Pharma COVID Roundup: News from Sanofi, GSK, Novartis, Takeda, BI
The latest on manufacturing and potential treatments for COVID-19 with news from Sanofi, GSK, Novartis, Takeda, BI, Moderna, Regeneron, and Novavax.
Manufacturing and supply news for COVID-19 vaccines and drugs
Sanofi, GSK To Supply 200 M Doses of COVID-19 Vaccine to Gavi
Sanofi and GlaxoSmithKline have signed a statement of intent with Gavi, a global public health partnership, to make 200 million doses of their COVID-19 vaccine available, if approved by regulatory authorities and subject to contract, to the COVAX Facility, part of a global initiative for COVID vaccines.
The COVAX Facility is part of COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, a global initiative to provide governments with early access to COVID-19 vaccine candidates. COVAX is led by Gavi, the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization.
Sanofi and GSK initiated a Phase I/II study for their adjuvanted recombinant protein-based vaccine against COVID-19 in early September (September 2020) with a total of 440 subjects enrolled and anticipate first results in early December 2020, to support the initiation of a Phase III study before the end of 2020. If these data are sufficient for licensure application, the companies plan to request regulatory approval from the first half of 2021. In parallel, the companies are scaling up manufacturing of the antigen and adjuvant respectively.
Source: Sanofi and GlaxoSmithKline
Takeda, Moderna, Japan Gov’t in Supply Pact for COVID-19 Vaccine
Takeda, with the Japanese government, has agreed to purchase and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. This effort is part of a three-way agreement among Takeda, Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, and Japan’s Ministry of Health, Labour and Welfare (MHLW). The pact is part of an initiative by the Japanese government to ensure the supply of COVID-19 vaccines in Japan.
Under the agreement with the MHLW and Moderna, Takeda will be responsible for securing the necessary regulatory approvals in Japan prior to distributing the 50 million doses of Moderna’s COVID-19 vaccine in Japan. Moderna will provide finished product and will support Takeda in its development and regulatory efforts to ensure timely access starting during the first half of 2021.
The pact with Moderna follows Takeda’s recent announcement that it is establishing the capability to manufacture the COVID‑19 vaccine candidate from Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, at its facilities in Japan to provide long-term supply to Japan. Takeda’s pacts with Moderna and Novavax are supported by the MHLW and the Japan Agency for Medical Research and Development.
Moderna, Qatar Gov’t in Supply Pact for COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has entered into a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, the company’s vaccine candidate against COVID-19.
mRNA-1273 is currently being studied in a Phase III trial of 30,000 participants at the 100-µg dose level in the US. Earlier this month (October 2020), Moderna completed enrollment of the Phase III study.
Moderna says it is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year beginning in 2021.
Source: Moderna
Updates on COVID-19 treatments and vaccines
Novartis, Molecular Partners in $231-M Pact for COVID-19 Drugs
Novartis and Molecular Partners, a Zurich-based clinical-stage biopharmaceutical company, have formed a collaboration to develop, manufacture, and commercialize two Molecular Partners’ drug candidates against COVID-19, MP0420 and MP0423, in a deal worth up to $231 million ($66 million upfront and $165 million in future payments).
Under the agreement, Novartis will make an upfront payment of CHF 60 million ($66 million) to Molecular Partners, which includes equity in the company. Molecular Partners will receive a further payment of CHF 150 million ($165 million) upon Novartis electing to take up the option to both therapeutic candidates as well as royalty on sales. Molecular Partners has agreed to forgo royalties in lower-income countries.
During the option period, Molecular Partners will conduct Phase I clinical trials for MP0420, which are expected to begin in November 2020. It will also perform all remaining preclinical work for MP0423, and Novartis will conduct Phase II and Phase III clinical trials, with Molecular Partners as the sponsor of these trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. During the clinical-development stage, Molecular Partners will provide clinical supply. The companies will work together to scale up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar division of Novartis, to provide global supply.
The two drug candidates are part of Molecular Partners’ DARPin portfolio, which are derived from single-domain proteins. Molecular Partners says this allows for smaller sized proteins (one-tenth the size of a monoclonal antibody).
Source: Novartis and Molecular Partners
UK Gov’t Begins Rolling Review of Moderna’s COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, reports that the Medicines and Healthcare products Regulatory Agency (MHRA), the UK pharmaceutical regulatory agency, has started the rolling review process of mRNA-1273, the company’s vaccine candidate against COVID-19.
The rolling review process allows the MHRA to begin its independent assessment using the information submitted by Moderna and new evidence as it becomes available until the application is deemed complete.
mRNA-1273 is currently being studied in a Phase III trial of 30,000 participants at the 100-µg dose level in the US. Earlier this month (October 2020), Moderna completed enrollment of the Phase III study.
Source: Moderna
Novavax Provides Update for Phase III Trials of COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has provided an update on its Phase III trials for NVX-CoV2373, its COVID-19 vaccine candidate.
The company has enrolled over 5,500 participants to date (as reported on October 27, 2020) in an UK trial, which will enroll 15,000 volunteers. Novavax expects this trial to be fully enrolled by the end of November (November 2020). Interim data are expected early in the first quarter of 2021, dependent on the overall COVID-19 attack rate. These data are expected to serve as the basis for global licensure.
Novavax expects Phase III clinical trials to begin in the US and Mexico by the end of November (November 2020). Novavax’ US/Mexico Phase III clinical trial is being conducted with support from Operation Warp Speed, a US government initiative to speed the development of COVID-19 vaccines and treatments. The trial calls for the enrollment of up to 30,000 participants in the US and Mexico.
The company added that it has made progress in large-scale manufacturing with delays experienced versus original timing estimates. Novavax has been developing large-scale manufacturing processes at multiple sites globally and plans to use its CDMO partner, Fujifilm Diosynth Biotechnologies, and its Morrisville, North Carolina site to support production for the US Phase III clinical trial.
Overall, Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases.
Source: Novavax
Regeneron Reports Positive Results for COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, reported positive results from an ongoing Phase II/III trial evaluating its investigational antibody cocktail, REGN-COV2, against COVID-19.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
The trial in the COVID-19 outpatient setting showed that REGN-COV2 met primary and key secondary endpoints and reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits).
The Phase III portion of this trial continues in non-hospitalized patients. REGN-COV2 is also being studied in a Phase II/III clinical trial for treating hospitalized COVID-19 patients and is in a Phase III trial for preventing COVID-19 in household contacts of infected individuals.
REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the US, and Roche will develop, manufacture, and distribute it outside the U.S.
Source: Regeneron Pharmaceuticals
Boehringer Ingelheim Begins Phase II Trial of COVID-19 Drug
Boehringer Ingelheim has initiated a Phase II clinical trial of BI 764198, the company’s drug candidate being evaluated in COVID-19 hospitalized patients for alleviating damage to the lung and for decreasing the risk or severity of acute respiratory complications.
BI 764198 is an inhibitor of TRPC6, a receptor-operated cation channel. TRPC6 may cause a cascade of cellular damage resulting in disruption of cellular barrier function, hyper-permeability, edema, and acute respiratory distress syndrome, according to information from the company.
Boehringer Ingelheim is currently involved in a set of initiatives to address COVID-19, including the research and development of SARS-CoV-2 antibodies that can neutralize the virus, small molecules to inhibit its replication, and therapy development to prevent microcoagulation (blood clots). Boehringer Ingelheim is also an active participant in a global access initiative with the Bill and Melinda Gates Foundation as well as global development initiatives.
Source: Boehringer Ingelheim
