(BPT) - The race to create and distribute effective COVID-19 vaccines continues. Big pharmaceutical companies are producing promising vaccines and initial distribution is underway, however, this is not without numerous concerns or logistical hurdles. What you don't hear much about is the smaller biotech companies working hard behind the scenes to develop alternative medicines that have big potential in fighting the novel coronavirus and much more.
Concerns with current big pharma options
The COVID-19 pandemic is rapidly changing vaccine technology, with innovative approaches that are moving away from the use of live viruses towards genetic-based approaches using RNA and DNA vaccines.
Rather than injecting a weakened form of a virus or bacteria into the body, like with the flu vaccine, DNA and RNA vaccines use part of the virus' own genes to create antigens that stimulate an immune response. So, when someone who was treated with the vaccine gets exposed to the virus later on, their immune system will be able to fight it off more easily and reduce their risk for serious illness.
While it's critical to produce a safe, effective COVID-19 vaccine, the leading candidates are RNA vaccines, which despite promising results, do have several drawbacks. RNA is very easily destroyed due to the body's natural enzymes and chemical reactions which will break the RNA apart. As a result, these vaccines need to be manufactured, shipped and stored under very specific and extremely cold conditions in order to try to slow or prevent that breakdown of RNA.
These stability and manufacturing issues can lead to limited production capabilities, leaving governments and communities fighting for available supplies. Distribution and storage is complex, with one option requiring more than -70 degrees Celsius refrigeration. Supply chain issues may be an ongoing issue.
Small biotech with big ideas and the potential to save lives
While leading pharmaceutical companies are spearheading the fight against COVID-19, it's important to consider the potential technologies that smaller organizations are researching. One of those companies is Orbis Health Solutions, a South Carolina-based biotech using its deep cancer research experience and established vaccine technology to create a new approach to fighting COVID-19 - a DNA vaccine that addresses the shortcomings of the current frontrunners and with the ability to combat future viruses and biological threats.
Based on the research and science of Thomas E. Wagner, Ph.D., the company's founder and chief scientific officer, the potential COVID-19 vaccine uses a blueprint based on Orbis' success in treating cancer through personalized vaccines. In addition to positive data from its Phase IIb cancer clinical trial, proof-of-concept studies have demonstrated that Orbis' vaccine technology platform has a wide range of possibility, from addressing agriculture and veterinary applications to fighting future pandemics and biological threats.
'We have developed a very successful vaccine against cancer, which is the most difficult challenge for the immune system," says Wagner. "Now we've shifted our science and technology to fight the current COVID-19 pandemic and what we're seeing is incredibly hopeful.'
The science for the new vaccine is based on cancer vaccine technology that delivers foreign substances (antigens) to help the immune system to recognize an invader and trigger an immune response. In cancer therapy, this is created with antigens from a patients' own tumor. For COVID-19, Orbis scientists have created a synthetic replica of portions of the DNA code of the virus focusing on the spike proteins, which is the external part of the virus that penetrates a healthy cell. The vaccine contains this information in order to trigger a response and help teach the immune system how to fight the foreign invader and eliminate the virus.
Neutralizing antibodies in 100% of trial participants
The good news: Early data shows promise. Results of a clinical trial evaluating 20 healthy volunteers demonstrated that one inoculation with the vaccine led to 100% of participants expressing neutralizing antibodies against the virus, meaning the vaccine is successful in triggering that critical immune response to COVID-19.
The Orbis COVID-19 vaccine doesn't use any part of the virus itself, only the DNA encoding the spike protein. For this reason, it is believed to be a safe option with few side effects. What's more, there's no need for low-temperature storage and it's highly scalable, so it may be easier to quickly get enough vaccine worldwide, especially to those who need it most.
'We are very encouraged by these Phase I data, which represent a critical milestone for our vaccine technology platform and echo the early success of our personalized cancer vaccine,' said George E. Peoples, M.D., chief medical officer of Orbis Health Solutions. 'Following further data analysis and discussion with regulatory authorities, we remain committed to initiating a larger Phase II trial that will move us one step closer to bringing this important treatment to patients as soon as possible so that we can help address this global health emergency.'
These trials are particularly important because if successful, they will provide definitive proof of concept for the platform that could be rapidly applied to future vaccines to help with new viruses and health concerns within a matter of weeks versus months to years. To learn more, visit http://orbishealthsolutions.com/.
"Just as COVID-19 didn't exist a few years ago, other diseases and viruses will evolve," Wagner says. "The proprietary delivery platform for the Orbis vaccine provides a blueprint that can be updated quickly with different DNA information, which allows for rapid vaccine development and deployment to address the next viral or biological threat. This platform has the potential to save many lives both now and in the future."