James Laufenberg, CEO of ImmunoGenetix was interviewed by OneMedRadio where he discussed a therapeutic DNA based composition to treat HIV, GenePro. “The idea with GenePro is that what we want to do is synthetically mimic a virus so that there’s an effective stimulation of the immune system,” Jim says. Considering this safer approach to HIV treatment, the company has a promising future. See audio and transcribed interview below.
Brett Johnson: Good day, this is Brett Johnson with OneMed Radio in New York City. Today, we are with Jim Laufenberg, who is the chief executive officer of ImmunoGenetix, a Lenexa, Kansas based firm that’s developed vaccine treatments for HIV called GenePro. Jim, thanks for joining us today.
Jim Laufenberg: Well, thank you, Brett, for having me.
BJ: So can you tell us a little bit about GenePro and where you are in its development?
JL: Yes. GenePro is a therapeutic DNA based composition that we have taken out of the University of Kansas by an inventor that was recruited there from Johns Hopkins, Dr. Opendra Narayan. He’s a well published and received over $20 million in NIH funding towards this composition. We have published in the non-human primate and we’ve had our meeting, initial pre-I&D meeting with the Food and Drug Administration and we’re engaging in that process.
So we’re rather teed up on a number of exciting things to move forward now to open up our I&D. What we need to complete now are two I&D enabling studies and we’re using a delivery device called the TriGrid electroporation delivery. So we’re partnering with Ichor Medical Systems in San Diego and most of the developers in DNA vaccines are looking at electroporation to enhance uptake of this molecule.
BJ: Uh-hum.
JL: We anticipate, you know, doing our obviously safety, toxicology, and some immunogenicity data going forward and if everything goes according to plan, we’ll open our I&D next year to initiate a phase I2a clinical trial.
BJ: Sure.
JL: And I’m sure it’d be positive. Yup.
BJ: So what does GenePro do and what problem does it solve?
JL: Well, currently, HIV is being treated by anti-retroviral therapy known as drug cocktails. So there are about a dozen drugs that clinicians use and they manipulate these drugs and use three or four at any given time in their HIV-positive patients. Unfortunately, these drugs are starting to show resistance that are being developed and one out of four patients will develop drug resistance to one of those drugs and also some very untoward side effects such as increased fat and sugar in the blood stream. So, you know, while they have been somewhat of godsend in treating HIV from developing into AIDS over the past decade, there is an unmet need to have new approaches.
DNA vaccines and GenePro have the promise of reconstituting the immune system so that our natural immune defenses can find this virus, attack it, and bring it down. We could talk a little bit about some very recent findings around what are called elite controllers if you’d like to get into that, Brett.
BJ: Sure. If you can give us sort of a layman’s description of how this stuff works, that’d be fine.
JL: So, what happens is that there is a white blood cell that will attack viruses as they enter our body and in HIV, we don’t do a very good job of detecting that virus. But there’s a small population in society that can normally suppress this virus and they’re called elite controllers or long-term non-progressors. Well these elite controllers, about 3% of the population generate this very specific white blood cell called the CD8 memory cell specific to HIV and they can actually control this virus without having drugs on board, and that recently was found and published in reputable journal.
We have published data both in the mouse model as well as the macaque Rhesus model showing that we generate this specific type of white blood cell, the CD8 memory cell. So that GenePro can actually find the virus, take it down to undetectable levels, and then allow these memory cells to lie low in case that virus reappears. That’s very exciting. There was a lot of language going on right now saying that this s a functional cure in the industry and the area of HIV and AIDS is focused on these functional cures such as potentially what GenePro has.
BJ: Sounds very exciting. So where did the technology come from and can you tell us a bit about the background on the science?
JL: Well, yes. The technology came from the University Kansas Viral Pathogenesis Lab. Its director was Dr. Opendra Narayan. He is now deceased. He was affectionately known as Bill and Bill was widely published in over 150 peer-reviewed journal articles and again substantial funding from the NIH through a series of R01 grants. This vaccine essentially has been passaged through various animal models rendering it relatively safe.
The idea with GenePro is that what we want to do is synthetically mimic a virus so that it’s very important so that there’s an effective stimulation of the immune system, a natural stimulation of the immune system. So therefore, it’s a rather aggressive composition with seven genes representing this virus and a series of genes that are deleted or left off so that GenePro does not cause safety issues such as integration into the body itself.
BJ: I see. So in terms of getting this into the market now, where are you at in the development of this product?
JL: We’re completing what we hope is the remaining I&D enabling studies in rat and rabbit and hopefully opening an I&D about this time next year to enter into a phase I2a clinical trial in 30 to 40 HIV-positive patients. We’d like to hold that trial close by at the University of Kansas if possible so that we can recruit locally, but also receive some economic development grants and also support with the National Institutes of Health. Therefore, we would obtain both safety data in man and efficacy data somewhere in the timeframe of the end of 2013 if everything goes according to plan.
What we hope to do during that process is to attract enough attention from the industry to provide partnership capabilities to move forward after that point.
BJ: Terrific. Can you talk about from a corporate side in terms of investment that has gone into the company and who’s invested and how much you’re looking to raise in the future?
JL: Right. So, Brett, we have a very clean cap table consisting of accredited angel investors and that’s all in common stock, voting stock and that’s about half of our cap table. The other half of our cap table is economic development convertible notes. And we have a small preferred series A stock that actually can be bought out. So again, that’s a relatively clean cap table with a pre-money valuation of $8 million based upon fully diluted share at a dollar a share.
BJ: And you’re looking to raise how much?
JL: Yeah. Well, currently, we’re concluding a $1 million round. In addition to that, we have a matching about a half million dollars that was announced from the Kansas Bioscience Authority and that’s a non-dilutive grant for this developmental activity and these are pre-I&D activities right now.
And in the State of Kansas we can use transferrable Kansas angel tax credits for high net worth individuals who invest between $50,000 to $100,000, they actually get a 50% tax credit. For those high net worth individuals that are out of the state of Kansas, there’s actually a market for those tax credits. So it’s really a great way to influence development of unique technology in the state of Kansas and that’s why we’re in Kansas.
Then when we go out to San Francisco in January, we will be launching a $5 million round in order to anticipate our phase I2a clinical trial.
BJ: Perfect. Can you tell us a little bit about your background and the other members of the management team?
JL: Right. So we have a small board of directors, there are five of us and I’m sure of that. My background is a business background. I have an MBA. I have 25 years at Marion Laboratories and its iterations now, so Sanofi-Aventis. The other members of our board are all industry-specific individual, deep experience. We have an entrepreneur out in San Francisco Dr. Bill Garner who has Harvard training. He’s launched a number of companies and he provides really good scientific advice as well. The other members of our board have finance, legal, and foundation and human resource. The most important thing I can say about our board is that we’re all on the same page. We understand our exit points and our mission to have a return for our investors with an appropriate exit.
BJ: Terrific. Can you talk a little bit about sort of the scope for this opportunity and what the possibilities can be for GenePro?
JL: Right. Brett, the promise of GenePro technology and DNA vaccines generally is that they can change the way these diseases are treated in a safer approach. Specific to GenePro, we would anticipate a clinician being able to put their patients on GenePro, deliver it on a quarterly basis in the clinic much like oncology drugs are delivered. And then as the patients are monitored with the viral load and a different type of white blood cell, CD4, measured, they could provide drug holidays for their patients on these toxic drug cocktails.
As clinicians gain experience with GenePro, they could delay the onset usage of the drug cocktails as well and I think clinicians would really welcome that type of flexibility. Of course what that also could do, by allowing a reduction in current standard of care drug therapy, you could more than likely reduce the overall cost of healthcare.
BJ: Well certainly that would be something welcomed in this day and age. That is Jim Laufenberg who is the CEO of ImmunoGenetix, a Lenexa, Kansas private firm that has developed GenePro, an interesting treatment for HIV. Thanks for joining us today, Jim.
JL: Thank you, Brett. Have a great day.