HONG KONG, SHANGHAI, and UNIONDALE, N.Y., Nov. 12, 2018 /PRNewswire/ -- Angion Biomedica and Sinovant Sciences today announced a collaboration and license agreement for BB3, Angion's investigational small molecule mimetic of hepatocyte growth factor (HGF), in the People's Republic of China, Hong Kong, Macau, and Taiwan (Greater China). Angion is currently developing BB3 in a Phase 3 trial for the treatment of delayed graft function (DGF) following kidney transplantation and in a Phase 2 trial for the treatment of acute kidney injury (AKI) following open-heart surgery requiring cardiopulmonary bypass.
"We are very pleased to partner with Sinovant to develop and commercialize BB3 in Greater China," said Jay Venkatesan, M.D., CEO of Angion. "Our collaboration will help to address the morbidity, mortality, and healthcare costs associated with DGF and AKI in the rapidly growing patient markets in Greater China. Sinovant's deep knowledge of China, experienced management team, and demonstrated commitment to innovation make them the ideal partner for Angion in the region."
"DGF and AKI are each associated with high morbidity and mortality and there are no approved therapies globally," said Dr. Rae Yuan, President of Sinovant. "There is a pressing need in Greater China for new medicines that can reduce the burden associated with kidney diseases, and we are excited to work with Angion to accelerate the availability of this promising new therapy."
Under the terms of the agreement, Angion has granted Sinovant an exclusive license for the development, commercialization, and manufacture of BB3 in Greater China. Angion will receive significant upfront, regulatory, and commercial milestone payments as well as royalties on sales in Greater China. Sinovant and Angion will cooperate to jointly develop BB3 in DGF and AKI, with Sinovant taking the lead on development activities in Greater China. Sinovant expects to initiate clinical trials with BB3 in Greater China immediately upon receipt of the necessary regulatory approvals.
About DGF and AKI
Delayed graft function (DGF) is a form of acute kidney injury (AKI) that manifests postoperatively in 20-30% of renal transplantation patients globally and is associated with a 40% decrease in long-term graft survival.1 In Greater China, persistent organ shortages have led to greater use of deceased donor kidneys, which is expected to drive increases in observed rates of DGF.
AKI is characterized by an abrupt loss of kidney function and may be caused by a variety of factors. In the surgical setting, AKI is a common complication of open-heart surgery requiring cardiopulmonary bypass. Up to 30% of patients recovering from open-heart surgery experience an AKI-associated complication, resulting in a five-fold increased risk of death during hospitalization2. Risk factors for AKI in the post-surgical setting include existing kidney disease, compromised heart function, exposure to nephrotoxic drugs, advanced age, and diabetes.
T.R. Winston & Company, LLC, served as financial advisor to Angion, and assisted in the negotiations with Sinovant. Morgan, Lewis & Bockius LLP served as legal advisor to Angion.
BB3 is a potent, small molecule mimetic of HGF which activates the c-Met receptor. Activation of the HGF/c-Met pathway stimulates blood vessel formation, tissue repair, and regeneration, and reduces deposition of extracellular matrix, a non-cellular collection of macromolecules produced in excess by injured tissue leading to organ dysfunction and fibrosis. In a prior Phase 2 study with BB3 in patients with poor kidney function post-transplant, treated patients were shown to have improved renal function, decreased serum creatinine, and reduced need for dialysis relative to patients who received placebo. Angion is currently conducting a Phase 3 study with BB3 in patients presenting with early signs of DGF and a Phase 2 study with BB3 in patients at increased risk for AKI following cardiovascular surgery.
Angion Biomedica Corp. is a biopharmaceutical company discovering and developing novel therapeutic agents for acute and chronic organ diseases and disorders. Angion's programs are currently focused on renal transplantation, AKI, and chronic kidney disease, with a pipeline of additional indications and product candidates. For further information, please visit www.angion.com.
Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D in China to meet the needs of patients in Greater China and around the world. Sinovant's mission is to develop and commercialize new medicines that address the most pressing public health challenges in China while simultaneously advancing Chinese biopharmaceutical research abroad. For further information, please visit www.sinovant.com.
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Director, Business Development
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1 Siedlecki et al. (2011)
2 O'Neal et al. (2016)