Kadvax Technologies, Inc — Department of Health and Human Services STTR Phase I: NIDA

Description

Methamphetamine MA use disorder is a major problem for over million people world wide with no FDA approved pharmacotherapy However anti addiction drug vaccines hold promise by inducing drug specific antibodies that form antibody MA complexes in the blood which are too large to cross the blood brain barrier thus reducing the rate and quantity of MAandapos s brain entry This inhibits MAandapos s psychoactive effects This study will evaluate the safety and dosing of a MA vaccine KOsten MethAmphetamine KO MA vaccine to produce anti MA antibodies AB in MA dependent human subjects KO MA links MA to a tetanus toxoid TT carrier through succinyl methamphetamine SMA and the TT SMA conjugate is formulated with a potent adjuvant system SA consisting of alum and the co adjuvant entolimod recombinant TRL receptor agonist The KO MA vaccine is superior to our previous TA CD cocaine vaccine because it generates substantially higher levels of anti drug AB in animals Previous cocaine and nicotine vaccine clinical trials failed because many patients did not produce sufficient antibody responses for efficacy and FDA approval These higher AB levels with KO MA reflect to a combination of a more potent carrier protein tetanus toxoid TT vs cholera toxoid subunit B for TA CD and an additional potent adjuvant system SA Our strong preliminary data with KO SA demonstrates substantially high anti MA AB levels capable of reducing MA induced behavioral effects in rodents KO MA also shows no potentiation of MA cardiovascular effects and no pyrogenecity or any other significant toxicity in animal studies The KO MA is stable for months by physiochemical assays Our two goals are manufacture KO MA and do accelerated stability testing for months at C and conduct human studies in normal controls and MA users The first human study STTR Phase tests the safety and efficacy of proposed doses of entolimod in normal humans by comparing a single dose of TT SA to TT alum We expect that TT SA should double the anti TT AB level of TT alum The second study STTR Phase FDA Phase will compare medical safety and efficacy of cGMP manufactured KO MA at doses g and g to placebo These two doses are administered three times over weeks in two separate cohorts of MA users cohort We expect KO MA to produce substantial levels of anti MA AB above g ml with no significant adverse effects Entolimod has been given to almost humans at times the proposed dose Thus humans have already safely gotten all the major components of KO MA TT Alum FDA approved and entolimod adjuvant We have had two pre IND communications with FDA including a review of our human study protocol and have responded to all the FDA concerns by conducting the studies requested by them for filing a successful IND except the studies proposed here If approved this KO MA vaccine would be the first FDA approved therapy for MA abuse The KO MA vaccine could be a therapeutic blocking agent with a world wide market as large as million people and a relatively minimal medical care investment of initial injections followed by single injections every months This same vaccine technology platform can be applied to virtually every other abused drug except alcohol and the nicotine market in the USA is estimated at well over $ billion Another significant element of this research program involves SA entolimod alum as a general vaccine adjuvant system