Press Releases
Press Releases
Samsung Biologics, National OncoVenture, and Eutilex obtains IND Approval from FDA
INCHEON, S. Korea, 27 January 2021 – Samsung Biologics announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market.
In late 2018, Korea’s National OncoVenture (NOV), a government-funded virtual oncology drug development program, approached Samsung Biologics for the development of EU101(NOV1801), an anti-4-1BB therapeutic monoclonal antibody provided by Eutilex. Studied by NOV and Eutilex with humanized mice, EU101(NOV1801), effectively eradicated human tumors and showed synergistic anti-tumor activity with immune checkpoint blockade.
“We are extremely glad to be notified of EU101(NOV1801)’s IND approval from the FDA,” said John Rim, CEO of Samsung Biologics. “This is our third IND approval demonstrating our unparalleled quality and speed, and as our CDO business continues to expand geographically in the next decade, we look forward to assisting many more clients in bringing their products to market faster and better as the most qualified CDMO partner.”
Young-Whan Park, president of NOV, said, “In order to conduct the domestic and global clinical trials of EU101(NOV1801) in parallel, we plan to file another IND with the Ministry of Food and Drug Safety in Korea within the first half of this year, working together with Samsung Biologics.” Dr. Soo Young Choi, COO of Eutilex, added, “In the US, we will be able to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) through Phase I of clinical trials within the first half of the year.”
Samsung Biologics’ CDO business has shown rapid growth and success since its business expansion, signing over 60 CDO contracts within two years to obtain three IND approvals by the FDA as well as one Clinical Trial Application (CTA) approval by the EMA. Leveraging Samsung Biologics’ extensive expertise for the submission process, the successful IND was achieved with no further significant comments from the regulatory agency.
INCHEON, S. Korea, 27 January 2021 – Samsung Biologics announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market.
In late 2018, Korea’s National OncoVenture (NOV), a government-funded virtual oncology drug development program, approached Samsung Biologics for the development of EU101(NOV1801), an anti-4-1BB therapeutic monoclonal antibody provided by Eutilex. Studied by NOV and Eutilex with humanized mice, EU101(NOV1801), effectively eradicated human tumors and showed synergistic anti-tumor activity with immune checkpoint blockade.
“We are extremely glad to be notified of EU101(NOV1801)’s IND approval from the FDA,” said John Rim, CEO of Samsung Biologics. “This is our third IND approval demonstrating our unparalleled quality and speed, and as our CDO business continues to expand geographically in the next decade, we look forward to assisting many more clients in bringing their products to market faster and better as the most qualified CDMO partner.”
Young-Whan Park, president of NOV, said, “In order to conduct the domestic and global clinical trials of EU101(NOV1801) in parallel, we plan to file another IND with the Ministry of Food and Drug Safety in Korea within the first half of this year, working together with Samsung Biologics.” Dr. Soo Young Choi, COO of Eutilex, added, “In the US, we will be able to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) through Phase I of clinical trials within the first half of the year.”
Samsung Biologics’ CDO business has shown rapid growth and success since its business expansion, signing over 60 CDO contracts within two years to obtain three IND approvals by the FDA as well as one Clinical Trial Application (CTA) approval by the EMA. Leveraging Samsung Biologics’ extensive expertise for the submission process, the successful IND was achieved with no further significant comments from the regulatory agency.