Groundbreaking Research and Development
In response to the Global health crisis posed SARS-CoV-2, Stark Therapeutics is taking a novel approach to vaccine development. By focusing on a target previously defined in the original SARS outbreak, Stark Therapeutics is providing an additional vaccine option not yet explored by existing strategies.
Here are our next steps...
We'll be evaluating our vaccine candidates in a three phased process:
Proof of Concept
Viral Challenge & Efficacy
Toxicology & Safety Profiling
Within one month, Stark Therapeutics will rapidly produce multiple vaccine candidates for preclinical evaluation and optimize production to support clinical trials.
IND & Clinical Trials
Following completion of our preclinical testing, Stark Therapeutics will work with the FDA and NIAID to quickly and safely begin clinical trials.
Frequently Asked Questions
What is it, and how does it work?
Stark Therapeutics is developing a series of vaccine candidates based on a modified SARS-CoV-2 protein and producing them in a mammalian expression system. This vaccine type is known as a subunit vaccine. Following purification, the vaccine is administered through an intramuscular injection. It then works by activating cells known as Cytotoxic T cells. CTLs stop productive infection by destroying cells infected with SARS-CoV-2 and stopping them from producing viruses.
How safe is it?
Recombinant subunit based vaccines represent a significant portion of approved vaccines. Whooping cough, Hepatitis B, and HPV vaccines are examples of effective and safe vaccines that have been approved. Because they do not contain the needed parts for viral replication, administration of our vaccine approach poses no risk of leading to SARS-CoV-2 infection.
What are the advantages?
The target of STK-VAX, known as the nucleocapsid, relies primarily upon training T cells to target infected cells. This is different than the antibody response generated by other vaccine candidates in that there are generally fewer chances of variability in patient response. This also reduces the chance of our vaccine becoming less effective in the event SARS-CoV-2 mutates.
While we remain optimistic about the speed and intensity that other organizations are making in vaccine development, to date, no DNA or mRNA based vaccines have received FDA approval despite two decades of development. This is reflected by our choice of taking a more conventional subunit vaccine approach and benefits from their long standing safety, efficacy, and scalability.
What are the disadvantages?
In order to create the best vaccine protein possible, Stark Therapeutics uses a specialized mammalian cell line for production. While highly scalable, this is potentially more expensive than other options. However, such systems are comparable to Janssen Pharmaceutical’s PER.C6® which is being used for their own vaccine development program.
How long will it take?
We expect to reach clinical trials within the next four months. Our preclinical grade vaccine candidates will be ready in the next four weeks. Following the completion of our preclinical studies, an estimated 8-12 weeks, we'll be working with the FDA to rapid provide our vaccine for clinical evaluation. Uniquely, because of the simplicity of our approach, Stark Therapeutics is more likely to reduce time to clinical trials and approval.
STK-AVi1 Type II Diabetes Mellitus
With over 30 million diabetics in the United States alone, a long term solution is needed for this silent epidemic. Stark Therapeutics is combining interference RNA and an Adeno-associated Viral delivery system to enhance insulin sensitivity. By reversing insulin resistance on a molecular level, we hope to provide a single administration treatment to those who are non-responsive to aggressive treatment options.
Preserving muscle mass is a key goal in staving off the effects of aging. Using the same platform for our T2DM therapy, Stark Therapeutics is working to prevent the loss of both the quality and quantity of skeletal muscle in patients over the age of 55.
STK-AVi13 ROS Inhibitor
In parallel to our work on Type II diabetes and Sarcopenia, Stark Therapeutics is exploring the use of our approach in preventing radical oxygen species generation in skeletal muscle which has potential to improve on metabolic and physical function. We hope to further investigate this in the context of metabolic disorders involving mitochondrial dysfunction.
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