Medpacto said that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to combination therapy of Vactosertib and paclitaxel for treating metastatic gastric adenocarcinoma.

Vactosertib is a drug candidate that selectively inhibits transforming growth factor-beta (TGF-β), a mechanism that inhibits the therapeutic effect of immunotherapy.

The drug plays a role in regulating the tumor microenvironment so that immune cells can attack cancer cells and inhibit cancer stem cell production and tumor vascularization, solving resistance problems of anticancer drugs and inducing the death of cancer cells, the company said.

With the ODD designation, the company expects to accelerate the commercialization of Vactosertib and paclitaxel's combination therapy. The drug is now undergoing local phase 2a clinical trials.

The company also presented the phase 1b results of the combination treatment during the European Society for Medical Oncology (ESMO) 2020 recently. The result showed a median progression-free survival (PFS) of 5.5 months in combination therapy with Vactosertib and paclitaxel.

“After the company saw encouraging progression-free survival rates recorded in phase 1b clinical trial, the Phase 2a clinical trial is also progressing smoothly,” a company official said. “The company expects that the market value of Vactosertib will increase according to the orphan drug designation.”

ODD is a status given to certain medications called orphan drugs, which show promise in the treatment, prevention, or diagnosis of orphan diseases. The designation provides tax and license application fee exemption and grants a monopoly for seven years if it succeeds in becoming the first drug approved in the field.