COVID-19 Vaccine Development

Moderna Announces Positive Interim Data of COVID-19 mRNA Vaccine

On 18th May 2020, Moderna Inc., a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced positive interim clinical data of mRNA-1273, its vaccine candidate against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Phase I study is led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna, stated: “These interim Phase I data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg. When combined with the success in preventing viral replication in the lungs of a preclinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine

Progress for Oxford University’s Vaccine

On 13th May 2020, the University of Oxford published results of their study of adenovirus-vectored vaccine (ChAdOx1 nCoV-19) in rhesus macaques. Results showed a significant reduction of viral load in bronchoalveolar lavage fluid and respiratory tract tissue of vaccinated animals challenged with SARS-CoV-2 compared with control animals, and no pneumonia was observed in vaccinated rhesus macaques1.

On 23rd April 2020, the University of Oxford began the Phase I clinical trial of their COVID-19 vaccine, assessing ChAdOx1 nCoV-19’s if healthy people can be protected from COVID-19 and to provide additional information on the vaccines safety and it ability to induce an immune response against the virus. A licensed vaccine (MenACWY) is used as an active control in the study to help understand participants’ response to ChAdOx1 nCoV-192.

AstraZeneca and the University of Oxford have partnered for the global development and distribution of the University’s vaccine candidate. Professor Sir John Bell, Regius Professor of Medicine at Oxford University, said: “Our partnership with AstraZeneca will be a major force in the struggle against pandemics for many years to come. We believe that together we will be in a strong position to start immunising against coronavirus once we have an effective approved vaccine. Sadly, the risk of new pandemics will always be with us, and the new research centre will enhance the world’s preparedness and our speed of reaction the next time we face such a challenge.” 3

1https://www.biorxiv.org/content/10.1101/2020.05.13.093195v1

2http://www.ox.ac.uk/news/2020-04-23-oxford-covid-19-vaccine-begins-human-trial-stage

3https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-oxford-university-announce-landmark-agreement-for-covid-19-vaccine.html

Pfizer and BioNTech Initiate COVID-19 mRNA Vaccine Dosing in U.S. as Part of Global Development Programme

On 5th May 2020, Pfizer and BioNTech announced that the first participants had been dosed in the United States (U.S.) in a Phase I/II clinical trial for mRNA vaccine BNT162. The trial aims to determine the safety, immunogenicity, and optimal dose level of four mRNA vaccine candidates, each representing a different combination of mRNA format and target antigen, evaluated in a single, continuous study. It will allow the evaluation of the various mRNA candidates simultaneously to identify the safest and potentially most efficacious candidate in a greater number of volunteers, in a manner that will facilitate the sharing of data with regulatory authorities in real-time.

Bourla, Chairman and CEO, Pfizer stated: “With our unique and robust clinical study program underway, starting in Europe and now the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most. The short, less than four-month timeframe in which we’ve been able to move from preclinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_biontech_dose_first_participants_in_the_u_s_as_part_of_global_covid_19_mrna_vaccine_development_program

COVID-19 Research and Therapeutic Development

World Health Organisation (WHO) Temporarily Suspends Trial of Hydroxychloroquine Over Safety Concerns

On 25th May 2020, the WHO announced the temporary suspension of tests of the anti-malarial drug hydroxychloroquine as a coronavirus treatment in order to review safety concerns. Decision from the agency come after a research paper issued in the Lancet, a peer-reviewed medical journal, showed that people taking the drug were at higher risk of death and developing heart problems than those that were not.

WHO Director-General Tedros Adhanom Ghebreyesus stated: “The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board. The other arms of the trial are continuing. This concern relates to the use of hydroxychloroquine and chloroquine in COVID-19. I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria.”

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19—25-may-2020

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext

Covis Pharma Launches Phase III Trial for Alvesco Inhaler for the Treatment of COVID-19

On 19th May 2020, Covis Pharma announced the launch of a Phase III trial assessing the safety and efficacy of its asthma drug Alvesco (ciclesonide) in non-hospitalized patients 12 years of age and older with symptomatic COVID-19. The initiation of the trial is after the Food and Drug Administration (FDA) approval of the company’s Investigational New Drug (IND) filing for Alvesco for the treatment of COVID-19.

Michael Blaiss, M.D., Clinical Professor of Pediatrics, Medical College of Georgia at Augusta University, stated: “There is promising scientific evidence that Alvesco, an inhaled glucocorticoid, may both reduce COVID-19 symptoms and suppress viral replication. Evaluating Alvesco in this Phase III clinical trial is an important step towards determining its efficacy in treating individuals who have tested positive for the virus, and we are hopeful that it will become an important tool in the world’s response to this public health emergency.”

https://www.prnewswire.com/news-releases/covis-pharma-bv-initiates-phase-3-clinical-trial-of-alvesco-ciclesonide-inhaler-for-the-treatment-of-covid-19-301061105.html

Global Study to Assess Chloroquine in Prevention of COVID-19 in Health Care Workers

A group collaboration between physicians and scientists are establishing a research network to evaluate promising therapies for coronavirus (COVID-19). The research group, called the COVID-19 Research Outcomes Worldwide Network (CROWN), aims to evaluate if the antimalaria drug chloroquine can prevent COVID-19 infection or decrease its severity in front-line health-care workers. Health-care workers will be randomised into four groups; three of the groups will receive chloroquine at various doses while the fourth group will receive an inactive placebo. The trial will assess whether the drug can prevent health-care workers from developing COVID-19 disease or decrease the severity of illness for those who do become infected and determine the lowest dose required to provide benefit.

One of the study’s principal investigators, Michael S. Avidan, MD, head of the Department of Anaesthesiology at Washington University stated: “Because of their repeated close contacts with infected patients, front-line health-care workers in all parts of the world have a higher risk of contracting COVID-19 than most members of the general public. In some places, more than 10% of those who have become infected are health-care workers. There is an urgent need to identify drugs that are effective at preventing infection or mitigating its severity.”

https://medicine.wustl.edu/news/global-study-to-test-malaria-drug-to-protect-health-workers-from-covid-19/

GlaxoSmithKline (GSK) to Trial Rheumatoid Arthritis Drug Otilimab for the Treatment of Pneumonia Caused by COVID-19 Infection

GlaxoSmithKline (GSK) is set to initiate a trial on investigational rheumatoid arthritis drug otilimab for the treatment of pneumonia caused by COVID-19 infection. GSK identified the drug after screening its portfolio and pipeline for potential candidates against COVID-19.

The drug entered a Phase III trial in rheumatoid arthritis last year. Otilimab works by neutralising the biological function of Granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine found in high levels in patients with COVID-19. The company will test whether a single dose of otilimab could dampen the inflammation in patients with pneumonia caused by COVID-19.

https://www.fiercebiotech.com/biotech/gsk-taps-experimental-arthritis-antibody-to-calm-cytokine-storm-hitting-covid-19-patients

Phase II Trial to Explore Prostate Cancer Drug to Reduce COVID-19 Symptoms in Men

On 15th May 2020, the University of California, Los Angeles (UCLA) announced initiation of a Phase II trial to assess FDA approved prostate cancer drug, Degarelix, to help with clinical COVID-19 outcomes in infected males. The trial will assess if temporarily suppressing male hormones will reduce the severity of COVID-19 illness and lead to shorter hospitalisation time, decrease the need for intubation, and improve mortality. As part of the study, researchers will look into the suppression of male hormones using Degarelix, to temporarily shut down the production of TMPRSS2 , a receptor believed to be used by the virus to enter the lungs and attack lung tissue.

Principal investigator Matthew Rettig, MD, professor of medicine and urology at the David Geffen School of Medicine at UCLA and member of the UCLA Jonsson Comprehensive Cancer Centre stated: “It’s becoming pretty clear that men are more likely than women to die from COVID-19 and we think there is a connection between prostate cancer research and our understanding of COVID-19 research.”

https://cancer.ucla.edu/Home/Components/News/News/1504/1631

Algernon Submits Ethics Approval in Australia for COVID-19 Trial of Ifenprodil

On 15th May 2020, Algernon Pharmaceuticals, a clinical stage pharmaceutical development company, announced that it had submitted for ethics approval in Australia for a planned multinational Phase IIb/III trial of NP-120 (Ifenprodil) for COVID-19. According to Algernon they believe NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs, which play a role in the cytokine storm that contributes to the loss of lung function and ultimately death reported in COVID-19 infected patients.

http://www.globenewswire.com/news-release/2020/05/15/2034248/0/en/Algernon-Submits-for-Ethics-Approval-in-Australia-for-Multinational-Phase-2b-3-Human-Study-of-Ifenprodil-for-COVID-19.html

Abivax Receives Ethics Approval to Conduct Phase IIb/III Trial of ABX464

On 14th May 2020, Abivax, a clinical-stage biotechnology company developing novel treatments for inflammatory diseases, viral diseases and cancer, announced that France’s National Agency for the Safety of Medicines (ANSM) and French Ethics Committee (CPP) gave approval for initiation of a randomised, double-blind, placebo-controlled Phase IIb/III trial of ABX464 to prevent severe inflammation that leads to acute respiratory distress syndrome in elderly or high-risk patients.

ABX464 was observed to upregulate miR-124, which plays a key role in inflammation and could potentially down-regulate multiple cytokines involved in the COVID-19 induced cytokine storm. The trial will be performed at hospitals in France and other European countries. Patients will be randomised to be treated with BX464 oral dosing once-daily or placebo and standard of care for 28 days, recruitment is expected to be completed within a few months.

https://www.abivax.com/press-releases/

NIH Initiates COVID-19 Trial of Hydroxychloroquine and Azithromycin

On 14th May 2020, the NIH announced initiation of Phase IIb trial to evaluate malaria drug hydroxychloroquine, given together with the antibiotic azithromycin to treat COVID-19 infected patients. Study participants will be randomly assigned to receive short-term treatment with either hydroxychloroquine and azithromycin or matching placebos.

The primary endpoint of the trial is to determine whether hydroxychloroquine and azithromycin can prevent hospitalisation and death due to COVID-19. While hydroxychloroquine and azithromycin are both considered safe in most people, they can cause side effects ranging from headache and nausea to, rarely, heart rhythm problems that can be life-threatening. Because of the risk of heart problems, FDA cautions that use of hydroxychloroquine for COVID-19 should be limited to clinical trials or for treating certain hospitalized patients under emergency use authorisation (EUA) so clinicians can monitor patients for adverse effects.

https://www.nih.gov/news-events/news-releases/nih-begins-clinical-trial-hydroxychloroquine-azithromycin-treat-covid-19

Gilead’s Veklury® Approved in Japan for Patients With Severe COVID-19

On 7th May 2020, Gilead Sciences announced that the Japanese Ministry of Health, Labour, and Welfare (MHLW) had granted approval of Veklury® (remdesivir) for treatment for SARS-CoV-2 infection. The approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ global Phase III trial, Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from Gilead’s compassionate use program, including patients in Japan1.

On 1st May 2020, Gilead Sciences announced the FDA granted an EUA for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalised patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country. The EUA is based on data from two global clinical trials: a Phase III study in patients with moderate to severe symptoms of COVID-19 and Gilead’s global Phase III study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir2.

1https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gilead-announces-approval-of-veklury-remdesivir-in-japan-for-patients-with-severe-covid19

2https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19

FDA and E.C. approvals

Novartis Receives European Commission (E.C.) Approval for Zolgensma®

On 19th May 2020, Novartis announced that AveXis, a Novartis company, received E.C. approval for Zolgensma® (onasemnogene abeparvovec) for the treatment of patients with spinal muscular atrophy (SMA). SMA is a rare genetic neuromuscular disease affecting infants, Zolgensma® is a gene therapy that addresses the genetic root cause of the disease by replacing the function of the missing or nonworking SMN1 gene, delivering a new working copy of the SMN1 gene into a patient’s cells, halting disease progression.

E.C. approval is based on the completed Phase III STR1VE-US and Phase I START trials that evaluated the efficacy and safety of a one-time IV infusion of Zolgensma® in symptomatic SMA Type 1 patients <6 months of age at dosing. Discussions are in place between AveXis and E.U. governments and reimbursement agencies to agree on terms of innovative “Day One” access program to enable rapid access in all E.U. countries given urgent need to treat SMA.

https://www.novartis.com/news/media-releases/avexis-receives-ec-approval-and-activates-%22day-one%22-access-program-zolgensma-only-gene-therapy-spinal-muscular-atrophy-sma

FDA Authorises First Diagnostic Test of Using Home-collected Saliva Samples for COVID-19 Testing

On 8th May 2020, the FDA announced the authorisation of the first diagnostic test using at-home collection of saliva specimens. The FDA issued the EUA to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), to allow testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. The EUA for Rutgers Clinical Genomics Laboratory’s molecular test permits testing of a saliva sample collected from the patient using a designated self-collection kit. Once patients collect their saliva sample, they return it to the Rutgers Clinical Genomics Laboratory in a sealed package for testing. The authorisation is limited only to Rutgers Clinical Genomics Laboratory test and only upon prescription.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva

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