[CORPORATE NEWS] FDA Agrees to Phase IIb/III Protocol for Cerebraca® Wafer
Date: August 14, 2026
Everfront Biotech announced on August 14 that it has officially received a letter from the U.S. FDA agreeing to the initiation of the Phase IIb/III clinical trial for Cerebraca® Wafer.
The U.S. FDA has agreed to Everfront Biotech’s proposed Phase IIb/III clinical study protocol for Cerebraca® Wafer in patients with recurrent glioblastoma. The study is intended to generate clinical data that may support a future discussion with the FDA regarding a potential Breakthrough Therapy Designation pathway.
Cerebraca® Wafer is an investigational drug candidate and has not yet been approved by the U.S. FDA or any other regulatory authority.
🔗 More Media Coverage (Chinese Version): Clinical Trial Details: For more information regarding the Phase IIb/III clinical study (NCT07349693), please visit the NIH ClinicalTrials.gov database at: https://clinicaltrials.gov/study/NCT07349693
Product Highlights of Cerebraca® Wafer:
Cerebraca® Wafer is a revolutionary implantable drug designed for the localized treatment of malignant brain tumors. Developed using multiple patented innovations, the product aims to solve critical challenges in brain cancer therapy—such as chemoresistance, high cancer stem cell content, and tumor recurrence.
Cerebraca® Wafer works by targeting receptor tyrosine kinase (RTK) signaling networks, modulating tumor resistance, and counteracting PD-L1-mediated immune evasion, a common barrier to effective treatment. In Phase I/IIa trials, no drug-related adverse effects were reported. Recurrent GBM patients showed a median overall survival of 15.7 months, with RTK-high subgroups reaching up to 26.2 months—a significant improvement over the current standard of care (6–9 months).
Everfront Biotech is actively seeking strategic partnerships and licensing opportunities to co-develop this promising therapy and extend its benefits to more patients worldwide.
Introduction to Everfront Biotech Inc.:
Everfront Biotech Inc. was founded in 2010, with a focus on research and development of new drugs, specifically the screening and further development of potential small molecules for clinical study. The company’s team is responsible for all aspects of product development, from front-end potential product development to pre-clinical research, chemistry manufacturing and controls (CMC), clinical trial submissions, and clinical trial planning and execution. To date, the Everfront Biotech team has successfully applied three clinical trials: Cerebraca® Wafer (for malignant brain tumors), HK-001 (for amyotrophic lateral sclerosis), and EF-009 (for pancreatic cancer), which have been approved for IND applications in both the United States and Taiwan.
Everfront Biotech’s new drug development is in line with national policies, and the Cerebraca® Wafer and HK-001 products were granted the certifications of biotech and new drug in 2016. The company has received the government subsidies in three science and technology projects as of 2022 from the Ministry of Economic Affairs.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the potential impact of clinical data on patients, the progress of Everfront’s product candidates and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization. Actual results may differ materially from those described in the forward-looking statements due to various important factors, including but not limited to Everfront’s ability to demonstrate the safety and efficacy of its drug candidates; whether clinical results will support further development or regulatory approval; decisions by regulatory authorities regarding approval of Everfront’s drug candidates; Everfront’s ability to achieve commercial success if its drug candidates are approved; Everfront’s ability to obtain and maintain intellectual property protection for its technology and drugs; Everfront’s reliance on third parties to conduct drug development, manufacturing and other services; Everfront’s limited operating history and its ability to obtain additional funding to support its operations and complete the development and commercialization of its drug candidates; whether Everfront can enter into additional collaboration agreements beyond its existing strategic collaborations or relationships; and those risks more fully discussed in the “Risk Factors” section in Everfront’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Everfront and Everfront assumes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
