Everfront Biotech’s Novel Brain Tumor Implant Drug Cerebraca® Wafer Gained International Recognition, to Present Global Clinical Trial Plans at 2025 CNS Annual Meeting in the U.S.
Date: October 14, 2025
At the Congress of Neurological Surgeons (CNS) Annual Meeting, held in Los Angeles, California, USA, on October 13, 2025, Everfront Biotech disclosed the clinical results of the Cerebraca® Wafer’s Phase I/IIa trial, along with the design and outlook for the future international multicenter Phase IIb clinical trial.
【Taipei, October 14, 2025】Everfront Biotech today announced that its innovative implantable drug for the local treatment of Glioblastoma (GBM), Cerebraca® Wafer, successfully completed its Phase I/IIa clinical trial in 2024. This achievement marks a significant development milestone for the company. Everfront is actively preparing to submit the clinical study report to the U.S. Food and Drug Administration (FDA) to pave the way for the next phase of trials.
The breakthrough clinical trial results made their international debut at the Congress of Neurological Surgeons (CNS) Annual Meeting, held in Los Angeles, California, USA, from October 11 to 15, 2025. Dr. Jen-Wei Liu, Chief Science Officer of Everfront Biotech, noted that Dr. Clark Chen, the company’s Scientific Advisory Committee member and a renowned neurosurgery expert in the US, delivered an oral presentation at the CNS Annual Meeting. The session drew the attendance of hundreds of experts and scholars for listening and engaging in enthusiastic discussion afterward. Dr. Liu extended his gratitude to the attendees for their high level of interest and support regarding the clinical progress of Cerebraca® Wafer.
Dr. Chen’s presentation, titled ”A Pivotal Phase IIb/III Clinical Trial of Localized Glioblastoma Treatment Targeting RTK-Defined Networks,” will highlight the clinical outcomes from the Phase I/IIa trial of Cerebraca® Wafer, and outline the design and vision for the upcoming multinational, multicenter Phase IIb clinical program.
Key Highlights from the Phase I/IIa Clinical Trial:
- No drug-related serious adverse events (≥ Grade 3) observed
- Median overall survival (mOS) of all patients reached 15.7 months
- In the RTK (Receptor Tyrosine Kinase)-high expression subgroup, mOS extended to 26.2 months
In addition, animal studies demonstrated that EF-001, the active compound in Cerebraca® Wafer, can diffuse over 2 cm within brain tissue in canine models, while maintaining high local drug concentrations and minimal systemic exposure—indicating strong local therapeutic control and low systemic toxicity.
Dr. Liu noted that these findings are expected to draw significant interest from the international scientific and pharmaceutical communities. “Cerebraca® Wafer has the potential to become a new localized targeted implant therapy for glioblastoma. The Phase IIb global trial is planned to launch between late 2025 and early 2026, marking a major step for Everfront in entering the global new drug market,” he said.
【Oral Presentation】
Everfront Biotech’s Novel Brain Tumor Implant Drug Cerebraca® Wafer Gains International Recognition, to Present Global Pivotal Clinical Trial Plans at 2025 CNS Annual Meeting in the U.S.
Speaker
Dr. Clark C. Chen, MD, PhD
Time: October 13 (Monday) 3:44 – 3:50 pm
Place: 2025 CNS – Section on Tumors 1: Incorporation of Targeted Therapies in the Management of Brain Tumors in the Molecular Age
Dr. Clark Chen delivered an oral presentation titled: “A Pivotal Phase IIb/III Clinical Trial of Localized Glioblastoma Treatment Targeting Receptor Tyrosine Kinase Defined Networks.”
The session attracted hundreds of experts and scholars who attended the presentation and engaged in lively discussions afterward.
The speaker, Dr. Clark Chen (center), was joined by Dr. Jen-Wei Liu (left), Chief Science Officer, and Dr. Jui-Hao Lee (right), Clinical Director and Spokesperson, for a group photo at the venue.
About Dr. Clark C. Chen (Source: website)
Dr. Clark C. Chen, MD, PhD, is Director of the Brain Tumor Program in the Department of Neurosurgery at the Warren Alpert School of Medicine, Brown University. He also serves on Everfront Biotech’s Scientific Advisory Board. Dr. Chen specializes in surgical treatment of brain cancers and leads a NIH-funded research lab dedicated to glioma therapies. He has authored over 300 peer-reviewed scientific publications and has been repeatedly recognized as a “Top Doctor” by national and international institutions.
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.
