UTRECHT, The Netherlands and PHILADELPHIA, March 05, 2024 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma delta T cell engagers, today announced that Pfizer has achieved a clinical development milestone for PF-08046052 (formerly SGN-EGFRd2 /LAVA-1223), prompting the first milestone payment of $7 Million to LAVA.

荷兰乌得勒支和费城，2024年3月5日（环球通讯社）--LAVA Therapeutics N.V.（纳斯达克：LVTX，“LAVA”），一家临床阶段免疫肿瘤学公司，专注于开发其专有的双特异性γδT细胞参与者Gammabody®平台，今天宣布辉瑞公司已实现PF-08046052（以前的SGN-EGFRd2/LAVA-1223）的临床开发里程碑，促使向LAVA支付700万美元的第一笔里程碑付款。

LAVA granted Seagen (acquired by Pfizer in December 2023) a worldwide, exclusive license to PF-08046052 in September 2022..

LAVA于2022年9月向Seagen（2023年12月被辉瑞收购）授予PF-08046052全球独家许可。。

“We are very pleased with the initiation of clinical development by Pfizer of PF-08046052, formerly SGN-EGFRd2/LAVA-1223. We have always viewed this molecule with excitement about its potential in oncology. Achievement of this milestone is another important step in realizing the potential of LAVA’s Gammabody® platform.

“我们非常高兴辉瑞公司开始临床开发PF-08046052，前身为SGN-EGFRd2/LAVA-1223。我们一直对这种分子在肿瘤学中的潜力感到兴奋。实现这一里程碑是实现LAVA Gammabody®平台潜力的另一个重要步骤。

As the Phase 1 study advances, we look forward to continued clinical progress and future data readouts,” said Stephen Hurly, President and Chief Executive Officer of LAVA..

随着第一阶段研究的进展，我们期待着持续的临床进展和未来的数据读数，”LAVA总裁兼首席执行官斯蒂芬·赫尔利（StephenHurly）说。。

“The initiation of the Phase 1 study for PF-08046052 marks the third asset utilizing LAVA’s Gammabody® platform to enter the clinic and will add further information on safety, clinical pharmacology and potential anti-tumor activity to the growing database for this novel class of molecules,” commented Charles Morris, M.D., Chief Medical Officer, LAVA.

“PF-08046052的第一阶段研究的启动标志着利用LAVA的Gammabody®平台进入临床的第三项资产，并将为这类新型分子的不断增长的数据库添加有关安全性，临床药理学和潜在抗肿瘤活性的进一步信息，”LAVA首席医学官Charles Morris医学博士评论道。

“We are especially encouraged by the ongoing progress for PF-08046052 and PSMA-directed LAVA-1207, currently in a Phase 1/2a study. Both programs direct Vγ9Vδ2 T cells to validated targets and have the potential to provide important proof-of-concept for LAVA’s Gammabody® platform.”.

“PF-08046052和PSMA指导的LAVA-1207目前正在进行1/2a期研究，我们特别受到鼓舞。这两个项目都将Vγ9Vδ2 T细胞导向经过验证的靶标，并有可能为LAVA的Gammabody®平台提供重要的概念证明。”。

About PF-08046052 (formerly LAVA-1223)

关于PF-08046052（原LAVA-1223）

PF-08046052 is a potential first-in-class asset utilizing the Gammabody® platform designed to conditionally activate Vγ9Vδ2 (Vgamma9 Vdelta2) T cells, upon crosslinking to epidermal growth factor receptor (EGFR), to trigger the potent and preferential killing of EGFR-positive tumor cells. EGFR is a well-validated target that is over-expressed in multiple solid tumor types, including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC) and pancreatic ductal adenocarcinoma (PDAC).

PF-08046052是一种潜在的一流资产，利用Gammabody®平台设计用于在与表皮生长因子受体（EGFR）交联后有条件地激活Vγ9Vδ2（Vgamma9-Vdelta2）T细胞，以触发EGFR阳性肿瘤细胞的有效和优先杀伤。EGFR是一种经过充分验证的靶标，在多种实体瘤类型中过度表达，包括结直肠癌（CRC），非小细胞肺癌（NSCLC），头颈部鳞状细胞癌（HNSCC）和胰腺导管腺癌（PDAC）。

PF-08046052 is being evaluated in an ongoing Phase 1 study (NCT05983133) by Pfizer under an exclusive worldwide license agreement. In accordance with the agreement, LAVA received a $50 million upfront payment and is eligible to receive milestones of up to approximately $650 million upon achievement of development, regulatory and commercial milestones as well as royalties on potential sales..

辉瑞公司根据全球独家许可协议，正在进行一项正在进行的第一阶段研究（NCT05983133）中对PF-08046052进行评估。根据该协议，LAVA收到了5000万美元的预付款，并且有资格在实现开发、监管和商业里程碑以及潜在销售的版税后获得高达约6.5亿美元的里程碑。。

About LAVA Therapeutics

关于LAVA Therapeutics

LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody® platform to develop a portfolio of bispecific gamma-delta T cell engagers for the potential treatment of solid tumors and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell antitumor effector functions upon cross-linking to tumor-associated antigens..

LAVA Therapeutics N.V.是一家临床阶段免疫肿瘤学公司，专注于推进其专有的Gammabody®平台，以开发双特异性γδT细胞参与者组合，用于潜在的实体瘤和血液恶性肿瘤治疗。该公司利用双特异性抗体，通过与肿瘤相关抗原交联后触发Vγ9Vδ2（Vgamma9 Vdelta2）T细胞抗肿瘤效应子功能，选择性杀死癌细胞。。

A Phase 1/2a dose escalation study (NCT05369000) to evaluate the lead program, LAVA-1207, in patients with metastatic castration-resistant prostate cancer (mCRPC) is actively enrolling in Europe and the United States in a study evaluating monotherapy and combination treatment with interleukin-2 (IL-2).

一项评估转移性去势抵抗性前列腺癌（mCRPC）患者lead计划LAVA-1207的1/2a期剂量递增研究（NCT05369000）正在欧洲和美国积极参与一项评估单一疗法和联合治疗的研究。白细胞介素-2（IL-2）。

The Company is also planning to expand the Phase 1/2a study to include a combination arm with KEYTRUDA®(pembrolizumab), through a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA. The Company licensed PF-08046052 (formerly SGN-EGFRd2/LAVA-1223) to Pfizer for clinical development and commercialization.

该公司还计划通过与美国新泽西州拉赫韦的默克公司（Merck＆Co.，Inc.）的临床合作，扩大1/2a期研究，以包括与KEYTRUDA®（pembrolizumab）的联合治疗。该公司将PF-08046052（以前的SGN-EGFRd2/LAVA-1223）许可给辉瑞公司进行临床开发和商业化。

For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, X, and YouTube..

有关更多信息，请访问www.lavatherapeutics.com，并在LinkedIn、X和YouTube上关注我们。。

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA

KEYTRUDA® 是美国新泽西州拉威市默克有限责任公司的子公司默克夏普多姆公司的注册商标

LAVA’s Cautionary Note on Forward-Looking Statements

LAVA关于前瞻性声明的警示说明

This press release contains forward-looking statements, including with respect to the Company’s anticipated growth and clinical development plans including the timing and results of clinical trials. Words such as “anticipate,” “believe,” “could,” “will,” “may,” “expect,” “should,” “plan,” “intend,” “estimate,” “potential,” “suggests” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.

本新闻稿包含前瞻性声明，包括公司的预期增长和临床开发计划，包括临床试验的时间和结果。诸如“预期”、“相信”、“可能”、“将要”、“可能”、“预期”、“应该”、“计划”、“打算”、“估计”、“潜在”、“建议”等词语和类似表达（以及引用未来事件、条件或情况的其他词语或表达）旨在识别前瞻性陈述。

These forward-looking statements are based on LAVA’s expectations and assumptions as of the date of this press release and are subject to various risks and uncertainties that may cause actual results to differ materially from these forward-looking statements. Forward-looking statements contained in this press release include but are not limited to statements relating to the therapeutic potential, development and potential uses of LAVA’s product candidates, the timing of initiation of clinical trials, including the expansion phase of the Phase 1/2a trial to evaluate LAVA-1207 in combination with KEYTRUDA®, availability of information regarding clinical development plans, progress and data from clinical trials, the potential uses of LAVA’s product candidates to treat various tumor targets, including CRC, NSCLC, PDAC and HNSCC, and improve patient outcomes and the sufficiency of resources to pursue development activities.

这些前瞻性声明基于截至本新闻稿发布之日LAVA的预期和假设，并受到各种风险和不确定性的影响，这些风险和不确定性可能导致实际结果与这些前瞻性声明存在重大差异。本新闻稿中包含的前瞻性声明包括但不限于与LAVA候选产品的治疗潜力、开发和潜在用途有关的声明，临床试验的启动时间，包括评估LAVA-1207与KEYTRUDA®组合的1/2a期试验的扩展阶段，有关临床开发计划、临床试验进展和数据的信息的可用性，LAVA候选产品治疗各种肿瘤靶点（包括CRC、NSCLC、PDAC和HNSCC）的潜在用途，以及改善患者预后和资源充足性以开展开发活动。

Many factors, risks and uncertainties may cause differences between current expectations and actual results, including, among other things, the Company’s ability to leverage its initial programs to develop additional product candidates using our Gammabody® platform, and the failure of LAVA’s collaborators to support or advance collaborations or LAVA’s produ.

许多因素、风险和不确定性可能导致当前预期与实际结果之间的差异，其中包括公司利用其初始计划使用我们的Gammabody®平台开发其他候选产品的能力，以及LAVA的合作者未能支持或推进合作或LAVA的产品。

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ir@lavatherapeutics.com

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