Nam Hyun-woo has worked as a staff writer at The Korea Times since 2013, mostly covering business and politics. He currently belongs to the Business Desk where he covers topics such as emerging tech, AI, ICT and Korea's chaebol community. Prior to joining the team, he was the paper's correspondent for the presidential office of Korea during the Yoon Suk Yeol and Moon Jae-in administrations.
Samsung BioLogics' 1st development client wins FDA approval
Samsung BioLogics' plant No. 3 in Incheon / Courtesy of Samsung BioLogics
By Nam Hyun-woo
By Nam Hyun-woo
Samsung Biologics' first contract development client, ImmuneOncia Therapeutics, has won U.S. Food and Drug Administration (FDA) approval for Phase 1 clinical study on its cancer immunotherapy drug.
On April 10, the FDA granted Investigational New Drug (IND) approval for ImmuneOncia's IMC-002, just a month after the two sides applied for it, according to Samsung BioLogics, Thursday.
IND approval requires a wide range of documentation and in-depth information on the subject drug, and the approval process often takes some time. Approval is a major step for drug makers toward releasing a new drug on the market.
Leveraging its contract development capabilities, the IND of IMC-002 was approved by the FDA without significant difficulties, Samsung BioLogics said. It provided ImmuneOncia with in cell line and process development, and non-clinical and clinical material production. The two companies have had a development and manufacturing agreement since 2018.
“We are excited to join in ImmuneOncia's success,” Samsung BioLogics CEO Kim Tae-han said. “This IND approval is a product of the strong collaboration between Samsung BioLogics and ImmuneOncia. As a world-leading contract manufacturing, development and research partner, we will continue to support ImmuneOncia and ensure client satisfaction through Samsung's competitive advantages.”
“We are very impressed with the outstanding service Samsung BioLogics provided in the full development scope ― from cell line development, process development, preclinical and clinical manufacturing, and IND filing support,” ImmuneOncia CEO Song Yun-jeong said. “The two companies collaborated exceptionally well together during the whole development process including the IND evaluation period, allowing us to enter Phase 1 clinical trials for IMC-002 much quicker."
IMC-002 is an immune checkpoint inhibitor antibody, which can help macrophages in the human body fight off cancer cells. According to ImmuneOncia, IMC-002 is expected to help patients with metastatic, locally advanced solid tumors and relapsed or refractory lymphomas.
Samsung BioLogics is currently providing support in 51 contract development projects, helping clients receive IND approval.
“Samsung's role as a contract developer in the global biopharma market has seen rapid growth, and we plan to expand geographically to support even more clients globally and domestically,” a Samsung BioLogics official said.
ImmuneOncia was established in 2016 as a joint venture between Yuhan and Sorrento Therapeutics of the U.S.
Also on Thursday, Samsung BioLogics said it had renewed a separate contract manufacturing deal with Immunomedics of the U.S. on an FDA approval for the commercial launch of the latter's drug, with the value of the deal growing five times.
According to a regulatory filing, the value of its deal with Immunomedics grew to $164 million from $30 million. This is the first time that Samsung BioLogics has seen a price increase in a contract manufacturing deal after getting FDA approval.