Key Developments: Inovio Pharmaceuticals Inc (INO.A)
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Latest Key Developments (Source: Significant Developments)
Inovio Pharmaceuticals, Inc.'s Collaborator ChronTech AS Reports Interim Phase II Clinical Study Results From ChronVac-C Vaccine For Hepatitis C Infection
Inovio Pharmaceuticals, Inc. announced the release of preliminary clinical trial results by collaborator ChronTech AS of their open label phase II clinical study of ChronVac-C, ChronTech's vaccine to treat hepatitis C virus (HCV) infection. The study investigated the use of the ChronVac-C DNA vaccine administered with Inovio's MedPulserTM-DDS electroporation device followed by a drug regimen (ribavirin + PEG-interferon-a) in chronic HCV positive subjects. These initial results do not show a statistically difference so far between treatment outcomes of the vaccinated and non-vaccinated groups. The vaccinated group did display a safety profile. In this 29 patient phase II study, 17 patients were treated with two monthly vaccinations of ChronVac-C (500 ug) followed by interferon and ribavirin. In the control arm, 12 patients were treated with interferon and ribavirin alone. ChronTech has made analysis 12 weeks after treatment. HCV viral load reduction or elimination is assessed by measuring HCV RNA levels. At treatment week 12, 71% of the pre-vaccinated group had less than 15 international units of HCV RNA compared to 58% in the non-vaccinated group; 65% were HCV RNA negative compared to 58% in the non-vaccinated group. There were no serious adverse events and the number of patients with moderate adverse events was statistically lower in the pre-vaccinated group than in the non-vaccinated group (p <0.05, Fishers exact test). Full Article
Inovio Pharmaceuticals Inc Closes $15.1 Million Offering Of Common Stock and Warrants
Inovio Pharmaceuticals Inc announced that it has closed an underwritten offering of 27,377,266 shares of its common stock and warrants to purchase up to 13,688,633 shares of common stock at a combined price of $0.55 per share and related warrant for gross proceeds of $15.1 million. The warrants are exercisable at an exercise price of $.7936 per share and will expire, unless exercised, on the date that is 180 days after the fifth anniversary of the date of issuance. The net proceeds from the sale of the shares and the related warrants, after deducting the underwriters' discounts and other estimated offering expenses payable by Inovio, was approximately $14.0 million, which does not include any potential proceeds from the cash exercise of any warrants. Inovio intends to use the net proceeds of the offering (including any resulting from the exercise of the warrants) for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses, manufacturing expenses and potential acquisitions of companies and technologies that complement our business. Cowen and Company, LLC acted as sole book-running manager for the offering. Brean Capital, LLC acted as co-lead manager for the offering. Maxim Group LLC acted as co-manager. Full Article
Inovio Pharmaceuticals Inc Prices $15.1 Million Offering of Common Stock and Warrants
Inovio Pharmaceuticals Inc announced that it has priced an underwritten offering of 27,377,266 shares of its common stock and warrants to purchase up to 13,688,633 shares of common stock at a combined price to the public of $0.55 per share and related warrant for gross proceeds of $15.1 million. The warrants are exercisable at an exercise price of $.7936 per share and will expire, unless exercised, on the date that is 180 days after the fifth anniversary of the date of issuance. The net proceeds from the sale of the shares and the related warrants, after deducting the underwriters' discounts and other estimated offering expenses payable by Inovio, will be approximately $14.0 million, which does not include any potential proceeds from the cash exercise of any warrants. Inovio intends to use the net proceeds received from the sale of the securities for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses, manufacturing expenses and potential acquisitions of companies and technologies that complement business. Full Article
Inovio Pharmaceuticals Inc and VGX International Inc To Initiate Clinical Trial For Hepatitis C Therapeutic Vaccine (INO-8000)
Inovio Pharmaceuticals Inc and its development partner VGX International Inc will move Inovio's hepatitis C (HCV) DNA vaccine into a phase I/IIa clinical trial by the end of 2013. This advancement is based on outstanding results of a preclinical study which demonstrated for the first time that a multi-antigen SynCon HCV vaccine can generate robust T-cell responses not only in the blood but, more importantly, in the liver, an organ known to supress T-cell activity. VGX International is funding all preclinical and clinical development. Full Article
Inovio Pharmaceuticals Inc Announces Positive Interim Results in Phase II Leukemia Trial
Inovio Pharmaceuticals Inc announced that preliminary results of a phase II clinical trial to treat leukemia with a WT1 DNA vaccine delivered with Inovio's electroporation delivery system showed robust vaccine-specific antibody responses in all vaccinated subjects evaluated to date. Furthermore, T cell immune responses, including those of the killer T cells, were detected. Antibody and T cell responses are strong signals of the DNA vaccine's potential to treat the disease. data was presented today at an international conference, DNA Vaccines 2012, in San Diego, Ca , by Dr. Christian H. Ottensmeier , MD, PhD, the trial's principal investigator and Professor of Experimental Cancer Research at the University of Southampton, UK. These interim results, from eight patients, are part of a phase II trial that will enroll 31 patients in its chronic myelogenous leukemia (CML) arm. To date, 14 CML patients have been enrolled while another 13 unvaccinated CML patients have been enrolled to serve as a control group. The vaccine has been shown to be safe overall and well-tolerated in the trial subjects. A detailed analysis of T cell immune responses as well as the impact of the vaccination on the molecular marker, BCR-ABL, which is a specific chromosomal abnormality that is associated with chronic myelogenous leukemia (CML) disease, will be performed. Full Article
Inovio Pharmaceuticals Inc's Hepatitis B Vaccine Killer T Cells Demonstrate Potential To Clear HBV In Liver
Inovio Pharmaceuticals Inc announced that synthetic hepatitis B (HBV) therapeutic vaccine generated T cell responses that eliminated targeted liver cells in mice. In the study, Inovio researchers and collaborators constructed a DNA vaccine encoding an HBV core antigen using the SynCon vaccine technology and administered it via Inovio's electroporation-based delivery technology. The Company is also investigating additional HBV antigens to develop a multi-component vaccine that can provide the host immune system multiple targets to clear the hepatitis B virus and infected liver cells. Full Article
Inovio Pharmaceuticals, Inc.'s Universal Avian Flu Vaccine Generates Protective Antibody Responses Against Six H5N1 Viruses In Phase I Trial
Inovio Pharmaceuticals, Inc. announced that SynCon avian influenza vaccine generated protective HAI titers against six different unmatched strains of H5N1 in a phase I clinical trial - a distinct clinical achievement on Inovio's path to develop universal influenza vaccines. By design, Inovio's SynCon flu vaccine is not matched to any single virus. Importantly, the vaccine generated a hemagglutination inhibition (HAI) titer of 1:40 or higher against at least one of the six tested H5N1 strains in eight of 17 (47%) immunized subjects, demonstrating the vaccine's broad coverage; 12 of 17 (71%) vaccines generated an HAI titer of 1:20 or higher, indicating a positive vaccine response, against at least one H5N1 strain. The vaccine based on one or more of these new gene sequences is designed to achieve cross-strain or universal protection against the natural and frequent mutations of influenza strains that will inevitably emerge within each targeted subtype. In this study, a total of 17 patients completed a full H5N1 immunization regimen consisting of two intramuscular (IM) vaccinations with a synthetic DNA vaccine encoding three flu antigens (HA, NA, NP) followed by two intradermal (ID) vaccinations of only the HA antigen using Inovio's skin electroporation device. The vaccine was found to be well tolerated at each immunization. Reported adverse events and injection site reactions were mild to moderate and required no treatment. Full Article
Inovio Pharmaceuticals, Inc. Receives U.S. Patent Protection For Synthetic Vaccine For Cervical Dysplasia And Cancer
Inovio Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office granted U.S. Patent No. 8,168,769, covering Inovio's SynCon vaccine for cervical dysplasias and cancers caused by human papillomavirus (HPV). The patent granted to the Trustees of The University of Pennsylvania has been exclusively licensed to Inovio under its existing license agreement with the university. The patent includes claims that cover Inovio's synthetic consensus HPV antigens and DNA constructs and vaccines that include these antigens, including Inovio's cervical dysplasia/cancer vaccine, VGX-3100. This patent also covers methods of treating a patient using the SynCon cervical dysplasia/cancer vaccine. Full Article
Inovio Pharmaceuticals, Inc. Receives U.S. Patent For SynCon H1N1 Influenza Universal Vaccine
Inovio Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office granted U.S. Patent No. 8,133,723, covering Inovio's SynCon universal vaccine related to H1N1 influenza. The patent granted to the Trustees of The University of Pennsylvania has been licensed exclusively to Inovio under its existing license agreement with the university. The patent includes claims that cover the synthetic consensus H1 antigen and DNA constructs and vaccines that include this antigen, including universal influenza vaccine INO-3510. This patent also covers methods of treating a patient using the SynCon universal influenza vaccine. Full Article
Inovio Pharmaceuticals, Inc. Closes $4.0 Million Underwritten Financing
Inovio Pharmaceuticals, Inc. announced that it has closed an underwritten public offering of 7,699,712 shares of its common stock and warrants to purchase up to 5,774,784 additional shares of its common stock, which included the partial exercise of the underwriter's overallotment option to purchase additional units at the public offering price. These securities were sold in units, consisting of one share of common stock and 0.75 of a warrant to purchase one share of common stock, at a price of $0.5195 per unit. The gross proceeds of the offering were $4.0 million. Net proceeds to Inovio, after deducting the underwriter's discounts and other estimated offering expenses payable by Inovio, were approximately $3.7 million. Brean Murray, Carret & Co. acted as sole bookrunner of this offering. Inovio intends to use the net proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses. Full Article
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