Pharma COVID Roundup: News from Moderna, Pfizer, BioNTech, RegeneronBy
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, Pfizer, BioNTech, Fosun Pharm, CSL, Regeneron, Roche, CureVac, Thermo Fisher, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna To Supply Philippines with More Doses of COVID-19 Vaccine
The Philippines has agreed to secure seven million additional doses of the COVID-19 vaccine from Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, to bring its confirmed order commitment up to 20 million doses.
The seven million additional doses are secured through a partnership with the private sector. The initial procurement by the Philippines of 13 million doses was announced earlier this month (March 2021). Under that agreement, deliveries would begin in mid-2021.
Moderna’s COVID-19 vaccine is not currently approved for use in the Philippines, and the company says it will work with regulators to pursue necessary approvals prior to distribution.
CSL Releases Doses of AstraZeneca’s COVID 19 Vaccine
CSL Limited, a Melbourne, Australia-based biopharmaceutical company, has released 830,000 locally made doses of AstraZeneca’s COVID-19 vaccine in Australia.
The fill–finish of the vaccine was at vaccine facilities Parkville, Melbourne, Australia at Seqirus, a vaccine subsidiary of CSL.
CSL says there are an additional 2.5 million doses in cold storage that are undergoing the final stages of testing, approval, and release and that these doses will be distributed in the coming weeks (as reported on March 24, 2021). The manufacturing process is ongoing, and CSL says it expects to release an average of a million doses a week over the course of the campaign, subject to regulatory approvals.
Manufacture of the first batch commenced in November (November 2020) at CSL Behring in Broadmeadows, Victoria, Australia with the thaw of a vial of starter material. Since then, CSL has grown the vaccine in 2,000-L bioreactors before harvesting the bulk drug substance and filtering it into a concentrate to be ready for the final stages of filling into vials.
Hong Kong Receives Shipment of Sinovac’s COVID-19 Vaccine
Hong Kong has received the second batch of Sinovac’s COVID-19 vaccine to bring the total amount of vaccine doses delivered to about two million doses.
In February (February 2021), Hong Kong received one million doses of the vaccine.
Source: Hong Kong government
Stelis Biopharma To Supply 200 M Doses of Russia’s COVID-19 Vaccine
Stelis Biopharma, the biopharmaceutical division of Strides, a Bangalore, India-based pharmaceutical company, and the Russian Direct Investment Fund (RDIF), a sovereign wealth fund in Russia, have partnered to produce and supply a minimum of 200 million doses of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology.V.
Sputnik V is made up of two different viruses belonging to the adenovirus family, Ad26 and Ad5. These adenoviruses have been modified to contain the gene for making the SARS-CoV-2 spike protein. The two adenoviruses are given separately. Ad26 is used in the first dose, and Ad5 is used in the second to boost the vaccine’s effect.
Stelis and RDIF say they intend to commence supplies from the third quarter of 2021. Stelis will also continue to work with the RDIF to provide additional supply volumes beyond the initial agreement.
The agreement between RDIF and Stelis Biopharma was reached under the aegis of Enso Healthcare, part of Enso Group, RDIF’s coordination partner for sourcing Sputnik V vaccines in India.
Source: Stelis Biopharma
Updates on COVID-19 treatments and vaccines
Pfizer Initiates Phase I Study of Oral COVID-19 Drug
Pfizer is progressing dosing for a Phase I study of an oral antiviral therapeutic for SARS-CoV-2, the virus that causes COVID-19.
The drug candidate, PF-07321332, is a SARS-CoV2-3CL protease inhibitor. The Phase I trial is being conducted in the US.
Pfizer is also investigating an intravenously administered investigational protease inhibitor, PF-07304814, which is currently in a Phase Ib multi-dose trial in hospitalized clinical trial participants with COVID-19.
Hong Kong Gov’t Temporarily Suspends Fosun/BioNTech’s COVID-19 Vaccine for Pkg Issues
The Hong Kong government has temporarily suspended vaccination of Comirnaty, the COVID-19 vaccine from Fosun Pharma, a Shanghai-based pharmaceutical company, and BioNTech, a Mainz, Germany-based immunotherapy company, due to packaging issues in two batches of the vaccine.
BioNTech is partnered with Pfizer for the COVID-19 vaccine globally, excluding China, where BioNTech has a collaboration with Fosun Pharma for both clinical development and commercialization.
The Hong Kong government received written notification from Fosun Industrial of observed deviations in the vial seal of the vaccine in select batches. BioNTech and Fosun Pharma have initiated an investigation to identify the root cause of these packaging issues. While the investigation is ongoing, the Hong Kong government temporarily suspended vaccination of two batches of the vaccine.
The government reports that the companies says that there is no risk to product safety, but as a precaution, vaccination with the batches has been suspended.
CureVac Evaluating COVID-19 Vaccine Trial Protocols for Variants
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has announced plans to expand and further specify the protocols of its ongoing late-stage clinical trials for CVnCoV, its COVID-19 vaccine candidate, to include variant specification and efficacy.
CVnCoV efficacy is currently being evaluated in a Phase IIb/III trial in Europe and Latin America. The company has ongoing discussions with the European Medicines Agency to potentially include an amendment related to select virus strains in the study.
For its Phase IIa dose-confirmation trial in older adults in Peru and Panama, CureVac has submitted a protocol amendment to include a secondary objective for vaccine efficacy. The study initially aimed to evaluate CVnCoV in adults. The expanded trial analysis is expected to allow for collection of relevant efficacy data, which includes the important group of approximately 270 participants above the age of 60, treated with 12 µg of CVnCoV.
CureVac expects data readouts from both clinical trials in the second quarter of 2021 and intends to file for formal marketing authorization within the second quarter of 2021.
The company reports that its COVID-19 vaccine candidate protects against COVID-19 variants of concern in a transgenic mouse model. The neutralization capacity of robust antibody titers was shown to be impacted by the B.1.351 variant (also referred to as the South African variant) compared to the original strain.
Regeneron Reports Positive Results for COVID-19 Antibody Cocktail; Supply Updates
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, reports positive Phase III results for REGEN-COV, its antibody cocktail (consisting of casirivimab and imdevimab) for treating non-hospitalized COVID-19 patients.
The Phase III outcomes trial in high-risk non-hospitalized COVID-19 patients met its primary endpoint and showed that the antibody cocktail reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo.
REGEN-COV also met all key secondary endpoints in the Phase III trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers). In addition, a companion Phase II trial in low-risk symptomatic or asymptomatic non-hospitalized patients with COVID-19 showed significant and comparable viral load reductions across doses ranging from 300 mg to 2,400 mg.
The US Food and Drug Administration updated US emergency use authorization (EUA) fact sheets for all authorized monoclonal antibody treatments, indicating that REGEN-COV retains potency against key emerging variants.
Supply of the antibody cocktail
Regeneron anticipates recording approximately $260 million in REGEN-COV US net product sales from the US government in the first quarter of 2021, representing final deliveries from an initial agreement with the US government. Sales under the second US government agreement are now expected to begin in the second quarter of 2021. The company is expected to provide approximately 750,000 doses at the 2,400-mg dose level, but now anticipates being able to provide approximately 1.25 million doses if the 1,200-mg dose is added to the EUA. The company says the US government is obligated to purchase all finished doses supplied by June 30, 2021, up to 1.25 million doses total, and may accept doses after this date at its discretion.
Roche, which is responsible for REGEN-COV outside the US, continues to work with the European Medicines Agency, governments, and other health authorities globally.
Daiichi Sankyo Initiates Phase I/II Trial for mRNA COVID19 Vaccine
Daiichi Sankyo has started the first vaccinations in a Phase I/II clinical trial in Japan of the company’s mRNA COVID-19 vaccine, DS-5670.
DS-5670 is being developed using Daiichi Sankyo’s proprietary novel nucleic-acid delivery technology. Daiichi Sankyo is leading the research and development in collaboration with the University of Tokyo’s Institute of Medical Science and the Japanese government.
Source: Daiichi Sankyo
News on COVID-19 testing
FDA OKs First Machine Learning-Based COVID-19 Screening Device
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Tiger Tech Solutions, a Miami, Florida-based company that develops wearable technology, for the first machine learning-based COVID-19 non-diagnostic screening device.
The Tiger Tech COVID Plus Monitor is intended for use by trained personnel to help prevent exposure to and the spread of SARS-CoV-2, the virus that causes COVID-19. The device identifies certain biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions (such as sepsis or cancer) or hyper-inflammatory states (such as severe allergic reactions), in asymptomatic individuals over the age of five.
The device is designed for use following a temperature reading that does not meet criteria for fever in settings where temperature check is being conducted in accordance with guidelines by the Centers for Disease Control and Prevention and local institutional infection. The device is not a substitute for a COVID-19 diagnostic test and is not intended for use in individuals with symptoms of COVID-19.
Source: US Food and Drug Administration
Thermo Fisher Provides Updates on COVID-19 Testing
Thermo Fisher Scientific has provided updates on various diagnostic testing and related testing capabilities for COVID-19.
Thermo Fisher Scientific and Artificial, a Palo Alto, California-based company developing flexible automation software, have entered into a strategic technology collaboration to develop a software automation platform for Thermo Fisher’s standardized COVID-19 testing platform volumes.
Separately, Thermo Fisher has developed and launched a COVID-19 testing program with Color Health, a Burlingame, California-based distributor of healthcare services, and with providers of laboratory testing, to increase COVID-18 testing capacity in schools. Testing programs can include PCR-based testing as well as rapid antigen, depending on the school and/or district.
Thermo Fisher has also announced the completion of the US Food and Drug Administration (FDA) listing for its Applied Biosystems QuantStudio 5 Dx Real-Time PCR System, a platform for molecular diagnostic workflows for infectious disease, oncology, and COVID-19 testing.
Additionally, Thermo Fisher has launched a surveillance solution to monitor indoor environments for in-air pathogens, including SARS-CoV-2, the virus that causes COVID-19.