J. Joseph Kim
Analyst · Charles Duncan with Piper Jaffray. Please go ahead with your question
Thanks, Bernie. Good morning, everyone on this transformative day for Inovio, our many shareholders and stake holders. I say transformative because we invested $727 million license agreement and strategic cancer vaccine collaboration with MedImmune we just announced this morning, and we just added a second major pharma partnership for Inovio’s CNA based immunotherapy technology. This significant deal also unveiled the pivotal step in our overall immuno-oncology strategy in which our goal is to take immunotherapy to the next level by planning a vital role in combination therapy. Let me outline the detail. MedImmune, which is AstraZeneca’s global biologics research and development arm, has acquired exclusive rights to our HPV cancer product called INO-3112. This immunotherapy targets cancer caused by human papillomavirus types 16 and 18 it is already in Phase I clinical trial for cervical and had a neck cancer. MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline and HPV-driven cancers. In addition, MedImmune and Inovio will conduct research and design of the two additional DNA-based cancer vaccine products that are not in Inovio's current product pipeline. MedImmune will have the exclusive rights to develop and commercialize these products. MedImmune will pay Inovio $27.5 million upfront, or development cost as well as development and commercialization milestone totalling upto $700 million. Inovio is also entitled to receive upto double digit sale royalties on INO-3112 product sales for the two additional cancer products MedImmune will fund development cost and pay Inovio certain development and milestone payments and royalties on sales. Finally, Inovio retains all rights to VGX-3100 for HPV-associated pre-cancer, in fact, our phase III preparations are progressing well and we are on track for a 2016 trial initiation. This new deal stands as Inovio’s second major pharma industry partnership in less than three years, adding to our global hepatitis B license with Roche. For a little background, just MedImmune deal would not have been materialized if not for the best-in-class T-cell data generated in our phase II trial of VGX-3100 which is the core of our newly licensed INO-3112 product. In fact, you all get much more detail from the VGX-3100 study, yes I’m pleased to report that a top tier peer-reviewed medical journal has accepted our clinical paper for publication. We don’t control the publishing date, but I expect you will see this publication by year-end. We have always said that all of us at T-cell and our immuno-oncology strategy begins with our T-cell. There are three characteristics that set our T cell activating immunotherapy technology apart from others and access the foundation for our cancer strategy. Number one, we activate T-cells in vivo meaning directly in the patient’s body. Number two, our immune responses are best-in-class generating fully functional antigen specific T-cells in high quantity without unwanted inflammatory responses and number three, the killing effect of those T-cells co-relates with better clinical outcomes and benefits. With these powerful T-cell characteristics, we are building an arsenal of cancer acting products that you will hear more about in due course. I want to emphasize we have only scrapped [ph] the surface of the cancer related antigen that we can mix and match to design new anti cancer products. So how do we develop and commercialize these products? Let me review the three strong strategy that we’ve been working on for some period of time. First, we aim to leverage the power of our products as mono therapies for single agents, second, we will advance immune-oncology combinations of our products with conventional oncology products and in particular third party immunotherapy subset checkpoint inhibitors and third, we will advance in-house immunotherapy combinations of our T-cell activating product with our own checkpoint molecule. I will expand on this strategy evidence. The oncology’s field recognizes that some cancers are potentially addressable with single immunotherapy such as that is as a monotherapy. This first throng [ph] may be more attractive for early stage disease and you have seen us move down this path with VGX-3100, our immunotherapy product for getting high grade cervical pre cancer. We also have plans to pursue other HPV related anogenital pre-cancer indications. There are slowly progressing early stage cancer for which immunotherapy may also be appropriate first line therapy such as prostate cancer, the second prong [ph] of immune-oncology strategy is to combine our T-cell activating product with complimentary immunotherapy technology where we believe we can contribute significantly to maximizing the clinical utility and the value of the combination. One of the most impactful technology development that has brought immunotherapy into the realm of oncology in recent years has been the success of checkpoint inhibitors which helps to overcome cancer cells ability to hide and protect themselves from T-cells, while this technology attracts a significant enthusiasm the fact is that individual checkpoint inhibitors have not exceeded overall response rates of 20% to 40%. As was expressed by leading oncologists at ASCO this year, this technology alone is not adequate. Taking the field of immunotherapy to the next level, requires more targeted and robust T-cell generation and Inovio’s cancer vaccine are designed especially to make that happen. If you allow me an analogy, think of checkpoint inhibitors as providing the ability to break down the patent [ph] wall in order to reveal the cancer cell hiding behind. But, there has to be an army of highly trained, well armed T-cells ready to move through the bridge and destroy the cancer cell, while that does not always exist naturally Inovio’s products activate the immune system to raise up and command these army of T-cells. Today’s field with MedImmune brings together these two powerful forces; let me make an important point. We have been signing for this step for a long time. We strongly subscribe to the notion that a product must first demonstrate its utility as a single agent before it can be considered potentially impactful and valuable as a component of a contamination [ph] therapy, look with all sorts of data; you are just waving your hands and hoping for the best. With VGX-3100 data and the first INO-3112 data in hand, we are optimistic about the prospects for 3112 to play a vital role as a product immune-oncology combination, and we will continue to initiate studies of cancer vaccines that will allow us to characterise the potential and undertake even more ambitious combination study. So the MedImmune deal is the first visible step in our plants combined other companies’ complimentary immunotherapy molecule as subtest checkpoint inhibitors. In a mutually beneficial combination arrangement, we’ve always said there is ongoing interest by multiple companies and our other organizations in these important T-cell generating capability. We will continue to strive for addition of partnerships that combine our T-cell generating cancer vaccine product with more checkpoint molecules. There is a third prong [ph] to our immuno-oncology strategy that I will detail briefly. Almost all current checkpoint inhibitors are based on conventional monoclonal antibody technology, when I say conventional these dMAb products must be constructed manufactured and purified in factory and then delivered into the body. This process is complex and expensive and you have already heard about Inovio’s stake about a DNA based monoclonal antibodies, we call them dMAb. Book an engineer, send any code for monoclonal antibodies directly and generate these antibodies directly in the person’s body so they combine with the targeted cancer cell and help break down the castle wall. While you have so far only heard of our dMAb in the context of infectious diseases, we have already constructed multiple dMAb base checkpoint molecule of our own and are testing these candidates in animal model. You will by end hear more about the first steps of Inovio’s team and products targeting cancer. So those are the three prongs of our immuno-oncology strategy that Inovio is executing on. We believe this is a winning strategy for Inovio, our shareholders and a broad set of patients in need. We already have and expect to soon show many further accomplishments and advancement in each part of this strategy. This morning’s call was of course originally scheduled as our second quarter review, so I’ll touch on some of the additional accomplishments I have and already mentioned. In the second quarter of 2015, DARPA, the U.S. Defense Advanced Research Projects Agency selected Inovio to lead a collaborative team to develop a preventive vaccine and treatment for those infected with the Ebola virus. It was the promise of our team [ph] that brought us to the DARPA’s table and sealed the deal for a $45 million grant. Remember, we also secured a $12.2 million award last fall from DARPA to also develop dMAb products for influenza and bacterial infections. And by the way MedImmune is already a key collaborator on both of these contracts. Second, in partnership with Roche, Inovio initiated a Phase I clinical trial which is now recruiting patients to evaluate our INO-1800 immunotherapy in patients who are chronically infected with hepatitis B virus. This trial initiation triggered a $3 million milestone payment from Roche to Inovio. Third, we secured a partnership with Europe’s largest cancer organization EORTC, to evaluate INO-3112 in combination with chemotherapy, chemo-radiotherapy for the treatment of patients with locally advanced cervical cancer. This trial is expected to begin in 2016 and will be part of MedImmune’s development plan for INO-3112. Finally, we continue to execute the steps towards launching our plan Phase III study of VGX-3100 in cervical dysplasia, a rigorous process of scaling up our immunotherapy production with all the quality assurances checkmark is advancing as is the scaling up of our commercial device design and production. We are aiming to meet with the FDA before year-end. We recognize that much of our progress is behind this team and is not readily visible, but our team, our hardworking dedicated team is working hard every day to advance our R&D and pre clinical work or our engineering and our clinical development. These programs never move as quickly as we would all like, but we are pleased with the important advancements we are accomplishing and we are where we need to be able to – to be able to play a vital role in the emerging immuno-oncology field. Now our CFO, Peter Kies will comment on our financials. Peter?