TrialSite has reported that Lilly’s monoclonal antibody (LY-CoV555) evidenced promise at a trial site location in southern Texas and that shortly thereafter recent interim analysis data from Lilly backed that observation. Now Regeneron’s monoclonal antibody cocktail designed to take on COVID-19, REGN-COV2 apparently yields positive results in San Antonio, Texas as well as a local trial site operation called Sun Research Institute, one of about 150 such sites globally reports on positive observations to local press. Reports of progress are so promising that local media suggests the therapy could be available in weeks. Probably not possible but the progress here is worth noting in the TrialSite.
The Investigational Product
REGN-COV2 is actually a combination cocktail of two monoclonal antibodies developed by Regeneron. The two are known as REGN10933 and REGN10987. Both of them were designed in Regeneron labs leveraging their VELOCISUITE® research and development platform.
The federal government has contributed with at least $450 million for the manufacture and supply of this advanced monoclonal antibody combination. The initial report published in Science describes the “humanized mice and convalescent humans” antibody cocktail in more detail. TrialSite introduced the investigational cocktail product when describing a research site that was literally just launched for the study; the trial site was so new they didn’t even have a website as of the writing on July 6.
REGN-COV2 Unorthodox Trajectory?
Upon introducing the new Mesa trial site operation, it became apparent that this was no orthodox clinical trial. In fact, Regeneron hadn’t even completed a true Phase 1 study before announcing clinical trials including Phase 3. TrialSite was able to speak with a very helpful spokesperson at Regeneron who shared that Regeneron had established an approach with the U.S. Food and Drug Administration (FDA) that included a “sentinel” cohort population for purposes of assessing safety.
Meaning a group of 30 patients infected with SARS-CoV-2 located in hospitals and or treated in ambulatory care were administered the drug and monitored by an Independent Data Monitoring Committee (IDMC). Apparently, the data, which was still blinded (e.g. not even Regeneron could see), was so promising that the IDMC gave a greenlight and Regeneron accelerated full throttle. In the meantime, another Phase 1 study evaluating different doses materialized later in July and runs through October, 2021.
Helpful Regeneron Updates
Thanks to again one of the more helpful media persons in any big pharmaceutical company, Regeneron shared with TrialSite that the company still hasn’t published the data for the sentinel population as of yet, however they are conducting an ongoing Phase 1 safety data. Moreover, Regeneron’s reports at this stage that literally hundreds of volunteers have been dosed with REGN-COV2. The spokesperson noted that the company will publish the full set of safety data when the full Phase 1 portion is complete. She reminded that all Regeneron-run clinical trials for REGN-COV2 are monitored by the IDMC. TrialSite emphasizes the fact that the IDMC is monitoring ongoing and that hundreds of patients have been dosed leads to a significantly promising potential for REG-COV2.
Presently, Regeneron has disclosed four (4) clinical trials involving this monoclonal antibody cocktail including a Phase 1/2 clinical trial (NCT04425629) for ambulatory care (e.g. patients with positive SARS-CoV-2 test); Phase 1/2 clinical trial (NCT04426696) for hospitalized patients; a Phase 1 clinical trial (NCT04519437) investigating occurrences of “adverse events of special interests (AESIs) in participants treated with multiple REGN-COV2 doses as well as an assessment of serum concentration in various doses and finally the only Phase 3 study (NCT04452318) that focuses on healthy individuals that may have been exposed to the pathogen via a household contact, etc. Again, the local media report for San Antonio makes clear this activity centers around a Phase 3 trial.
TrialSite learned from the recent email interaction with the Regeneron spokesperson that clinical trials for ambulatory and hospitalized patients mentioned above have progressed to Phase 2 &3 yet that data hasn’t yet been updated in the federal repository Clinicaltrials.gov.
As reported by local media FoxSanAntonio, Sun Research Institute participates in the Phase 3 trial of REGN-COV2, and is one of 150 trial sites worldwide. Based on the fact that the ambulatory study has progressed to Phase 3, this is the specific study referenced by FoxSanAntonio. The primary focus of this Clinical trial (NCT04425629) includes: 1) investigate the safety and tolerability of REGN-COV2 as compared to placebo; 2) evaluate the virologic efficacy of REGN-COV2 compared to placebo in reducing viral shedding of COVD-19; and 3) evaluate the clinical efficacy of REGN-COV2 as compared to placebo.
As reported by Morgan Burrell of FoxSanAntonio, some of the participants were actually interviewed. David Sanchez and his sister both stepped up to participate in this important research—which by itself in these times is admirable and worthy of kudos. Sanchez reports he caught the virus and wanted to give back.
Moreover, Site Director Beneta Parthiban offered some hints to the outside world about REGN-COV2. She noted, “This infusion has been going great, and the patient has really good positive results of this.” The director continued, “Some of them [patients] have been recovering really fast.”
TrialSite spoke briefly with Ms. Parhiban who confirmed the Phase 3 ambulatory study and that she was given the greenlight for these media statements.
Positive Findings Compares with Lilly’s LY-COV555 Observations
As was the case with site observations with the Lilly monoclonal antibody product, here positive findings are making their way to the local press. Now thanks to a local FoxSanAntonio report, it would appear that REGN-COV2 is making patients infected with SARS-COV-2, the pathogen behind COVID-19, heal faster.
Both Lilly and Regeneron may be on to the development of powerful treatments for COVID-19. Given TrialSIte has also been extensively reviewing possible off-label, generic and economical approaches to treat COVID-19, it will be very interesting to monitor all of this over the next weeks. Should both Lilly and Regeneron be on to something big, will they price for exorbitant profits or rather, to ensure universal access to COVID-19 treatments?
About Sun Research Institute
Based in San Antonio, Texas, Sun Research Institute is a comprehensive trial site organization conducting and managing a range of clinical trials. The team is led by Dr. Carl E. Dukes, Principal investigator, board certified in Internal Medicine and Nephrology. A graduate from University of Texas Medical School, under his guidance Sun Research Institute has grown into a substantial operation managing the research of many global biotech and pharmaceutical sponsors across therapeutic areas such as asthma, allergies, vaccines and more.
With at least six physicians on staff (Sub-investigators), the trial site organization includes Site Director Beneta Parthiban, MS, CCRC, two full-time coordinators and other support staff. More on Sun Research Institute can be found on Facebook.
Dr. Carl E. Dukes, Principal investigator
Call to Action: Sponsors interested in accessing large Hispanic patient populations should consider Sun Research Institute.