Pharma COVID Roundup: News from Moderna, Novavax, Gilead, Mylan, Lilly

The latest from pharma companies on potential COVID-19 treatments and vaccines with news from Moderna, Novavax, Gilead, Mylan, Lilly, Glenmark, and Sorrento.

News from Moderna, Novavax, Gilead Sciences, and Mylan

FDA Fast-Tracks Moderna’s COVID-19 Vaccine Candidate
Moderna, a Cambridge, Massachusetts-based clinical-stage biopharmaceutical developing messenger RNA (mRNA) therapeutics and vaccines, reports that the US Food and Drug Administration (FDA) has granted fast-track designation for the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus.

On May 6, 2020, the FDA completed its review of the company’s investigational new drug (IND) application for mRNA-1273 to allow it to proceed to a Phase II study, which is expected to begin shortly (as reported on May 12, 2020). Moderna is finalizing the protocol for a Phase III study, expected to begin in early summer of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS), supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the company’s facilities and that of its strategic collaborator, Lonza.

Source: Moderna

Novavax To Receive $384 M To Develop COVID-19 Vaccine and Mfg
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, reports it will receive additional funding up to $384 million from the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines, for Phase I and II clinical trials and the large-scale manufacture of Novavax’s vaccine candidate (NVX-CoV2373) against SARS-CoV-2, the virus that causes COVID-19.

The additional funding, in addition to $4 million CEPI invested in March (March 2020), will also support scale-up of Novavax’s NVX-CoV2373 vaccine antigen as well as Novavax’ proprietary Matrix-M adjuvant, which is designed to enhance immune responses by stimulating high levels of neutralizing antibodies. In addition, the CEPI funding will allow Novavax to increase its large-scale manufacturing capacity for both the antigen and adjuvant in multiple locations.

Novavax says it plans to use the CEPI funding to advance NVX-CoV2373 with the following activities: (1) a Phase I/II clinical trial with the Phase I portion starting this month (May 2020) in Australia and the Phase II portion conducted in multiple countries following successful Phase I results that are expected in July (July 2020); (2) process development for scaled-up production to potentially allow manufacturing of up to 100 million vaccine doses by the end of 2020; and (3) access to large-scale manufacturing capacity in multiple countries with a goal of potentially producing over one billion doses during 2021.

Novavax and CEPI say they agree on the importance of global equitable access to the vaccines produced out of the partnership. It is anticipated that vaccines will be procured and allocated through global mechanisms now under discussion as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the World Health Organization and global leaders earlier this month (May 2020).

Source: Novavax and CEPI

Mylan, Others in Pact To Supply Gilead’s Antiviral COVID-19 Drug
Gilead Sciences has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers to further expand supply of Gilead’s antiviral drug, remdesivir, as a potential treatment for COVID-19.

The agreements allows Mylan, Cipla, Ferozsons Laboratories, Hetero Labs, and Jubilant Lifesciences to manufacture remdesivir for distribution in 127 low- and middle-income countries, including India.

Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production. The licensees also will set their own prices for the generic product they produce. The licenses are royalty-free until the World Health Organization (WHO) declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.

Mylan says that it will be able to develop a bioequivalent version of remdesivir, including production of its own active pharmaceutical ingredient and the finished dosage form in sterile powder lyophilized vials for administration of the medicine by intravenous infusion. Mylan says it will be in a position to provide product in the coming months, subject to reviews by national regulatory bodies and the Prequalification Program of the WHO.

EMA expands compassionate use of remdesivir

In a separate development, the European Medicines Agency (EMA) has recommended expanding the compassionate-use programs for Gilead Sciences’ investigational antiviral drug, remdesivir, to treat COVID-19 patients who are not on mechanical ventilation and to allow for a shorter treatment duration based on the results of two recent clinical studies.

The EMA says that compassionate use-programs for remdesivir should be expanded to include hospitalized patients who need supplemental oxygen, non-invasive high-flow oxygen devices, or extracorporeal membrane oxygenation (ECMO). The EMA is also recommending a five-day treatment duration in addition to a ten-day course based on the results of a Gilead study that found a shorter treatment course did not result in loss of efficacy for patients who were not on ventilators or ECMO.

Source: Gilead Sciences, Mylan, and the European Medicines Agency

NIAID Initiates Clinical Trial for Combo Therapy of Gilead’s Remsdesivir and Lilly’s Baricitinib for COVID-19
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring a randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral, Gilead Sciences’ remdesivir plus the anti-inflammatory drug, Eli Lilly and Company’s baricitinib for coronavirus disease 2019 (COVID-19) The trial (as reported on May 8, 2020) is now enrolling hospitalized adults with COVID-19 in the US. The trial is expected to open at approximately 100 US and international sites. Investigators currently anticipate enrolling more than 1,000 participants.

Baricitinib is licensed to Eli Lilly and Company by Incyte and marketed under the brand name Olumiant. It is approved in the US and in more than 65 additional countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Some people with COVID-19 experience acute respiratory distress syndrome (ARDS), in which inflammation of the lungs leads to shortness of breath and rapid breathing. Baricitinib, taken orally, inhibits cytokine signaling in the body that play roles in causing inflammatory responses, according to information from the NIAID.

Source: National Institute of Allergy and Infectious Disease

News from Glenmark and Sorrento Therapeutics

Glenmark Advances Generic Favipiravir for COVID-19
Glenmark Pharmaceuticals, a Mumbai, India-based pharmaceutical company, has initiated Phase III clinical trials in India on favipiravir, a generic form of Fujifilm Toyama Chemical’s Avigan, an antiviral drug being evaluated to treat COVID-19.

Favipiravir is approved in Japan for treating influenza virus infections. Glenmark reports that clinical trials in India have begun (as of May 12, 2020) and over 10 government and private hospitals in India are being enrolled for the study. Glenmark estimates study completion by July/August 2020. The drug is also in clinical development for treating COVID-19 by Fujifilm. Glenmark says it has successfully developed the active pharmaceutical ingredient and the formulations for the product through its in-house R&D team.

Source: Glenmark Pharmaceuticals

Sorrento Therapeutics To Develop Antibody Cocktail Against COVID-19
Sorrento Therapeutics, a San Diego-based clinical-stage biopharmaceutical company, and Mount Sinai Health System, a New York-based hospital and medical research system, have entered into an agreement for the investigation and development of an antibody cocktail, COVI-SHIELD, to potentially treat COVID-19.

The companies say the collaboration aims to generate antibody products that would act as a “protective shield” against SARS-CoV-2, the virus that causes COVID-19, potentially blocking and neutralizing the activity of the virus in naïve at-risk populations as well as recently infected individuals. Each dose of COVI-SHIELD, if approved, would deliver a cocktail of three antibodies, which together, would recognize three unique regions of the SARS-CoV-2 Spike protein.

If approved, it is anticipated that COVI-SHIELD will be offered for administration as a prophylactic for those returning to work and as a therapeutic to those who have been exposed to SARS-CoV-2. The companies say COVI-SHIELD prevention and treatment is designed to be administered as often as necessary, with each dose expected to provide antiviral protection for up to two months.

Sorrento is completing all investigational new drug filing requirements for the triple antibody combination therapy and expects to commence Phase I trials of the drug candidate in the third quarter of 2020.

Source: Sorrento Therapeutics

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