PT-886

中国北京、上海、广东松山湖，美国圣地亚哥 2024年10月9日，专注于肿瘤领域创新药物发现和开发的临床阶段生物技术公司凡恩世制药公司（Phanes Therapeutics）今天宣布，其自主研发的全球首创的双特异性抗体（双抗）PT886与默沙东PD-1抑制剂KEYTRUDA®（帕博利珠单抗）的联合治疗已完成首例患者给药。首例患者给药是在胃癌和胃食管交界癌的临床试验组进行的。 如之前宣布的，凡恩世正在根据与默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）签订的临床试验合作协议开展此项临床研究。PT886是一款全球首创靶向claudin 18.2和CD47的双抗。PT886已于2022年获得美国食品药品监督管理局（FDA）授予的用于治疗胰腺癌的孤儿药资格认定，并于今年早些时候获得FDA快速通道资格认定，用于治疗转移性claudin 18.2阳性胰腺癌患者。PT886目前正在进行PT886单药、与pembrolizumab联合、与化疗联合（联合或不联合pembrolizumab）的评估。 PT886在美国的多中心I/II期临床试验（NCT05482893），即 TWINPEAK 研究，目前正在评估 PT886在局部晚期或转移性胃腺癌、胃食管交界处癌和胰腺癌患者中的安全性、耐受性、药代动力学和初步疗效。PT886在中国的I期临床试验也正在开展中（CTR20241655）。 KEYTRUDA®为已注册商标，商标权利人为美国新泽西州罗威市Merck & Co., Inc.的子公司Merck Sharp & Dohme LLC。 关于凡恩世制药 凡恩世制药（Phanes Therapeutics, Inc.）是一家临床阶段的生物技术公司，致力于肿瘤领域创新型药物的研究和开发。目前公司有三个处于临床阶段的项目，包括best-in-class单克隆抗体（mAb）项目PT199，以及两个first-in-class双特异性抗体（bsAbs）项目PT886和PT217。PT886和PT217都已获FDA孤儿药和快速通道资格认定。 凡恩世制药已经通过其专有技术平台PACbody®、SPECpair®和ATACCbody®建立了强大的研发管线，以开发新型生物制剂，解决癌症领域高度未满足的医疗需求的问题。PACbody®，是一种不需要蛋白质工程来构建双特异性抗体专有方法，从而使抗体分子保持具有卓越CMC特性的天然结构。SPECpair®技术平台，能利用传统的单克隆抗体制备工艺来生产具有天然IgG结构的双特异性抗体。ATACCbody®技术平台，是一种使用可调节活性的免疫肿瘤分子靶向实体瘤的专有技术，旨在最大限度地降低细胞因子风暴的风险。 关于更多凡恩世制药信息，请访问公司网站：www.phanesthera.com。 有关商务合作或媒体咨询，请分别联系bd@phanestx.com或media@phanestx.com。 推荐阅读： 凡恩世制药DLL3/CD47双抗PT217完成中国I期临床研究首例患者给药 凡恩世制药CD73单抗PT199完成中国I期临床研究首例患者给药 凡恩世DLL3/CD47双抗PT217获FDA第二个孤儿药认定，用于治疗神经内分泌癌 凡恩世制药claudin 18.2/CD47双抗PT886完成中国I期临床研究首例患者给药 凡恩世制药宣布与罗氏达成临床供药协议 凡恩世PT217获得FDA快速通道资格认定，用于治疗广泛期小细胞肺癌患者 凡恩世PT886获得FDA快速通道资格认定，用于治疗转移性claudin 18.2阳性胰腺癌患者 凡恩世制药双抗PT886临床试验申请获CDE批准 凡恩世宣布其三个专有技术平台获美国专利商标局授权注册商标 凡恩世制药DLL3/CD47双抗PT217临床试验申请获CDE受理 凡恩世制药claudin 18.2/CD47双抗PT886临床试验申请获CDE受理 凡恩世制药CD73单抗PT199临床试验申请获CDE受理 凡恩世制药宣布与默沙东公司达成临床试验合作与供药协议 国际著名肿瘤专家陆舜教授加入凡恩世临床顾问委员会 凡恩世制药宣布成立肿瘤临床顾问委员会 凡恩世制药宣布PT217双抗美国I期临床完成首例患者给药 全球首创！凡恩世宣布其Claudin 18.2/CD47双抗PT886美国I期临床完成首例患者给药 凡恩世与安斯泰来子公司Xyphos Biosciences达成研究合作协议 凡恩世宣布与百济神州达成临床供应协议，用于评估PT199与替雷利珠单抗的联合用药 专访凡恩世生物王明晗博士：创新照亮肿瘤治疗之路

SAN DIEGO, Oct. 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the first patient has been dosed in the clinical study of PT886 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The dosing was conducted in a cohort of gastric and gastroesophageal junction cancers. As previously announced, Phanes is conducting this study under a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada). PT886 is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma earlier this year. PT886 is currently being evaluated as monotherapy and in combination with pembrolizumab, or with chemotherapy, either alone or in combination with pembrolizumab. The multi-center Phase I/II clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers. A Phase I clinical trial of PT886 is also ongoing in China (CTR20241655). KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. ABOUT PHANES THERAPEUTICS Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA. The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody®, SPECpair® and ATACCbody® to develop novel biologics that address high unmet medical needs in cancer. For more information about Phanes Therapeutics, please visit For business development or media inquiries, please contact [email protected] or [email protected], respectively. SOURCE Phanes Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED