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Invest in Stark Therapeutics

Stark Tx is changing the way the world treats chronic diseases with gene therapy

Highlights

1
Working on a gene therapy based cure for Type II Diabetes
2
Applying premiere biotech techniques (Adeno-associated virus and interference RNA technologies)
3
Poised to launch a study to evaluate T2DM therapy with support from Michigan State University
4
Developed and produced a COVID-19 vaccine in under four weeks
5
Initiated a preclinical study to evaluate the vaccine, which yielded positive results
6
Raised $50K from XX for competitive "Fight the Virus" challenge

Our Founder

CEO & CTO
Developed both Stark Therapeutics’s Vaccine and type II diabetes treatment. Powers-Knapp/Chancellors scholar @ University of Wisconsin Madison.
I have an obsessive focus for many technical topics ranging from biotech to materials science. My experience in gene therapy has shown me that it is an underutilized area of therapeutics outside of rare diseases. I believe that this type of treatment is the answer to treating pervasive chronic diseases more effectively than existing solutions

Gene therapeutics are the future of medicine

We're working on a genetic based therapy to cure Type II Diabetes known as STK-AVi1.


What's your mission? How does this make you different?

I hold innovation to be the core driving force behind Stark Therapeutics. This may not sound novel, but the pharmaceutical and biotech industries have not yet applied gene editing tech to chronic conditions like T2DM. Changing the way these conditions are treated is a key goal to what we’re doing.

Problem

Type II Diabetes

Type II diabetes (T2DM) is a lifelong disease which afflicts over 30 million people in the US alone. Current treatment requires continual lifestyle changes, medical monitoring, and medication intake. While there are multiple therapeutic options, each has its drawbacks in the form of limited effectiveness, side effects, or cost. For example, metformin is a popular T2DM drug that can be effective if taken correctly. However, a cumulative analysis of 1.6 million T2DM patients found that >30% of patients discontinued metformin chiefly due to painful gastrointestinal side effects. If you can’t take effective treatments because of side effects, you really don't have a treatment at all.

Economic Costs of Diabetes in the U.S. in 2017 American Diabetes Association Diabetes Care Mar 2018, dci180007

Therapy basics

Though complex, our diabetes therapy can be broken down into three key areas: using a non-pathogenic virus, known as adeno-associated virus or AAV, and gene inhibiting tech, interference RNA or RNAi, we “knockdown” two regulators of cell growth and metabolism. These two genes have been previously targeted (imperfectly) by currently approved T2DM medications. We apply a muscle specific genetic level therapy using AAV and RNAi to 1) directly increase insulin to insulin receptor binding and 2) enhance energy usage through modifying mitochondrial function. Both of these functions are essential in treating and reversing T2DM. Not only is this approach vastly more targeted (ie. may reduce the likelihood of side effects), but this technology creates change in skeletal muscle which may persist for >10 years following a single administration. In other words, we hope that this approach reduces the chance of side effects for patients and represents a much more long-term solution. A solution that effective would disrupt the entire chronic disease treatment space.

More on our targets...

Diving a bit deeper into the targets of our therapy, we are focused on two genes that are linked to distinct pathways that work synergistically to control cellular growth, maintenance, and energy usage in skeletal muscles with this data being compiled from hundreds of peer-reviewed studies. These genes down-regulate (reduce the activity/expression of) these pathways and thus function to inhibit cell growth, maintenance, and energy usage depending on external factors like exercise, fasting, etc. By inhibiting our targets, myostatin, MSTN, and gene "X" (withheld for IP), we are able to shift emphasis to cellular hypertrophy and maintenance leading to more energy utilization. The exact mechanisms behind this are multifold, but increased insulin sensitivity is accomplished through enhanced insulin receptor binding (IRS-1) and glucose transporter (Glut4) function. Hypertrophy is primarily accomplished via up-regulation of the mTORc1 pathway. Additionally, enhanced oxidative and lipolytic (fatty acid oxidation) energy metabolism are mediated by upregulation of PGC-1a. Current medications such as metformin and thiazolidinediones share a few of these targets like Glut4 and PGC-1a (respectively), but are unable to directly interact with these targets leading to side effects and reduced efficacy.



What we've done so far...

While most of our previous work has been on problem solving outside of the lab, we've managed to get things into a succinct plan of attack by partnering with existing institutions that routinely handle the studies necessary for our next steps. Specifically, we're working with Michigan State University's In Vivo facility which conducts research and supports the development of groundbreaking therapeutics such as STK-AVi1. Intrigued by our approach, we also have the support of Dr. Karl Olson who has over 70 publications and >35 years experience in type II diabetes research.  Dr. Olson has since become an advisor irrespective of our work with Michigan State University.

Brief excerpt from Dr. Olson's letter of support covering Stark Therapeutics's type II diabetes therapy & preclinical efficacy study. The full document is available in "downloads" section.



What's next?

With our funding from this campaign, we're moving right into the preclinical evaluation for our T2DM therapeutic. With most things already in place, we would start in the next 3-5 weeks. Depending on the results of each study, we may make a few tweaks to study design to keep us on time and on target.



Market Size & Impact


Approximately 30M Americans have T2DM with an additional 88M at risk for developing diabetes (prediabetes). In 2015, US healthcare costs associated with treating T2DM were >$200B. As a “cure” for Type II diabetes, we expect to capture a significant portion of this market, especially for those with more severe complications.

What's the vision for this startup?

As we move forward, I would like to expand our therapy beyond T2DM as there is a clear use case in muscle preservation and in applications beyond therapeutics such as long duration space flight.

What previous projects have you worked on?

Covid-19

We received $50,000 from XX to make a novel COVID-19 vaccine and do an initial preclinical proof of concept study in animals. In the biotech world, 50k would be a rounding error. Long story short, very few would think it possible to either make a vaccine or test it for 50k... doing both would likely be deemed impossible. Working with leading research organizations like BASi, we not only accomplished these goals, but we also did it in less than 7 weeks with our preclinical study showing the type of immune response we wanted (Th1 via cytokine profiling). That same week, Pfizer and Moderna also released studies indicating that there was now significant overlap between the types of immune responses we generated and their vaccines being evaluated in clinical trials. Though the approach employed by us was very different and our preclinical study a success, we did not believe that we had as much to offer in the way of improving patient outcomes when compared to the alternative vaccines developed by the competition. We will continue to closely monitor the results from the Phase III clinical trials being conducted for any signs that our approach may be more impactful again. Comparatively, our vaccine did not benefit from the lack of IP, effective but easily adapted approach, enhanced industry focus on the same end goal, and government funding among other things that our T2DM therapeutic does not face outright.

Anthony working on vaccine development with Expi293 cells.

Downloads

Overview