Alphamab Oncology a clinical stage biopharmaceutical company focusing on innovative biologics medicine for oncology, and Sanofi , a global biopharmaceutical leader, announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. , a wholly-owned subsidiary of Alphamab Oncology, signed an agreement with Sanofi Investment Co., Ltd to establish strategic collaboration to advance clinical studies to investigate KN026 in combination with Taxotere® in HER2+ breast cancer, and Sanofi is granted an exclusivity period to negotiate the in-licensing of KN026 subject to the achievement of certain clinical milestones.
KN026 is an anti-HER2 bispecific antibody which can simultaneously bind two non-overlapping epitopes of HER2 and lead to a dual HER2 signal blockade, presumedly causing HER2 to aggregate on the cell surface and endocytose. Current clinicals trials shown promising preliminary efficacy and excellent safety profile in late-stage breast cancer patients who have failed multiple treatments in China, laying a solid foundation for future development of combination therapies in multiple front line settings. Given its clinical profile, KN026 has the potential to address the medical needs of around 2 million patients suffering from HER2-positive breast cancer in China, USA and key European markets.
Taxotere® (Docetaxel) is a microtubule inhibitor that interferes with the growth and spread of cancer cells in the body. It is used to treat breast cancer, lung cancer, prostate cancer, gastric cancer. In China, Taxotere® is indicated for breast cancer (BC) including: 1) single agent for locally advanced or metastatic BC after chemotherapy failure; 2) with trastuzumab for the 1st line treatment of metastatic BC patients with HER2 overexpression; 3) and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.
Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "KN026 is a core candidate of our innovative bispecific antibody pipeline, and has shown convincing advantages in safety and efficacy from current clinical studies. There are significant unmet need for the treatment of HER2-positive breast cancer. We hope, through the collaboration with Sanofi, a global biopharmaceutical leader, to further drive KN026's China and global development strategy, to provide a superior therapeutic solution to Her-2 positive patients."
Pius S. Hornstein, PhD, General Manager General Medicines and Country Lead, Sanofi China commented, "Building on Sanofi's heritage in oncology, we see a significant opportunity to impact the health of breast cancer patients by partnering with Alphamab, a biopharmaceutical leader in China. This strategic partnership also demonstrates Sanofi's ambition to play a more active role in the Chinese healthcare ecosystem, offering more new treatments for the large Chinese population with joint efforts from other leading companies."
Under terms of the agreement, Jiangsu Alphamab and Sanofi will collaborate to evaluate the combination of KN026 and Taxotere® (Docetaxel) for HER2+ breast cancer. Patient enrollment has started for the initial multicenter, open-label study.
KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.
KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has excellent safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.
About Alphamab Oncology
Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.
Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into Phase I – III clinical development phases in China, US and Japan.
The Company also has state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA's cGMP standards.Alphamab Oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world.
Visit http://www.alphamabonc.com for more information.
About Sanofi China
Sanofi is a leading global biopharmaceutical company focused on human health. In 1982, Sanofi opened an office in China as one of the first multinational corporations to support China's opening-up and reform. Sanofi China has a diversified business that ranges from pharmaceuticals and human vaccines to consumer healthcare. Sanofi has 12 offices, 4 R&D sites, 3 production sites and 1 digital innovation hub in China. Sanofi is committed to introducing innovative medicines and vaccines in China, and leading digital innovations to serve the broadest base of the Chinese people.
For more information, please visit www.sanofi.cn or subscribe to the Sanofi China official WeChat account: SanofiChina and LinkedIn account: Sanofi.
Sanofi is dedicated to supporting people through their health challenges. Sanofi is a global biopharmaceutical company focused on human health. Sanofi prevents illness with vaccines, provides innovative treatments to fight pain and ease suffering. Sanofi stands by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
Alphamab Oncology Forward-Looking Statements
This press release contains statements related to our future business and financial performance and future events or developments involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Alphamab Oncology's management and business operation, many of which are difficult to predict and generally beyond Alphamab Oncology's control. These are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Alphamab Oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and Alphamab Oncology's disclosures. Should one or more of these risks or uncertainties materialize, or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. Other than as required by applicable law, Alphamab Oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE Alphamab Oncology
Alphamab Oncology 是一家专注于肿瘤生物创新药物的临床阶段生物制药公司，全球生物制药领导者 Sanofi 今天宣布， Alphamab Oncology 的全资子公司江苏 Alphamab Biopharma Pharmaceuticals Co ., Ltd 与赛诺菲（Sanofi） Investment Co ., Ltd .签订协议，有限公司建立战略合作，推进临床研究，以研究 KN026联合 Taxotere ®在 HER2+乳腺癌中的应用，赛诺菲（Sanofi）被授予专有权，可根据某些临床里程碑的达成协商 KN026的许可使用期限。
KN026是一种抗 HER2双特异性抗体，能同时结合 HER2的两个非重叠表位，导致双重 HER2信号阻断，推测导致 HER2聚集在细胞表面和内吞。目前的临床试验表明，我国多项治疗失败的晚期乳腺癌患者具有良好的初步疗效和良好的安全性，为今后在多个一线环境下开展联合治疗奠定了坚实的基础。鉴于其临床概况， KN026有潜力满足中国、美国和欧洲主要市场约200万 HER2阳性乳腺癌患者的医疗需求。
Taxotere ®（多西他赛）是一种微管抑制剂，可干扰癌细胞在体内的生长和扩散。用于治疗乳腺癌、肺癌、前列腺癌、胃癌。在中国， Taxotere ®适用于乳腺癌（ BC ），包括：1）化疗失败后局部晚期或转移性 BC 的单一药物；2）曲妥珠单抗用于 HER2过度表达的转移性 BC 患者的一线治疗；3）多柔比星和环磷酰胺作为可操作的淋巴结阳性 BC 的辅助治疗。
Alphamab 肿瘤学创始人、董事长兼首席执行官 Ting XU 博士评论说：“ KN026是我们创新的双特异性抗体管线的核心候选者，从目前的临床研究中，在安全性和有效性方面显示出令人信服的优势。对于 HER2阳性乳腺癌的治疗，还没有得到满足。我们希望通过与全球生物制药领导者赛诺菲（Sanofi）的合作，进一步推动 KN026的中国和全球发展战略，为她-2阳性患者提供更好的治疗方案。
赛诺菲中国总经理兼国家首席执行官 Pius S . Hornstein 博士评论道：“基于赛诺菲（Sanofi）在肿瘤领域的传统，我们看到了通过与中国生物制药领军企业 Alphamab 合作影响乳腺癌患者健康的重大机遇。这一战略伙伴关系也表明赛诺菲（Sanofi）的雄心，即在中国医疗生态系统中发挥更积极的作用，在其他领先企业的共同努力下，为中国庞大人口提供更多新的治疗方案。”
根据协议条款，江苏阿尔法和赛诺菲（Sanofi）将合作评估 KN026和 Taxotere ®（多西他赛）用于 HER2+乳腺癌的联合治疗。病人登记已开始为最初的多中心，开放标签研究。
KN026是一种抗 HER2双特异性抗体，由 Alphamab 肿瘤学公司使用专有的基于 Fc 的异二聚体双特异性平台技术，称为 CRIB （ ChargeRepublicinducedBispecific ）。KN026能同时结合 HER2的两个非重叠表位，导致双 HER2信号阻塞。在临床前研究中， KN026与曲妥珠单抗和 Pertuzumab 单独或联合应用相比，具有潜在的等效或优越的疗效，如增加结合亲和力，以及 HER2阳性肿瘤细胞系的肿瘤抑制作用更好。此外， KN026对 HER2表达中或低表达的肿瘤细胞或曲妥珠单抗耐药的细胞系也有抑制作用。
KN026于2018年获得中国国家医药产品管理局（ NMPA ）和美国食品药品监督管理局（ FDA ）的 IND 批准。目前在中国正在进行多期 I / II 期临床试验，在美国处于 I 期临床试验阶段。I 期临床试验结果表明， KN026在 HER2阳性乳腺癌患者中具有良好的安全性、耐受性和潜在的优势抗肿瘤活性，经过多个抗 HER2治疗项目的进展。
关于 Alphamab 肿瘤学
Alphamab 在双特异性和蛋白质工程方面完全集成了专有生物技术平台。其高度分化的内部管道由8个抗肿瘤药物候选者组成，其中4个已进入中国、美国和日本 I-III 期临床开发阶段。
该公司还拥有最先进的制造能力设计和建设，以满足 NMPA 和欧盟/ FDA 的 cGMP 标准。阿尔法肿瘤致力于进一步发展其强大的肿瘤/免疫学管道，使世界各地的患者受益。
详情请访问 www.sanofi.cn 或订阅赛诺菲中国官方微信账户：赛诺菲中国和 LinkedIn 账户：赛诺菲（Sanofi）。
本新闻稿包含有关我们未来业务及财务表现以及涉及 Alphamab 肿瘤的未来事件或发展的声明，可能构成前瞻性声明。这些报表包括预测和估计及其基本假设、关于未来财务业绩、事件、业务、服务、产品开发和潜力的计划、目标、意图和预期的报表，以及关于未来业绩的报表。这些陈述可以用“期待”、“期待”、“预期”、“打算”、“计划”、“相信”、“寻求”、“估计”、“将”、“项目”或类似含义的词语来识别。我们还可以在其他报告、演示文稿、提交股东的材料和新闻稿中发表前瞻性声明。此外，我们的代表可不时作口头的前瞻性发言。该等陈述基于 Alphamab 肿瘤管理层及业务经营目前的预期及若干假设，其中许多难以预测，且一般超出 Alphamab 肿瘤的控制范围。这些风险和不确定性包括但不限于研究和开发固有的不确定性、未来临床数据和分析、监管机构关于是否以及何时批准任何可能为任何此类产品候选者申请的药物、装置或生物应用的决定。没有保证产品候选人如果获得批准将在商业上获得成功，治疗替代品的未来批准和商业成功， Alphamab 肿瘤学从外部增长机会中获益的能力，汇率和现行利率的趋势，成本控制政策及其后续变化的影响，未发行股票的平均数量和 Alphamab 肿瘤学的披露。如果这些风险或不确定因素中的一个或多个发生，或者根本预期不发生或假设证明不正确， Alphamab 肿瘤学的实际结果、表现或成就可能（负面或正面）与相关前瞻性声明中明确或暗示描述的结果或成就存在重大差异。除适用法律要求外， Alphamab 肿瘤学不承担因新信息、未来事件或其他原因而公开更新任何前瞻性声明的义务。