PepVax begins efficacy study for lead candidate
- Category: Vaccines
- Published on Friday, 01 September 2017 09:54
- Hits: 453
BETHESDA, MD, USA I August 31, 2017 I PepVax, Inc., an early-stage biotechnology company, announced today that it 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.
About PepVax, Inc.
PepVax, Inc. was founded in 2013 to harness the power of the human immune system to treat cancer. The company, which has a presence in the Washington, DC and Philadelphia regions, is developing multiple viable candidates to treat triple-negative breast cancer (TNBC) and has progressed from in-vitro trials to animal testing. The immunotherapy market is expected to grow to $9 billion by 2022 and may be used in up to 60% of cases of advanced cancer. Learn more at www.pepvax.co