- Investigational New Drug (IND) clearance from TFDA represents a key milestone in SynCore’s new drug pipeline development program.
- The global Phase III study has Orphan Drug Designation granted by US FDA and European Medicines Agency for the indication of metastatic Pancreatic Cancer.
- Commercial opportunity launch for a preferential product against an unmet medical need as first and only therapy of its kind with a strong intellectual property position.
Taipei, Taiwan, July 11, 2017 – Syncore Biotechnology Co., Ltd. (Syncore, 4192:TT), a drug development company headquartered in Taipei, Taiwan, announced today that it had received approval from Taiwan’s Food and Drug Administration (TFDA) of an Investigational New Drug (IND) application for a Phase III clinical trial for SB05 (EndoTAG®-1) in combination with Gemcitabine for patients with metastatic pancreatic cancer, following FOLFIRINOX* treatment. The global clinical trial will start enrollment in Taiwan before the end of 2017 with completion is expected by the second half of 2020.
This follows an April 2017 approval by the US Food and Drug Administration (FDA) for a pivotal global phase III study, under US FDA and European Medicines Agency (EMA) Orphan Drug Designation. Such designation allows for an abbreviated clinical development schedule to encourage a faster time to market for medicines considered urgently required by drug regulatory agencies.
“The TFDA approval marks a significant step in our quest to find a more effective treatment against metastatic pancreatic cancer, one of the most virulent of cancers. We look forward to addingTaiwan patients to the clinical trial of SB05 (EndoTAG®-1) to our existing global development plans, and to bring new hope to sufferers of this condition worldwide,” said General Manager of SynCore, Dr. Muh-Hwan Su.
About SB05 (EndoTAG®-1)
SB05 (EndoTAG®-1) is a novel composition of neutral and positive lipids loaded with the chemotherapy agent Paclitaxel. These lipids interact with newly-formed, negatively charged endothelial cells required for the growth of tumor blood vessels, releasing the chemotherapy agent and suppressing formation of such blood vessels, so inhibiting tumor growth. Clinical data suggests that the oncology asset is responsible for significant improvement in progression-free survival and/or overall survival with evidence of anti-tumor activity and a favorable safety profile. SB05 (EndoTAG®-1) has received IND approval as a treatment for triple-negative breast cancer (TNBC) in Belgium (EMA), Taiwan (TFDA) and Australia (TGA) and has completed Phase II clinical studies in pancreatic cancer, triple-negative breast cancer (TNBC), neoadjuvant breast cancer and liver metastasis.
FOLFIRINOX is a chemotherapy combination considered the first line therapy for the treatment of advanced pancreatic cancer, and consists of the following four drugs / agents:
FOL – folinic acid (leucovorin)
F – fluorouracil (5-FU)
IRIN – irinotecan (Camptosar)
OX – oxaliplatin (Eloxatin)
About Pancreatic Cancer
Pancreatic cancer is a highly malignant disease with patients usually diagnosed at an advanced stage. With an extremely low five year-survival rate and extremely poor prognosis for patients, the pancreatic cancer market has current unmet medical needs.² The global treatment market is expected to grow from its current level of USD 2 billion to USD 2.9 billion by 2021 (GBI Research) revealing that promising new drugs in treating pancreatic cancer with potential market exclusivity might significantly impact the market.³
SynCore Biotechnology Co., Ltd. (4192:TT) is a biopharmaceutical company with a comprehensive pipeline portfolio of new drugs in the areas of oncology, ophthalmology, dermatology and infectious diseases. The EndoTAG® technology platform is wholly owned by SynCore.
¹ National Cancer Institute (https://www.cancer.gov/about-cancer/treatment/drugs/FOLFIRINOX)
² American Cancer Society.
“Pancreatic Cancer Survival Rates, by Stage”.
3 GBI Research.
“Pancreatic Cancer Therapeutics in Major Developed Markets to 2021 – Strong Late Stage Pipeline Holds Promise for Increasingly Diverse Market Landscape”
This press release may contain certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of SynCore Biotechnology Co., Ltd.