Regeneron and its “VELOCISUITE®” platform was used to develop a treatment for Ebola (REGN-EB3), currently used by the Congolese government to fight that horrific virus. The New York State-based venture has, like many biopharma companies, dedicated a full force operation to target COVID-19. In a 24X7 operation, the company reports “sleepless nights” and “headway” toward a potential vaccine. After initiating hundreds of virus-neutralizing antibodies, they have declared public plans to initiate large-scale manufacturing by mid-April with antibody cocktail therapy with the potential to commence human clinical trials by early summer.
In addition to collaborating with Sanofi (a French pharmaceutical company) to repurpose a drug (Kevzara®) that could address conditions experienced by COVID-19 patients, the company appears to be making notable progress in its mission to find a vaccine for the novel coronavirus. TrialSite News breaks down this information, offered by Regeneron via their press release, so that hopefully more people can have a better understanding of the current situation.
Who heads up their COVID-19 R&D?
Christos Kyratsous, PhD, Vice President of Research, Infectious Diseases and Viral Vector Technologies.
What is Regeneron’s goal?
They seek to discover and develop a novel multi-antibody cocktail that can be administered as prophylaxis before exposure to the SARS-CoV-2 virus, or as a treatment for those already infected.
Ultimately, how do they do this?
Well, all coronaviruses have a single glycoprotein on the virus surface called the spike protein, which is the protein on the virus-cell surface that binds to the host cell and is required for infectivity. Regeneron’s SARS-CoV-2 antibodies will target the spike protein to block its infection with the host cell, and thus neutralize the virus.
How are they trying to accomplish this feat?
They have been working on isolating hundreds of virus-neutralizing, fully human antibodies from the company’s VelocImmune mice, which have been genetically modified to have a human immune system. In parallel, they have also isolated antibodies from humans who have recovered from COVID-19. They undertake this latter activity to maximize the pool of potential potent antibodies. From this large pool of candidates, they will select the top two antibodies for a ‘cocktail’ treatment based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desired qualities.
Importantly, Regeneron focuses on identifying therapeutic antibodies—what are these?
Therapeutic antibodies are naturally occurring proteins that identify and fight pathogens like bacteria or viruses. These antibodies consist of constant regions and variable regions which recognize and bind the matching target. Monoclonal antibodies have two arms that bind the same target tightly, and with high specificity, potentially reducing side effects. It is important to note that antibodies are not rejected by the patient’s immune system—hence the company engineers’ therapeutic antibodies that specifically recognize drug targets. Production of these therapeutic antibodies in mice is a common method, taking advantage of a natural process. Mice, just like humans, produce and select antibodies to defend themselves against pathogens.
What is Regeneron’s VelocImmune technology?
Part of their VELOCISUITE, VelocImmune is their unique technology for producing fully human monoclonal antibodies. The technology can create a great number of optimized antibody candidates efficiently and directly from immunized mice. In this way, they can overcome traditional limitations of traditional platforms by producing full human antibodies that tightly bind to therapeutic targets and avoid potential immune responses that may occur in patients receiving antibodies that contain nonhuman (typically mouse) components.
Why are they taking a “multi-antibody” approach?
This allows for targeting of different parts of the virus and may aid in the protection against multiple viral variants.
Is Regeneron utilizing a similar methodology as it did to develop the Ebola drug?
Yes. The technologies and process they are using now to discover and develop a COVID-19 vaccine, employed a successful treatment for the Ebola virus infection.
Is their current Ebola drug FDA approved?
No. But it is under review by the FDA, and it is in use in Africa.
What is their VelociMab® technology, and what are they utilizing it for?
VelociMab® is a group of technologies that Regeneron developed to enable the sponsor to move with unprecedented speed from the identification of a therapeutic antibody into clinical studies. It enables the high throughput screening of potential therapeutic antibodies and the rapid generation of cell lines for recombinant human antibodies. It essentially allows researchers to go from mouse immunization to production cell line bioreactor harvest within eight months.
Because of the need for speed, Regeneron can prepare manufacturing-ready cell lines as lead antibodies are selected. In this way, they, in parallel, commence manufacture as they discover—a powerful capability.
What are the company’s key targets to be measured against?
They seek to produce hundreds of thousands of prophylactic doses per month by the end of the summer, and the hope is to have smaller quantities available for clinical trials by the beginning of the summer.
What is their collaboration with U.S. Health & Human Services’ Biomedical Advanced Research and Defense Authority (BARDA) about?
Regeneron has been collaborating with the federal government for some years. For example, in 2017, they announced a partnership with BARDA involving two collaborative tracks, including 1) discover research, develop and manufacture a portfolio of antibodies targeting up to 10 pathogens that pose a significant risk to public health, including the Influenza virus, and 2) continue to build on a prior agreement to develop and manufacture the Ebola virus therapy.
About Regeneron Pharmaceuticals
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists for nearly 30 years, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and more than a dozen product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, and infectious and rare diseases. Regeneron is accelerating and improving the traditional drug development process through its unique VelociSuite® technologies, including VelociGene® and VelocImmune®, and ambitious initiatives such as The Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world.