The Cortellis team regularly attends industry conferences to provide summaries, updates and insights on what’s happening across the life sciences R&D landscape. Here we summarize select proceedings from the spring BIO Europe Conference.*
In the wake of the coronavirus COVID-19 (SARS-CoV-2) pandemic and a lockdown on worldwide travel, the 14th Annual BIO-Europe Spring Partnering meeting was restaged as the largest-ever virtual partnering event in life sciences. During a live panel discussion on the unprecedented challenge and need for rapid innovation and collaboration the pandemic has created, industry leaders shared their strategies to develop diagnostics and therapeutics to combat COVID-19. Phyllis Arthur, VP Infectious Diseases and Diagnostics Policy, BIO, reported that to date, 86 drugs have been investigated for COVID-19 globally, with 349 trials started, including in China for HIV and Ebola therapeutics as well as those conducted by the World Health Organization (WHO) and the National Institutes of Health (NIH) across the world.
Moderna’s race to create a vaccine using their established and successful ‘rapid response platform’ was described by its CEO, Stephane Bancel. Two days after the genetic sequence of the novel coronavirus was published, the company, working with the NIH, finalized the sequence for its vaccine candidate mRNA-1273 and began production. On January 20, the company reached out to The Coalition for Epidemic Preparedness Innovations (CEPI) for financial help. Production of the first clinical batch was completed on February 7, and on February 21 an IND was filed. On March 16, the first subject was dosed in a phase I study investigating safety and immunogenicity in 45 subjects; data are expected in the next few months. Moderna has started to make at-risk phase II material and is working with the FDA to begin a phase II trial this spring. If positive immunogenicity is achieved, the company aims for emergency use of the vaccine in the third quarter of 2020 to protect healthcare workers and other people at high risk. Moderna expects to progress to a phase III study later in 2020, with an eye on a commercially available vaccine in 2021.
If positive immunogenicity is achieved, Moderna aims for emergency use of the vaccine this Fall to protect healthcare workers and other people at high risk.
Janssen Pharmaceutical’s Hanneke Schuitemaker, Global Head, Viral Vaccine Discovery and Translational Medicine, remarked how they too had been on ’high alert‘ since the first cases began to appear in China. A recombinant adenoviral vector vaccine, using a human PER.C6 cell line and Janssen’s AdVac and PER.C6 technology platforms, has been developed. It is currently in preclinical immunogenicity testing, with lead candidate selection expected by the end of April. Janssen plans to begin manufacturing clinical trial material for a phase I study to begin later this year. In parallel, the company is scaling up manufacturing to ensure a stockpile of vaccines that can be immediately deployed when there is first evidence that it is safe and sufficiently immunogenic against COVID-19.
Regeneron has quickly produced highly potent neutralizing antibodies to COVID-19, as it did for Ebola, using its VelocImmune platform created for genetically engineered humanized mice, for which it is now scaling up manufacture. Clinical trials are planned for June. These therapeutic antibodies can also act as prophylactic passive vaccines, said George Yancopoulos, Regeneron President and CSO, which will not have the long-term immunity of an active vaccine but can be developed faster and potentially be available by the end of August.
An even nearer-term approach is Regeneron’s existing approved rheumatoid arthritis anti-IL-6 antibody sarilumab (Kevzara), investigated following Chinese reports of the remarkable effects of anti-inflammatories on severe covid-19 patients. Regeneron, The Biomedical Advanced Research and Development Authority (BARDA), the FDA and New York medical centers have enrolled 40 to 50 patients in a U.S. trial of sarilumab for COVID-19. Within a few weeks, data could be ready to confirm whether the drug is safe and effective in severely affected patients.
Conclusion: Large scale manufacturing is essential
The panel closed by concluding that a top priority was large scale rapid manufacturing. Otello Stampacchia from Omega Funds stated that for every month the U.S. undergoes ‘stay-at-home’ measures, the effect on the country’s GDP was close to $1 trillion; therefore, governments need to invest in manufacturing capacity ‘at risk’ and not wait until drugs are proven effective.
Continue checking our blog for additional updates and late-breaking news related to COVID-19. These include clinical trials, development pipelines, regulatory changes and more. Visit this page to view additional resources to help accelerate treatment and vaccines to combat the coronaviruses.
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