October 14, 2021
Wayshine Biopharm, a clinical-stage pharmaceutical company, today announced that its First-in-Class CNS penetrable EGFR/EGFRvIII inhibitor, namely WSD0922, has received R01 grant from the U.S. Food and Drug Administration (FDA) to support the ongoing phase I/IIA clinical development. FDA ODD R01 funding was granted for efficient and innovative clinical studies evaluating safety and/or efficacy of orphan drug for the potentially life-changing treatment of rare diseases with an unmet medical need and exerting a broad and positive impact on rare disease drug development.
WSD0922 has previously received IND approval from FDA for the treatment of Glioblastoma, Anaplastic Astrocytoma and cancers with CNS metastasis patients. Phase I/IIA to evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of WSD0922 is ongoing at Minnesota, Arizona and Florida, the three campuses of Mayo Clinic.
"FDA ODD R01 grant is another significant milestone in the WSD0922 development program," commented Dr. Wei Zhong, Ph.D., CEO and Founder of Wayshine Biopharm. " We are very pleased that the FDA has granted the funding to support the ongoing Phase I/IIA clinical development of WSD0922. The R01 grant by the FDA based on encouraging preclinical and clinical data truly reflects our drug’s great potential and innovation. The clinical potential of WSD0922 has been recognized and endorsed by the FDA and expertise in the field. Thanks FDA scientific review panel, FDA orphan drug office, collaborator Mayo Clinic, patients and patients’ family strong support. Really appreciate investors’ patience, trust and continuous support.”
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