Pharma COVID Roundup: News from Moderna, Pfizer, Gilead, NovartisBy
The latest on manufacturing and potential treatments for COVID-19 from Moderna, Pfizer, Gilead, Novartis, AstraZeneca, Emergent BioSolutions, CSL Behring, and Biocon.
Moderna To Begin Phase III Trials for COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, reported promising results from a Phase I study of mRNA-1273, the company’s mRNA vaccine candidate against COVID-19, and announced plans to begin a Phase III trial later this month (July 2020).
Results from participants in the initial dose cohorts who received both vaccinations across three dose levels (25, 100, 250 µg) and were evaluated at pre-specified timepoints reaffirm a positive interim data assessment announced on May 18, 2020 and that showed mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2, the virus that causes COVID-19, according to information from Moderna.The study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Moderna says it is working closely with Operation Warp Speed, a US government program that aims to begin delivering millions of doses of a vaccine for COVID-19 in 2021, and the NIH, including NIAID’s COVID-19 Prevention Trials Network (COVPN), to conduct the Phase III study. The Phase III study protocol has been reviewed by the US Food and Drug Administration (FDA) and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies. Data will be reviewed by an independent Data Safety Monitoring Board organized by the NIH. Moderna anticipates sites to be initiated from July 21, 2020 and for enrollment into the study to commence on July 27, 2020.
FDA Fast Tracks Pfizer’s, BioNTech’s COVID-19 Vaccine Candidates
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, report that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, BNT162b1 and BNT162b2, being developed to help protect against SARS-CoV-2, the virus that causes COVID-19, have received fast-track designation from the US Food and Drug Administration (FDA).
This designation was granted based on preliminary data from Phase I/II studies that are currently ongoing in the US and Germany as well as animal immunogenicity studies. The companies released early data from the ongoing US Phase I/II study for the product candidate BNT162b1 on July 1, 2020. Early data from the German trial of BNT162b1 are expected to be released in July (as reported on July 13, 2020). The company says the BNT162 program is evaluating at least four experimental vaccines, each of which represent a combination of messenger RNA (mRNA) format and target antigen. The vaccine-development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s vaccine-development capabilities.
Subject to regulatory approval, the companies say they expect to start a Phase IIb/III trial later this month (July 2020) and are anticipating enrolling up to 30,000 subjects. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies say they currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.
Gilead Releases Promising Data on Remdesivir for COVID-19
Gilead Sciences reports additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, which showed an improvement in clinical recovery and a 62% reduction in the risk of mortality compared with standard of care.
The data are being presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference, AIDS 2020: Virtual, and include a comparative analysis of a Phase III trial and a real-world retrospective cohort of patients with severe COVID-19.
Gilead will also be presenting new analyses of the company’s compassionate-use program, which demonstrated that 83% of pediatric patients and 92% of pregnant and postpartum women with a broad spectrum of disease severity recovered by Day 28. No new safety signals were identified with remdesivir across these populations. Gilead recently announced the initiation of a global, open-label Phase II/III trial to evaluate the safety, tolerability and pharmacokinetics of remdesivir in pediatric patients from birth to less than 18 years of age. Gilead is also collaborating on a study for pregnant women.
In May 2020, the US Food and Drug Administration granted emergency use authorization for remdesivir for the treatment of hospitalized patients with severe COVID-19.
Earlier this month (July 2020), Australia’s Therapeutic Goods Administration (TGA), the national pharmaceutical regulatory agency in Australia, granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms. Provisional approval is limited to a maximum of six years. Gilead may apply for full registration when additional clinical data required by the TGA to confirm the safety and efficacy of the medicine are available.
Novartis Launches Portfolio of Medicines for Treatment of COVID-19
Novartis has launched an initiative in low-income and lower-middle-income countries to provide affordable access to 15 medicines from Sandoz, Novartis’ generics and biosimilars business, used in treating major symptoms of COVID-19.
The drugs are used to treat gastrointestinal illness, acute respiratory symptoms, pneumonia, and septic shock. They include: amoxicillin, ceftriaxone, clarithromycin, colchicine, dexamethasone, dobutamine, fluconazole, heparin, levofloxacin, loperamide, pantoprazole, prednisone, prednisolone, salbutamol, and vancomycin.
The medicines will be made available to governments, non-governmental organizations (NGOs) and other institutional customers in up to 79 eligible countries at zero-profit to Novartis. Countries will have the flexibility to select the medicines in the portfolio that meet their healthcare needs. Eligible countries must be included on the World Bank’s list of low-income and lower-middle-income countries.
AstraZeneca, IQVIA Partner for US Clinical Trial of COVID-19 Vaccine
AstraZeneca has partnered with IQVIA, a contract research organization and business-intelligence provider, for clinical studies in the US to evaluate the efficacy of AstraZeneca’s COVID-19 vaccine candidate, AZD1222
The US studies are part of Operation Warp Speed, a US government program that aims to begin delivering millions of doses of a vaccine for COVID-19 in 2021.
The expansive subject study is expected to begin enrolling participants this summer (summer 2020).
Emergent BioSolutions Gets $34.6-M US Gov’t Contract for COVID-19 Treatment
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, the Mount Sinai Health System, a New York-based hospital and medical research system, and ImmunoTek Bio Centers, a Lafayette, Louisiana-based bio-tech company procuring and collecting human blood plasma, have agreed to collaborate to develop, manufacture, and conduct clinical trials to evaluate Emergent’s COVID-19 hyperimmune globulin product, COVID-HIG, with $34.6 million in funding from the US government.
The Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) is providing the funding to evaluate COVID-HIG, including a post-exposure prophylaxis study on healthcare providers at high risk of COVID-19 infection and other high-risk populations.
The funding is in addition to earlier funding of $14.5 million from the Biomedical Advanced Research and Development Authority, which is part of the Department of Health and Human Services, to support the development of Emergent’s COVID-HIG.
The collaborators will establish plasma collection capabilities at Mount Sinai through an extension of ImmunoTek’s US Food and Drug Administration-approved establishment license and technical transfer to Mount Sinai.
Mount Sinai and Emergent will evaluate COVID-HIG in a post-exposure prophylaxis study in individuals at high risk of exposure to COVID-19, such as front-line healthcare workers and military personnel. Under the agreement with the JPEO-CBRND, Emergent will collaborate to collect convalescent plasma to manufacture COVID-HIG for use in a clinical study under a potential Expanded Access Program to support military personnel.
Plasma from recovered donors will support the development and manufacture of COVID-HIG for evaluation in clinical trials and for potential emergency use or broader patient use as allowed by the FDA. Emergent will support ImmunoTek and Mount Sinai in other regulatory and compliance efforts related to plasma collection and supply and in other activities leading up to a submission of an investigational new drug application to the FDA.
Biocon’s Itolizumab Gets OK in India for COVID-19 Drug
Biocon, a Bangalore, India-based pharmaceutical company, has received market approval from the Drugs Controller General of India for Alzumab (itolizumab) injection 25 mg/5 mL for emergency use in India as a treatment of cytokine release syndrome in moderate-to-severe acute respiratory distress syndrome patients due to COVID-19.
Biocon has repurposed itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 for treating chronic plaque psoriasis. Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s biomanufacturing facility in Bangalore.
CSL, University of Queensland Start Clinical Trial of COVID 19 Vaccine
As part of a partnership with the University of Queensland (UQ) in Australia, CSL Behring reports the first healthy volunteers have been dosed to evaluate a COVID-19 vaccine.
In February (February 2020), CSL partnered with UQ to provide technical expertise as well as a donation of its proprietary adjuvant technology to support UQ’s preclinical development program. In June (June 2020), UQ, CSL and the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, formed a partnership in which CEPI and CSL will fund clinical development and industrial-scale manufacturing of the vaccine of potentially millions of doses of vaccine per year, should the vaccine be approved, with CSL as the manufacturer.
The clinical batch of vaccine for use in the trial has been manufactured by UQ and the Commonwealth Scientific and Industrial Research Organization, Australia’s national science agency, with technical assistance from CSL and Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in March (March 2020).
UQ researchers say they anticipate the preliminary results of the trials in around three months (as reported on July 13, 2020) and, if successful, will hand the vaccine’s development over to CSL to move into the next stage, a larger trial with a broader group of volunteers.
CEPI Provides $66 M for Clover Biopharma’s COVID-19 Vaccine
The Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, has expanded its partnership with Clover Biopharmaceuticals, a Chengdu, China-based biopharmaceutical company, with an additional $66 million in funding to advance the development and manufacture of Clover’s protein-based COVID-19 S-Trimer vaccine candidate.
The additional investment of $66 million upfront in the vaccine candidate will fund preclinical studies, the execution of Phase I clinical trials, preparation of sites for an efficacy trial, and support scale-up of Clover’s manufacturing capacity to potentially allow the production of hundreds of millions of doses per year.
The results of these clinical trials and initial manufacturing scale-up activities will inform planning for efficacy trials and full manufacture of the vaccine. If the early-stage clinical development is successful, the partnership agreement anticipates CEPI providing additional investment which will fully fund the S-Trimer vaccine candidate through to licensure in China and globally. Clover’s protein-based COVID-19 S-Trimer vaccine candidate is based on Clover’s proprietary Trimer-Tag vaccine technology platform.
This agreement builds on CEPI’s initial partnership with Clover, announced in April 2020, which supported the preparations and initiation of a Phase I clinical trial of the vaccine candidate which began enrolling participants on June 19, 2020.
Clover says it is exploring development pathways for the S-Trimer vaccine to be made accessible to populations in China and globally. Under the terms of the agreement, it is anticipated that vaccine output funded by CEPI’s investment will be procured and allocated through the COVID-19 Vaccine Global Access (COVAX) Facility, which the company says aims to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.