Samsung Biologics and ImmuneOncia Therapeutics Inc. Development and Manufacturing Agreement Accomplishes IND Clearance of IMC-002 (anti-CD47 antibody)
SONGDO, South Korea, April 22, 2020 /PRNewswire/ -- Samsung Biologics (207940.KS) and ImmuneOncia Therapeutics Inc. announced the successful FDA IND approval of IMC-002 under a development and manufacturing agreement with Samsung Biologics since 2018. As a result, ImmuneOncia will begin Phase 1 clinical trials of the pipeline product.
IMC-002 is an immune checkpoint inhibitor antibody, which blocks CD47-SIRP- α interaction between tumor cells and macrophages. According to ImmuneOncia, IMC-002 is expected to help patients with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.
Leveraging Samsung Biologics' global CDO capabilities, IMC-002 IND was approved by the FDA without significant comments. Samsung Biologics provided ImmuneOncia with services in cell line development, process development, non-clinical and clinical material production.
Samsung Biologics is currently providing support to 51 CDO development projects and is distinctly able to help clients achieve the most optimal path to IND approval by providing Faster & Better services. Samsung's presence as a CDO in the global biopharma market has demonstrated rapid growth, and the company has announced plans to expand geographically to support even more clients globally and domestically.
"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," said Yun Jeong Song, CEO of ImmuneOncia. "The two companies collaborated exceptionally well together during the whole development process including the IND evaluation period, allowing us to enter phase I clinical trials for IMC-002 much quicker."
"We are excited to join in ImmuneOncia's success," said Dr. Tae Han Kim, CEO of Samsung Biologics. "This IND approval is the product of the strong collaboration between Samsung Biologics and ImmuneOncia. As a world-leading CMO, CDO and CRO partner, we will continue to support ImmuneOncia and ensure client satisfaction through Samsung's competitive advantages: faster timeline, excellent quality, and outstanding capability."
IMC-002 is a fully human IgG4 monoclonal antibody designed to block the CD47–SIRPα interaction in order to promote the phagocytosis of cancer cells by macrophages. It binds to human CD47 with an optimal affinity that maximizes efficacy without binding to RBCs or causing anemia which is often seen in other CD47 blocking agents under development. For more information about the upcoming Phase 1 clinical trial, visit clinicaltrials.gov, identifier number NCT04306224.
About Samsung Biologics Co., Ltd.
Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With a flawless regulatory approvals record, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.
About ImmuneOncia Therapeutics, Inc.
ImmuneOncia is an immuno-oncology-centric biopharmaceutical company. Established in 2016 as a joint venture company between Yuhan and Sorrento, ImmuneOncia leverages both companies' expertise in drug development and antibody engineering. The company's mission is to bring safe, effective, and novel immunotherapies to oncology patients world-wide, and its portfolio includes diverse immune checkpoint antibodies. ImmuneOncia has successfully completed a Phase I study of IMC-001, its leading candidate anti-PDL1 antibody, and a multi-regional Phase II study is planned for 1H2020. For more information, visit www.immuneoncia.com.
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SOURCE Samsung Biologics