Inovio Pharmaceuticals Clarifies Facts of its VGX-3100 Phase II Trial and Immunotherapy Technology Inovio Responds to False and Misleading Speculation Regarding Immunotherapy Study
BLUE BELL, Pa., June 11, 2014 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) wishes to clarify that a third party article published on June 10, 2014, was misrepresentative of facts and can only be taken as malicious. The referenced article does not reflect the progress, status, and potential of Inovio's active immune therapy technology and products and is rife with false and misleading conjecture.
As previously communicated on multiple earnings calls and in other public forums, Inovio has indicated that it expects to report mid-year the top-line results of its phase II clinical trial evaluating VGX-3100 for the treatment of cervical dysplasia. We designed this double blind, placebo controlled phase II study to comprehensively measure efficacy, HPV viral clearance, immunogenicity, and safety. At this time the data remains blinded. We aim to report this data by the end of July.
With respect to efficacy, we are measuring regression of disease from late stage cervical pre-cancer (CIN2/3) to early stage pre-cancer (CIN 1) or elimination of disease. The study is 80% powered to achieve a 52% response rate among vaccinated subjects versus a hypothesized 25% in the placebo group. This 25% figure was chosen based on response rates of natural regression that have ranged widely between 4% and 40% in other studies.
We are hopeful that these results could lead to a novel therapeutic option for women to avoid the invasive current surgical procedure. There exists the prospect that our immunotherapy approach may eliminate the presence of HPV virus to minimize future recurrences.
What we are also measuring in all of these patients are T cell responses. T cells are the vital agent of oncology immunotherapies. This has been clearly validated by the recent advancements of checkpoint inhibitor products, which have achieved admirable results based on their ability to allow T cells to perform their intended function (killing targeted cells), as well as in unrelated CART technology products.
Overall, Inovio designed a technology platform to generate antigen-specific T cells with the potential to eliminate cancers and infectious diseases. T cell data from our phase I study of VGX-3100, our DNA immunotherapy targeting pre-cancers and cancers caused by HPV, showed that our SynCon® DNA-based immunotherapy delivered with our CELLECTRA® device generated systemic T cell responses with magnitude and durability exceeding other technologies. We also measured and showed the killing effect of these T cells against the targeted cells. No other technologies have demonstrated T cell responses on par with Inovio's, including those referenced in yesterday's article. These T cell results are precisely why Inovio is executing its plans to expand Inovio's HPV therapies to treat head and neck cancer (announced June 10th) and cervical cancer this quarter. These T cell results also provide us confidence in our plans to broadly go after other major cancers with our proprietary immune therapy products INO-5150 for prostate cancer (with Roche) and INO-1400 (breast, lung, and pancreatic cancers) in 2014.
Moreover, with this CIN 2/3 phase II study Inovio is in a position to show for the first time how the level of T cells and their specific functions in the body may be correlated to clinical efficacy in an active immunotherapy setting using a large, controlled study. The correlation between T cells and efficacy could be instrumental in guiding Inovio's development path for its technology, using different products and technology combinations to target cancers and infectious diseases. As has been pointed out by many astute investors and industry experts, the value of such T cell immune data cannot be underestimated.
It was with hesitation that we have responded to inane conjecture. However, we have received a substantial amount of communication from stakeholders and wished to reiterate the facts around our technology, products, and clinical study.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2013, our Form 10-Q for the quarter ended March 31, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
SOURCE Inovio Pharmaceuticals, Inc.