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Soligenix Inc. is looking to leverage its clinical and research experience to help bring to market a vaccine to treat COVID-19. The team working to make that happen includes a scientist at UH and an assistant professor at the John A. Burns School of Medicine. An article published on Friday explains the deal.

The group initiative is being led by Dr. Axel Lehrer, an expert in vaccine development, who is drawing strength by collaborating with a group of lab colleagues in the Departments of Tropical Medicine, Medical Microbiology, and Pharmacology at JABSOM. Soligenix is expected to play a key role in the venture and joins Hawaii Biotech as the only two biotechnology companies in the group.

Prior Clinical Work Supports Efforts Toward COVID-19 Vaccine

Dr. Lehrer commented on why he thinks this venture will be successful. Responding to a question about the program, he said, “In general, my laboratory focuses on developing vaccines for neglected and emerging infectious diseases including understanding the epidemiology and pathology for the infectious agents,” He added, “It was a natural response for us to start working on a COVID-19 vaccine.”

Prior work from Dr. Lehrer that demonstrated success of an Ebola virus vaccine and from a Zika virus vaccine has paved the way towards finding a vaccine for COVID-19. Soligenix may play a vital role in the final product by integrating its heat-stabilization technology. As a part of its Public Health Solutions business segment, Soligenix is showing success in maintaining the potency of treatment drugs without the need for cold storage. In fact, biodefense drugs can be held at temperatures as high as 104 Fahrenheit and remain effective. Dr. Lehrer noted that the technology allows the Ebola virus vaccine to withstand high temperatures and maintain their potency for a minimum of 12 weeks. The heat-stabilization technology also allows for vaccines to be produced in large quantities. 

COVID-19 Testing To Begin

Past success may hold near-term promise. According to Dr. Lehrer, his team will be using similar and successful technology for the COVID-19 vaccination platform. The first stage, expected to begin in the next few weeks, will be to conduct test trials in small animals. From there, if preliminary data is promising, the dialogue with the FDA can begin to initiate the process required to bring a successful drug to market. The relaxed FDA guidelines during this pandemic may help bring a vaccine to market quickly.

According to Dr. Lehrer, “The typical path to a vaccine licensed by the FDA is approximately fifteen years if no hurdles are hit. However, if we can use an accelerated development path, we are confident to be able to start human clinical trials in 12-18 months.”

Beyond the potential of heat-stabilization technology, a second role of Soligenix may be to provide the experience of putting together a plan of distribution. Noting that beyond a successful product, an entirely different kind of plan is needed to develop and distribute the product. Soligenix has that experience and is already working closely with the regulatory branches of oversight.

The role of Soligenix will be significant based on what Dr. Lehrer recently acknowledged, saying, “There are always many hurdles in making available sufficient amounts of material and so in the spirit of using scarce resources that the whole world may need soon, careful decisions will have to be made by global public health authorities in developing the best strategies on how to organize vaccination campaigns once a product has been developed.”

Why This Team Has Hope

Confidence is high that the group initiative can be successful. It’s been noted that in comparison to RNA based approaches for other Coronavirus vaccines, Lehrer’s conventional method, using antigens to prolong the resistance of the virus for longer duration’s of time, has already proven to be a successful develop model for other RNA vaccines on the market. 

On an extremely positive note, Dr. Lehrer, said, “It seems very likely that our approach will be successful,” He added, “Others also work on candidates that are quite similar. However, we believe that through our collaborations we will be able to develop a product with very positive storage conditions that will allow widespread use.” 

Most certainly, the race for a cure is on. And, prior success can provide a large head start when strategizing a plan to utilize the most effective development processes. The team is well-rounded, has prior success in antigen based vaccines, and has Soligenix to add its industry expertise and the potential of using its heat-stabilization technology.

If the program goes according to plan, it can be a significant windfall to the team. For Soigenix, as the only publicly traded company in the group, a sharpy increase to shareholder value can be the shared prize.

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