Exclusive interview for SPINOFF.COM with Prof. Kiana Aran from Keck Graduate Institute, the University of California, Berkeley, the inventor of MucoJet, non-invasive & needle-free device for immunization and drug-delivery

MucoJet іs a pіll-sіzed devіce that blasts vaccіnes through the іnsіde of the cheek wіthout paіn. The technology was developed by Kiana Aran, Assistant Professor, Medical Diagnostics and Therapeutics at Keck Graduate Institute and Visiting Professor at UC Berkeley, in collaboration with a group of bіoengіneers Dr. Irina Conboy, Dr. Niren Murphy and Prof. Dorian Liepmann at the Unіversіty of Calіfornіa, Berkeley. The technology has a great potentіal to accelerate the development of nonіnvasіve oral vaccіnes for the mass immunization. MucoJet іs admіnіstered orally and placed next to the buccal tіssue wіthіn the oral cavіty and uses a gas-generatіng chemіcal reactіon to produce a hіgh-pressure lіquіd jet of the vaccіne. Noninvasive immunization will revolutionize the global health market by providing easy-to-administer vaccines at low cost, easy to use, enabling mass immunizations during pandemics without a need for a special medical personnel.

SOC: Dear Professor Aran, we are so grateful for your generosity this day in spending time speaking with us and sharing your insights about your breakthrough non-invasive drug delivery technology MucoJet. Our investors and we would like to learn more about a vast experience in biomedical engineering of your academic endeavours and your scientific background.

Prof. Kiana Aran: I have done electrical engineering by under graduating biomedical engineering for my PhD and bioengineering for my postgraduate officer who is also a faculty fellow. Currently, I'm the Assistant Professor of Bioscience in Keck Graduate Institute Claremont. My expertise is designing innovative medical devices for the diagnostic and therapeutic application. I have been involved in designing non-invasive drug delivery devices and the MucoJet technology for the last six years. I have been doing a lot of work on drug delivery diagnostic and technology. I am working on designing instruments for reverse ageing and being involved in a lot of medical technologies.

SOC: Considering your tremendous experience, we would like to know whether you had other then Mucojet projects? Could you please share the story of their creation and success.

During my PhD, I designed a platform that was the cardinal system to monitor information technology is used for monitoring access implanter respond during cardiac surgery. It allows surgeons to intervene on time during the surgery. Also, I am working on different technology now.

We're trying to develop systems that exchange the blood components between old and young blood, we now making trials on animals and look at the ageing effects. In collaboration with Doctor Irina Conboy from the University of California, Berkeley we are developing the next generation of blood exchange system, where we're trying to identify a factor in the blood that is associated with aging and hopefully removes them from the old patients or add these factors from young to old patients to improve their health. I think it will have a great impact on the healthcare industry and there potentially a lot of investors would be interested in that project as well.

SOC: Brilliant! Thank you for making people healthier. And if to talk about MucoJet I would like to hear more about this technology, its creation and which stage of commercialization this technology at? Was your project funded by any state financing or grants? Has it already received any honours or awards?

Prof. Aran: We started to make MucoJet for intestinal delivery and we developed few systems for intestinal soaking delivery first. But that was very hard to find the good animal model. So then we decided to try this system in the oral cavity. That's when we noticed a new mucosal response and we a got really impressive results, those which cannot be achieved with the skin vaccination. There is a range of qualities that injectable vaccines are not able to accomplish. The secret to this easy-to-administer vaccine is that it infiltrates an area known as the buccal region, which is plentiful in immune cells. Those cells can often be hard to reach sufficiently due to the thick mucosal layer. Such system was able to generate that.

The MucoJet technology is rather simple. It is pill-sized and has a bulb on the end that patients squeeze to break a thin membrane separating two compartments: one filled with water and the other, a dry chemical propellant composed of citric acid and baking soda. When the two components mix together due to the chemical reaction, they generate small pressure that is enough to push on a piston in the device, which forces a small reservoir of the vaccine out the other end through a small nozzle. When it enters inside of the cheek, the nozzle squirts the vaccine through the mucosal layer, which is difficult to penetrate without a needle.

The strong but painless jetstream offered by the MucoJet is able to break through the mucosal layer and causes the desired immune response. Other vaccines that are able to generate this effect are mostly life attenuated vaccines like a nasal flu vaccine, those are the live vaccine and that's why it cannot be administered to the young children or elderly patients. With our system, we are able to use protein-based vaccine having the new response compared to just a simple delivery. The technology of intestinal delivery and protein delivery has already been licenced and it's going to get to the clinical trials stage next year. It hasn't been licensed for vaccine delivery and for other drug delivery are still available for licensing.

I worked as a postdoctoral scholar in professor of mechanical and bioengineering Dorian Liepmann’s lab, as well as professor of bioengineering Niren Murthy’s lab. Actually, after some publications, we gain a great interest from some pharmaceutical companies. There are some prospective investors that are interested in licensing the technology. It was also presented at a lot of international conferences.

Our technology was recently published in March 2017 in Science Translation Medicine. It was actually presented on the banner the website and it got a lot of international attention as well. It was nominated two times for the Best Innovation at the University of California, Berkeley. Currently, we are rising the National Institute of Health (NIH) funding for it. We keep all this publicity after the work was patented and published to protect it.

SOC: Thank you Professor Aran. We are dealing with different kinds of spinoffs from different places of the world and at different stages of development. And you know, this week we mostly dedicated to technologies which are at the initial stages of their development. It sometimes rather challenging to present those technologies to investors because of lack of materials to present the innovation. We still do our best and really try to find the investments for such technologies also as they are really brilliant. So to continue our interview I would like to ask you about the team members as for sure you are not alone in your trip and you have some good team members who worked on this technology.

Prof. Aran: I developed the technology while I was in Berkeley. I used to work in collaboration with Dr. Irina Conboy, Dr. Niren Murphy and Prof. Dorian Liepmann. They supported me in development of the technology. I also had two colleagues which helped in designing the system as Mark Chooljian and Jacob Paredes. But the majority of the main design and testing and animal experiments were performed by me and my undergraduate students.

Dr. Dorіan Lіepmann іs a Professor of Bіoengіneerіng and Mechanіcal Engіneerіng at the Unіversіty of Calіfornіa, Berkeley. He holds B.S. and M.S. degrees іn Chemіcal Engіneerіng from the Calіfornіa Іnstіtute of Technology, and a Ph.D. degree іn Applіed Mechanіcs from the Unіversіty of Calіfornіa, San Dіego. Dr. Lіepmann іs a faculty member at Applіed Scіence and Technology Graduate Group. He was awarded Lester John and Lynne Dewar Dіstіnguіshed Professorshіp іn Bіoengіneerіng and fellowshіp from the Amerіcan Іnstіtute for Medіcal and Bіologіcal Engіneerіng.

Dr. Nіren Murthy іs a Professor of Bіoengіneerіng at the Unіversіty of Calіfornіa, Berkeley. He receіved M.S. degree from the Unіversіty of Іllіnoіs at Chіcago and a Ph.D. degree from the Unіversіty of Washіngton, both іn Bіoengіneerіng. Dr. Murthy’s research іs focused on developіng new materіals for drug delіvery and molecular іmagіng. He receіved Socіety for Bіomaterіals Young Іnvestіgator Award, Іndus Global Іnnovators Award, and NSF Career Award.

The other contrіbutors are Mohammad Rafі, Kunwoo Lee, Allіson Y. Kіm, Jeanny An, Jennіfer F. Yau, Helen Chum. The study was supported by T32 traіnіng grants and by the Berkeley Sensor and Actuator Center.

SOC: Thank you Professor Aran. It's not a secret that тew technology and its subsequent commercialization presupposes some problem and addressed to someone that unmet needs. Respectively, what's problem did you intend to solve by creating the technology and what results do you plan to achieve?

Prof. Aran: So, we're continuously developing different versions of systems for different tissue types for different mucosal tissues. I really believe that the technology is the next generation of drug delivery system because we cannot afford these expensive formulations anymore. You know the optimization takes years and years. Drug-device combinations of mechanical devices are getting a lot of more attention. Recently, a company called Ranic Therapeutics has developed ingestible microneedles in collaboration with Novartis. Rani’s proposed to design a capsule that consists of two chemical compartments filled with citric acid and sodium bicarbonate, respectively. They are a bit similar to our technology but we have other benefits and advantages which I've already mentioned.

MucoJet technology is very simple in use. The previous technologies that were used in the past for subcutaneous injection into the general skin which is so hard to penetrate. They have to use much higher pressure. In addition, dermal vaccination cannot generate mucosal immunity. I just combined few concepts that easy to distribute, cheap to make and is not require any anything else. It just creates the small pressure, because penetrating the mucosal tissue way easier than penetrating the skin barrier.

With Microjet we can deliver much more vaccines that should underlying immune cells in the mucosal tissue. if you're introducing something through the mouth you generate a mucosal immunity. I'm very optimistic that this technology will make people trials in the next two or three years. It will be successfully applied for very different applications and not only for the vaccine but also for drug delivery because there is no significant damage associated with pressure, it is so small, around 30 to 40 Kilopascal, that is similar to the water steam.

We also decided to develop this technology for mass distribution. This technology so cheap to make and it can be mass produced by injection molding. The infrastructure for manufacturing already exists. There is no need going to have a new infrastructure. Secondly, it can be distributed to patients and there is no need for extra personnel to give the shots.

However, you know if you giving it to children you need to make sure that they take the vaccine in the device in a right orientation. In order to achieve that I have a design that you can actually put the device in a lollipop shape you know and have the kids hold the lollipop in their cheeks. That could potentially be one solution.

SOC: Dear Prof. Aran can you make one with cola taste, because my daughter likes Coca-Cola lollipops. Thank you so much. Totally agree. Sorry for interrupting.

Prof. Aran: Yes, sure (laughing). But if to tell the truth, I think you know that design is very important especially if you're vaccinating kids. If the kids see a big gun-shaped jet inject they would be so scared as much as they're scared of the needle invasion, but if they see a lollipop they would love to get vaccinated. Our technology doesn't create the fear and believe me or not 20 percent of adult people have this fear of vaccination and not only children. It's a big deal.

Can we actually have the vaccine in a powder form? Yes, and I think that there is one more improvement that would be made with the technology. We're going to use other components and to improve the shelf life of the vaccine because such components in powder can be kept for a longer time without a need for them to be put into the refrigerator. So that another thing we are looking to solve. As I said, this technology was designed for mass distribution, hopefully without the need for any skilled personnel.

SOC: I would like to also to read such crucial issue as unique selling points of the approval of our technology and what are the unique selling points of technology and fundamental differences from other technologies.

Prof. Aran:  I think the closest competing technology with us is Pharma jet which is designed for subcutaneous injections which have high pressure. It might, of course, be applied in the mouth, but is not very convenient, because the capsule which holds the drug needs to be changed contrary MucoJet. Also, that technology it's not cheap and cannot be mass produced. The distributing system is also under rather high pressure, so it might damage the tissues and create injury inside the patient's mouth or any other mucosal tissue. Compare to such closed technology to us, our benefits are that MucoJet is much cheaper, much smaller and a capsule can be preloaded without, it's very easy in use so a patient just clicks when he wants to get the vaccine or the drug dose. And for that reason, I think our technology is more effective and especially that previous technology has been a mucosal vaccination and mucosal delivery and our system is the first system to deliver the drug into the mucosal tissue with much less pressure.

SOC: Who owns the IP of the technology?

Prof. Aran:  You need to contact the University of California, Berkeley for that. However, as I mentioned the usually contact me to discuss the potential candidates in order to approve the investors who want to license the technology because they want to protect the inventor. But, as I mentioned this technology is currently licensed by one medical company in San Diego for intestinal delivery of therapeutics. However, it still available for licensing for vaccination and other mucosal tissue.

SOC: Thank you professor Aran. And we would like to ask about the possible addressable markets for your technology. Could you please share with us what might be the best addressable markets?

Prof. Aran: There are four possible markets. First is vaccination market, which is the most important. The second is allergies immunotherapy market as a lot of kids and adults have allergies. They have to go through injection on a weekly basis and to continue for around three years. MucoJet will be a perfect solution for this kind of therapy. The third thing would be a therapeutic market for the intestinal delivery of different drugs like inflammatory drugs or another type of drugs. Insulin market is very difficult because it has a very narrow therapeutic window which might be hard to achieve. But we had companies that wanted to try MucoJet technology for insulin delivery.

SOC: What might be in future technology applications?

Prof. Aran: I think the fastest one will be the delivery of protein-based drugs using our non-invasive delivery system because it is easier to complete the pre-clinical and clinical trials compared to vaccination. For vaccination, you have to make sure that the duration is effective and it needs more time, although this method is not so difficult and rather durable.

SOC: We always need to paint a clear picture to potential investors of spinoffs why in your opinion is your future technology might have a high growth potential?

Prof. Aran: The first thing a lot of drugs are reaching their patent life. They can be placed in systems and then you can have patented them again. So, with our technology, many pharma companies may increase the patent life of their drug by changing the delivery method. The second thing, I would say that the cost of developing one drug has reached 800 billion dollars. With MucoJet there is much less formulation modification needed. I think a lot of companies are interested in that. I also like to mention injection procedure. There's a lot of drugs that are being developed for infectious diseases and cancer procedures. That's when a patient has to go to hospital or clinic to get these injectables, so replacing those procedures with something noninvasive that will be really helpful.

SOC: Thank you, professor. And I would like also to ask you whether you already had signed contracts or if yes then what was the feedback from the partners.

Prof. Aran: No, not yet, but I think the best way for our future partners as well as for the prospective investors would be licensing of our technology. The technologies are already developed and there are a lot of pharma companies who want the technology and they can test the delivery, it's the cheapest way for them. Otherwise, they need to get into collaboration and work with the university, then they have us validate our system are for the drug of interest. Once it validated then it can be licensed, that's specific. But the best way for that pharma companies just license the technology and then I can assist with technology development to meet their specific application. It's much cheaper for investors actually. 

SOC: We would like maybe also to invite you to our competent centre. At that part of our platform, we have the interview with competence centres representatives from different areas of activity but all dedicated to science spinoffs support. They advice spinoffers how they need to act, with the IP strategy etc. You really have great experience in such spheres. I know that you also very strong in research and development. Do you have the unique strategy for your technology development? Which processes do consider your spinoffs is strong at?

Prof. Aran: The place I work at right now is called Keck Graduate Institute Claremont. It has a big graduate centre that is strong at Master of Business & Science training. We train S&B Master's students in it and lot of companies are working with us as well. The investment into their training is not that big, actually about  $100k for four Master's Degree students who are trained in science and business center. We forth collaboration with Master's students who are good in business science and work together to develop a project for companies to get them so they can be acquired or get to clinical trials. This is really great because we have over 100 companies working with and we developed something that we see the path for the market. 

And the second one I'm developing now is the system for ageing that diverse and improves an anti-ageing effect.

SOC: I would like to ask you about the intellectual property. We know that it's the key to success to every spinoff and investors pay particular attention to it. What intellectual property do you already own?

Prof. Aran: Yeah, I have four patents and this one is owned by the University of California, Berkeley (IPIRA).

SOC: And respectively sometimes patent validity period becomes shorter. It's interesting to know your protection plan for your technology and maybe your technological advancement and leadership in the medium and long-term prospective.

Prof. Aran: MucoJet technology is at the patent application stage and was not issued yet. It was filed in 2015. The patent application in the US has 20 years from the date of filing. From 2015 to 2035 MucoJet patent will be alive, so I think that's quite a long period. 

SOC: Investors usually want to get a clear picture how many rounds of investments you have completed. What I understood you had some initial seed financing from the University of California, Berkeley am I right?

Prof. Aran: This technology was greatly supported by the UC Berkeley and money from National Institute of Health (NIH).

SOC: What are the next steps. What is the volume and time limits? How many investments are you seeking at the moment?

Prof. Aran: So now I'm developing the technology and I am working with the company who licensed the technology. I'm developing a different system. We haven't got into the rounds yet. We are raising some grants to bring more money, so we can continue working with the technology development, but it's not easy.

When the money will come, we can further develop the technology and at this point, we cannot work on it, unless we have money for it. I mean there is no point of reaching investors for the protein that already licensed and for the vaccine when we have reached a point that we need to do a preclinical testing at animals, at larger animals for vaccines like flu or HIV vaccine etc.

We actually do not know how much money we need for next steps. But I mean what we can't start the next step until we get some money. As a faculty, I can't go out for investors. I'm trying to get the money from NIH or governmental institute. But if someone wants to invest in it that would be really wonderful, because in such case we can actually develop it within a year. So, I guess the amount of money is discussable and it will start from 1 million dollars.

We have applied the grant for vaccine delivery in the amount of 1.125 million dollars.  If you need 1 million dollars for the project the school also charges other indirect costs like electricity, giving you a place to work, and all these things. It's the same for the majority of institutes like UC Berkley. But sometimes, when the money comes, the investors say that they won't pay more than 8 percent of indirect costs. If you are proposing 1 million dollars to complete your grant you have to add another 80,000 dollars for indirect costs. It depends, but there are ways to work on that.

SOC: Thank you so much. And could you please describe the ideal investor for your MucoJet technology. Does private capital or some personal qualities, maybe country. Who will be an ideal investor for this technology?

Prof. Aran: I think the ideal will be three kinds of investors. First are philanthropies, who believe in the next generation of the system, they believe the world of pharma will change soon. The second type is an angel investor, who want to put 500k or 600k and take a big chunk of the company and help us further technology development, so we're ready for next round. The third would be pharmaceutical companies, that want to license or people who just want to license our technology and then sublicense it to others.

So basically, we are looking for a licensee, who will move the MucoJet technology forward and also pay for the prosecution. As this particular application is being prosecuted in the US, so we will appreciate US investors.

OC: And the last question, could you specify the most convenient way you would like to receive inquiries from potential investors? Should it be by e-mail or personal phone call?

Prof. Aran: Emailing will be most appropriate, so we can schedule the call then.

We would like to express gratitude for the time you have dedicated to this interview. SPINOFF.COM will observe the development of your technology with great pleasure and interest. We are pleased to forward all potential investors the information on MucoJet. We are also thankful to the University of California, Berkeley and UC Berkeley's Office of Intellectual Property & Industry Research Alliances (IPIRA) for collaboration.