The University of Georgia and its Center for Vaccines and Immunology has partnered with a Virginia-based biotech company called CEI-SCI-Corp (CVM) to develop an immunotherapy candidate (LEAPS COVID-19) designed to treat COVID-19 patients with the highest risk of dying.
The parties are coming together to develop novel immunotherapies targeting the most at risk COVID-19 patients. The research show promise based on a preexisting collaboration between the company and the National Institute of Allergy and Infectious Diseases (NIAID) which while conducting preclinical research on mice after the H1N1 flu pandemic in 2009, found that the company’s LEAPS technology actually showed promise in mice infected with the H1N1 virus. Hence now the University of Georgia and its Center for Vaccines and Immunology steps in and executes a collaboration with the company. But what is the intellectual property behind the company’s proprietary immunology-based platform called LEAPS?
What is the Underlying Hypothesis underlying the Research Collaboration?
The collaborators here are considering LEAPS for those infected with COVID-19 that are more at risk for death, such as the elderly and those with compromised lung function or immunosuppression. The hypothesis: The onset of COVID-19 symptoms takes between 2- and 14-days post infection, a period of time that may allow for intervention for those that are at the highest risk and with a known exposure.
What is LEAPS COVID-19?
The Ligand Antigen Epitope Presentation System (LEAPS) platform technology has produced in animal models the ability to design antigen-specific immunotherapeutic peptides that preferentially direct the immune response to a cellular (e.g. T-cell), humoral (antibody) or mixed response and are also capable of enhancing important T-regulatory (Treg) responses. Hence, LEAPS technology supports the development of immunotherapeutic products for diseases for which disease associated antigenic peptide(s) sequences have already been identified, such as a number of infectious diseases, some cancers and even autoimmune diseases.
What was the earlier Research garnering attention?
CEI-SCI-Corp has been actively collaborating with NIAID on experiments on the H1N1 virus which originated from the 2009 H1N1 flu pandemic. LEAPS peptides demonstrated promise when applied to after virus infection had occurred. In preclinical research studies with mice, LEAPS actually reduced morbidity and mortality in mice that had been infected with the H1N1 virus
Who serves as Principal Investigator in the collaboration?
Ted M. Ross, director of the Center for Vaccines and Immunology, Georgia Research Alliance a scholar and professor of infectious diseases at University of Georgia, will drive the joint collaboration involving CEI-SCI-Corp’s COVID-19 studies at UGA. According to Professor Ross, “LEAPS has the potential to be a powerful tool against SARS-CoV-2 the causative agent of COVID-19 based on its dual anti-viral and anti-inflammatory properties.” Ross continued that the team could drive success by “Combining the prior pre-clinical data of LEAPS against H1N1 with our advancing knowledge of COVID-19, we aim to rapidly evaluate the technology’s potential to meet the urgent need to treat patients at greatest risk of dying from this global pandemic. The University of Georgia’s biocontainment labs at the Center for Vaccines and Immunology are ideally suited for these studies, and will serve as critical assets in this collaboration with CEI-SCI-Corp.”
What are the University of Georgia Biocontainment Labs?
The Biocontainment Labs are one of the core facilities at the University of Georgia Office of Research. Their Biocontainment Labs are one of the most technologically advanced of its class in the United States. The labs are dedicated to studying infectious diseases that affect both animal and human.
CEI-SCI-Corp, based in Vienna, VA, has been around for decades (founded 1983). The company is dedicated to R&D directed at improving the treatment of cancer and other diseases using the immune system, the body’s natural defense system. Its lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection) is currently being developed as a potential therapeutic agent targeting the patient’s own immune system to produce an anti-tumor response (oncology). Data from Phase I and II clinical trials points to the potential that Multikine stimulates the activities of a healthy person’s immune system. Hence it potentially can enable the use of the patient’s own anti-tumor immune response.
Business & Financials
The company doesn’t operate in good financial health as it has accumulated $14 million in debt and operates at a loss of $21 million with only $9 million cash in the bank, according to Yahoo Finance. At present, its stock trades at $12.87 for a market capitalization of $468 million.
What is their lead therapy?
Multikine, currently in a pivotal Phase III clinical trial for advanced primary squamous cell carcinoma of the head and neck. The company received Orphan Drug Status for this application. The study was fully enrolled with 929 patients by Sept. 2016 and the endpoint is a 10% increase in the overall survival of patients between the two main comparator groups in favor of the group receiving the Multikine treatment regimen. The determination of the endpoint of this global study is achieved when there are a total of 298 deaths in the two groups. They hope if successful to achieve a Biologics License Application (BLA) to the FDA for Multikine for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.
Why is their approach different?
Multikine is administered before standard-of-care surgery because that is when the immune system is thought to be strongest (i.e. as a neoadjuvant). It is also administered locally around the tumors and near the draining lymph node.
Ted M. Ross, director of the Center for Vaccines and Immunology, Georgia Research Alliance a scholar and professor of infectious diseases at University of Georgia