South Korea’s Kosdaq-listed MedPacto Inc. announced Tuesday it has gained the U.S. Food and Drug Administration (FDA) orphan drug designation for its investigational oral cancer drug vactosertib in combination with paclitaxel for the treatment of metastatic gastric adenocarcinoma.
With the designation, MedPacto now qualifies for various development incentives, including tax credits for clinical testing and seven-year marketing exclusivity when approved as a first-in-class drug.
MedPacto shares jumped 8.67 percent to close Tuesday at 114,100 won ($97.55) in Seoul.
Vactosertib is a highly selective and orally available inhibitor of TGF-β type I receptor to block the TGF-β signaling pathway, which contributes metastasis of various types of cancer. More than 30 TGF-β type I inhibitors have so far been developed worldwide but high side effects make commercial development challenging.
MedPacto is engaged in a phase 1b/2a trial in Korea, working together with MSD to evaluate the safety and efficacy of vactosertib for treating patients with colorectal and gastric cancer, and with AstraZeneca for treating patients with metastatic non-small cell lung cancer.
Vactosertib is highly effective when used in combination with existing chemo and immunotherapies. MedPacto expects the latest FDA designation will help speed up commercialization of the combination therapy for metastatic gastric cancer.
The orphan drug designation is granted for drugs and biological products to treat a serious and life-threatening disease that primarily affects fewer than 200,000 people in the U.S.
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