On March 8, 2022 Prestige BioPharma Limited (950210: KRX), a Singapore-based biopharmaceutical with operations in USA and South Korea, reported that the preclinical data of their First-in-Class pancreatic cancer treatment, PBP1510 (INN-Ulenistamab), has been shared in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2022 held virtually on March 7-8, 2022 (Press release, Prestige BioPharma, MAR 8, 2022, View Source [SID1234609689]).
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Preclinical data of PBP1510 presented in the poster shows notable regression in tumour volume and weight in subcutaneous as well as orthotopic patient derived cancer xenograft (PDX) mouse models treated with PBP1510 compared to gemcitabine and IgG controls. In the orthotopic PDX model, tumour cells derived from pancreatic cancer patients are surgically implanted into the pancreas of mice. Such models are of high clinical relevance as they aid in establishing organ-specific tumour microenvironment with great accuracy.
In repeated dose toxicity studies, no notable systemic or local toxicity was observed for up to 40 mg/kg of PBP1510. Absence of anti-drug antibodies was noted in all animals receiving PBP1510 indicating low immunogenic potential.
Based on the efficacy and safety demonstrated in the preclinical study, PBP1510 is currently in Phase 1/2a clinical trial in France and Spain.
The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. ODD is granted to investigational drugs intended for the safe and effective treatment of rare diseases with an unmet medical need that affect very few individuals but cause great suffering. This designation provides companies with certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for health technology assessments in certain countries, and if approved, marketing exclusivity in the EU and the U.S. for certain years.
Prestige has strong pipeline portfolio comprising innovative antibody drugs and biosimilars including the frontrunning Herceptin biosimilar HD201 (Tuznue) filed to EMA, Health Canada and MFDS, an Avastin biosimilar HD204 (Vasforda) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe. The company’s second First-in-Class antibody PBP1710 targeting CTHRC1, a ubiquitous protein overexpressed in many types of cancer, is currently in preclinical stage.
Lisa S. Park, CEO of Prestige BioPharma, commented: "We will identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy," and "Prestige will accelerate the development of PBP1510 that has demonstrated solid evidence and potential as the new cure for pancreatic cancer".