On December 2, 2019 Samyang Biopharm USA, Inc. (View Source) a global biotech subsidiary of the Samyang Pharmaceuticals Corp. (View Source), reported that the company has entered into a worldwide licensing agreement with CanCure LLC. Financial terms of the agreement were not disclosed (Press release, Samyang Biopharmaceuticals, DEC 2, 2019, View Source [SID1234551836]).
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Under the terms of the agreement, CanCure grants Samyang worldwide rights for the development, manufacturing and commercialization of SYB-010 (formerly CuraB-10), a first-in-class compound currently engaged in Investigational New Drug (IND)-enabling studies. CanCure will collaborate with Samyang to complete nonclinical studies to support an IND Application to regulatory authorities and initiation of the phase 1 clinical program; after which Samyang will be responsible for all activities related to CuraB-10. CanCure will receive an upfront payment and is eligible for future clinical, regulatory and sales milestone payments, as well as royalties on net sales worldwide. Samyang Biopharm USA plans to file an IND in 2021, with a goal of starting SYB-010 clinical trials shortly after IND approval.
"We are thrilled to establish this alliance with CanCure, an innovative biotechnology company who has made great strides in the development of its lead oncology compound to reach IND-enabling studies," said Helen Hyun Jung Lee M.D., President/CEO, Samyang Biopharm USA, Inc. "CanCure shares Samyang’s passion and commitment to discovering breakthrough medicines that may improve the lives of cancer patients worldwide and this transformational collaboration provides our company with a promising clinical candidate that will enable us to advance our capabilities and programs."
In recent years, immune checkpoint inhibitors have proven to be a critical advancement in cancer treatment and those programs have achieved modest success in targeting the T lymphocyte arm of the immune system. In cancer model systems, SYB-010 potently activates both the T lymphocyte and NK (natural killer) cell arms of the anti-tumor immune response, and when combined with inhibitors of PD-1, PD-L1 or CTLA4 in models that are not responsive to those therapies alone has broadened the potential for an immune attack on cancer.
"CanCure is very -enthusiastic with the prospect of Samyang’s research and development team advancing the SYB-010 program and feel that Samyang has the proper mix of science and business acumen to give birth to a medicine with great promise," said Jennifer Wu, PhD, Founder and President of CanCure. "We look forward to the exploration of this compound and the uncovering of its potential as it advances towards the beginning of clinical studies."
About SYB-010
SYB-010 is a first-in-class immune stimulatory monoclonal antibody targeting a tumor-released immune suppressive molecule, soluble MHC class I chain-related protein (sMIC). In preclinical animal studies, monotherapy with the murine version of SYB-010 effectively reduces tumor size and prolongs overall survival. This innovative antibody also enhances tumor response to immune checkpoint blocking therapies when used in combination, and elicits a positive response even in tumors that failed to respond to these therapies.