TrialSite recently profiled Columbus, Ohio-based Aventiv Research as the independent trial site organization was selected by Pfizer as a site to participate in the BNT162 COVID-19 vaccine trial program. Now, local media (WSYX/WTTE) reports that the Columbus-based site was also selected by Eli Lilly for participation in the BLAZE-1 study investigating advanced monoclonal antibodies targeting COVID-19. This particular study involves LY-CoV555 and LY-CoV016, one of which originated out of a collaboration between Lilly and AbCellera (March) and the other a license deal with Junshi Biosciences in China (May). Dr. Samir Arora founded Aventiv Research back in 2007; the Columbus principal investigator recently expressed his excitement about this antibody treatment under investigation emphasizing to local Columbus media that if this particular treatment proves successful in clinical trials, it would be one of the first medications on the market to help patients fight off COVID-19.
COVID-19 in Columbus, OH
Statewide, Ohio, with 11.7 million people, has a reported 139,604 cases of COVID-19 as of September 16, 2020 with 4,511 deaths statewide. With a COVID-19 portal, Columbus keeps track of the pandemic and its local impact. Thus far, the city and county have experienced 473 and 645 deaths respectively. In both the city and county, a majority of the deaths from COVID-19 have occurred in long term care facilities (65% in the city and 66% in the county).
Columbus is 54% non-Hispanic white, 29% non-Hispanic black, 6% Hispanic and 6% Asian. As far as cases in the city, whites account for 31%, Blacks 28% and Hispanic’s 13% (double their proportionate population). At least in Columbus, Whites died at higher rates (a majority in long term care) at 61% of the total. The death rates in Columbus point to investigation into the long term care facilities.
What are the Investigational Therapies?
The BLAZE-1 study has arrived in Columbus, Ohio, as an experimental treatment option targeting COVID-19. But what drugs are involved? The press often doesn’t explain this aspect of a clinical trial, hence TrialSite News.
BLAZE-1 actually involves two monoclonal antibodies, including “LY3819253 or LY-CoV555” and “LY3834279 or LY-CoV016.” But what are these?
TrialSite introduced LY-CoV555 in a few different articles but essentially it’s a potent neutralizing IgG1 monoclonal antibody (mAb) targeted against the spike protein of SARS-CoV-2. The mAb was actually designed to block or impede viral attachment and penetration into the host cells, hence actually neutralizing SARS-CoV-2 and therefore, offering the patient the prospect of both prevention of COVID-19 as well as a possible treatment option.
LY-CoV555 was the result of a collaboration between Lilly and University of British Columbia spin-off AbCellera to develop monoclonal antibodies targeting COVID-19. Lilly inked a deal with AbCellera back in March 2020 after the impressive Vancouver-based startup secured a partnership with the U.S. government via a DARPA contract. TrialSite reported that thanks to the discovery features of AbCellera, just at the onset of the pandemic Lilly scientist cranked day and night rapidly developing the antibody in just three months once AbCellera and the Vaccine Research Center at NIAID identified it from a sample from one of the first known infected COVID-19 patients. Born was the first investigational new medicine specifically designed to attack SARS-CoV-2, the virus behind COVID-19. Lilly just announced positive proof of concept data for LY-CoV555.
By May, Eli Lilly announced a co-development partnership with China-based Junshi Biosciences, a biopharmaceutical company specializing in discovery, development and commercialization of novel therapies. Targeting therapies to combat COVID-19, the pair had already developed multiple neutralizing antibodies as potential candidates and a lead asset poised to enter clinical trials in the second quarter: LY-CoV016. This powerful investigational product was made via a collaboration of a Chinese biotech and a national research lab.
Developed by Junshi in China, as the pandemic raged Lilly’s chief scientific officer Daniel Skovronsky, MD, PhD, emphasized the “urgent need to study multiple complementary approaches to address this disease.” Dr. Skovronsky communicated about the targeted therapy, saying, “The data generated by Junshi Biosciences suggest the lead antibody may have appropriate properties to support testing its therapeutic use in patients as well as exploring its potential for preventing infection in at-risk individuals.” Lilly went on to license the intellectual property, exclusively for all territories except for “Greater China.”
LY-CoV016 was formerly JS016, a recombinant fully human monoclonal neutralizing antibody that targets the SARS-CoV-2 surface spike protein receptor binding domain, hence can block the binding of viruses to host cell surface receptor ACE2. This investigational therapy was the result of a joint project between Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science.
The BLAZE-1 Study Comes to Columbus
Formally titled “A Randomized Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants with Mild to Moderate COVID-19 Illness,” BLAZE-1 was designed to measure how well both LY-CoV555 (made in collaboration with AbCellera) andLY-CoV016 (made by collaboration in China) work against SARS-CoV-2. The monoclonal antibodies will be administered to participants with early symptoms of COVID-19, via an injection into a vein. The investigational team at Aventiv Research will take samples from the back of the nose to assess how much the virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site; the remaining assessments can be performed in the home or via phone.
The study includes three arms, including A) LY-CoV555 only arm, B) combined LY-CoV555 plus LY-CoV016, and C) placebo.
The study team, led by Dr. Arora in Columbus, reviews A) the change from Baseline to Day 11 in viral load and B) percentage of participants with viral load greater than a prespecified threshold.
Aventiv Research At the Forefront
By participating in this clinical trial, Dr. Arora truly brings Columbus, Ohio into a leading position, at the forefront of investigating monoclonal antibodies targeting COVID-19. By working with life science-based therapies designed to not only treat but to actually stop the infection from happening these investigational treatments become critical weapons in the arsenal in this pandemic. Literally millions could benefit if these therapies work. And that’s the next step as the principal investigator from Columbus told ABC 6, “Basically, we’re looking for a drop in the viral load.” The study is early on, just initiated weeks ago.
Call to Action: If you are based in the Columbus area and want to learn more about this study, call 614-501-6164 or visit AventivResearch.com.