A Universal Genetic Pandemic Response

mRNA vaccines are incredibly versatile and potent. mRNA encoding an antigen of interest can be manufactured using a DNA template, capable of being synthesized in 1-3 days, or ready in long term storage in a plasmid cell bank. One advantage of using mRNA rather than DNA itself as a vaccine is that it is easier to deliver than synthetic DNA as it only needs to access the cytoplasm as opposed to the nucleus of the cell. In addition, RNA serves as its own adjuvant, helping to activate the immune system during its natural life cycle inside the cell (Figure 1). Strand Therapeutics’s innovative mRNA technology leads the pack in the new wave of synthetic biology powered gene therapies and has the ability to engage the immune system in a safe, effective way unachievable by existing technologies.

In global pandemics, a rapid response is key to ensuring safety among the global populace. Currently, vaccine production takes 18-24 months to manufacture and test against a given pathogen. Moving forward, emergent threats due to an expanding populace and climate change will leave the global community with minuscule windows of response before global threats emerge. As a global community, we must build rapid response capabilities that allow us to create robust vaccine platforms for emergent threats at a moments notice.

We propose a fully automated closed system for rapid mRNA manufacturing. This system would be capable of responding to known threats in a matter of weeks, as well as creating de novo vaccine solutions to new pathogens in a similar timeframe, all while maintaining the highest level of standards and quality control via automated bio-manufacturing and digital tracking oversight of quality control. This system would not only eliminate the need for “universal” flu vaccine, but could also drastically reduce the need for massive cold storage facilities and cold chain distribution challenges. 

Most importantly, this solution addresses those members of the human populace on the front lines of outbreaks (rural Asia, Africa, etc.), though due to the increased global community of travel and trade, infectious threats to any corner of our population are relevant to the world at large, most recently highlighted by the threat of COVID-19 and its spread from rural China to all western nations.

Our approach is both a biological breakthrough of a vaccine platform, and a technological breakthrough of miniaturization and automation of genetic vaccine production. What this means is that not only can we rapidly produce vaccines at an unprecedented rate, but we endeavor to produce systems tat can be deployed into a global network of "Centers of Excellence," where vaccines are created at the points of emergence and capable of walling off threats before they spread globally. This approach eliminates vast cold supply chain management and logistical challenges which make vaccine deployment into developing regions of the world incredibly challenging.

Strand empowers patients to take control of their lives. Strand was co-founded by MIT biological engineers, building on the idea of creating smart therapies capable of making autonomous decisions. While traditional gene therapies lacked control, the synthetic biology team at MIT built the world’s first mRNA “programming language,” creating the only platform of its kind for advanced mRNA smart therapeutics.

Strand’s mRNA programming technology promises to make mRNA therapies safer and more effective by programming the location, timing, and intensity of therapeutic protein expression inside a patient’s body using mRNA-encoded logic circuits. These circuits can implement cell-type specific expression by sensing and classifying the unique miRNA expression signatures of cells, as well as controlling the dosage of protein expression by responding to exogenously administered small molecules.

We have published this work in top tier, scientific, peer-reviewed journals. Links below:

https://www.ncbi.nlm.nih.gov/pubmed/30327560

https://www.ncbi.nlm.nih.gov/pubmed/26237515

https://www.ncbi.nlm.nih.gov/pubmed/29439214

https://www.ncbi.nlm.nih.gov/pubmed/25566800

https://www.ncbi.nlm.nih.gov/pubmed/24877739

Automation within mRNA therapeutics opens the possibility for a truly global rapid pandemic response network. Unprecedented turnaround times are possible when correct automation and digitalization steps are adopted from companies with the expertise and drive to tackle highly technical issues facing advanced gene therapy process development. Strand Therapeutics, as a hybrid tech and biotech company, is capable of building technologies that will lead the way in how we think about seasonal vaccination strategies as well as global pandemic resilience. Through a global network of highly autonomous and intelligently stocked “pre-vaccine” resources, we can be better protected against the unexpected in an increasing global world. Additionally, technology could eventually be rolled out to make custom small scale therapeutics for commercial applications in rare and orphan diseases affordably and at scale.

Currently, our R&D activities are limited to the lab, where we serve no people directly. In one year, we plan to be gearing up to enter our first clinical trial, which will still place us at zero, but will place us on the cusp of serving close to 100 patients. In five years, given accelerated approval in some developing regions fo the world, we plan to have our vaccine and cancer treatment platforms rolled out to 1,000s of patients worldwide!

While science sometimes moves slowly, pandemics move rapidly. In teh next year, we plan to build and validate our rapid response manufacturing platform for mRNA therapeutics. Moving beyond this stage, in five years we plan for our drugs to begin to launch worldwide and gain widespread attention in developing regions where we can provide rapid, protective immunity against any and all emerging threats to local and global health security!

Investment in automation within biotech is still limited. Convincing investor to get behind a hybrid model, where both biological and technical innovation are leveraged, can be a difficult task. 

At Strand, we take a hybrid approach and seek to leverage both types of innovation to shrink the resources required to respond to global outbreaks.

Full time: 13

Part time: 10

Contractors: 5

Advisors: 8

Jacob R Becraft, CEO and Co-founder, Strand Therapeutics

Jake Becraft is a synthetic biologist and biotech entrepreneur. Currently, he is the CEO and co-founder of Strand Therapeutics. Jake has been featured in Fierce Biotech, Bloomberg, the Boston Business Journal, and BioCentury, among others. He is credited with creating the world’s first synthetic biology programming language for mRNA during his tenure at MIT. He currently is on the advisory board of Starlight Ventures, an early stage venture firm designed to address humanity's greatest challenges and opportunities. Jake also serves on the Executive Board of Public Health United, a non-profit focused on educating scientists across disciplines to foster their communication skills in order to become their own scientific ambassadors. He received his Ph.D. in Biological Engineering from MIT and his B.S. in Chemical Engineering from the University of Illinois at Urbana-Champaign.

Tasuku Kitada, Head of R&D, President, and Co-founder, Strand Therapeutics

Tasuku is an experimental biologist by training with a Ph.D. in Molecular Biology from UCLA and a postdoc in synthetic biology at MIT. He won several awards at RNA and synthetic biology conferences during his postdoc for his work involving the creation of RNA-encoded genetic circuits. He previously was an analyst of a ~$2B biotech hedge fund. He has a comprehensive understanding of the current biotecha competitive landscape, regulatory processes at the FDA, and drug reimbursement systems. He is also skilled at company valuation.

We will develop drug candidates using our mRNA platform that can convert anti-PD-1 non-responders into responders. After promising phase 1 data, we open the possibility to partner with leading biopharma companies that are already marketing FDA approved anti-PD-1 drugs and monetize via licensing deals or sell our individual assets, allowing us to expand work into the platform on a cash positive basis.