The Life Sciences Report: At Inovio Pharmaceuticals Inc. (INO:NASDAQ), you are developing therapies in a variety of cancer and infectious disease indications. Is there a common thread that links the types of therapies you're developing?
Joseph Kim: We do have a common thread: It's our DNA-based platform of product development. All of our products are designed with synthetic DNA sequences that encode for a particular antigen, whether that antigen is from a cancer or an infectious disease agent. We have designed T-cell and antibody-generating vaccines and immunotherapies that can jumpstart our patients' own immune systems to fight off cancer cells or invading pathogens like viruses and bacteria.
TLSR: Let's get right into the different things Inovio is working on, starting with VGX-3100. You have plans for several trials in Phase 3 and Phase 2 with this compound. Can you describe what you're looking at with this particular therapy?
JK: VGX-3100 is a treatment for diseases caused by a human papillomavirus (HPV) infection. We have shown in our Phase 2b study of VGX-3100 in cervical dysplasia, or cervical precancer, that we can make these cervical precancers go away by boosting the patient's own immune system. In addition to clearing the disease through this noninvasive immunotherapy, we have also shown that we clear the virus that caused the disease in the first place, which otherwise chronically stays in the cervix of the patient. At this moment, we are waiting for the FDA to give us a green light to start our Phase 3 clinical studies in the cervical dysplasia indication.
We also have gotten the OK from the FDA to start applying VGX-3100 in treatment of a similar disease caused by the same viral infection, called vulvar neoplasia, or precancer of the vulva. We plan to start a Phase 2 clinical trial in this indication in 2017, and we look forward to seeing efficacy and safety data from this patient population as well.
TLSR: It sounds like the study you're doing in head-and-neck cancers with MedImmune (a subsidiary of AstraZeneca Plc [AZN:NYSE]) is also HPV-related. Is this a similar therapy?
JK: Yes. MEDI0457, the product we licensed out to MedImmune in 2015, is built based on VGX-3100, with an added component, an interleukin-12 immune activator, that was also developed by Inovio. It is a very similar product.
What we licensed out to MedImmune in our MEDI0457 deal involves the granting of these treatment areas involving HPV-caused cancers, such as head-and-neck, cervical and other anal and genital cancers. MedImmune is studying MEDI0457 in combination with its PD-L1 inhibitor in metastatic head-and-neck cancer patients first, but we expect it to expand into other cancer indications in coming months.
TLSR: Is what you're doing with Regeneron Pharmaceuticals Inc. (REGN:NASDAQ) in glioblastoma along the same lines—coupling your T-cell activation with a PD-1 inhibitor?
JK: Yes, exactly. Our recently announced collaboration deal with Regeneron allows us to combine Regeneron's PD-1 inhibitor with our new cancer therapy, INO-5401, which is composed of three of our top cancer antigens selected through extensive preclinical work, which allows us to generate high levels of killer T-cells in patients who, in this case, have been newly diagnosed with glioblastoma multiforme (GBM).
We expect this combination trial to demonstrate a one-two punch, with the T-cell-generating capabilities of INO-5401 combined with Regeneron's PD-1 inhibitor, which is designed to shut down the defensive mechanisms of these tumors. We're very excited, and we look forward to getting patients enrolled for the study.
TLSR: Can you give a timeline for that?
JK: We just signed and announced this agreement. We expect the clinical study to be approved and to start enrolling GBM patients in H2/17.
TLSR: One of the major obstacles in treating GBM is that you have to get across the blood-brain barrier. Do either of these compounds have the ability to cross that barrier?
JK: In general, the blood-brain barrier presents a very complex situation. It really depends on the disease and the patient. We believe we will have T-cells and antibodies that can traverse through the barrier to impact the disease in a positive form.
TLSR: In April, you released some positive preliminary results in the expanded Phase 1 study of your Ebola DNA vaccine. Could you give us an update on that vaccine, as well as your Zika vaccine and any of the other vaccines moving forward in the Inovio pipeline?
JK: In February and again in April, we presented multiple infectious disease vaccine Phase 1 data that, put together, present a great demonstration of our product platform's capabilities, as well as each vaccine's ability to generate strong immune responses, respectively, in each of those indications. Let me go one by one.
INO-4212 is a vaccine designed to prevent Ebola infection and disease. It's funded with a $45 million ($45M) contract from the Defense Advanced Research Projects Agency (DARPA). We have presented on our first 200-subject study. In this evaluation, we reported that 170 out of 179 evaluable subjects demonstrated strong antibody responses, which is a measurement of how well the vaccine is working in these volunteers. That's a 95% seroconversion rate, or a 95% immune response rate, in these subjects. We were very excited about this. We reported this most recently at the World Vaccine Congress in April.
We also reported on a 40-person study with our Zika vaccine. Similar to what we reported for Ebola, we had all 39 of 39 evaluable subjects generate strong antibody responses as well. That's a 100% seroconversion rate, or immune response rate, in this Zika vaccine Phase 1 study.
Last but not least is our Middle East Respiratory Syndrome (MERS) vaccine study. It's being conducted in 75 volunteers in the United States. Similar to our Ebola and Zika vaccines, consistently we saw over a 92% seroconversion rate. When you combine that with the T-cell responses, the response rate overall goes to almost 100%.
What these studies demonstrate is the potency of the vaccine in each indication in a substantial number of subjects in each study. Collectively, the even more powerful message from these three studies is the level of consistent, robust immune response we see from three different vaccines against three different pathogens. We are able to generate high percentages of responders with strong antibody responses in these populations.
TLSR: Can you anticipate when any of these would get FDA clearance and could be used in the field?
JK: These things do depend, especially with MERS and Ebola, on what the outbreak conditions are and so on. But for the Ebola vaccine, we are planning to have a meeting with the FDA in H2/17 to map out a clearer path for getting this product approved through the FDA. MERS is following a similar path. For Zika, which is slightly different, we are designing a Phase 2 clinical study based on our successes from the Phase 1 study.
All of these products could have an expedient approval path. We will certainly have a lot more information on the clarity of these paths in H2/17.
TLSR: Would you provide an update on development of your PENNVAX vaccine?
JK: PENNVAX is our HIV vaccine, which was initially designed and developed through a $25M contract from the National Institutes of Health (NIH) in 2008. We received follow-on funding of $16M in support of our HIV program. PENNVAX-GP, the product itself, is undergoing a Phase 1 clinical study in 94 volunteers in the U.S., conducted by the HIV Vaccines Trials Network (HVTN), an organization funded through the NIH. The study was fully enrolled last year. We expect to have the first reporting of immune responses and safety for this vaccine later in May, at the HVTN Conference.
TLSR: What milestones and catalysts do you foresee over the next few quarters that investors might be interested in watching for?
JK: Let's start with data reports. We started off the year with positive Phase 1 data from our Ebola, Zika and MERS clinical studies.
We expect to have at least three more clinical data reports in 2017, starting with PENNVAX-GP for HIV. We also expect to report on a 60-patient prostate cancer therapy study at cancer conferences in 2017, and on a 90-patient Phase 1 study for our therapeutic vaccine for hepatitis B infection, an immunotherapy product named INO-1800. We are very excited about reporting on these three studies in 2017.
We will cross additional milestones by starting four different clinical studies with efficacy endpoints built into them as our primary outlook. One is our Phase 3 study for cervical dysplasia. Second is the Phase 2 VGX-3100 treatment for vulvar neoplasia. Then there are two other cancer studies with a Phase 2 component built into them. This includes MEDI0457 in a metastatic head-and-neck cancer patient study, in combination with MedImmune's checkpoint PD-L1 inhibitor. Last but not least is INO-5401 in combination with Regeneron's 2810 PD-1 inhibitor in treating newly diagnosed GBM patients. Starting each of these studies represent meaningful milestones.
TLSR: You have a pipeline that is pretty expansive. Can you talk about how Inovio manages so many programs—so many irons in the fire, if you will?
JK: Inovio is no longer a small or early-stage biotech. I consider Inovio a midstage life sciences company with later-stage products in a very full product pipeline—one Phase 3 program, three Phase 2 programs, and multiple Phase 1s behind that. We have a very coordinated and extensive clinical product pipeline, in contrast to most of our peers in biotech. We're more akin to bigger companies like Regeneron, when compared on the philosophy of developing multiple products through our platform.
In terms of our focus, obviously we put the majority of our efforts in later-stage products. We also gain extensive funding through our partnerships and collaborations—through companies like MedImmune and Regeneron, as well as external funding from DARPA, NIH, the Bill & Melinda Gates Foundation, just to mention a few.
We are able to do a lot with the very dedicated group of individuals who come to work at Inovio every day, with the mantra that the patients are waiting for the new medicines we're so much looking forward to bringing to the market.
TLSR: Is there anything else you would like investors to know about Inovio?
JK: Let me just add that our maturing into a larger biotech company is not just about the size of our market or the number of employees, but really the amount of data we have collected in all the clinical studies throughout our pipeline. We have dosed over 1,400 people in various clinical studies, 4,000 separate times, and shown a very strong safety profile, unmatched by any other novel therapy or vaccine platform out there. In terms of effectiveness, we've seen very robust and consistent immune responses in almost 1,000 of these patients, and counting.
We at Inovio can be very proud of this collection of data, but they also give us a lot of confidence in terms of going into various targets, including glioblastoma, where we know we have a very safe product. We are hopeful that we, in combination with PD-1, can bring about important benefits to patients. We are very excited about where this company is going, and where our programs are going in the near future.
TLSR: Thank you very much.
Dr. J. Joseph Kim was appointed president and CEO of Inovio Pharmaceuticals in June 2009. Dr. Kim cofounded VGX Pharmaceuticals, a synthetic vaccine company, in 2000, to develop intellectual property related to immunotherapeutics licensed from the University of Pennsylvania. He led that company for nine years and acquired Inovio Biomedical in 2009 to form Inovio Pharmaceuticals. Previously, Dr. Kim was a senior vaccine developer at Merck & Co., where he successfully led efforts in manufacturing and process development for several FDA-approved products for hepatitis, and developmental vaccines and therapeutics for HIV/AIDS. Dr. Kim earned a bachelor's degree in chemical engineering and economics from the Massachusetts Institute of Technology, where he was a U.S. Senate Honors Scholar. He holds a Ph.D. in biochemical engineering from the University of Pennsylvania, and a master's degree in business administration (finance) from the Wharton School. Dr. Kim has published more than 100 peer-reviewed scientific papers, holds numerous patents and sits on several editorial boards and review panels.
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Disclosure:
1) Tracy Salcedo conducted this interview for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She owns, or her family owns, shares of the following companies mentioned in this interview: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
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3) Inovio Pharmaceuticals Inc. had final approval of the content and is wholly responsible for the validity of the statements. Opinions expressed are the opinions of Joseph Kim and not of Streetwise Reports or its officers.
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