转自：医药观澜
▎医药观澜/报道
1月18日，威尚生物医药（Wayshine Biopharm）宣布其创新药物WSD0628获FDA批准在美国开展临床试验。WSD0628是一款能穿透血脑屏障的ATM靶向抑制剂，拟开发联合放疗作为放疗增敏剂用于脑胶质母细胞瘤（GBM）、间变型胶质瘤（AA）以及其他肿瘤的神经中枢转移。
WSD0628由威尚生物医药有限公司自主研发，临床试验 “A Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WSD0628 in Combination with Radiation Therapy for Recurrent Brain Cancer”在梅奥诊所（Mayo Clinic）的明尼苏达州、亚利桑那州和佛罗里达州三个临床中心开展。
“我们很荣幸FDA接受了WSD0628在美国的临床试验申请，这是具有里程碑意义的一步。”威尚生物医药CEO兼创始人钟卫博士说：“WSD0628的高活性、高选择性、良好的穿过血脑屏障能力、PK、非醛氧化酶底物，良好的安全窗口，且在多种颅内PDX模型中包括但不限于脑胶质瘤、儿童脑干肿瘤、癌症脑转移，联合放疗显著延长总生存期。WSD0628的发明设计体现了我们的创新能力和公司的承诺，其临床潜力得到FDA的认可，靶向未满足临床需求的肿瘤。感谢合作伙伴梅奥诊所的大力支持及FDA在评审中给予的帮助，期待WSD0628在临床中的优异表现。”
关于威尚生物医药有限公司
威尚生物医药有限公司是一家跨国药物研发公司，遵循科学，致力创新，主要专注于未满足临床需求的脑部肿瘤靶向药物研发。运作模式以基因学为基础，寻找生物靶点，验证靶点，设计化合物。WSD0922是一款能穿透血脑屏障的EGFR/EGFRvIII靶向抑制剂，适应症为脑部肿瘤，目前已经得到FDA临床批件在美国开展1期及2a期临床试验及孤儿药资格并获得FDA ODD R01基金支持，合作方为梅奥诊所。WSD0628是一款能穿透血脑屏障的ATM靶向抑制剂，联合放疗用于脑部肿瘤，目前已经得到FDA临床批件在美国开展1期及2a期临床试验并获得NCI U19基金支持，合作方为梅奥诊所。公司的策略性研发管线，以WSD1227为例，可以单药或联合用药治疗脑部肿瘤，目前在临床前IND准备阶段。
WAYSHINE BIOPHARM HOLDING LIMITED ANNOUNCES THE IND APPROVAL BY THE FDA FOR WSD0628 IN COMBINATION WITH RAIDATION THERAPY FOR THE TREATMENT OF RECURRENT BRAIN CANCER
JANUARY 18, 2023
Wayshine Biopharm has received IND approval from FDA for its innovative experimental medicine WSD0628, a First-in-Class CNS penetrable ATM inhibitor as radiosensitizer in combination with radiation therapy for the treatment of recurrent brain cancer patients. The WSD0628 program is under the sponsorship of Wayshine and the clinical trial, entitled “A Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WSD0628 in Combination with Radiation Therapy for Recurrent Brain Cancer” will be performed at Minnesota, Arizona and Florida, the three campuses of Mayo Clinic.
"We are very pleased that the FDA has approved the application of IND, which is a significant development milestone in advancing our Portfolio," said Wei Zhong, Ph.D., CEO and Founder of Wayshine Biopharm. " The high potency, high selectivity, good brain penetration with good PK, non-Aldehyde Oxidase substrate, good safety window of WSD0628 significantly prolonged overall survival in intracranial pdx models including but not limit to GBM, DIPG and cancers with brain mets when combo with radiation. The discovery of WSD0628 truly reflects our innovation and commitments and the clinical potential has been recognized and endorsed by the FDA, for this substantial unmet medical need. Really appreciate collaborator Mayo Clinic for strong support and FDA's help during the IND review, and look forward to the excellent performance of WSD0628 in clinical practice “.
ABOUT WAYSHINE BIOPHARM
Wayshine Biopharm is a global based science-driven innovative organization, focusing primarily on discovery and development of CNS penetrable medicines, for the treatment of brain cancer and cancers with CNS metastasis. The mission of the company is to develop precision medicines to address unmet medical needs of brain cancers. The business model is to use functional genomics to identify pathways and biological targets that could be exploited in the field of medicines, and then to screen designed proprietary compounds with the support from local and international Contract Research Organizations (CROs). Leading program, namely WSD0922, a first-in-class BBB penetrable EGFR/EGFRvIII inhibitor for brain cancers, has received IND approval and orphan drug designation from FDA and phase I/IIA clinical trial is conducted at Mayo Clinic with FDA ODD R01 grant support. WSD0628，a first-in-class BBB penetrable ATM inhibitor as radiosensitizer in combination with radiation therapy for brain cancers, has received FDA IND approval and phase I/IIA clinical trial is conducted at Mayo Clinic with NCI U19 grant support. Strategic pipelines, as example WSD1227 also for brain cancer as monotherapy or combination therapy, are under FDA IND enabling studies. For more information, please visit: http://www.wayshinebiopharm.com.
