11月22日， 2021年--威尚生物控股今日宣布其世界首创能穿透血脑屏障的放疗增敏剂创新药物WSD0628获美国国家癌症研究所（NCI）U19基金拨款支持其临床前及临床开发。NCI U19基金支持通过开发可穿越血脑屏障 (BBB) 的新型有效药物并在临床中对其进行测试，以改善成人胶质母细胞瘤 (GBM) 的治疗。
“NCI U19基金资助是 WSD0628 开发计划中的一个重要里程碑。” CEO兼创始人钟卫博士评论道。 “我们非常高兴NCI 提供资金支持 WSD0628 的临床前和临床开发。NCI 基于令人鼓舞的临床前数据的 U19 拨款真实反映了我们的创新和承诺，WSD0628 的临床潜力得到了NCI认可和领域内专家的支持。感谢 NCI 科学评审委员会、合作伙伴梅奥诊所和耶鲁医学院的大力支持。WSD0628的高活性、高选择性、高穿过血脑屏障能力、良好的 PK、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，联合放疗显着延长总生存期确定了 WSD0628 的临床开发计划。WSD0628的临床申报工作正在进行中，预计临床批件将在 2022 年下半年获得并开展临床一期剂量爬升试验。 “
| 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，与国内外CRO进行实验合作。WSD0922是世界首创能穿透血脑屏障的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一期及二期A临床实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。公司的策略性研发管线，以WSD0628和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。更多信息，请访问：http://www.wayshinebiopharm.com
| 关于NCI U19基金
NCI U19基金用于支持通过开发可穿过血脑屏障 (BBB) 的新型有效药物并在临床中对其进行测试来改善成人脑胶质母细胞瘤的治疗，这将推动治疗药物从临床前开发、IND临床批件研究至进入人类试点临床研究。更多信息，请访问：NCI-funded Glioblastoma Therapeutics Network (GTN) Will Work Collaboratively to Develop New Treatments | News & Events | DCTD (cancer.gov)
Wayshine Biopharm Holding Limiyed Announces WSD0628 Receives NCI U19 Funding Support for Preclinical and Clinical Development
November 22, 2021--Wayshine Biopharm, a clinical-stage pharmaceutical company, today announced that its First-in-Class CNS penetrable radiosensitizer, namely WSD0628, has received U19 grant from the US National Cancer Institute (NCI) to support the preclinical and clinical development. The Glioblastoma Therapeutics Network (GTN) NCI U19 funding was granted to improve the treatment of adult glioblastoma (GBM) by developing novel effective agents that can cross the blood brain barrier (BBB) and testing them in the clinic.
NCI U19 grant is a significant milestone in the WSD0628 development program, commented Dr. Wei Zhong, Ph.D., CEO and Founder of Wayshine Biopharm. We are very pleased that the NCI has granted the funding to support the preclinical and clinical development of WSD0628. The U19 grant by the NCI based on encouraging preclinical data truly reflects our innovation and commitments and the clinical potential of WSD0628 has been recognized and endorsed by the NCI. Thanks NCI scientific review panel, collaborator Mayo Clinic and Yale Medical School’s strong support. The high potency, high selectivity, high brain penetration with good PK, good safety window and significant overall survival prolongation in intracranial pdx models including but not limit to GBM, DIPG and cancers with brain mets when combo WSD0628 with radiation warrant the clinical development of WSD0628. The IND enabling study is ongoing. FDA IND approval and phase I clinical trial are expected in the second half of 2022.”
| About
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. Strategic pipelines, as example WSD0628 and 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
