EN
登录

迈威生物在 2025年 AACR年会上发布 6项创新药物及平台研究结果

Mabwell Releases 6 Study Results of Innovative Drugs and Platforms at the 2025 AACR Annual Meeting

CISION 等信源发布 2025-04-30 19:59

可切换为仅中文


SHANGHAI

上海

,

April 30, 2025

2025年4月30日

/PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, presented 6 study results of innovative drugs and platforms in poster format at the American Association for Cancer Research (AACR) annual meeting, held from

/PRNewswire/ -- 迈威生物(688062.SH),一家全产业链布局的创新型生物制药公司,在美国癌症研究协会 (AACR) 年会上以海报形式展示了6项创新药物和平台的研究成果,会议于

April 25 to 30, 2025

2025年4月25日至30日

.

Poster Presentation

海报展示

1. A B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiate the antitumor activity in B7-H3-positive cancers

1. 一种靶向B7-H3的抗体药物偶联物7MW3711与PARP抑制剂在B7-H3阳性癌症中协同增强抗肿瘤活性。

Published Abstract Number: 830

发表的摘要编号:830

Both PARP inhibitors and B7-H3-targeting ADC are feasible therapies to chemotherapy resistant solid tumors. Mabwell combines its self-developed 7MW3711 with PARP inhibitors to explore the synergistic antitumor activity of the ADC+PARPi combination strategy in preclinical solid tumor models.

PARP抑制剂和靶向B7-H3的ADC都是对化疗耐药的实体瘤可行的治疗手段。迈威生物将其自主研发的7MW3711与PARP抑制剂联用,在临床前实体瘤模型中探索ADC+PARPi联合策略的协同抗肿瘤活性。

In this study, the synergistic antitumor activity shown by 7MW3711 in combination with PARPi  suggests that it is a promising strategy to combine DNA damage repair inhibitor and B7-H3-targeting ADC for the treatment of B7-H3-positive solid tumors. The data provide evidence for the potential utility of 7MW3711 combination with PARPi for treatment of B7-H3-expressing tumors and support the rationale for further clinical application..

本研究中,7MW3711与PARPi联合展现出的协同抗肿瘤活性表明,将DNA损伤修复抑制剂与靶向B7-H3的ADC结合使用,是治疗B7-H3阳性实体瘤的一种有前景的策略。数据为7MW3711与PARPi联合用于治疗表达B7-H3的肿瘤提供了潜在效用的证据,并支持了进一步临床应用的合理性。

2. Design and synthesis of the novel camptothecin analog MF6 for application into site-specific antibody-drug conjugate

2. 设计并合成新型喜树碱类似物MF6用于位点特异性抗体药物偶联物的应用

Published Abstract Number: 5733

发表的摘要编号:5733

This study preliminarily validated the antitumor activity and safety of MF6, a novel payload based on the Mtoxin™ platform, in multiple in vivo and in vitro models. The experimental results demonstrated that MF6 possessed favorable tumor-killing activity and maintains significant efficacy in multidrug-resistant models resistant to DXd.

本研究初步验证了基于Mtoxin™平台的新型载荷MF6在多种体内和体外模型中的抗肿瘤活性和安全性。实验结果表明,MF6具有良好的肿瘤杀伤活性,并在对DXd耐药的多药耐药模型中仍保持显著疗效。

ADCs constructed using the clinically validated site-specific conjugation technology IDDC™ and our novel payload MF6 demonstrated good uniformity and stability, and exhibited significant antitumor efficacy in multiple CDX models. Additionally, these ADCs show a potent bystander killing effect enabling the killing of nearby tumor cells and thereby further enhancing the antitumor efficacy.

使用经过临床验证的位点特异性偶联技术IDDC™和我们新颖的有效载荷MF6构建的ADC表现出良好的一致性和稳定性,并在多个CDX模型中展现出显著的抗肿瘤效力。此外,这些ADC显示出强大的旁观者杀伤效应,能够杀伤附近的肿瘤细胞,从而进一步增强抗肿瘤效力。

ADCs synthesized with MF6 have excellent serum and plasma stability and pharmacokinetic properties, providing strong support for future clinical application..

使用MF6合成的ADC具有出色的血清和血浆稳定性以及药代动力学特性,为未来的临床应用提供了有力支持。

3. MW-C01/C02, novel CLDN1-targeting antibody-drug conjugates, demonstrate compelling anti-tumor efficacy and favorable safety profiles in preclinical studies

3. MW-C01/C02,新型靶向CLDN1的抗体药物偶联物,在临床前研究中显示出显著的抗肿瘤效力和良好的安全性。

Published Abstract Number: 1573

发表的摘要编号:1573

MW-C01/C02 are novel CLDN1-targeting ADCs, developed based on our own ADC site-specific conjugation technology platform IDDC™. Claudins localize to tight junctions in healthy tissues, while their overexpression in solid tumors leads to aberrant exposure outside of these junctions, making them attractive targets for ADC therapies.

MW-C01/C02 是基于我们自有的 ADC 定点偶联技术平台 IDDC™ 开发的新型靶向 CLDN1 的抗体药物偶联物 (ADC)。Claudins 在健康组织中定位于紧密连接,而其在实体瘤中的过表达会导致在这些连接之外的异常暴露,使它们成为 ADC 疗法的理想靶点。

Studies have shown that high expression of CLDN1 is associated with tumor proliferation, invasion, metastasis, and poor prognosis. MW-C01/C02 exhibit robust binding, rapid internalization, and potent cytotoxicity in CLDN1-positive cancer cell lines. MW-C01/C02 demonstrate potent anti-tumor activity in both preclinical CDX and PDX models and show good PK and safety profiles in primates..

研究表明,CLDN1 的高表达与肿瘤增殖、侵袭、转移和不良预后相关。MW-C01/C02 在 CLDN1 阳性的癌细胞系中表现出强大的结合能力、快速的内化作用和有效的细胞毒性。MW-C01/C02 在临床前 CDX 和 PDX 模型中显示出显著的抗肿瘤活性,并在灵长类动物中表现出良好的药代动力学和安全性特征。

4. 2MW7061, a novel LILRB4xCD3 bispecific T-cell engager targeting monocytic acute myeloid leukemia

4. 2MW7061,一种新型的针对单核细胞急性髓系白血病的LILRB4xCD3双特异性T细胞接合器

Published Abstract Number: 2116

发表的摘要编号:2116

2MW7061 (LILRB4xCD3) is a bispecific T-cell engager (TCE) targeting LILRB4 developed based on Mabwell's TCE platform. With its unique structural design and mechanism of action, 2MW7061 exhibits minimal binding to T cells while demonstrating potent cytotoxicity against tumor cells, thereby significantly improving its safety margin without compromising efficacy.

2MW7061(LILRB4xCD3)是一款基于迈威生物TCE平台开发的靶向LILRB4的双特异性T细胞衔接器(TCE)。凭借其独特的结构设计和作用机制,2MW7061对T细胞的结合极小,同时对肿瘤细胞显示出强大的杀伤活性,从而显著提高了其安全性窗口,且未削弱疗效。

In preclinical models of AML (acute myeloid leukemia), 2MW7061 showed strong anti-tumor activity. Non-primate toxicology studies indicate a favorable safety profile, highlighting its therapeutic potential for treating AML patients..

在急性髓系白血病(AML)的临床前模型中,2MW7061显示出强大的抗肿瘤活性。非灵长类毒理学研究表明其具有良好的安全性,突显了其治疗AML患者的潜力。

5. An innovative T cell engager platform with optimized CD3 affinity and formats for targeting hematologic and solid tumors

5. 一种创新的T细胞接合器平台,具有优化的CD3亲和力和针对血液系统肿瘤及实体瘤的形式。

Published Abstract Number: 2866

发表的摘要编号:2866

As a promising cancer therapeutic strategy, T‑cell engagers (TCEs) simultaneously bind to CD3 on T cells and tumor-associated antigens (TAAs) on cancer cells, facilitating the formation of an immunological synapse that activates T cells and directs their cytotoxic activity toward tumor cells. Clinical data have robustly demonstrated the efficacy of TCEs in hematologic malignancies; however, their clinical benefits in solid tumors remain to be fully validated.

作为一种有前景的癌症治疗策略,T细胞接合器(TCE)能够同时结合T细胞上的CD3和癌细胞上的肿瘤相关抗原(TAA),促进免疫突触的形成,激活T细胞并引导其细胞毒性作用针对肿瘤细胞。临床数据已充分证明TCE在血液系统恶性肿瘤中的疗效;然而,其在实体瘤中的临床效益仍有待进一步验证。

As agonists, TCEs present significant developmental challenges that require a delicate balance between efficacy and safety. In response, Mabwell has established an innovative TCE platform that meticulously optimizes various parameters—including CD3 affinity, TAA selection, and bispecific antibody format—to effectively widen the therapeutic window and maximize clinical outcomes..

作为激动剂,TCE面临显著的开发挑战,需要在疗效与安全性之间取得微妙平衡。为此,迈威生物建立了一个创新的TCE平台,通过精心优化多个参数(包括CD3亲和力、TAA选择以及双特异性抗体形式),有效拓宽治疗窗口并最大化临床效果。

6. 7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers

6. 7MW4911,一种新型靶向钙粘蛋白17的抗体药物偶联物,在胃肠道癌症的临床前模型中显示出显著的疗效。

Published Abstract Number: 5466

发表的摘要编号:5466

7MW4911 is a novel ADC developed by Mabwell targeting CDH17, a membrane protein highly expressed in gastrointestinal cancers with limited normal tissue distribution, offering a promising therapeutic strategy for gastrointestinal malignancies. 7MW4911 is composed of a proprietary anti-CDH17 monoclonal antibody, a cleavable linker, and innovative cytotoxic payload Mtoxin™, with full intellectual property ownership.

7MW4911 是由迈博威尔开发的一种新型抗体药物偶联物 (ADC),靶向 CDH17,这是一种在胃肠道癌中高度表达而正常组织分布有限的膜蛋白,为胃肠道恶性肿瘤提供了有前景的治疗策略。7MW4911 由专有的抗 CDH17 单克隆抗体、可裂解连接子和创新的细胞毒性载荷 Mtoxin™ 组成,并拥有完全的知识产权。

In preclinical CDX and PDX models, 7MW4911 demonstrated robust antitumor activity and superior efficacy over MMAE-based ADCs in multidrug resistance models. Pharmacokinetic and safety studies in non-human primates support a favorable profile and a high non-severely toxic dose (HNSTD), enabling clinical advancement.

在临床前CDX和PDX模型中,7MW4911在多药耐药模型中表现出强大的抗肿瘤活性,并且疗效优于基于MMAE的ADC。在非人灵长类动物中的药代动力学和安全性研究支持了其良好的特性以及高非严重毒性剂量(HNSTD),有助于临床开发推进。

7MW4911 represents a differentiated and promising ADC candidate for GI cancers, with an IND submission to the NMPA and FDA planned for H2 2025..

7MW4911 代表了一种差异化且前景广阔的 GI 癌症 ADC 候选药物,计划于 2025 年下半年向 NMPA 和 FDA 提交 IND。

About Mabwell

关于迈威生物

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established.

迈威生物 (688062.SH) 是一家全产业链布局的创新型生物医药公司。我们致力于提供更有效、更可及的治疗和创新药物,以满足全球医疗需求。自 2017 年起,建立了覆盖靶点发现、早期发现、成药性研究、临床前研究、临床研究和生产转化的先进研发体系。

Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market approval, 3 products are in pivotal trials.

基于世界级、最先进的研发引擎,迈威生物已拥有 16 项处于不同研发阶段的管线产品,包括 12 个创新药候选产品和 4 个生物类似药产品。我们专注于肿瘤、免疫、骨骼、眼科、血液和感染等疾病领域。其中,3 款产品已上市商业化,1 款产品提交上市申请,3 款产品处于关键临床试验阶段。

We have also undertaken 1 national major scientific and technological special project for 'Significant New Drugs Development', 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit.

我们还承担了 1 项“重大新药创制”国家科技重大专项,2 项国家重点研发计划项目,以及多个省市级科技创新项目。迈威生物的泰州工厂具备符合 NMPA、FDA 以及 EMA 的国际 GMP 标准的强大的自主生产能力,并已通过欧盟 QP 审计。

The large-scale manufacturing base in .

大规模制造基地在 。

Shanghai

上海

and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is 'Explore Life, Benefit Health' and our vision is 'Innovation, from ideas to reality'. For more information, please visit

泰州的ADC商业化生产基地正在建设中。我们的使命是“探索生命,造福健康”,我们的愿景是“创新,从理念到现实”。欲了解更多信息,请访问

www.mabwell.com/en

www.mabwell.com/zh

.

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature.

本新闻稿包含前瞻性声明,包括但不限于我们候选产品的潜在安全性、有效性、监管审查或批准及商业成功,以及与公司产品开发、临床研究、临床和监管里程碑及时间表、市场机会、竞争地位、可能或假设的运营结果、业务策略、潜在增长机会及其他具有预测性质的声明。

'Forward-looking statements' are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, 'expect,' 'anticipate,' 'intend,' 'plan,' 'believe,' 'estimate,' 'potential,' 'predict,' 'project,' 'should,' 'would,' and similar expressions and the negatives of those terms..

“前瞻性声明”并非历史事实,而是涉及多种风险和不确定性的声明,这些风险和不确定性可能导致实际结果与前瞻性声明中明示或暗示的任何未来结果存在重大差异。这些声明可以通过使用前瞻性表述来识别,包括但不限于“预期”、“预计”、“打算”、“计划”、“相信”、“估计”、“潜在”、“预测”、“展望”、“应该”、“将”以及类似表述和这些术语的否定形式。

Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel.

前瞻性声明基于公司当前的预期和假设。前瞻性声明受多种风险、不确定性和其他因素的影响,其中许多因素超出公司的控制范围,包括但不限于:环境;政治;经济;社会;立法;我们对候选产品依赖,其中大部分仍处于临床前或不同阶段的临床开发中;我们对第三方供应商的依赖,例如合同研究组织和合同制造组织;临床试验固有的不确定性;我们完成候选产品所需临床试验并获得监管机构批准的能力;我们保护知识产权的能力;新冠疫情的潜在影响;任何高管或关键人员的流失。

In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results..

如果这些风险或不确定性中的一个或多个恶化,或者任何假设不正确,实际结果可能与所述结果严重不符。

The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

公司告诫所有人士不要过分依赖任何此类前瞻性声明,这些声明仅截至本新闻稿发布之日有效。公司不承担任何义务,除非法律及适用的股票管理机构规则特别要求,公开更新或修改任何此类声明以反映任何预期变化或事件、条件、或情况的变化,或可能影响实际结果与前瞻性声明中所述结果产生差异的可能性。

All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement..

本新闻稿中的所有前瞻性描述、数据和假设均适用于本声明。

SOURCE Mabwell

来源:迈博威尔

WANT YOUR COMPANY'S NEWS

想要你公司的新闻

FEATURED ON PRNEWSWIRE.COM?

荣登PRNEWSWIRE.COM?

440k+

44万+

Newsrooms &

新闻编辑室 &

Influencers

影响者

9k+

9k+

Digital Media

数字媒体

Outlets

插座

270k+

27万+

Journalists

记者

Opted In

已选择加入

GET STARTED

开始使用