PepVax, an early-stage biotechnology company, has initiated its in vivo efficacy study for lead candidate, PVX-009. The company is harnessing the power of the immune system to target a specific protein, MAGE A, in an effort to find a treatment for triple negative breast cancer (TNBC).

PepVax has designed the efficacy studies to look at variables most likely to affect the results of the candidate. This includes confirming level of the dosages finalized by the previous toxicology studies, confirming the need for an adjuvant, and deciding the type of checkpoint inhibitors between anti-PDL1 and anti-CTLA4, if either.

The scope of the study is to determine which combination provides the best immune response to stop the growth of the TNBC tumor in mice. "Using a combination of transgenic and immuno-compromised mice, this design will provide the best data to confirm how well the candidate will work in human patients," said Mahesh Narayanan, CEO of PepVax. "Our goal is make sure the drug is safe but also effective against TNBC and this test will verify what we found in the in vitro and ex vivo studies."

Staying on the projected timeline, PepVax plans to file for the FDA's IND application for approval into Phase 1 human trials in late 2018/early 2019. The company recently raised a bridge round of funding in order to continue R&D efforts and expects to begin to raise its Series A investment round in Q4 2017.