MEdPACTO

January 19, 2022 – A genome-based drug discovery and clinical-stage biotechnology company, Medpacto’s preparation for the global Phase 3 combination trial with the global pharmaceutical company, MSD, for colorectal cancer patients is progressing along as planned. 

MedPacto has announced its successful pre-IND (Investigational New Drug) meeting with the United States’s Food and Drug Administration (FDA) to launch a global phase 2b/3 clinical trial on January 19th.

The pre-IND meeting is for discussing the clinical trial plan in regards to the drug development. During the course of the pre-IND meeting, the drug development company receives guidance from the FDA prior to submitting an IND application. MedPacto requested the pre-IND meeting with the FDA last quarter.

With the pre-IND meeting successfully completed, filing an IND application for the global Phase 2b/3 is expected to go well. MedPacto plans to then apply for IND for a global phase 3 clinical trial.

MedPacto is currently conducting a clinical trial evaluating the safety and efficacy of Vactosertib, MedPacto’s inhibitor of TGF-β type I receptor, in combination with MSD’s anti-PD-1 therapy, KEYTRUDA as the third-line treatment, in patients with metastatic or locally advanced colorectal (mCRC).

MedPacto has released the interim results of Phase 1b and 2a clinical trials using a combination treatment of Vactosertib and Keytruda for treating colorectal cancer patients. According to the interim result, the median overall survival(mOS) was 15.8 months which is more than double the extended results as compared to the mOS of current standard therapies, therefore verifying its potential as a new treatment. Based on these results, MedPacto began executing a global phase 3 clinical collaboration agreement with MSD last December.

Collaborative global phase 3 clinical trial with MSD is a multi-institutional, randomized controlled trial comparing efficacy to the standard treatments. MSD will supply Keytruda to MedPacto. The trial will be initiated to about  500~600 patients at around 40 sites in the United States, South Korea and etc., and is aiming to start recruiting patients within this year. 

“This pre-IND meeting is an advance procedure of IND application for global clinical trial phase 2b/3 for the colorectal cancer patients” “with the pre-IND meeting successfully completed, we are expecting to submit an application for the global clinical trial phase 3 to get approval within the first half of this year.” Stated a MedPacto representative.

Vactosertib is a TGF-β inhibitor that inhibits transforming growth factor-beta (TGF-β) signaling the promotion of the metastasis and proliferation of cancer cells by modulating the tumor microenvironment. Vactosertib plays a synergistic role in improving the response of various drugs and suppressing the proliferation and metastasis of cancer cells. 

MedPacto is currently conducting combination trials with Vactosertib targeting several cancers such as, but not limited to, Pancreatic, NSCLC, Bladder, Gastric and Desmoid sarcoma cancer.