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, 2023Wayshine 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 “.
