Pharma COVID Roundup: News from Sanofi, GSK, Novavax, RegeneronBy
The latest on manufacturing and potential treatments for COVID-19 with news from the Biden Administration, Sanofi, GlaxoSmithKline, Novavax, and Regeneron.
Manufacturing and supply of COVID-19 vaccines and drugs
President Joe Biden Issues Executive Order on Supply Chains
Supply-chain vulnerabilities exposed during the COVID-19 pandemic as well as those existing pre-pandemic were behind an executive signed by President Joe Biden this week (February 24, 2021) to require a 100-day supply-chain review of four product areas, including pharmaceuticals and their ingredients.
The 100-day review is intended to identify near-term steps the Administration can take, including with Congress, to address vulnerabilities in supply chains. In addition to pharmaceuticals and ingredients, the other product areas for the 100-day supply-chain review are semiconductors, key minerals and materials, such as rare-earth metals, and advanced batteries, such as those used in electric vehicles.
In addition, the executive order directs year-long reviews for six sectors, which includes the public health and biological preparedness industrial base. The other sectors are:the defense industrial base; the information and communications technology industrial base; the energy sector industrial base; the transportation industrial base; and supply chains for agricultural commodities and food production.
These sectoral reviews direct federal agencies and departments to review a variety of risks to supply chains and industrial bases. For example, these reviews must identify critical goods and materials within supply chains, the manufacturing or other capabilities needed to produce those materials, as well as a variety of vulnerabilities created by failure to develop domestic capabilities. Federal agencies and departments are also directed to identify locations of key manufacturing and production assets, the availability of substitutes or alternative sources for critical goods, the state of workforce skills and identified gaps for all sectors, and the role of transportation systems in supporting supply chains and industrial bases.
Agencies are directed to make specific policy recommendations to address risks as well as proposals for new research and development activities. The US government also plans to conduct regular, ongoing reviews of supply-chain resilience, including a quadrennial review process.
Novavax, Gavi in Agreement To Supply 1.1 Bn Doses of COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has reached a memorandum of understanding with Gavi, a global public health partnership, for the supply of 1.1 billion doses of its COVID-19 vaccine, and is executing an agreement with Takeda for the supply of 250 million doses of its COVID-19 vaccine in Japan.
The memorandum of understanding between Gavi and Novavax is to provide a cumulative volume of 1.1 billion doses of NVX-CoV2373, Novavax’s recombinant protein-based COVID-19 vaccine candidate, to the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines.
Gavi leads the design and implementation of the COVAX Facility and will work with Novavax to finalize an advance purchase agreement for vaccine supply and global distribution allocation via the COVAX Facility and its partners.
The vaccine doses will be manufactured and distributed globally by Novavax and the Serum Institute of India (SII), a vaccine manufacturer, the latter under an existing agreement between Gavi and SII. The agreement with Gavi advances the joint commitment from Novavax, SII, and Gavi to ensure equitable access to NVX-CoV2373 worldwide across low-, middle- and high-income countries using a tiered pricing schedule.
NVX-CoV2373 is being studied in two ongoing pivotal Phase III clinical trials: in the US and Mexico, as well as in the UK, for the prevention of COVID-19. Novavax has completed enrollment of the Phase III study in the US and Mexico.
The trial is being conducted with support from an US government partnership (formerly Operation Warp Speed), which includes the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. BARDA is also providing up to $1.75 billion under a Department of Defense agreement.
Supply pact in Japan
In addition, Takeda will supply Novavax’s COVID-19 vaccine candidate (TAK-019) in Japan. Takeda will receive a manufacturing technology transfer from Novavax and will be responsible for the development and commercialization based on manufacturing capacity of over 250 million doses of TAK-019. Takeda is also announced that the first subject was dosed in its Phase I/II study of TAK-019 in Japan. Results from the TAK-019 study are expected in the second half of 2021. Once available, the study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency as part of the new drug application filing process. Pending regulatory approval, Takeda intends to start distributing TAK-019 in late 2021.
Updates on COVID-19 treatments and vaccines
Sanofi, GSK Initiate Phase II Study of COVID-19 Vaccine
Sanofi and GlaxoSmithKline (GSK) have initiated a new Phase II study with 720 volunteers, aged 18 and over, to select the most appropriate antigen dosage for Phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.
The new Phase II trial will evaluate three different antigen doses with a fixed dose of adjuvant, in a total study population of 720 volunteers, in the US, Honduras, and Panama. Results of the Phase II trial will inform the Phase III protocol.
In December 2020, Phase I/II study results showed an immune response comparable to patients who had recovered from COVID-19 in adults aged 18 to 49 years, but a lower immune response in older adults, likely due to an insufficient concentration of the antigen. If data from the new Phase II trial are positive, a global Phase III study is planned for the second quarter of 2021. Positive results from the Phase III study would lead to regulatory submissions in the second half of 2021, with the vaccine expected to be available in the fourth quarter of 2021, if approved.
In parallel to the new Phase II study, Sanofi has commenced development work against new variants, which will be used to inform next stages of the Sanofi/GSK development program.
GSK Reports Results Evaluating mAb COVID-19 Treatment
GlaxoSmithKline (GSK) has announced results from a Phase II proof-of-concept study with otilimab, an investigational anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody (mAb).
The primary endpoint of the study was the proportion of COVID-19 patients who were alive and free of respiratory failure 28 days after treatment with a single dose of otilimab in addition to standard of care (including antiviral treatments and corticosteroids), compared to patients being treated with standard of care alone. Data from patients of all ages did not reach statistical significance; however, a pre-planned efficacy analysis showed that otilimab plus standard of care was effective in patients 70 years and older showed, compared to patients who received the standard of care alone. Given these data, GSK has decided to amend the study to expand this cohort to confirm these findings.
The company says recent research suggests the role of the cytokine GM-CSF in the immune response to COVID-19 may be more prominent in patients over the age of 70. The additional cohort of the study will follow a similar study design and will enroll approximately 350 patients aged 70 years and older.
Regeneron Adjusts COVID-19 Trial After Review from Data Monitoring Committee
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has announced changes to a Phase III trial assessing REGEN-COV, its investigational antibody cocktail (consisting of casirivimab and imdevimab), in non-hospitalized patients with COVID-19, following recommendations from an Independent Data Monitoring Committee (IDMC).
The IDMC found clear clinical efficacy on reducing the rate of hospitalization and death with both the 1,200-mg and 2,400-mg doses of REGEN-COV compared to placebo and recommended stopping enrollment into the placebo group.
Regeneron is following the IDMC recommendation and says it will immediately stop enrolling patients in the placebo group. The trial will continue to enroll patients into both the 1,200-mg and 2,400-mg treatment groups. The company has not yet had access to any of the unblinded data, including the relative treatment benefit of the 1,200-mg and 2,400-mg doses, and will share detailed results when available in March 2021.
Source: Regeneron Pharmaceuticals