On February 5, 2018 Yuhan Corporation (KRX:000100.KS) (Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq:SRNE) (Sorrento) reported that the South Korean Ministry of Food and Drug Safety (MFDS) has approved ImmuneOncia Therapeutics’ (51% Yuhan/49% Sorrento joint venture formed in March 2016) IND for the initiation of clinical trials for Sorrento-discovered anti-PD-L1 monoclonal antibody STI-A1015 (IMC-001), which is exclusively licensed to ImmuneOncia for select regional markets by Sorrento (Press release, ImmuneOncia Therapeutics, FEB 5, 2018, View Source [SID1234531898]).
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Yuhan had initially contributed more than $10M to the formation of ImmuneOncia and towards the development of IMC-001, with a commitment of additional funding for clinical development of IMC-001. Sorrento contributed its antibody STI-A1015 (IMC-001) and two other antibodies, as well as cGMP manufacturing and regulatory expertise support for the data submission package for the IND.
The clinical Phase 1 studies will enroll patients suffering from solid tumors at two clinical sites in South Korea, namely, Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC).
"We are proud to announce the acceptance of the IND by MFDS for our anti-PD-L1 antibody IMC-001. Throughout the IND-enabling activities, our team has worked collaboratively with our Sorrento colleagues to generate a high-quality submission package that was very well received by MFDS", said Dr. Kwang Ho Cheong, CEO of ImmuneOncia Therapeutics.
"Yuhan is proud of this outstanding achievement by Dr. Cheong and the ImmuneOncia team. Together with our friends and partners from Sorrento, we created ImmuneOncia to develop important immunotherapies for cancer patients in South Korea and worldwide. Through our investment in ImmuneOncia, Yuhan has become a true biopharmaceutical company. We look forward to the future success of IMC-001 and the other antibody programs in ImmuneOncia’s pipeline", said Mr. Jung Hee Lee, CEO and President of Yuhan Corporation.
"We are very pleased with the progress made by our joint venture in the past year. We believe this is additional validation of our antibody technology as well as our in-house cGMP antibody manufacturing and development capabilities. Notably, Sorrento has retained the rights for STI-A1015 (IMC-001) in many major markets, including the EU, Japan and the US, and we intend to leverage ImmuneOncia’s clinical work to support our clinical development in these territories where we retain rights to STI-A1015 (IMC-001). We also think the success of ImmuneOncia further highlights our ability to create shareholder value through productive strategic partnerships," added Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics.
ImmuneOncia is exploring being publicly-listed on the South Korea Stock Exchange (KSEX) in 2019, which could result in additional sources of non-dilutive capital for Sorrento.
About IMC-001 (PD-L1 monoclonal antibody)
IMC-001 is a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody