SAN DIEGO & NATICK, Mass.--(BUSINESS WIRE)--Avenzo Therapeutics, Inc. (Avenzo), a clinical-stage biotechnology company developing next generation oncology therapeutics, today announced that it has entered into an exclusive licensing agreement with Allorion Therapeutics Inc. (Allorion) to develop and commercialize AVZO-021 (formerly ARTS-021), a potentially best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor globally (excluding Greater China).

圣地亚哥和内蒂克，马萨诸塞州。-（商业新闻短讯）--Avenzo Therapeutics，Inc.（Avenzo），一家开发下一代肿瘤治疗药物的临床阶段生物技术公司，今天宣布，它已经与Allorion Therapeutics Inc.（Allorion）签订了独家许可协议，以开发和商业化AVZO-021（以前的ARTS-021），全球（不包括大中华区）潜在最佳的细胞周期蛋白依赖性激酶2（CDK2）选择性抑制剂。

As part of the agreement, Avenzo also receives an exclusive option for an additional preclinical program planned for IND submission in early 2025..

作为协议的一部分，Avenzo还获得了计划于2025年初提交IND的额外临床前项目的独家选择权。。

CDK2 has emerged as a promising target given its role as a resistance mechanism to approved CDK4/6 therapies in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, and given its role as an oncogene in many cyclin E1 (CCNE1) amplified cancers. Avenzo will leverage its internal drug development expertise to advance AVZO-021, which is currently being studied in a Phase 1 clinical trial across multiple sites in the U.S.

鉴于CDK2在激素受体阳性（HR+）/人表皮生长因子受体2阴性（HER2-）乳腺癌中作为批准的CDK4/6疗法的耐药机制的作用，以及其作为癌基因在许多细胞周期蛋白E1（CCNE1）扩增的癌症中的作用，CDK2已成为一个有希望的靶标。Avenzo将利用其内部药物开发专业知识推进AVZO-021，目前正在美国多个地点进行一期临床试验。

for the treatment of HR+/HER2- metastatic breast cancer and other advanced solid tumors..

用于治疗HR+/HER2转移性乳腺癌和其他晚期实体瘤。。

“With this agreement, we have laid the foundation for our potentially best-in-class oncology pipeline,” said Athena Countouriotis, M.D., co-founder, president and CEO of Avenzo. “Patients with HR+/HER2- metastatic breast cancer continue to have limited therapeutic options, and we believe AVZO-021 may provide patients with a new treatment option both as a single agent and in multiple combinations.

Avenzo联合创始人、总裁兼首席执行官AthenaCountouriotis医学博士说：“通过这项协议，我们为我们潜在的一流肿瘤学管道奠定了基础。”。“HR+/HER2转移性乳腺癌患者的治疗选择仍然有限，我们认为AVZO-021可能为患者提供单一药物和多种组合的新治疗选择。

We are excited to advance the ongoing Phase 1 clinical study (NCT05867251), and to partner with the Allorion team to advance the program globally.”.

我们很高兴推进正在进行的第一阶段临床研究（NCT05867251），并与Allorion团队合作，在全球推进该计划。”。

Under the terms of the license agreement, Allorion will receive an upfront payment of $40 million and be eligible to receive additional payments based on achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Avenzo. Potential payments for both programs may total more than $1 billion..

根据许可协议的条款，Allorion将收到4000万美元的预付款，并有资格根据Avenzo实现的某些开发、监管和商业里程碑以及净销售额的分层版税获得额外付款。这两个项目的潜在付款总额可能超过10亿美元。。

“We developed AVZO-021 as a potential best-in-class CDK2-selective inhibitor to address an area of unmet medical need,” said Peter Ding, co-founder and CEO of Allorion. “The Avenzo team has a proven track record and deep expertise in developing and advancing next-generation oncology therapies. We are delighted to partner with Avenzo to drive innovation and transform the treatment landscape for cancer patients.”.

Allorion联合创始人兼首席执行官彼得·丁（PeterDing）表示：“我们开发了AVZO-021作为潜在的同类最佳CDK2选择性抑制剂，以解决尚未满足的医疗需求领域。”。“Avenzo团队在开发和推进下一代肿瘤治疗方面拥有良好的业绩记录和深厚的专业知识。我们很高兴与Avenzo合作，推动创新，改变癌症患者的治疗格局。”。

“AVZO-021 is a highly potent and selective CDK2 inhibitor for the treatment of HR+/HER2- breast cancer and CCNE1-amplified cancers,” said Afshin Dowlati, M.D., Professor of Medicine and Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve, and Director of the Early Phase Therapeutics Program.

“AVZO-021是一种高效和选择性的CDK2抑制剂，用于治疗HR+/HER2乳腺癌和CCNE1扩增的癌症，”大学医院塞德曼癌症中心和Case Western Reserve的医学和肿瘤学教授、早期治疗计划主任Afshin Dowlati医学博士说。

“I look forward to working with Avenzo as they continue to develop this therapy that has the potential to provide a new treatment option to patients fighting cancer.”.

“我期待着与Avenzo合作，因为他们将继续开发这种疗法，这种疗法有可能为抗癌患者提供新的治疗选择。”。

In preclinical studies, AVZO-021 exhibited nanomolar potency against CDK2 while sparing other CDKs with high selectivity over CDK1, a key driver of toxicity. In addition, AVZO-021 demonstrated efficacy in in vivo xenograft models, both as a single agent and in combination with CDK4/6 inhibitors. Allorion disclosed select data in poster presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2023..

在临床前研究中，AVZO-021对CDK2表现出纳摩尔效力，同时保留了对CDK1（毒性的关键驱动因素）具有高选择性的其他CDK。此外，AVZO-021在体内异种移植模型中显示出作为单一药物和与CDK4/6抑制剂组合的功效。Allorion在2023年10月举行的AACR-NCI-EORTC分子靶标和癌症治疗国际会议上的海报展示中披露了精选数据。。

About Avenzo Therapeutics, Inc.

关于Avenzo Therapeutics，Inc。

Avenzo Therapeutics is a clinical-stage biotechnology company focused on developing the next generation of oncology therapies for patients. The company’s lead drug candidate, AVZO-021, is a novel, highly potent and selective inhibitor of CDK2, a key enzyme involved in cell cycle regulation. AVZO-021 is being studied in a Phase 1 study in the U.S.

Avenzo Therapeutics是一家临床阶段生物技术公司，专注于为患者开发下一代肿瘤疗法。该公司的主要候选药物AVZO-021是一种新型，高效和选择性的CDK2抑制剂，CDK2是参与细胞周期调控的关键酶。AVZO-021正在美国进行第一阶段研究。

for the treatment of advanced solid tumors. Avenzo is headquartered in San Diego, California. For more information, visit us at www.avenzotx.com or on LinkedIn..

用于治疗晚期实体瘤。Avenzo总部位于加利福尼亚州圣地亚哥。有关更多信息，请访问www.avenzotx.com或LinkedIn。。

About Allorion Therapeutics Inc.

关于Allorion Therapeutics Inc。

Allorion Therapeutics is a clinical-stage biotechnology company that focuses on creating new small molecule drugs for treating cancer and autoimmune diseases. The company has a team of experienced drug discovery and development professionals who identify new drugs with unique mechanisms of actions and develop innovative data and screening platforms for long-term success.

Allorion Therapeutics是一家临床阶段生物技术公司，专注于开发用于治疗癌症和自身免疫性疾病的新型小分子药物。该公司拥有一支经验丰富的药物发现和开发专业人员团队，他们可以识别具有独特作用机制的新药，并开发创新数据和筛选平台，以取得长期成功。

Allorion Therapeutics aims to advance new drugs with high potential and clinical relevance..

Allorion Therapeutics旨在开发具有高潜力和临床相关性的新药。。