Inovio Pharmaceuticals, Inc. Partners with Geneone Life Science Inc. for MERS Immunotherapy Clinical Development
May 27 15
Inovio Pharmaceuticals, Inc. announced it will advance its DNA vaccine for MERS (Middle East Respiratory Syndrome) into a phase I clinical trial in healthy volunteers in a collaboration with GeneOne Life Science Inc. Inovio and GeneOne will conduct a phase I trial to evaluate the safety, tolerability and immunogenicity of Inovio's DNA-based MERS vaccine. The companies are currently conducting pre-IND activities and plan to start the clinical study before year end of 2015. GeneOne will conduct and fund the clinical study in return for milestone-based co-ownership of the immunotherapy. Upon successful completion of the study, the companies plan to jointly seek additional third party support and resources to further develop and commercialize this product. In preclinical tests, INO-4500 showed robust and durable immune responses. Animals vaccinated with INO-4500 generated strong neutralizing antibodies and robust CD8+ T cells to MERS antigens. These findings are vital given the importance of neutralizing antibodies in preventing infection and the role T cells play in clearing infection by killing cells that harbor the virus. T-cell responses against multiple strains of MERS virus. Inovio's SynCon technology has the ability to activate immune responses against multiple disease-specific antigens and elicit broad protection against diverse unmatched strains of pathogens in humans. These DNA-based immunotherapy products have shown a favorable safety profile in clinical studies to date.
Inovio Pharmaceuticals Launches Clinical Testing of DNA Immunotherapy for Ebola
May 12 15
Inovio Pharmaceuticals (INO) announced that it has started the first phase of clinical trial evaluating its DNA immunotherapy for safety, tolerability, and immune responses in treating Ebola. In the pre-clinical testing stage, DNA-based Ebola immunotherapy protected 100% of immunized animals from death and sickness after being exposed to a lethal dose of the Ebola virus.
Inovio Pharmaceuticals, Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015; Provides Clinical Development Update
May 11 15
Inovio Pharmaceuticals, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company’s total revenue was $5.166 million for the three months ended March 31, 2015, compared to $2.357 million for the same period in 2014. The increase in revenue was primarily due to payments received from Roche under its partnership agreement established in September 2013. Loss from operations was $8.367 million against $10.000 million a year ago. The net loss attributable to common stockholders for the quarter ended March 31, 2015, was $10.581 million, or $0.18 per diluted share, compared to $10.821 million, or $0.20 per diluted share, for the quarter ended March 31, 2014.
The company is preparing to launch a phase III registration study of VGX-3100 in early 2016. Necessary steps include scaling up commercial-level production of its immunotherapy product and delivery devices, and completing an end-of-phase-II meeting with the FDA. As part of its expanding franchise targeting all HPV-associated precancers and cancers, the company reported preliminary data from its first cancer study, a head & neck cancer trial, showing that INO-3112 (VGX-3100 plus Inovio's IL-12 based immune activator) generated strong CD8+ T cell responses in 3 of 4 patients. The received regulatory approval to initiate a phase I study of the company’s prostate cancer DNA immunotherapy, INO-5150, targeting prostate-specific membrane antigen and prostate-specific antigen. The company intends to begin enrolling patients in the second quarter of 2015. The company initiated with its partner Roche a phase I trial for the company’s hepatitis B immunotherapy, INO-1800. This randomized, open-label, active-controlled, dose escalation study is evaluating the safety, tolerability, and immunogenicity of Inovio's hepatitis B immunotherapy alone or in combination with Inovio's IL-12-based immune activator. With collaborators under a DARPA-funded project, the company expects to start a phase I study of its Ebola immunotherapy, INO-4212, in the second quarter of 2015. The company reported that in a 12-patient phase I study the company’s single-clade PENNVAX®-B HIV immunotherapy induced in HIV-infected patients CD8+ T cells with functional characteristics similar to those of long-term non-progressors (rare HIV-infected individuals who, without treatment, do not progress to further stages of the disease): "Synthetic consensus HIV-1 DNA induces potent cellular immune responses and synthesis of granzyme B, perforin in HIV infected individuals," Molecular Therapy. Building on these data, the company created its global, multi-clade PENNVAX®-GP preventive and therapeutic HIV DNA immunotherapy candidate with funding via a $25 million NIH contract. The company expects that the HVTN to initiate a phase I study of PENNVAX®-GP in the second quarter of 2015. The company phase I/IIa studies of INO-3112 in head & neck and cervical cancers; INO-1400 (hTERT antigen) in breast, lung or pancreatic cancer patients; and INO-8000, targeting hepatitis C virus genotypes 1a and 1b, in collaboration with GeneOne Life Sciences, Inc., are ongoing.