On November 10, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company specializing in antibody drug development, reported that the company has obtained a patent in Indonesia for PBP1510 (INN-ulenistamab), the company’s first-in-class anti-PAUF monoclonal antibody (Press release, Prestige BioPharma, NOV 10, 2022, View Source [SID1234623692]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PBP1510 has thus far been patented in a total of ten countries including Indonesia, Korea, United States, Japan, Australia, Taiwan, Russia, South Africa, Singapore, and Malaysia. In addition, it is currently under review for patent registration in 14 countries such as Canada and New Zealand.

Being a first-in-class anti-PAUF treatment, PBP1510 prevents the progression and metastasis of the cancer induced by PAUF (Pancreatic Adenocarcinoma Up-regulated Factor) and creating a more responsive environment for antitumor immunotherapy. Thus, it is expected to provide significant benefit to patients suffering from PAUF-positive pancreatic cancer.

In 2020, PBP1510 was granted Orphan Drug Designation by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Korea Ministry of Food and Drug Safety (MFDS). Currently, it is undergoing phase 1/2a clinical trial in Europe and U.S.

To bring the new promising drug to patients as early as possible, Prestige Biopharma is planning to apply for FDA’s Fast Track program, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.