Edition 2 / June 2020
Dr. Mike Ironside,
Interim Head of Development, Manufacturing & Project Management,
The Pharma Industry’s early response to the COVID-19 pandemic has been nothing short of inspiring, and the race to develop vaccines and treatments is gaining even more momentum as the infection takes its course. The massive efforts being undertaken by Academia, Biotechs and Pharma companies alike is being supported in full by CDMO suppliers like CordenPharma, who provide expertise and resource to support the development of potential new therapies. Beyond that, CDMOs are also directly assisting the wider healthcare community through provision of much needed medicines in a time of crisis.1
According to the World Health Organization, since the onset of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and associated Coronavirus Disease (COVID-19), there are already more than 120 vaccines under development, and almost as many drugs being evaluated, both anti-virals and indirect therapies.2 By mid-May, Pfizer, Johnson & Johnson, Moderna and several others all had well-advanced vaccine candidates, with many entering clinical trial phases.3-6 In fact on May 28th, CordenPharma and Moderna announced the extension of their lipid supply agreement to support increased production for Moderna’s mRNA-1273 vaccine candidate.
According to the Journal of the American Medical Association (JAMA), the genetic sequence for COVID-19 (SARS-CoV-2) was released to the public database on January 10th.7 With solid viral vector, infection, death and patient data, plus early anecdotal and empirical patient-group study findings, therapeutic developments began almost immediately.
Due to collaboration and financial incentives from both private and public groups, drug developers and their contract partners continue to accelerate their efforts to deliver effective therapeutics to treat the COVID-19 infection.
Although the approval of a vaccine solution for the SARS-CoV-2 virus is likely to be on an accelerated timescale, there is common agreement among the life-science community that therapeutics to treat COVID-19 infections and its complications will be approved well-before vaccines become generally available.8
Since January, the pharmaceutical industry has been organizing a focused response along a number of therapeutic fronts to diagnose and treat the infection. Among the earliest therapeutics introduced were rapid diagnostic tools granted Emergency Use Authorization by the FDA on March 16th.9
A wide range of potential therapeutics emerged in April along large and small-molecule development paths, many of which had already been developed for other therapeutic applications. Early antivirals like oseltamivir and HIV combinations were also being evaluated. By mid-April, the pharmaceutical industry was screening several promising small-molecule candidates including: 8,10
The industry’s response on the biologics front has been equally robust. In April, several biomolecules (both new and existing) were being seriously evaluated, with prominent drug developers advancing approximately eight monoclonal antibody (mAb) candidates as potential treatments.8,10
Notably, Regeneron Pharmaceuticals entered into an agreement with the US Department of Health and Human Services to use its proprietary mAb technologies to quickly identify and validate COVID-19 antibody candidates.11 Johnson & Johnson entered into a similar agreement with H&HS, along with a commitment to supply a billion doses world-wide.
Drug developers have also been busy advancing next-generation cell therapies including RNA-based therapeutics. Targeting proteins and other means to disrupt the virus, researchers are also pursuing peptide platform technologies that elicit T-cell responses and nanobody-based treatments designed to interrupt COVID-19’s complex crystal structure sequence.
As developments and data continue to demonstrate or refute the viability of development efforts, the crisis, like the virus, will run its course. Pharma responded to the pandemic with an impressive agility and flexibility that drew upon vast reserves of expertise and a deep desire to ease the evident human suffering.
While Pharma’s mission has always been to stop or control infection & disease, the diversity of therapeutic routes and modalities being pursued to treat the current virus and manage the effects of COVID-19 point to the industry’s increasing ability to respond faster and more effectively than ever before. Moreover, this faster movement of clinical programs also means that trusted CDMO partners like CordenPharma are playing an even more crucial role in helping the pharmaceutical industry provide access to safe, effective treatments to patients globally.
Stay up to date with the latest thought leadership articles and news from CordenPharma.