Dear friends, colleagues, and shareholders,
I hope this letter finds you and your families well and remaining healthy during this difficult time. The COVID-19 pandemic has become a far-reaching problem throughout the globe with no regard for a country’s wealth or status in the world.
Before this global health crisis began and the subsequent quarantines instituted, ERC was very close to achieving its initial commercialization opportunity for the Gliovac vaccine. In January, we had our most recent meeting with the National Institution of Health Excellence (NICE) about applying for commercialization of Gliovac in the United Kingdom. Some minor changes to our application were recommended at that time, but with the onset of the COVID-19 crisis our efforts have out of necessity been placed on temporary hold. These changes have been made, and the application will be resubmitted to NICE at the earliest possible time. I am confident that this process towards commercialization in the UK will proceed as planned.
In addition to our efforts in the United Kingdom, we have continuing projects to achieve commercialization throughout the world. Unfortunately, these projects have also been placed on temporary hold by the COVID-19 crisis. EMEA application for conditional Approval will hopefully resume in May. The Pediatric plan Post Approval in the PIP European Committee has been applied for during this crisis. Finally, we continue our strong push to obtain FDA approval for Gliovac/ERC1671 in The United States. Our phase 2 clinical trial at University of California Irvine, and now at Harvard’s Dana-Farber Cancer Institute continue in spite of the COVID-19 pandemic. In addition, we continue to strongly pursue our focused plan directly with the FDA to successfully achieve expedited approval. Most importantly, throughout the COVID-19 crisis, patients continue to have access to our Gliovac/ERC1671/SITOIGANAP vaccine both through the ongoing clinical trials as well as through our very successful Right to Try program in the United States. To date, our longest-lived patients are still alive after 6 years following treatment with Gliovac for their recurrent GBM disease.
The COVID-19 crisis is unprecedented in its scope and would have seemed farfetched even coming out of a Hollywood movie script. This crisis has challenged the best of countries, with the best of healthcare systems, as well as the solidarity of the people. In this moment of crisis, ERC has risen to the challenge. Thanks to you and the Belgian Government, ERC continues to function as a world leader in the field of immunotherapy.
Cancer vaccines present the most complex challenges for the human immune system. ERC’s immunotherapy technology has proven highly effective in the face of the intricacies posed by glioblastoma. COVID-19 disease is caused by the SARS-CoV-2 Coronavirus. This coronavirus is likely to mutate slowly in comparison to glioblastoma cancer cells. ERC’s technology is highly adaptable for use against the SARS-CoV-2 virus. ERC has developed a concept for manufacturing both a prophylactic and therapeutic vaccine for COVID-19 disease. We have already successfully filed a patent application for our COVID-19 vaccine in the United States. In addition, we strongly believe that our new technology can be applied to all types of viruses including but not limited to influenza (the flu virus), the Ebola virus, other coronaviruses, as well as many other future deadly viruses. We are currently in discussions with the infectious disease research unit of the United States Army (USAMRIID) to work in collaboration with us to develop and bring this new vaccine to commercialization.
As a result of our efforts over the past few weeks we have had significant interest from new investors hoping to help fund the development of our COVID-19 vaccine. Our COVID-19 vaccine is a unique concept. Firstly, it is designed to be both therapeutic for treating patients already suffering from COVID-19 disease, as well as prophylactic in order to prevent COVID-19 disease in patients not yet infected with the SARS-CoV-2 virus. Secondly, if successful our new viral vaccine technology could be easily adapted to combat almost any other type of viral pathogen that may be encountered in the future.
ERC should be very proud to be able to adapt our glioblastoma vaccine platform for use in the fight against the global COVID-19 pandemic. ERC has the historic opportunity to lead the world in finding a solution to this current global catastrophe. I am humbled and excited by this moment. With the unwavering support of you our shareholders, as well as the entire ERC team, I am certain that we will achieve great success.
Please do not hesitate to contact me directly at any time either by phone or by email with any questions.
With my best regards
Apostolos Stathopoulos MD, PhD