New Targeted Drug Cerebraca® Wafer: Dawn of Treatment for Malignant Brain Tumors
Date: 2023/11/21
On December 2nd, from 1:00 to 1:40 PM, a lecture titled ” The Cerebraca® Wafer Journey to the Global Stage.” will be presented at the Healthcare+ EXPO Taiwan 2023 booth of Hualien Tzu Chi Hospital (Booth N802). The speakers for this session include Dr. Shinn-Zong Lin, the hospital Superintendent, and Directors Jen-Wei Liu and Yuan-Sheng Li from Everfron Biotech
Malignant brain tumors represent one of the most challenging types of tumors to treat in humans, with an average survival period of only 4 to 6 months upon recurrence. Existing medical treatment options have proven to be limited, and for over two decades, there has been no significant breakthrough in the introduction of more effective therapeutic drugs. Dr. Shinn-Zong Lin, the Superintendent of Hualien Tzu Chi Hospital, has led the innovative research and development team at Tzu Chi Innovation Center in collaboration with Everfront Biotech to successfully develop the targeted anti-malignant brain tumor drug, Cerebraca® Wafer. Clinical trials were initiated in 2017, and the Taiwan Phase IIa clinical trial has concluded enrollment. Global Phase IIb clinical trials are anticipated to commence next year.
The current treatment efficacy for recurrent malignant gliomas is limited, demanding urgent exploration of new therapeutic approaches. On December 2nd at 1:00 PM, Dr. Shinn-Zong Lin, the Superintendent of Tzu Chi Hospital, along with Director Jen-wei Liu and Director Yuan-Sheng Li from Everfront Biotech, jointly presented the latest developments in the new drug for malignant brain tumors, “The Cerebraca® Wafer Journey to the Global Stage.” at the Hualien Tzu Chi Hospital booth (Booth N802) on the 4th floor of Hall 1 at the Healthcare+ EXPO Taiwan 2023 in Taipei Nangang Exhibition Center.
Over a decade ago, Dr. Shinn-Zong Lin, who concurrently serves as the Director of Tzu Chi Innovation Center, along with Vice Director Horng-Zyh Harn and Professor Tzyy-Wen Chiou, the Vice President of Research and Development at Dong Hwa University, led a research team that discovered the potential of Angelica sinensis (Danggui) extract components in cancer treatment. Subsequently, they synthesized a single small-molecule multi-targeted drug for combating malignant glioma cells. Combining this with sustained-release tablets, they developed the product Cerebraca® Wafer. Utilizing this sustained-release tablet, the small-molecule drug is locally released to the lesion. This innovative approach has been patented in the United States, China, Japan, the European Union, and Taiwan.
Following the technology transfer to Everfront Biotech, new drug development and clinical trials were initiated. The results demonstrated superior efficacy compared to existing clinical drugs, significantly improving overall survival. The 6-month progression-free survival rate reached 100%, garnering recognition as a Clinical Innovation in the 2022 National Innovation Award.
Hualien Tzu Chi Hospital and Everfront Biotech, in the development and clinical trials of Cerebraca® Wafer, have observed superior efficacy compared to existing clinical drugs. This groundbreaking achievement has significantly improved the overall survival period, with a 100% progression-free survival rate at 6 months. Such outstanding results earned recognition in the form of the 2022 National Innovation Award for Clinical Innovation.
Since 2017, Phase I clinical trials have been conducted to validate the safety of the new drug Cerebraca® Wafer. Throughout the clinical trial period, there were no drug-related adverse reactions reported. With concerted efforts from the neurosurgical teams at Hualien Tzu Chi Hospital, Tri-Service General Hospital, and Taichung Veterans General Hospital, the second-phase clinical trial has been completed, enrolling a total of 10 patients in Phase IIa. The clinical research report is expected to be finalized by the end of the year.
Results from the published Phase I trial indicate a median overall survival period of 26.2 months for patients with recurrent malignant brain tumors treated with Cerebraca® Wafer, a significant improvement compared to the existing treatment options with a median survival of 6.4 months.
Mr. Shia, in his forties, discovered a glioma on the right parietal lobe in 2015. Despite undergoing two craniotomies, chemotherapy, radiotherapy, and targeted therapy, the tumor continued to grow. In the advanced stage of cancer, he applied for compassionate use in Taiwan. In 2019, at Hualien Tzu Chi Hospital, after the removal of half of the malignant brain tumor, Cerebraca® Wafer was implanted successfully, effectively inhibiting the growth of tumor cells. Dr. Tsung-Lang Chiu, Director of the Center for Neurological Science, stated that the team has been continually monitoring Mr. Shia, who has survived for over 3 years and 11 months since the implantation of Cerebraca® Wafer.
Source: https://www.tcnews.com.tw/news/item/20650.html, https://www.cna.com.tw/postwrite/chi/357362
In 2017, Everfront Biotech, in collaboration with Hualien Tzu Chi Hospital and others, initiated Phase I clinical trials to validate the safety of the new drug Cerebraca® Wafer. Currently, through the dedicated efforts of the neurosurgical teams at Hualien Tzu Chi Hospital, Tri-Service General Hospital, and Taichung Veterans General Hospital, the Phase IIa clinical trials have been successfully completed
【Expert Lecture】
The Cerebraca® Wafer Journey to the Global Stage
Speaker
Dr. Shinn Zong Ling (Superintendent of Hualien Tzu Chi Medical Center)
Dr. Jen-Wei Liu (Director of Everfront Biotech Inc.)
Dr. Yuan-Sheng Li (Director of Everfront Biotech Inc.)
Time: December 2 (Saturday) 1:00 – 1:40 pm
Place: N802, 4F (Hualien Tzu Chi Medical Center)
Visit Information:
- Exhibition Dates
Date: 2023/11/30(Thu) – 12/3(Sun)
Time: 10:00 AM ~ 6:00 PM (Last day closes at 4:00 PM)
- Exhibition Place
Taipei Nangang Exhibition Center, Hall 1, 4F
Add: 4F., No.1, Jingmao 2nd Rd., Nangang District, Taipei City 11568, Taiwan Map
- Visiting Eligibility Application
STEP 1. Login / New Member Registration
STEP 2. Please confirm personal basic information to complete the registration procedure
STEP 3. Scan your [Admission QRCode] at the exhibition entrance.
More information: https://expo.taiwan-healthcare.org/en//index.php
長弘生物科技本次參展攤位位於4F 國科會新創區 (N814)，期待您的來訪。
Product Highlights of Cerebraca® Wafer:
Everfront Biotech’s innovative new drug, Cerebraca® Wafer, is a precision medicine sustained-release wafer that revolutionizes the treatment of malignant brain cancer. Through multiple patented novel features, Cerebraca® Wafer has successfully addressed the challenges of treating malignant brain cancer, which is difficult to manage and prone to relapse. Chemotherapy gradually loses its effectiveness against brain cancer cells due to their drug resistance, and the high proportion of cancer stem cells further exacerbates the problem of cancer recurrence and treatment resistance. However, these issues can be addressed by the pharmacological mechanism of action of Cerebraca® Wafer. In addition, malignant brain cancer cells express PD-L1, which renders the immune system unable to kill cancer cells. The successful development of Cerebraca® Wafer has also addressed this issue. In Phase I clinical trials, Cerebraca® Wafer has demonstrated efficacy without any drug-related adverse reactions. The median or average cumulative survival of relapsed malignant brain cancer patients has reached 25-26 months, which is significantly better than existing strategies such as Gliadel® wafer implantation (6.4 months), Temodal capsules (5.8 months), or Avastin injection (9.4 months). Cerebraca® Wafer has been approved by the Taiwan Ministry of Health and Welfare and the Human Research Ethics Committee of Hualien Tzu Chi Hospital for compassionate use trials. For malignant brain cancer patients who cannot undergo surgery and have tumors growing at the cervical spine, implanting Cerebraca® Wafer through a small incision has resulted in tumor shrinkage. In addition, combining Cerebraca® Wafer with cytokine-induced killer cells (CIK) for treatment can achieve a recurrence-free survival period of more than 40 months. With its outstanding clinical results, Everfront Biotech Inc. is actively seeking partners to jointly develop this new drug and help more malignant brain cancer patients.
Introduction to Everfront Biotech Co., Ltd:
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.
