28/02/2023
Prestige Biopharma has requested for Fast Track designation of PBP1510, our first-in-class anti-PAUF for the treatment of pancreatic cancer. https://lnkd.in/g74twwdC
Pancreatic cancer is a highly aggressive and rapidly progressive disease, known to be the third leading cause of cancer-related death in the US. PBP1510 is anticipated to be an effective targeted therapy for a wider patient population and address unmet needs in patients for whom targeted therapy is currently not available.
Pancreatic Adenocarcinoma Up-regulated Factor (PAUF), a tumour-specific protein that plays an important role in carcinogenesis and metastasis, is found to be overexpressed in pancreatic cancer. Autocrine activation of intracellular signaling cascade by PAUF leads to increased gene expression for the proliferation, migration, and metastasis of pancreatic cancer cells. Based on the multi-functional role of PAUF in pancreatic cancer, PBP1510 neutralizes PAUF by binding to PAUF protein with high specificity and affinity to inhibit the proliferation, migration, invasion, and growth of pancreatic cancer cells.
In 2020, PBP1510 was granted designation by the US FDA, EMA and Korea MFDS. In addition, the company has applied for patent for the first-in-class antibody in 24 countries, which has been successfully registered in 10 countries as of now including the US, Korea, and Singapore.
The decision by FDA will be made within sixty days. Fingers crossed.
프레스티지바이오파마 PAUF, 췌장암항체치료제 HD201 HD204 투즈뉴 베스포다 파우프 PBP 싱가포르 바이오파마 바이오시밀러
