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May 11, 2015 Issue

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Nucleic Acid Therapeutics with Effective Cell and Tissue Delivery

 


Dr. David A. Giljohann

CEO

 

AuraSense Therapeutics LLC

www.aurasense.com

 

 

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 11, 2015

 

CEOCFO: Mr. Giljohann, would you tell us the idea behind AuraSense Therapeutics?

Dr. Giljohann: AuraSense follows the premise that nucleic acids when arranged in three dimensions are able to effectively enter cells and engage with targets. The 3-D architecture of nucleic acid is enabling in terms of creating new therapies.

 

CEOCFO: What are you working on today?

Dr. Giljohann: Our spherical nucleic acid, or SNA, creates many therapeutic options. Our first programs that we are most excited about are the topical applications of our platform for psoriasis. We have discovered and have been commercializing the fact that when you take spherical nucleic acids and put them in a cream, they can be applied to the skin where they show the remarkable ability to penetrate through the skin, enter cells and knock down target genes involved in inflammatory pathways for diseases such as psoriasis. We are excited to progress that program into pre-clinical and clinical testing. We are expecting to have a regulatory filing by the end of the year and first-in-human study in the first quarter of 2016.

 

CEOCFO: What is happening when the cream is touching the skin?

Dr. Giljohann: The cream consists of an agent to create viscosity, as simple as petroleum jelly or something that you pick up at a Walgreen’s or CVS. The cream contains our spherical nucleic acid compounds. The spherical nucleic acid is a presentation of nucleic acids in a dense array around the surface of the nanoparticle. That dense presentation of nucleic acids is recognized by cellular scavenger receptors on the surface of the cells. When these cellular scavenger receptors see the SNA and that dense presentation of nucleic acid, they recognized and then internalize the structures. When they internalize the structures we are then able to engage with biological pathways inside the cell such as those that are involved in disease states such as psoriasis.

 

CEOCFO: What have you discovered that others have not?

Dr. Giljohann: There has been a lot of development over the last twenty years trying to effectively deliver linear nucleic acids into cells and tissues. These approaches have always done that by encapsulating these linear nucleic acids inside lipid or polymer type vehicles. The down side to these types of carriers is that to some extent they have been shown to be toxic, and they have primarily been delivered to the liver as a target. In our case, the spherical nucleic acid is a three-dimensional presentation of nucleic acid, so not linear format but a 3-D format, allowing engagement with scavenger receptors on the surface of cells, which is a natural biological mechanism. Without the need of a lipid or polymer co-carrier, we are able to effectively deliver our SNA nucleic acid therapies into cells and tissues. The premise here is that architecture makes a difference. Linear nucleic acids that have been studied are not recognized by cells. When you create 3-D presentations of those same linear nucleic acids, that 3-D presentation is the magic ‘key’ to cellular recognition and internalization.

 

CEOCFO: Why did you choose psoriasis?

Dr. Giljohann: Psoriasis is a terrible disease that affects many. The inflammation of the skin is generally treated by systemically delivered antibodies. However, there is a great underserved part of the population which is those people with mild to moderate psoriasis. In our case, the value proposition is that we have created not a systemic delivered antibody, but a topical cream that can be applied by the patient themselves or in the clinic and it effectively works the same way as the systemic antibodies. The reason that you would want to use the topical format for a psoriasis drug is the ease and convenience of use in application. The cost of a topically therapy such as ours is projected to be less than the cost of therapy for a systemically delivered antibody type therapy. We think we will be able to address a patient population that is currently not being served by systemic antibodies and will benefit from the use of our spherical nucleic acid cream.

 

CEOCFO: What is the timetable on this product?

Dr. Giljohann: We are heading into animal testing now for toxicology. We have regulatory packages that are being submitted. Our planned first-in-human testing will happen in Q-1 of 2016.

 

CEOCFO: What is coming up behind this?

Dr. Giljohann: The next program we are using our spherical nucleic acids for is bladder cancer. In the case of bladder cancer, what we are doing is providing a local installation of the spherical nucleic acids into the bladder where they can penetrate both the bladder tissue as well as tumor tissue and can be used to activate the immune system and generate a robust clinical response. We apply it locally where we can leverage the tremendous ability of the spherical nucleic acids to enter cells and tissues effectively and activate an immune response through toll like receptor pathways, that then leads to a shrinkage of the tumor. When we get into clinic, it will result in a meaningful drug and a clinical response for patients with bladder cancer.

 

CEOCFO: What do you understand about the process of bringing drugs to market and having a financial breakthrough?

Dr. Giljohann: Firstly, a strong fundamental understanding of the science is imperative for knowing how to drive the business forward. Next, bringing in experts and forming the right team to bring the technology to market is critical for successful implementation. We have been fortunate here at the company to recruit a very strong management team that has successfully both financed companies as well as taken drugs into the clinic. I rely heavily on their expertise and knowledge in these areas as part of our team to pull the strong science forward commercially.

 

CEOCFO: Are you looking at partnerships or licensing?

Dr. Giljohann: Yes we are. The current focus of the company has been to take our two compounds that we are working on for psoriasis and bladder cancer forward into the clinic on our own. We do have a great platform potential with the technology, so while we are developing our two programs internally, we are in constant engagement with different pharmaceutical companies and potential partners who may be interested in using this SNA technology as an ability to get effectively into cell tissues to go after other diseases of interest. We have ongoing conversations and we are hopeful that we can expand the impact of this platform beyond the two drugs we are working on by virtue of forming partnerships.

 

CEOCFO: What is the overall interest from the medical community as well as the investment community?

Dr. Giljohann: Our technology generally falls in the area of nucleic acid therapeutics. After the historical small molecule drug revolution and then the antibody drug revolution more recently, the nucleic acid approach to creating new drugs has been hitting great milestones. There are many compounds in the nucleic acid drug development pipeline right now which are entering Phase II and III trials. That means that the field has been a strong area of interest both pharma companies as well as the investment community. In this case we have been fortunate to have a unique approach in this space, which we think enables us to tackle diseases in areas outside of the liver where the field has historically been limited. We are excited about the field as a whole and we are even more excited about the ability of our technology to function within that field with a unique and foundational new approach.

 

CEOCFO: When the medical community is looking at you, do they understand what you are doing or are they skeptical?

Dr. Giljohann: We have been excited about the great reception that we have been receiving in conversations with those in the medical community as well as key opinion leaders specifically in the disease that we are working on. We recently were at the meeting of the American Academy of Dermatology, where we spent a good amount of time speaking on the program that we are working on for psoriasis which is going into the clinic early next year. Every thought leader that we met with in the medical community was extremely excited about our programs. They understood very quickly about how a topical approach for psoriasis will be valuable to patients.

 

CEOCFO: You had a funding about two months back. How far will that take you?

Dr. Giljohann: We have cash that will last us through early-stage clinical trials with our two compounds, and we are always evaluating additional funding opportunities whether that is through partnerships, non-dilutive financing through grants, or financing that happens through our investors who been involved with the company to date. With the cash in hand to date, we are confident that we will get through some very critical proof points in the clinic, which will be great value drivers for the company and for the investors in our spherical nucleic acid technologies.

 

CEOCFO: Why does AuraSense Therapeutics stand above the crowd?

Dr. Giljohann: AuraSense Therapeutics is working in an exciting area which is the ability to target diseases genetically. Given the history of the human genome project we now have an untapped treasure trove in developing new therapeutics. AuraSense Therapeutics has created a construct, the spherical nucleic acid, which has unprecedented ability to get into cells and tissues effectively outside the liver and without toxicity. We think that is going to allow us to access many disease states from the encyclopedia of genomic knowledge that we now have. We expect our approach will really elevate the whole field nucleic acid therapeutics to start thinking of new diseases with genetic components involve.

 

CEOCFO: Final thoughts?

Dr. Giljohann: We are excited about the spherical nucleic acid construct, and going into the clinic next year with our first compound for psoriasis. We are eager to bring our technology forward to improve patient healthcare.



 

“The premise here is that architecture makes a difference. Linear nucleic acids that have been studied are not recognized by cells. When you create 3-D presentations of those same linear nucleic acids, that 3-D presentation is the magic ‘key’ to cellular recognition and internalization.” - Dr. David A. Giljohann


 

AuraSense Therapeutics LLC

www.aurasense.com



 

 



 

 


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