Lupus Vaccine Candidate Launches Phase 1b Study

A New Jersey-based biopharmaceutical company announced that it has dosed the first patients in its PREVAIL study, a Phase 1b/2a clinical trial evaluating PRV-3279 vaccine candidate.  

Provention Bio’s PRV-3279 vaccine is a humanized diabody targeting the B-cell surface proteins, CD32B and CD79B.

This vaccine development strategy has the potential to intercept the pathophysiology of systemic lupus erythematosus (SLE) and other B cell-mediated autoimmune diseases.

Systemic lupus erythematosus (SLE) is a chronic disease that causes inflammation in connective tissues, such as cartilage and the lining of blood vessels, which provide strength and flexibility to structures throughout the body says the National Institutes of Health (NIH).

While there's no cure for lupus, current treatments focus on improving quality of life through controlling symptoms and minimizing flare-ups. A conservative estimate suggests a prevalence of 161,000 with definite SLE and 322,000 with definite or probable SLE, says the NIH.

The 4 different types of lupus are:

• Systemic lupus is the most common form of lupus
• Cutaneous lupus is lupus that affects the skin in the form of a rash or lesions
• Drug-induced lupus is similar to SLE but occurs as the result of an overreaction to certain medications
• Neonatal lupus occurs when an infant passively acquires auto-antibodies from a mother with SLE

The PREVAIL study is a randomized, double-blind, placebo-controlled, multiple ascending dose Phase 1a study which will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of PRV-3279 in 16 healthy volunteers.

Upon successful completion of the Phase 1a study, Provention plans to initiate the Phase 2a portion of the study in lupus patients.

Francisco Leon, M.D., Ph.D., Co-founder and Chief Scientific Officer of Provention Bio said in a press release, "We believe that PRV-3279 is uniquely differentiated to allow for rapid inhibition of activated B cells, while sparing non-activated B cells from depletion or inactivation, thereby offering the potential for a more effective yet safer alternative to current B-cell targeted therapies.”  

“We look forward to reporting data from Part 1 of the study in the first half of 2020."

Results from a prior single ascending dose Phase 1 study established proof of mechanism and showed that PRV-3279 was well-tolerated. In addition, a single dose of PRV-3279 demonstrated an inhibitory effect on the immunogenicity of hepatitis A vaccine provided to volunteers during the trial.

PRV-3279 is a humanized diabody (a bispecific scaffold biologic molecule) targeting the B-cell surface proteins, CD32B and CD79B.  Simultaneous engagement of the CD32B and CD79B receptors triggers inhibition of B cell function and suppression of autoantibody production, thereby regulating B cells without causing depletion. 

Provention is initially developing PRV-3279 for the interception of systemic lupus erythematosus (SLE), a chronic autoimmune disorder characterized by an abnormal overactivation of B cells and subsequent pathologic production of auto-antibodies.  

PRV-3279 also has the potential to prevent or reduce the immunogenicity of biotherapeutics, including but not limited to, gene therapy vectors and transgenes.

Provention Bio, Inc. is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease.