Pharma COVID Roundup: News from J&J, Novavax, Regeneron, CureVac

The latest on manufacturing and potential treatments for COVID-19 with news from Johnson & Johnson, Novavax, Regeneron, CureVac, Aspen Pharmacare, and others.

Manufacturing and supply of COVID-19 vaccines and drugs

J&J, Aspen Pharmacare in Supply Pact for COVID-19 Vaccine
Aspen Pharmacare, a Durban, South Africa-based pharmaceutical company, has entered into a preliminary agreement with Janssen Pharmaceuticals and Janssen Pharmaceutica, two of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), for the technical transfer and proposed commercial manufacture of J&J’s COVID-19 vaccine candidate, Ad26.COV2-S.

Aspen Pharmacare will perform formulation, filling, and secondary packaging of the vaccine. The agreement is subject to the successful completion of the relevant technology-transfer activities and finalization of certain commercial manufacturing terms. Aspen Pharmacare has agreed to provide the necessary capacity required for the manufacture of the vaccine at its existing sterile-manufacturing facility in Port Elizabeth, South Africa.

Aspen has recently invested in excess of ZAR 3 billion ($190 million) in the facility. The company says the production area, where the vaccine is intended to be manufactured, has capacity to produce more than 300 million doses per annum.

Source: Aspen PharmaCare

Novavax, Australian Gov’t in Supply Pact for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has entered into an agreement with the Australian government to supply 40 million doses of its COVID-19 vaccine candidate, NVX-CoV2373.

The agreement provides for the delivery of NVX-CoV2373 to Australia starting as early as the first half of 2021, subject to the successful completion of Phase III clinical development and approval of the vaccine by Australia’s Therapeutic Goods Administration.

To date (as reported on November 4, 2020), Novavax has established various agreements for the supply of NVX-CoV2373 directly to the US and the UK, Canada and now Australia, and through partnerships, supply to Japan, South Korea, and India.

Novavax currently has a Phase III trial underway in the UK with another slated to begin in the US and Mexico this month (November 2020), as well as several Phase II trials ongoing and in the planning phases globally.

In a separate development, Novavax has secured two additional properties in Gaithersburg, Maryland to expand laboratory and office space to support manufacturing, R&D, and business operations for its COVID-19 vaccine candidate as well as its influenza vaccine. Novavax entered into a 15-year lease for approximately 122,000 square feet to be used for manufacturing, R&D, and offices. The company will invest in the build-out of the site to prepare for use beginning in early 2021.

In addition, the company’s affiliate, 14 Firstfield Holdings, purchased a 9.7-acre parcel of land that Novavax plans to develop in the future to accommodate the growth of the company. Novavax currently occupies approximately 79,000 square feet of office and laboratory space in Gaithersburg.

Source: Novavax (supply pact) and Novavax (expansion)

Kamada To Supply Israeli Gov’t with COVID Plasma Treatment
Kamada, a Beit Kama, Israel-headquartered plasma-derived biopharmaceutical company, has signed an agreement with the Israeli Ministry of Health (MoH) to supply an anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin (IgG) product for the treatment of COVID-19 in Israel.

Kamada will manufacture the product, to be supplied to the MoH, from convalescent plasma collected and supplied by the Israeli National Blood Services, a division of Magen David Adom (MADA), and additional Israeli medical institutions. The company says the initial order, planned to be supplied during the beginning of 2021, is sufficient to treat approximately 500 hospitalized patients. This initial supply is expected to generate approximately $3.4 million in revenue for Kamada during the first quarter of 2021.

The Phase I/II trial in Israel, in which enrollment was recently completed, is being conducted as part of Kamada’s global collaboration with Kedrion Biopharma, a Fort Lee, New Jersey-based company established in April 2020, for the development, manufacturing, and distribution of a plasma-derived IgG product as a potential treatment for COVID-19. The companies’ US clinical development of a plasma-derived IgG product as a potential COVID-19 treatment is expected to begin in early 2021 pending acceptance of an investigational new drug application.

Source: Kamada

Updates on COVID-19 treatments and vaccines

Regeneron Puts Trial for Certain Hospitalized COVID Patients on Hold
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has received a recommendation from an independent data monitoring committee (IDMC) to hold enrollment for one patient group of its clinical trials for REGN-COV2, the company’s investigational antibody cocktail for treating COVID-19. The trial was evaluating REGN-COV2 in hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation.

The IDMC made the recommendation to hold enrollment based on a potential safety signal and an unfavorable risk/benefit profile. The IDMC, however, recommended continuing enrollment of trials of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit was acceptable in these cohorts. The IDMC also recommended continuation of an outpatient trial without modification.

Regeneron says it is implementing the IDMC recommendations and is also informing the US Food and Drug Administration, which is currently evaluating REGN-COV2 for a potential emergency use authorization in mild-to-moderate outpatients at high risk for poor outcomes. Regeneron is also sharing the recommendation with the independent committee monitoring the RECOVERY trial in the UK, which is evaluating REGN-COV2 in hospitalized patients.

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.

Source: Regeneron Pharmaceuticals

CEPI Provides $258 M More To Fund Clover’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 $258 million to fund the development of Clover’s COVID-19 vaccine candidate, S-Trimer, a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

The additional investment brings CEPI’s total investment in Clover’s COVID vaccine candidate up to $328 million. A previous commitment of $69.5 million funded preclinical studies and Phase I clinical trials, preparations for a global Phase II/III efficacy study, and initial manufacturing scale-up activities.

The additional funding will support the global Phase II/III efficacy clinical trial, which is expected to begin before the end of 2020 (as reported on November 3, 2020). It will also fund additional clinical studies in special populations, such as people with autoimmune conditions, immuno-compromised individuals, pregnant women and children.

CEPI’s funding will also be used to potentially produce hundreds of millions of doses per year of the vaccine. The vaccine will be made available for procurement and allocation through the COVAX Facility, a global initiative that has an overall aim to procure and distribute two billion doses of COVID-19 vaccines by the end of 2021.

Source: Coalition for Epidemic Preparedness Innovations and Clover Biopharmaceuticals

CureVac Reports Positive Interim Data for its COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, has reported positive interim data from its ongoing Phase I dose-escalation study evaluating CVnCoV, its investigational SARS-CoV-2 vaccine candidate.

The company reported that the vaccine candidate was generally well tolerated across all tested doses (2-12µg) and induced strong binding and neutralizing antibody responses in addition to first indication of T cell activation.

CureVac says it intends to provide a detailed Phase I data overview and publication in a scientific journal in the coming weeks (as reported on November 2, 2020). The data support the decision to advance the 12-µg dose in a Phase IIb/III study. CVnCoV is currently also being investigated in a Phase IIa clinical trial in older adults in Peru and Panama.

Formulation of CVnCoV is based on lipid nanoparticle technology licensed from CureVac’s partner, Acuitas Therapeutics, a Canadian company that provides lipid nanoparticles for the formulation of various mRNA vaccines.

Source: CureVac

EDQM Issues Document on Recombinant Viral Vectored COVID-19 Vaccines
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has drafted a document on the control of viral vectored vaccines in order to support COVID-19 vaccine developers currently working on vaccines candidates.

The document provides a series of analytical strategy options for the control of recombinant viral vectored vaccines. It includes recommendations on tests that may be conducted at different manufacturing stages of viral vectored vaccines and can be used by COVID-19 vaccine developers as an aid in building appropriate analytical strategies during the development of their candidate vaccines. The principles described can also be used for other recombinant viral vectored vaccines.

The EDQM says this document is not binding and will be updated to adapt to the evolving situation and to take into account experience with new constructs or products.

Source: The European Directorate for the Quality of Medicines and Healthcare

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