A company tackling diabetic nephropathy through a new pathway
Vascular Pharmaceuticals is a private company developing a drug to treat diabetic nephropathy, based on a novel molecular pathway company researchers identified that contributes to diabetic kidney disease. With help from its partner Janssen, the company has moved its lead monoclonal antibody (mAb) compound through preclinical and Phase 1 studies and is now beginning the treatment stage of a Phase 2 program. Janssen has the option to acquire Vascular upon completion of the Phase 2 trial.
WHAT’S AT STAKE
Okay, I’m stuck on kidneys. Two months ago, this column spotlighted a company with drugs in development for kidney damage and disease, including diabetic nephropathy — the target of Vascular Pharmaceuticals’ lead drug. There is a good reason for the conjunction. Early this year, I began to encounter companies developing drugs with new, unique mechanisms of actions (MOAs) in the diabetes/endocrinology space, which for many years has been relatively quiet, even sleepy. I interviewed a small sample of those developers with the idea of eventually creating a series to look at the new MOAs the way we examined cancer immunotherapy during the past year in our “virtual roundtable,” using CtW (“Companies To Watch”) as a vehicle for whetting readers’ appetites. As stated in the August CtW, “Any so-called competition in a dormant space tends to increase awareness and market potential of that space.” Certainly, Vascular Pharmaceuticals is enlivening the area with its own unique approach to preventing and treating diabetic nephropathy, the main cause of chronic kidney disease.
Vascular spun out of research at UNC-Chapel Hill School of Medicine that discovered a causal relationship between the high-glucose blood levels in diabetes and cell-signaling changes that disrupt the kidney cells involved in filtration (leading to kidney damage). It now has an mAb drug candidate, VPI-2960B, entering midstage development designed to down-regulate the activation of a key receptor in the kidney cells, aVß3, an integrin, or cellular adhesion protein. The MOA differs categorically from the antifibrotic and anti-inflammatory approaches to kidney disease by other companies.
“Not by antagonizing the receptor but by normalizing its activity with VPI-2960B, we hope to stop the progression of damage in the kidney and hopefully even reverse diabetic nephropathy,” CEO Richard Shea says.
The move to founding a business began in 2005, but Shea says Vascular’s operations actually ramped up in 2009, when the company received a $1.2 million STTR (Small Business Technology Transfer) Phase 2 grant. “Although the grant was for a relatively small amount of money, it was significant because it was the first outside recognition of our potential,” he says. “The grant funded our proof-of-concept preclinical program.” About the same time, Vascular received further validation in signing a development pact with Janssen, later terminated and replaced with a funding agreement giving Janssen an option to buy the company once it completes its current Phase 2 trial. Janssen facilitated the formulation and optimization of the VPI-2960B mAb for clinical trials. VC funding has sustained Vascular in the meantime.
“In our Phase 2 trial, the drug is given as a biweekly injection, but the half-life would support extending the injection interval in later trials,” says Shea. “The Phase 2 trial uses an adaptive design, starting with 100 patients. We will monitor their progress over six months, then evaluate whether to enroll a second cohort of 200 more patients. Patients will be treated for one year. VPI-2690B has produced impressive results in our animal studies in both rat and pig models. We believe that the pathway will translate into humans, and our current Phase 2 trial will validate that hypothesis.” Phase 1 showed good safety. Now, in larger human trials, the toughest test begins.
Headquarters: Research Triangle Park, NC
Series A: #25M
MPM Capital, Intersouth Partners, Lumira Capital
Research partnership funding
Warrant agreement giving Janssen Biotech the right to acquire the company on prenegotiated terms after it completes its ongoing Phase 2 program in diabetic nephropathy, in exchange for a series of milestone payments.