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Posted date

2020.10.19

SynCore Biotechnology Co., Ltd.

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SynCore focuses on innovation by new drug R&D and integration of platform technologies. SynCore was established in 2008 and co-founded by Sinphar Group and the National Health Research Institute (NHRI) in Taiwan. SynCore inherited Sinphar’s experiences which have accumulated for more than 30 years in R&D, manufacturing, and international marketing. Such experiences enable SynCore to build up a comprehensive portfolio of new drugs to fulfill domestic and international market needs. SynCore utilizes and in-licenses unique compounds from all over the world to with the goal of developing new drugs that have great potential for breakthroughs. By professional and expeditious project management, SynCore accumulates intangible assets to promote its ethical, quality and safe marketing and commercialization values. SynCore keeps looking for international partners and guarantees stable and long-term profits through strategic alliances to enrich a sustainable operating energy. SynCore has a pipeline focusing in the areas of oncology, ophthalmology, dermatology and infectious diseases.

SB05PC (EndoTAG®-1) is a novel formulation of cationic liposomes for the treatment of solid tumors, carrying paclitaxel embedded in the liposomal lipid bilayer. Cationic liposomes are known to bind and internalize at tumor endothelial cells after intravenous administration, which is the basis for its mechanism of action. Using a cationic liposome formulation, the cytostatic and cytotoxic activities of paclitaxel are targeted to the activated tumor endothelial cells. Therefore, in contrast to conventional chemotherapy aiming at tumor-cell toxicity, EndoTAG®-1 specifically displays antivascular and antiangiogenic activity.

Based on the results of preclinical studies and clinical phase I and II studies and its new therapeutic concept, EndoTAG®-1 represents a promising candidate for the treatment of solid malignancies, both for taxane-sensitive and taxane-insensitive tumors.

Pancreatic cancer (PC) was the 3rd deadliest cancer in the United State surpassing breast cancer in 2016, with the 5-year overall survival rate of less than 9% for those newly diagnosed individuals. The notorious disease is set to become the 2nd leading cause of cancer-related deaths by 2020 in US (National Cancer Institute, NIH). Less than 20% of pancreatic cancer patients are diagnosed with resectable and potentially curable disease while the vast majority of patients have advanced disease at the time of diagnosis with a median survival of approximately 6 months.

FOLFIRINOX regimen is the standard first-line treatment for pancreatic cancer patients with good performance status. Despite its poor prognosis, systemic treatment with FOLFIRINOX (combination of oxaliplatin, irinotecan, fluorouracil and leucovorin) when compared to gemcitabine favored a selected population in terms of survival. However, the optimal management strategy for patients who fail initial FOLFIRINOX remains undefined. There is still no standard of care in second-line therapy for patients with disease progression; therefore, there is a current unmet medical need. SB05PC was well tolerated and did not cause substantial additional toxicity. SB05PC increased lifetime of patient by 20% compared to gemcitabine monotherapy in the phase II clinical trial. With the mission to provide better pancreatic cancer treatment and patient outcome, SynCore Bio meticulously follows the development of SB05PC (EndoTAG®-1), in combination with gemcitabine after FOLFIRINOX first-line treatment failure, which has achieved lower adverse effect than other standard treatments available. In addition,reaching an overall survival of 13.7 months. The clinical trial is conducted in USA, France, Taiwan, Israel, Hungary, Russia, and South Korea. It has also been granted Orphan Drug Designation by US FDA and European Medicines Agency. The close engagement with patients in conjoined treatment of FOLFIRINOX and EndoTAG®-1 is a key enrollment success strategy. However, pancreatic cancer patients may not know to look for available treatments currently available, so oncologists know to give this information for those who have a good performance status (ECOG 0 or 1), the first priority to treatment FOLFIRINOX, after metastasis of the patients, they can then be enrolled in this trial. In August 2020, the global phase III clinical trial has reached the targeted 218 patient enrollment and interim analysis results have been received from the Independent Data Monitoring Committee.

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