Firm will use proceeds to fully fund Phase II trial with lead cervical cancer DNA vaccine.
Inovio Pharmaceuticals will net about $23 million from a direct registered offering of common stock and warrants to a single institutional investor. The firm says the proceeds will allow it to fully fund a planned Phase II study with its lead DNA vaccine against cervical dysplasias and other cancers.
The $24.3 million gross offering comprises 21,130,400 shares of Inovio’s common stock and warrants to purchase up to 10,565,200 additional shares. The shares and warrants will be apportioned in units each comprising one share of common stock and 0.5 of a warrant to purchase one share of common stock, priced at $1.15 per unit. The warrants have a term of five years and an exercise price of $1.40 per share. Inovio has the right to call the warrants, dependent on a number of conditions and if the closing bid price of the common stock has been at least $2.80 over 20 days.
In addition to funding its Phase II cancer vaccine study, the firm says the injection of capital will support the progress of its preclinical DNA vaccine pipeline and the initiation of additional clinical trials in 2011. “We believe we now have sufficient cash to cover our operations into 2014,” comments J. Joseph Kim, Ph.D., president and CEO.
Inovio is focused on developing DNA vaccines for the prevention and treatment of cancers and infectious diseases. The firm is exploiting its SynCon™ platform to develop universal DNA vaccines capable of providing cross-strain protection against rapidly evolving viruses including HIV and influenza. SyCon is complemented by a proprietary eletroporation technology for DNA delivery, which is being used in house and is also being made available to third parties through licensing agreements for use in the delivery of DNA-based immunotherapies.
The Inovio pipeline is headed by its VGX-3100 cervical cancer therapeutic, which Inovio is developing in house and is poised to start in Phase II. Phase I studies with an avian influenza virus VGX-3400X are also in progress.
Inovio’s Pennax™ family of prophylactic and therapeutic HIV candidates are in either preclinical or early Phase I development. Phase I trials with the Pennvax-B vaccine are being partnered with the HIV Vaccine Trials Network for the potential prevention of HIV infection. A Pennax-B partenership with the University of Pennsylvania is evaluating the vaccine as a potential therapeutic for HIV. Pennax-G is poised to start in clinical development for the prevention of HIV and is being partnered by USMHRP (US Military HIV Research Program) and NIAID.
Inovio’s electroporation technology licensees include the U.K.’s University of Southampton, ChronTech, and Merck & Co. The University has completed a Phase I trial in prostate cancer. ChronTech separately completed a Phase I study in which the technology was used to deliver a potential HCV candidate. Merck is currently conducting a Phase I trial with a potential breast, lung, and prostate cancer candidate.
In November 2011 the firm was awarded a $733,438 under the U.S. government’s Patient Protection and Affordable Care Act of 2010 to support the proposed Phase II VGX-3100 study and the development of SynCon-derived universal flu and dengue vaccines.
Inovio claims its DNA vaccine design process can synthetically define antigens and gene sequences common across different viral subtypes or taxonomic groups of HCV, HIV, HPV, and influenza. By synthetically deriving consensus genes that look similar to a diverse panel of viral antigens, the resulting SynCon DNA vaccine constructs are hoped to provide a solution to the genetic shift and drift typically associated with infectious diseases and elicit broad, diverse immune responses capable of protecting against different and emerging strains of these pathogens.
Inovio separately claims its electroporation-based DNA delivery technology approach can improve the uptake of DNA-based therapeutics by 1,000 times or more. It says that when used to deliver DNA vaccines, the system increases levels of transferred gene expression by 100 times or more compared with expression following plasmid DNA delivered without other delivery enhancements. Interim clinical results have in addition indicated that the delivery system significantly boots resulting immune responses.