Biohaven将在ESMO大会上公布BHV-1530的新临床数据，BHV-1530是一种新型FGFR3靶向抗体偶联药物（ADC），搭载专有拓扑异构酶I（TopoIx）载荷-动脉网

Biohaven to Present New Clinical Data at ESMO Congress on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase：(TopoIx) Payload

CISION 等信源发布 2026-07-20 19:30

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Biohaven also announces new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with cemiplimab (Libtayo®)

Biohaven还宣布与Regeneron达成新的临床供应协议，以评估BHV-1530与cemiplimab（Libtayo®）联合使用的效果

Early clinical activity observed:

观察到早期临床活性：

Phase 1 dose-escalation data show early tumor reductions in patients with Fibroblast Growth Factor Receptor (FGFR)3-altered and wild-type overexpressing tumors. Signal activity including confirmed partial responses in heavily pretreated patients in multiple tumor types.

1期剂量递增数据显示，在成纤维细胞生长因子受体3（FGFR3）改变及野生型过表达肿瘤患者中，早期即观察到肿瘤缩小。在多种肿瘤类型中，包括经大量预治疗的患者中，均观察到信号活性，含确认的部分缓解。

Differentiated safety profile:

差异化的安全性特征：

No dose-limiting toxicities and no FGFR inhibitor-class toxicities observed, supporting a potentially broader therapeutic index than approved FGFR tyrosine kinase inhibitors (TKIs).

未观察到剂量限制性毒性，也未观察到FGFR抑制剂类毒性，这支持其可能具有比已获批的FGFR酪氨酸激酶抑制剂（TKIs）更宽的治疗窗。

Potential to expand the addressable FGFR3 population:

扩大FGFR3适用人群的潜力：

Unlike FGFR TKIs, which are restricted to the ~15–20% of metastatic urothelial cancer patients with FGFR3 alterations, BHV-1530 is designed to target FGFR3 regardless of alteration status, including wild-type overexpression seen in approximately 50% of metastatic urothelial cancer cases as well as other tumor types that overexpress FGFR3.

与仅适用于约15–20%携带FGFR3突变的转移性尿路上皮癌患者的FGFR酪氨酸激酶抑制剂（TKIs）不同，BHV-1530旨在靶向FGFR3，无论其突变状态如何，包括在约50%的转移性尿路上皮癌病例中观察到的野生型过表达，以及其他过表达FGFR3的肿瘤类型。

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Anti-PD-1 combination cohorts planned:

计划的抗PD-1联合治疗队列：

Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate BHV-1530 in combination with cemiplimab (Libtayo), building on preclinical data demonstrating synergistic activity between BHV-1530's TopoIx payload and immune checkpoint blockade.

Biohaven 已与再生元制药公司（Regeneron Pharmaceuticals, Inc.）达成临床供应协议，以评估 BHV-1530 与西米普利单抗（Libtayo）联合使用的疗效，此举基于临床前数据所显示的 BHV-1530 的 TopoIx 载荷与免疫检查点阻断之间的协同作用。

NEW HAVEN, Conn.

康涅狄格州纽黑文

，

July 20, 2026

2026年7月20日

/PRNewswire/ -- Biohaven Ltd. (NYSE:

/美通社/ -- Biohaven有限公司（纽约证券交易所：

BHVN

) ('Biohaven'), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, to be held October 23-27 in Madrid, Spain..

Biohaven（一家全球性临床阶段生物制药公司，专注于发现、开发和商业化能够改变生活的疗法，以治疗多种罕见病和常见病）今日宣布，其针对FGFR3的抗体药物偶联物（ADC）BHV-1530（采用新型拓扑异构酶I [TopoIx] 载荷）的最新数据将在2026年欧洲肿瘤内科学会（ESMO）大会上公布。该大会将于10月23日至27日在西班牙马德里举行。

继续阅读

Figure 1

图1

1019P - Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors

1019P - BHV-1530（一种首创的FGFR3抗体药物偶联物）在晚期肿瘤中的I期研究

October 23, 2026: 15:15 - 16:00

2026年10月23日：15:15 - 16:00

The new Phase 1 data planned for ESMO will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven's R&D Day on May 27, 2026. The new data will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors.

计划在ESMO公布的新一期1期数据，将为最初于2026年5月27日Biohaven研发日公布的早期1期数据提供具有临床意义的更新。新数据将包括在BH V-1530治疗晚期实体瘤患者的正在进行中的1期、开放标签、剂量递增研究中显示出的临床活性信号。

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The data from May 27 2026,

2026年5月27日的数据，

showed

显示

early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. This included a heavily pretreated patient with FGFR3-TACC3 fusion–positive metastatic urothelial cancer who had progressed on four prior lines of therapy, including Padcev (a nectin-4-directed ADC), pembrolizumab, and two FGFR-targeting small molecules.

在携带FGFR3基因改变和野生型过表达肿瘤的患者中，以及在多种肿瘤类型中，均观察到抗肿瘤活性的早期迹象。其中包括一名经大量预治疗的FGFR3-TACC3融合阳性转移性尿路上皮癌患者，该患者此前已接受过四线治疗并出现疾病进展，包括Padcev（一种靶向nectin-4的抗体偶联药物）、帕博利珠单抗以及两种靶向FGFR的小分子药物。

This patient has tolerated BHV-1530 with no FGFR-related toxicity. The data has shown a favorable safety profile, with no dose-limiting toxicities and no FGFR inhibitor–class toxicities, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy, that commonly constrain dosing and duration of approved FGFR tyrosine kinase inhibitors..

该患者对BHV-1530耐受良好，未出现FGFR相关毒性。数据显示其安全性良好，未出现剂量限制性毒性，也未出现高磷血症、指甲异常、口腔炎或视网膜病变等常见的FGFR抑制剂类毒性，而这些毒性通常限制已获批FGFR酪氨酸激酶抑制剂的剂量和用药持续时间。

Clinical Supply Agreement with Regeneron for BHV-1530 and Cemiplimab

与再生元公司就BHV-1530和Cemiplimab达成的临床供应协议

Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo) in patients with solid tumors based upon the emerging monotherapy clinical data and preclinical data demonstrating synergistic activity between BHV-1530 and immune therapy.

Biohaven 已与再生元制药公司（Regeneron Pharmaceuticals, Inc.）签订临床供应协议，以评估 BHV-1530 与西米普利单抗（cemiplimab，商品名：Libtayo）联合用药在实体瘤患者中的疗效。该决定基于新兴的单一疗法临床数据以及显示 BHV-1530 与免疫疗法具有协同作用的临床前数据。

BHV-1530's TopoIx payload has been demonstrated to generate immunogenic cell death and stimulate an antitumor immune response, providing a compelling mechanistic rationale for combination with checkpoint inhibition..

BHV-1530 的 TopoIx 载荷已被证明能够诱导免疫原性细胞死亡并激发抗肿瘤免疫反应，为与检查点抑制剂联合使用提供了有力的机制依据。

This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven's oncology pipeline. Of note, early clinical data from the BHV-1510 program demonstrate a signal consistent with this thesis, as responses have been observed in multiple patients with prior anti–PD-(L)1 therapy..

本协议在Biohaven与Regeneron就下一代TROP2靶向抗体偶联药物（ADC）BHV-1510已达成的现有临床供应协议基础上进一步扩展，进一步深化两家公司在Biohaven肿瘤产品管线方面的合作关系。值得注意的是，BHV-1510项目的早期临床数据显示出与该假设一致的信号，在接受过抗PD-(L)1治疗的多名患者中观察到了缓解反应。

About BHV-1530

关于BHV-1530

BHV-1530 is an antibody-drug conjugate directed against FGFR3, a validated but underexploited target in urothelial cancer and other FGFR3-driven cancers, and is a first in clinic FGFR3-directed ADC incorporating Biohaven's proprietary TopoIx payload. Unlike approved FGFR tyrosine kinase inhibitors, which are restricted to genomically selected patients and constrained by class-related toxicities, BHV-1530 is designed to target FGFR3 independent of requiring pathway inhibition, with the potential to address both FGFR3-altered and wild-type overexpressing tumors.

BHV-1530 是一种靶向 FGFR3 的抗体药物偶联物（ADC）。FGFR3 是尿路上皮癌及其他由 FGFR3 驱动的癌症中一个经证实但尚未充分开发的靶点。BHV-1530 是首款进入临床试验的靶向 FGFR3 的 ADC，其结合了 Biohaven 公司专有的拓扑异构酶 I（TopoIx）载荷。与已获批的 FGFR 酪氨酸激酶抑制剂不同，后者仅适用于经过基因组筛选的患者，且受限于类别相关的毒性，而 BHV-1530 的设计旨在不依赖通路抑制即可靶向 FGFR3，从而有望同时治疗 FGFR3 改变型肿瘤和野生型过表达肿瘤。

BHV-1530 is being studied in an ongoing Phase 1 dose-escalation trial in unselected patients with advanced urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer who have failed standard-of-care therapy, as well as other tumor types harboring FGFR3 genomic alterations.

BHV-1530 正在一项正在进行的 1 期剂量递增试验中接受研究，该试验面向未经选择、且标准治疗失败的晚期尿路上皮癌、头颈部鳞状细胞癌和非小细胞肺癌患者，以及携带 FGFR3 基因组改变的其他肿瘤类型患者。

Biohaven plans to initiate combination cohorts evaluating BHV-1530 with anti-PD-1 therapy, including the recently announced combination with cemiplimab (Libtayo), in the second half of 2026..

Biohaven 计划于 2026 年下半年启动联合队列研究，评估 BHV-1530 与抗 PD-1 疗法（包括近期宣布的与西米普利单抗（Libtayo）的联合方案）的疗效。

About Biohaven

关于Biohaven

Biohaven Ltd. (NYSE:

Biohaven有限公司（纽约证券交易所：

BHVN

) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms.

）是一家生物制药公司，专注于在免疫学、神经科学和肿瘤学等关键治疗领域发现、开发和商业化改变生命的治疗方案。Biohaven 正凭借其经证实的药物开发经验和多个专有药物开发平台，推进其创新治疗产品组合。

Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. For more information, visit .

Biohaven广泛的临床和临床前项目包括：用于癫痫治疗的Kv7离子通道调节；用于免疫性疾病治疗的MoDE™和TRAP™细胞外蛋白降解技术；以及用于神经肌肉疾病和代谢性疾病（包括肥胖症）治疗的肌抑素抑制剂。欲了解更多信息，请访问。

www.biohaven.com

。

Forward-Looking Statements

前瞻性陈述

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing, conduct, and outcomes of Biohaven's ongoing and planned clinical trials of BHV-1530, including the planned combination with cemiplimab under the clinical supply agreement with Regeneron, the potential therapeutic benefits, efficacy, safety, and tolerability of BHV-1530, and the timing of planned regulatory interactions and filings.

本新闻稿包含经1995年《私人证券诉讼改革法案》界定的前瞻性陈述，包括关于BHV-1530当前及计划临床试验的预期时间、实施和结果的陈述，其中包括根据与再生元（Regeneron）签订的临床供应协议计划开展的与cemiplimab的联合用药试验，以及BHV-1530的潜在治疗获益、疗效、安全性和耐受性，还有计划的监管互动和申报的时间安排。

The use of certain words, including 'continue,' 'plan,' 'will,' 'believe,' 'may,' 'expect,' 'anticipate,' 'on track,' 'potential,' and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements are not guarantees of future performance or results and involve substantial risks and uncertainties.

使用“继续”、“计划”、“将”、“相信”、“可能”、“预期”、“预计”、“进展顺利”、“潜力”等词语及类似表述，旨在识别前瞻性陈述。提醒投资者注意，任何前瞻性陈述均非对未来表现或结果的保证，并涉及重大风险和不确定性。

Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors, including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S.

实际结果、进展和事件可能因各种因素而与前瞻性陈述中的内容存在重大差异，这些因素包括：Biohaven 计划中及正在进行的临床试验的预期时间安排、启动情况及结果；与 FDA 的计划互动及提交文件的时间安排；预期监管申报的时间安排及结果；以及遵守适用的美国法律。

regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled 'Risk Factors' and 'Management's Discussion .

监管要求；Biohaven候选产品的潜在商业化及其预期时间；Biohaven候选产品成为成功疗法的潜力；以及Biohaven候选产品的有效性和安全性。与前瞻性陈述相关的其他重要因素详见Biohaven向美国证券交易委员会提交的文件，包括其中题为“风险因素”和“管理层讨论与分析”的章节。

MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd.

MoDE和TRAP是Biohaven Therapeutics Ltd.的商标。

Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc.

Libtayo 是再生元制药公司（Regeneron Pharmaceuticals, Inc.）的注册商标。

Investor Contact:

投资者联系：

Jennifer Porcelli

詹妮弗·波尔切利

Vice President, Investor Relations

投资者关系副总裁

[email protected]