GenScript ProBio Congratulates Eutilex's IND Clearance from MFDS

NANJING,China,March 7,2023 --Recently,Eutilex,a partner of GenScript ProBio,announced MFDS (Ministry of Food and Drug Safety) clearance of its hepatocellular carcinoma clinical trial application for innovative CAR-T program (EU307). GenScript ProBio extends congratulations on this. 2 years ago,GenScript ProBio and Eutilex announced that the parties entered into strategic collaboration on plasmid and virus process development and manufacturing for multiple CAR-T programs.

GPC3 is known to be over expressed in solid cancers including HCC. EU307 is a fourth-generation CAR-T therapy which targets GPC3-positive solid cancer. The experimental drug is expected to improve the viability of CAR-T cells and their ability to attack cancer cells through the secretion of cytokine (IL-18). The clinical approval time for this CAR-T therapy program is faster than the usual 6 to 9 months.

GenScript ProBio provided integrated plasmid and lentiviral vector CMC service to Eutilex and helped on the CTD document writing for MFDS IND filing. Based on the well-established platform process and analytical method,GenScript ProBio quickly developed a stable and scalable manufacturing process and project specific analytical methods for plasmids and lentiviral vectors,and worked closely with Eutilex to make timely adjustments and corrections according to the requirements from MFDS.

Eutilex CEO Kwon Byoung-se said,"The MFDS' latest nod for the phase 1 trial helped the company's all core immunotherapy pipelines (antibody treatment,T-cell therapy,and CAR-T therapy）enter clinical trials simultaneously. We are highly impressed by the GenScript ProBio's one-stop CDMO platform,and we want to collaborate closely to aim for benefiting patients worldwide."

Dr. Brian Min,CEO of GenScript ProBio said,"We congratulate Eutilex on MFDS clearance of its IND application,and we are honored to be part of this novel project. GenScript ProBio's complete quality management system and professional quality management team provide strong support for the successful approval of the project in Korea,and we wish that this clinical trial moves forward for benefiting cancer patients as soon as possible."

About Eutilex

Eutilex is a collection of people who are committed to improve health and well-being around the world. The core technology that Eutilex employs for drug development is selecting targets that faithfully enhance or suppress human immune responses. A series of immunomodulatory antibody therapeutics have been developed on that principle to treat cancers and autoimmune diseases. Another core technology of the Eutilex is to employ human peripheral T lymphocytes as a therapeutics. One of the product,4-1BB CTL,is being tested in clinic against various hematologic and solid cancers. Both antibodies and T cell therapeutics are expected to produce powerful therapeutic activities with no or minimal toxicity.

We,the Eutilex people,promise to provide better therapeutics to cure the incurable human diseases.

About GenScript ProBio

GenScript ProBio,a subsidiary of GenScript Biotech Corporation,offers end-to-end CDMO services from drug discovery to commercialization with proactive strategies,professional solutions and efficient processes in CGT,vaccine,biologics discovery and antibody protein drug,aiming to accelerate drug development for customers. GenScript ProBio has established companies in the United States,the Netherlands,South Korea,China (Hong Kong,Shanghai,and Nanjing) and other regions to serve global customers,and has helped customers in the United States,Europe,Asia Pacific and other regions obtain more than 40 IND approvals since October 2017. GenScript ProBio has established GMP capacity that meets regulatory requirements of the US Food and Drug Administration (FDA),European Medicines Agency (EMA) and National Medical Products Administration (NMPA).

https://www.genscriptprobio.com/