KUALA LUMPUR, March 8 -- Prestige BioPharma Limited announced that the preclinical data of their First-in-Class pancreatic cancer treatment, PBP1510 (INNUlenistamab), has been shared in a poster presentation at the European Society for Medical Oncology (ESMO) Targeted Anticancer Therapies (TAT) Congress 2022 held virtually on March 7-8, 2022.
ESMO is one of the leading professional organisations for medical oncology, together with American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO).
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.
Based on the efficacy and safety demonstrated in the preclinical study, PBP1510 is currently in Phase 1/2a clinical trial in France and Spain, according to a statement.
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.
More details at www.prestigebiopharma.com.
-- BERNAMA
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