癌症治疗的新方法,带来了重大挑战。由于各种因素,实际业绩可能与此类前瞻性陈述所显示的结果存在重大差异,包括但不限于:与我们的财务状况相关的风险和对额外资本的需求;我们的重组计划和修订后的业务计划的实际结果与预期不符的风险;与我们的开发工作相关的风险;我们的产品开发活动和临床试验的成本和成功;我们的监管文件提交时间延迟或药物未能获得批准的风险候选人;与任何经批准的药品商业化相关的风险,包括候选产品的市场接受率和程度;我们的销售和营销能力的发展以及与未能获得足够产品报销相关的风险;与我们在进行临床测试和产品制造等方面依赖第三方相关的风险;我们无法建立合作伙伴关系;与政府监管相关的风险;与市场批准相关的风险,与市场批准相关的风险,与市场批准相关的风险,与之相关的风险保护我们的知识产权;与员工事务和管理增长相关的风险;与我们的普通股相关的风险,与 COVID-19 疫情相关的风险;与俄罗斯和乌克兰冲突及相关的制裁相关的风险;包括通货膨胀和全球信贷和资本市场的不确定性;以及影响公司的其他风险和不确定性,包括我们截至2022年12月31日的10-K表年度报告、我们的表格季度报告中 “风险因素” 部分所述的风险和不确定性 10-截至2023年3月31日的季度以及我们在美国证券交易委员会其他文件中的问答。本新闻稿中包含的任何前瞻性陈述仅代表截至本文发布之日,公司没有义务更新任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。

DANYELZA, OMBLASTYS and Y-mAbs are registered trademarks of Y-mAbs Therapeutics, Inc.

DANYELZA、OMBLASTYS 和 Y-mabs 是 Y-mabs Therapeutics, Inc. 的注册商标。

Contact:

联系人:

Courtney Dugan
VP, Head of Investor Relations
E: cdu@ymabs.com
M: (917) 971-3466

考特尼·杜根
副总裁,投资者关系主管
E: cdu@ymabs.com
M: (917) 971-3466

Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA

Y-mabs Therapeutics, Inc
公园大道 230 号,3350 套房
纽约州纽约 10169
美国


译文内容由第三方软件翻译。


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