In late April 2019 Immunomedics and Everest Medicines II Limited, a C-Bridge Capital-backed biopharmaceutical company, confirmed that the companies had signed an exclusive license agreement to develop, register, and commercialize sacituzumab govitecan in Greater China, South Korea and certain Southeast Asian countries.

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC) targeting the human trophoblast cell-surface antigen 2 (Trop-2) receptor expressed by many solid tumors.

The drug combines a humanized monoclonal antibody with SN-38, a moderately-toxic active metabolite of irinotecan (a topoisomerase I inhibitor and analog of camptothecin) via a cleavable linker and delivers this directly to the targeted cell.

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The investigational agent has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic triple-negative breast cancer (TNBC) who have received two prior therapies for metastatic disease.

Triple-negative breast cancer is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. This means that the growth of the cancer is not fueled by the hormones estrogen and progesterone, or by the HER2 protein. As a result this type of cancer does not respond to hormonal therapy medicines or medicines that target HER2 protein receptors.

Asian territories
“We are pleased to be partnering with Everest Medicines to commercialize sacituzumab govitecan in the Asian market outside Japan and further develop the product in solid tumor indications of high unmet need in the territory,” noted Usama Malik, Chief Financial Officer and Chief Business Officer of Immunomedics.

“This agreement sets a new benchmark for a single-asset licensing deal for regional China and exemplifies our commitment to expand the geographic footprint and clinical use of sacituzumab govitecan for the benefit of cancer patients worldwide,” Malik added.

“Sacituzumab govitecan is an innovative and unique antibody-drug conjugate or ADC with a highly favorable clinical benefit rate across solid tumors and provides us the opportunity to address hard to treat cancers in key underserved regions across Asia,” explained Eric Rowinsky, M.D., U.S. Chief Medical Officer for Oncology at Everest.

“We look forward to partnering with Immunomedics’ clinical and regulatory teams to accelerate the development of sacituzumab govitecan across multiple indications in Greater China where there is great need for innovative cancer therapeutics of major impact,” Yang Shi, M.D., China Chief Medical Officer for Oncology at Everest.

Upfront payments
Under the terms of the agreement, Immunomedics will receive an upfront payment of US $ 65 million and an additional US $ 60 million based on U.S. FDA approval of sacituzumab govitecan in metastatic triple-negative breast cancer.

Everest will develop and commercialize the product in various global and local indications in the contracted countries. Everest is eligible to receive development and sales milestone payments of up to US $ 710 million, as well as escalating tiered royalties that begin in the mid-teens based on net sales.

Pursuant to the agreement, Everest Medicines will be responsible for all costs associated with the clinical development and commercialization of sacituzumab govitecan in its assigned territory, while a Joint Steering Committee will be established between the companies to oversee the overall strategy and priorities.

“This transformative deal reinforces Everest Medicines’ position as the preeminent biopharmaceutical company to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets,” said Ian Woo, President and Chief Financial Officer of Everest Medicines.

“Everest Medicines’ highly experienced team has a proven track record of delivering industry leading execution and we look forward to leveraging our deep knowledge and cumulative insights to address diseases with unmet need that are highly prevalent in these underserved regions,” said Sean Cao, Interim CEO of Everest Medicines.

“The announcement culminates a thoughtful and deliberate process, that expedites regional expansion of our lead product candidate in the world’s fastest growing pharmaceutical market and significantly enhances shareholder value. This partnership allows Immunomedics to continue on its path to becoming a global biopharmaceutical company, and importantly maintaining the strategic optionality in core established markets worldwide,” said Behzad Aghazadeh, Chairman of the Board of Directors of Immunomedics.