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[News]Relevant Organizations

1. Biocure Pharm signs contract to enter into a clinical trial for CAR-T cell products

Biocure Pharm, a biotech start-up in Daejeon, is expected to enter into a clinical trial for "BCP401", the CAR-T cell products for acute leukemia patients. On October 17th, the firm announced that it had signed a contract with CliPS, a contract research organization (CRO), for the domestic clinical trial. The open-label clinical trial is slated to be conducted at Asan Medical Center and St. Mary's Hospital for recurring and refractory B-cell acute lymphoblastic leukemia for which medicine is efficacious. The non-clinical trial for BCP 401 was completed in October 2018. Lee Sangmok, CEO of the firm, said, "Expectations for the results of the clinical trial are running high, given the safety and effectiveness confirmed during the preliminary trial." In parallel with the domestic clinical trial, preparations are also underway for global clinical trials in Germany and Italy. Mr. Lee recruited Hans Frykman, a professor of the University of British Colombia in Canada,as a Technical Officer for the global clinical trial. The firm plans to operate GMP production facilities in Europe and Southeast Asia. Discussions are currently being held with many countries regarding technology exports. Mr. Lee mentioned, "No CAR-T cell therapy product has ever been approved in South Korea. We plan to push ahead with the clinical trial through close discussions with KFDA."  


2. PharmABcine to establish its local entity in Delaware, United States 

PharmABcine, a biotech firm specialized in new antibody drugs, has laid the foundations for its further growth as a global firm. The firm announced on October 22 that it would establish its US entity (tentatively named WINCAL) in the state of Delaware. PharmABcine plans to provide full backing for the new firm, investing capital in the amount of about 11.8 billion KRW (about 10 million dollars). This local entity is expected to streamline clinical trials in following pipelines as well as the phase 2 clinical trial in the United States for TTAC-001 currently being carried out at Stanford Medical Center and the Florida Hospital Cancer Institute. The US entity will carry out R&D on non-tumor as well as tumor areas that the firm has focused on. Its pipelines are also forecast to expand into senile eye diseases such as diabetic retinopathy and macular degeneration. Recently, there has been active research on therapeutic products for eye diseases that inhibit VEGF which is the mode of mechanism for TTAC-001. R&D activities in this area have taken off as well. Yoo Jinsan, CEO of the firm, stated, "I decided to create a local branch in the US to create a network for global clinical trials and secure talented human resources. I am committed to turning PharmABcine into a world-class biotech firm.  


3. Bioneer acquires European certification for hepatitis C diagnostic agents
On October 29th, Bioneer announced that it had obtained a CE-IVD List A (CE marking for medical devices) for AccuPower® HCV Quantitative RT-PCR Kit (hereinafter "HCV Quantitative Analysis Kit). This achievement came after their acquisition of a CE-IVD List A for HIV-1 quantitative analysis kits last year. Back in 2016, Bioneer carried out a clinical trial to compare HBV and HCV quantitative analysis kits, along with HIV-1 quantitative analysis kits, using ExiStation™, a self-developed molecular diagnostic system. The successful completion of the comparative clinical trial, using molecular diagnostic devices by Roche such as COBAS 8800 and COBAS quantitative analysis kits, led to an application for a CE-IVD List A. ExiStation, a molecular diagnostic system that has also acquired a CE-IVD certificate used for the clinical trial is capable of making diagnosis of as many as twelve targets in parallel including AIDS, TB and sexually transmitted diseases as well as HCV. It is capable of testing a maximum of 48 specimens at once. A person concerned with the firm emphasized, "Certification for two out of three diagnostic items in the molecular diagnostic market has been completed on the back of HCV products' acquisition of CE-IVD and List A. If certification for HBV is completed within this year as expected, Bioneer will be recognized as the first  global molecular diagnostic in Asia. Certification for AIDS, hepatitis B and hepatitis C, which comprise two-thirds of the total molecular diagnostic market will help us to advance into the European market and increase sales."     


4. Ybiologics to develop a new medicine for blood cancer together with US firm  Pascal 
Ybiologics, a biotech firm in Daejeon, has set out to develop a medicine for blood cancer together with an overseas company. The firm announced on October 30 that it had signed a contract with Pascal Biosciences for joint research on double antibodies. They plan to develop double antibodies by applying ALiCE (Antibody-Like Cell Engager) into Pascal's leukemia-related new antibody. These new therapeutic products are expected to minimize toxicity while maintaining the performance of a T-cell Engager that connects T cells with cancer cells. Located in Canada and the United States, Pascal Biosciences is a biotech firm specialized in immuno-oncology. Pascal is in the process of developing a medicine for acute lymphoblastic leukemia and a cannabinoid-based medicine and holds an antibody that combines with an antigen expressed in acute lymphoblastic leukemia. As the antigen is expected to have fewer side effects, it has caught attention as a new target for acute leukemia. CEO Park Youngwoo said, "With its first overseas partnership agreement, our ALiCE double-antibody platform technology has been recognized for its potential in the blood cancer sector." Pascal is expected to demonstrate the excellence of our firm's platform technology." Patrick Gray, CEO of Pascal, expressed his expectation, saying, "We are excited to collaborate with YBiologics which has taken the lead in the double-antibody sector. This collaboration will lead to the development of a new medicine that could be a game-changer in the leukemia treatment industry."
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