Samsung Bio and Contract Development NOV·Utilex Anticancer Agents Receive US FDA Clinical Approval

Approval of Clinical Phase 1 and 2 Trial Plans for Immuno-Oncology Candidate 'EU101 (NOV1801)'

[Asia Economy Reporter Kim Ji-hee] Samsung Biologics announced on the 27th that the National Onco-New Drug Development Project Group (NOV) and Eutilex, with whom it has signed a contract for contract development, have received approval from the U.S. Food and Drug Administration (FDA) for the clinical phase 1 and 2 trial plans of the immuno-oncology drug candidate 'EU101 (NOV1801)'.

EU101 (NOV1801) was developed by Eutilex and selected as NOV's global oncology drug candidate in October 2018. It stimulates the co-stimulatory receptor '4-1BB' on T cells, a type of lymphocyte responsible for cellular immunity, activating the immune system to eliminate tumor cells.

Samsung Biologics formed a partnership by signing a CDO contract with NOV for EU101 (NOV1801) in December 2018. Subsequently, through research and development with NOV and Eutilex, they submitted an Investigational New Drug (IND) application to the FDA in December last year to initiate clinical phase 1 and 2 trials for EU101 (NOV1801).

With the FDA's approval of this plan on the 15th, NOV and Eutilex can now simultaneously conduct phase 1 and 2 clinical trials for EU101 (NOV1801). The phase 1 and 2 trials will evaluate safety, efficacy, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors. The trials are expected to involve a total of 75 to 96 participants.

Park Young-hwan, head of the National Onco-New Drug Development Project Group, stated, "To simultaneously conduct global clinical trials for EU101 (NOV1801) domestically and internationally, we plan to complete the submission of the IND to the Korean Ministry of Food and Drug Safety within the first half of the year in collaboration with Samsung Biologics."

John Lim, president of Samsung Biologics, said, "Congratulations to NOV and Eutilex on receiving FDA approval to initiate phase 1 and 2 clinical trials." He added, "We will continue to provide the world's best CDO services with high quality, speed, and excellent cost competitiveness to all domestic and international bio ventures possessing outstanding drug candidates."

Meanwhile, since officially entering the CDO business in 2018, Samsung Biologics has supported three FDA IND approvals to date.

This content was produced with the assistance of AI translation services.