This biotech company just completed a successful Phase 2 clinical trial for its respiratory illness vaccine for women of childbearing age. Please note that shares of biotech companies are speculative in nature and should be allocated to a small percentage of your overall portfolio.
Novavax (NVAX)
from The Medical Technology Stock Letter
Novavax (NVAX) recently announced positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in 720 women of childbearing age.
The randomized, blinded, placebo-controlled Phase 2 study was designed to evaluate the immunogenicity and safety of multiple formulations of Novavax’ RSV-F protein nanoparticle vaccine adjuvanted with aluminum phosphate. The primary outcome of the trial was safety and immune response, measured by levels of serum IgG antibody specific for the F protein. Participants received either one or two intramuscular injections featuring two different dose levels of vaccine antigen with a range of doses of aluminum phosphate adjuvant.
In our view, the consistency across doses/formulations and compared with previous studies is impressive. The NVAX F-protein vaccine delivered improved immunogenicity in a one-dose regimen, likely leading to improved patient convenience, vaccine uptake and compliance, thus decreasing the burden of RSV disease. In addition the single dose should lead to flexibility for administration during pregnancy. The study confirms a previous clinical trial in women of childbearing age from 2013. These data support the first maternal immunization trial, currently projected to begin in Q4:14.
The Company has requested a Type C meeting with the FDA this summer to discuss the entire suite of pre-clinical and clinical data in support of our application to initiate studies in pregnant women. A Type C meeting will allow the company to decide on multiple aspects of the next clinical trial(s). Now they appear to have the appropriate dose/formulation for registration trials – it will be interesting to note if the FDA allows a randomized trial designed for Phase II, but possibly with a crossover to a Phase III study. The impressive results reported, in our view, make us believe the path to market could be accelerated. Novavax expects to present the entire date-set at an appropriate scientific forum in the future.
These top-line data over the 91-day period following first immunization were highly successful for safety and efficacy and support Novavax’ maternal immunization strategy. While the most important trials are still ahead of them (e.g., in pregnant women to observe placental transfer of protection, combination trials with the NVAX quadrivalent flu vaccine), today’s results could not be any better. With four positive studies in more than 1,100 safety subjects, the path to NVAX developing a truly disruptive “respiratory vaccine” has just taken a major step forward.
Reiterate our BUY under 6 and 13 TARGET PRICE.
John McCamant, The Medical Technology Stock Letter, www.bioinvest.com, April 28, 2014