MedPacto's 'Bactosertib' Designated as FDA Orphan Drug for Combination Therapy in Pancreatic Cancer Treatment

MedPacto CI (Photo by MedPacto)

[Asia Economy Reporter Chunhee Lee] MedPacto's immuno-oncology drug 'Bactosertib' combined with '5FU/LV/Onivyde' has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA).

MedPacto, a biomarker-based innovative drug development company, announced on the 21st that the combination therapy of Bactosertib and 5FU/LV/Onivyde for pancreatic cancer treatment has been granted orphan drug designation by the FDA.

A company official stated, “The combination therapy of Bactosertib and 5FU/LV/Onivyde has already demonstrated high survival rates in preclinical studies, confirming its potential as a new treatment option for pancreatic cancer,” and emphasized, “This orphan drug designation is the second following gastric cancer, reaffirming that Bactosertib can be expanded to various cancer types.”

With this orphan drug designation, MedPacto will be eligible for grants supporting clinical trials and tax benefits. Additionally, it can undergo a fast-track review process, and if approved for marketing, it will have seven years of market exclusivity.

In April, MedPacto presented preclinical results at the American Association for Cancer Research (AACR) showing that administering the combination therapy for 50 days significantly reduced cancer cell metastasis. While the untreated group and the conventional therapy group recorded survival rates of 23% and 53%, respectively, the combination therapy group showed a survival rate of 84%, demonstrating high therapeutic potential. MedPacto is currently conducting investigator-initiated clinical trials phases 1b and 2a for the combination therapy.

According to market research firm GlobalData, the pancreatic cancer treatment market was valued at $1.9 billion (approximately 2.1851 trillion KRW) in 2019, indicating a relatively large market compared to the number of patients. MedPacto plans to pursue orphan drug designation for desmoid tumors and proceed with procedures for submitting Investigational New Drug (IND) applications for multinational clinical trials, aiming to develop various rare cancer treatments.