Inovio's accomplishments:
The results from VGX-3100 Phase 2 ( for Cervical Dysplasia ) met its Primary Endpoint & Secondary Endpoint in convincing fashion with LOW P-VALUEs, hence validating INO's proprietary DNA Vaccine Platform + proprietary Electroporation DNA Delivery Technology ( including other products in its pipeline )
NOTE :
P-Value indicates the validity of the Statistical Significance / Strength of a claim.
ONLY claims with P-Values of 0.05 or LOWER can be taken seriously by the medical community & FDA.
( Seems like AstraZeneca took it seriously. )
1. Primary Endpoint : Regression to CIN1 or Normal
( P = 0.017, 49.5% ( VGX-3100 ) vs 30.6% ( Placebo ) )
2. Secondary Endpoint : Virologica l Clearance & Regression to CIN1 or Normal
( P = 0.001, 40.2% ( VGX-3100 ) vs 14.3% ( Placebo ) )
VGX-3100 Phase 2 clinical trial was :
- Randomized
- Placebo-Controlled
- Double-Blinded
- 148 patients
- Multi-Location Global study including U.S., Australia, Canada, Estonia, Georgia, India, Republic of Korea, Puerto Rico, South Africa.
So, it seems like after checking-out the initial Phase 1/2 of VGX-3112 ( VGX-3100 + DNA based IL12 ), MedImmune / AstraZeneca grabbed the global rights with $725 million licensing deal.
NOTE :
INO's patent protected DNA-based IL12 ( Immune Activator ) is designed to :
- Enhance ( activate ) therapeutic T0Cells or preventive Antibodies
- Modulate the type of immune responses produced by the immunotherapy
- Impact durability of immune responses
- Drive immune responses to sites of infection, e.g. mucosal surfaces.
e.g.
In INO's HIV study, 89% of the subjects who received IL-12 DNA together with the INO's PENNVAX DNA Vaccine delivered with Electroporation produced a vaccine specific CD4+ or CD8+ T cell responses compared to 67% who received the DNA vaccine alone without the IL-12 DNA.
INO has over ten (10) DNA-based Immune Activators.
Different immune activators can play unique roles in achieving desired immune responses generated by DNA therapies.
Inovio has the following cancer studies under way:
breast, lung, pancreatic cancer, cervical cancer, aerodigestive cancer, prostate cancer.
And the following anti-infectious disease: Hepatitis (B,C), AIDS(A,C and D), influenza, MERSE, Ebola.
In the pipeline: chicungunya, malaria
Thursday, August 13, 2015
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