Eli Lilly’s novel antibody LY-CoV555 has demonstrated promise in a phase 2 study investigating its benefit in moderate-to-severe COVID-19 patients.

LY-CoV555 is designed to specifically neutralise SARS-CoV-2, the virus which causes COVID-19, and was identified from a blood sample taken from a recovered COVID-19 patient in the US.

The antibody came out of a collaboration between Lilly and AbCellera, agreed back in March, that focused on the development of antibody products for the treatment of the novel coronavirus.
In the first results from Lilly’s BLAZE-1 clinical trial, LY-CoV555 was able to reduce the rate of hospitalisations in the patient population, and also met the primary endpoint of change from baseline in viral load at day 11.

However, only one of the doses tested – 2800mg – met this primary endpoint, with the other two doses – 700mg and 7000mg – showing no significant improvement over placebo on this measure. Despite this, Lilly said that LY-CoV555 improved viral clearance at day 3, with fewer patients on receiving the drug demonstrating a persistently high viral load at later time points.

In terms of the key secondary endpoints, in the LY-CoV555 treatment arm, 1.7% of participants were hospitalised or visited an emergency room due to COVID-19 compared to 6% in the placebo arm.

Also, in exploratory analyses, Lilly added that LY-CoV555 seemed to improve COVID-19 symptoms at a faster rate compared to those who did not receive the antibody treatment.

Results from a phase 1/2a study of Johnson & Johnson’s (J&J) potential COVID-19 vaccine candidate have come back positive, as the company’s launches a large-scale phase 3 trial across three continents.

According to interim results published on the pre-print server medRxiv on Friday, a single dose of J&J’s JNJ-78436735/Ad26.COV2.S vaccine produced a strong immune response against the novel coronavirus, SARS-CoV-2, which causes COVID-19.

The pre-print results have not been certified by peer review, but given the speed at which drugmakers like J&J are developing their COVID-19 vaccines, there is less time to follow traditional protocol with regards to publishing trial data.

Researchers from J&J’s pharmaceutical division Janssen said, from data available at the interim analysis, 98% of participants had neutralising antibodies 29 days after vaccination. The levels of neutralising antibodies in the vaccine treatment group were in the same range as people who have recovered from COVID-19 infections.

In addition, 99% of participants had developed detectable antibodies, while the candidate also elicited strong antibody responses, strong T-cell responses and a Th1 response. The Th1 response is believed to protect against the risk of vaccine-associated enhanced respiratory disease.

High levels of neutralising antibodies are an important indicator of efficacy in early clinical trials, as they defend cells from pathogens, including SARS-CoV-2.

Although the results are promising and have led to a 60,000-participant phase 3 trial, only a small number of immune response results for people over the age of 65 were available at the time of the interim analysis.

In addition, J&J reported that similar immunogenicity was observed across both dose levels, although it added that it has selected the lower dose for further clinical evaluation.

Sanofi and GlaxoSmithKline (GSK) have announced that they are set to begin clinical testing of their recombinant protein-based COVID-19 vaccine in humans.

The partner drugmakers will study the vaccine candidate in 440 healthy adults in the US, and will evaluate the safety, immune response and tolerability of the shot.

The vaccine combines Sanofi’s baculovirus expression system, which is already used in its quadrivalent flu vaccine, and GSK’s AS03 adjuvant, which is designed to boost immune responses in participants.

Sanofi and GSK expect the first results from the clinical trial in early December, which will hopefully support the launch of a large-scale phase 3 trial in the same month.

Sanofi and GSK announced their partnership in April, and at that time the companies said they expect to complete the development required for availability by the second half of 2021.

In July, the UK government agreed a deal with the drugmakers for 60 million doses of the protein-based vaccine. The deal ensures early access to the COVID-19 vaccine if it proves effective in clinical trials, with the first doses going to priority groups.

A week later, Sanofi and GSK forged another agreement with the US government for 100 million doses of their vaccine. The companies were also selected to be included in Operation Warp Speed, a targeted initiative which aims to deliver 300 million doses of a COVID-19 vaccine to American citizens, free of charge, by January 2021.

Regeneron has released new data for its investigational COVID-19 antibody cocktail, and the early results are promising.

The first descriptive analysis from a ‘seamless’ phase 1/2/3 trial of the investigational treatment, REGN-COV2, showed that it reduced viral load and helped non-hospitalised COVID-19 patients to recover faster. On top of that, REGN-COV2 also showed positive trends in reducing medical visits.

The promising results come from a large programme investigating REGN-COV2, which Regeneron is also investigating as a treatment for hospitalised COVID-19 patients and for the prevention of infection in people who have been exposed to COVID-19 patients.

The descriptive analysis included the first 275 patients enrolled in the trial, and was designed to evaluate antiviral activity with REGN-COV2, as well as identify which patients are most likely to benefit from the treatment.

The study included patients from two different populations – those who had already mounted an effective immune response against SARS-CoV-2 (seropositive) and those whose immune response was not yet adequate (seronegative).

Notably, REGN-COV2 rapidly reduced viral load until day 7 of treatment in seronegative patients, with seropositive patients treated with the antibody cocktail seeing a rapid reduction in viral load.
“The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally occurring immune response. These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms,” said George Yancopoulos, president and chief scientific officer of Regeneron.

BioNTech has strengthened its vaccine manufacturing capacity following a deal with Novartis for a production site in Germany, ahead of the planned filing of its coronavirus shot in October.

According to BioNTech, the deal will expand its COVID-19 vaccine production capacity by up to 750 million doses per year once the site, based in the German city of Marburg, is fully operational.
In the first half of 2021, BioNTech added that it hopes to produce up to 250 million doses of its Pfizer-partnered BNT162b2 shot at the Novartis site.

The Marburg site is fully equipped for the production of recombinant proteins as well as cell and gene therapies, with Novartis having significantly invested in the site over the past five years. BioNTech and Novartis did not disclose the financial terms of the deal, although BioNTech said that the transaction is expected to close in the fourth quarter of 2020.

In July, Pfizer and BioNTech revealed the early positive data from their mRNA-based COVID-19 vaccine programme, with two of the candidates – BNT162b1 and BNT162b – demonstrating promising dose-dependent immunogenicity.

BioNTech also announced this week that it had been awarded a €375m grant from an initiative by the German Federal Ministry of Education and Research (BMBF), to support the accelerated development of SARS-CoV-2 targeting vaccines.

BioNTech and Pfizer have previously said that they are on track to submit BNT162b for regulatory review by October, if all goes to plan in the ongoing efficacy studies.

Almost a month after initiating the phase 2 portion of its COVID-19 vaccine trial in the US and Australia, Novavax has launched its first phase 3 trial in the UK.

The planned phase 3 study, which is being conducted in partnership with the UK government’s Vaccine Taskforce, will evaluate the efficacy, safety and immunogencity of Novavax’s COVID-19 vaccine, NVX-CoV2373.

The company is expecting to enrol and immunise up to 10,000 individuals aged between 18-84, with and without relevant comorbidities, over the next four to six weeks. Participants will either receive two intramuscular injections of Novavax’s vaccine and Matrix-M adjuvat, or a placebo shot.
The trial will aim to enrol at least 25% of participants over the age of 65, as well as give priority to groups that have been the most affected by COVID-19, including certain racial and ethnic minorities.

In a phase 1 study of Novavax’s vaccine candidate, the shot produced high levels of antibodies against the SARS-CoV-2 virus, which causes COVID-19, after a single dose of the vaccine.
Novavax has been awarded $1.6bn by the US government under the Operation Warp Speed scheme to accelerate the research and development of its vaccine candidates.

The UK government also signed a deal with Novavax in August, which led to the phase 3 clinical trial, and has also partnered with FUJIFILM Diosynth Biotechnologies to manufacture certain components of the vaccine in the UK.