The R&D collaboration aims to balance the need for speed with the goal of advancing high-quality antibodies.
Until a vaccine can be found that provides immunity against SARs-CoV-2 infections, an antibody-based therapy could emerge as an option to prevent or treat COVID-19 in the interim. Amgen and Adaptive Biotechnologies are hard at work on a potential medicine, and the top scientists from both companies recently provided their perspectives on their new R&D collaboration.
“We are focused on making progress as quickly as possible,” said David Reese, Amgen’s executive vice president for Research and Development. “We are trying to strike the right balance between getting the highest quality antibody or antibodies as therapeutic candidates with the shortest timeline that we can manage. We see our effort as complementary to other efforts in the industry. We don’t view this as a competition but as an all-hands-on-deck moment.”
Speaking at a webinar held April 9, Reese and Harlan Robins, chief scientific officer and co-founder at Adaptive Biotechnologies, addressed a range of questions on the science behind the collaboration and key factors that would determine the program’s success. Topics included the potential efficacy of neutralizing antibodies, the genetics of SARs-CoV-2, and Amgen’s manufacturing capabilities.
“To find a truly effective antibody—or as we like to say, the Michael Jordan of antibodies—is quite difficult,” said Robins. He likened the search now underway to “scouting every single high school basketball player in the country at the same time. But this is what Adaptive’s platform is built to do.”
A scale well beyond past efforts
The adaptive immune system is “nature’s most finely tuned diagnostic and therapeutic for most diseases,” Robins said. But when a deadly virus like SARs-CoV-2 appears suddenly, people with weakened immune systems or complications may succumb, while those with healthier immune systems survive and generate antibodies to protect against future infections. Potent antibodies culled from survivors could provide the basis for a therapy to prevent or treat COVID-19 in others by neutralizing the virus.
Neutralizing antibodies have been used to treat other diseases, including Ebola, with at least some success. Amgen and Adaptive hope to take this therapeutic approach to the next level by using Adaptive’s sophisticated DNA sequencing and machine learning capabilities to search for highly potent antibodies at a scale well beyond past research efforts for other diseases.
Robins said that Adaptive expects to screen a set of antibodies that is one or two orders of magnitude larger than the antibody pools evaluated in previous hunts for neutralizing antibodies. “We’re hoping that we’ll be more likely to find that needle in the haystack—that really special antibody,” he said.
Part of the challenge will be to find antibodies that are broadly effective against different strains of SARs-CoV-2 and the various mutations the virus may generate. Amgen’s deCODE Genetics subsidiary has been sequencing samples of SARs-CoV-2 RNA taken from individuals who tested positive in Iceland which can help provide additional insights.
“While we would love to have a single antibody, it’s possible that a cocktail of several antibodies will be required,” said Reese. “As we move along, we are making plans to be able to handle that.”
Saving patients, protecting health care workers
Once the best antibody or antibodies are identified, Amgen will apply its expertise in genetics, immunology, antibody engineering, and manufacturing to optimize, develop, and produce a potential therapy designed to prevent and treat COVID-19. Reese said it was too early to project what the effective dose of a neutralizing antibody might be, or how many doses Amgen would be positioned to manufacture while still maintaining the full supply of its other antibody and protein medicines.
“How much we will need will of course depend on the characteristics of the therapeutic itself,” he said. “I think the good news here is that, in all likelihood, we anticipate that one or two doses over a period of a few weeks could be sufficient in a therapeutic setting.”
Early intervention is also likely to be a key success factor for any neutralizing antibody, Reese said. “One thing we have clearly learned, especially from the Ebola experience, is that the time point at which you intervene has a huge effect on outcome. Administering the treatment earlier in the course of disease gives it a much greater shot at efficacy.”
He also emphasized that an antibody therapy could be used prophylactically to protect frontline health care workers until an effective vaccine emerges. Even then, given the enormous task of making and administering enough vaccine to immunize people around the world, an effective antibody therapy could still prove necessary and useful for years.
It is also too early to project how long it might take to advance a neutralizing antibody into clinical trials, Reese said. “I think it would be disingenuous to give a timeline when we are just moving forward with the research phase now. But we’re trying to work on a timeframe of months, not years. We are doing many things in parallel that we would do sequentially in a typical development program, balancing the goal of getting the highest quality antibody against speed.”
For more information on Amgen’s resources related to the SARS-CoV-2 pandemic, visit our COVID-19 Information Center.
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