By Wayne Koberstein, Executive Editor, Life Science Leader magazine
Follow Me On Twitter @WayneKoberstein
Stopping immune-mediated disease early, before it becomes a chronic condition
Provention Bio is in the early to late stages of clinical development of new drugs that manipulate immune tolerance to interrupt or prevent autoimmunity, inflammation, and other immune disorders. The company’s proprietary antibodies and vaccines address almost every stage of immune response, from innate immunity to the antigen- targeted response by lymphocytes and other blood components. The lead product, teplizumab, is an anti-CD3 mAb in Phase 3 for interception of Type 1 diabetes (T1D). There are three Phase 2 candidates: an anti-IL-15 mAb for interception of gluten- dependent celiac disease; PRV-6527, an oral CSF-1R inhibitor, for Crohn’s disease; and PRV- 300, an anti-TLR3 mAb, for ulcerative colitis. Earlier candidates include an interception of lupus, now entering Phase 2, and vaccines for preventing T1D and Coxsackie virus infection, in Phase 1.
WHAT’S AT STAKE
New medicines and therapies now emerging challenge not only the medical status quo but also the old order of the biopharma industry itself. The traditional pharma business model relied on large populations treated long-term with medicines for chronic or recurring conditions. But Provention Bio is tackling disease from another angle — intercepting or entirely preventing the progress of disease. The common mechanism that all of the company’s pipeline drugs employ is the immune system.
Ashleigh Palmer, cofounder and CEO, summarizes the Provention Bio approach: “We cover the full spectrum of immunity and autoimmunity, and that’s why our targets are addressing some of the major immune diseases today, such as inflammatory bowel disease, Type 1 diabetes, lupus, and celiac disease, the largest of the immune disorders for which there’s no approved medication.”
Palmer arrived in the United States from the U.K. in the early 1990s to head business development at Ohmeda and spun out Ohmeda’s inhaled nitric oxide therapy — then used to treat blue babies — into a new company, INO Therapeutics. “I was a young father, and here’s a drug that turns blue babies pink. Why wouldn’t Big Pharma develop it?” After INO, Palmer spent 10 years as a turnaround CEO brought in by hedge funds and VCs. “I fixed companies that were broken and struggling to survive in the venture capital model, which often rushes out, looks for a quick exit, and puts young financial experts onto boards that have no operating experience. They may end up developing technology that would otherwise not be funded but often leave drugs that would be justified from the patient’s perspective underdeveloped or neglected.” Palmer took what he learned from fixing companies and applied those lessons to founding a company, Celimmune, with a Janssen scientist, Francisco Leon, later the cofounder of Provention as well. They licensed an IL-15 inhibitor from Amgen, brought the drug through proof of concept for treating celiac disease, and sold Celimmune back to Amgen.
“The Celimmune experience was validation for us that we could work with Big Pharma, identify opportunities to develop drugs that were being underdeveloped or neglected, and put them into a new company. We are not going through the trashcans of pharma companies looking for discarded assets; we’re going through their attics looking for underdeveloped treasures. We recognize the pharma industry is predominantly focused on the end stages of immune-mediated disease after tissue damage has been done, often irreversibly, and then managing the patients on a chronic basis for a lifetime. Rarely does the industry try to go upstream or earlier in the continuum of autoimmunity or immune-mediated disease and look for opportunities to intercept the disease or to even prevent it.”
Even though Big Pharma might prefer a market of chronic-disease drugs, Provention Bio does not consider its earlier interventions as a marketing disadvantage. After all, if a drug could stop Type 1 diabetes in its tracks, what other great things might it accomplish?
Headquarters: None (Virtual)
$28.4M Series A (April 2017)
$63.9M IPO (July 2018)
Research Partnership Funding
Janssen (J&J) Licensed PRV-300 (anti-TLR3 mAb, ulcerative colitis); PRV-6527 (oral CSF-1R, Crohn’s Disease)
Amgen Licensed PRV-015 (anti-IL-15, celiac disease)
MacroGenics Acquired PRV-031 (teplizumab, Type 1 diabetes); licensed PRV-3279 (targeted bi-specific, lupus)
Vactech Licensed PRV-101 (Coxsackie virus B vaccine)
March 2019 Announced PROTECT Phase 3 Study of PRV-031 (teplizumab), recent-onset T1D, to commence in Q2 2019
November 2018 Co-development agreement with Amgen; in-licensing AMG-714 (PRV-015), celiac disease