Pharma COVID Roundup: News from Lilly, Moderna, Roche, AstraZeneca

The latest on COVID-19 vaccines/drugs and manufacturing from Lilly, Moderna, Roche, AstraZeneca, GSK, CureVac, Novavax, Inovio, and 3M.

Manufacturing and supply of COVID-19 vaccines and drugs

Lilly Enters Mfg Pacts with Cipla, Sun Pharma, Lupin for COVID Drug
Eli Lilly and Company has formed royalty-free, non-exclusive voluntary license agreements with three Indian pharmaceutical companies (Cipla, Sun Pharma, and Lupin) for the manufacture and commercialization of baricitinib, Lilly’s arthritis drug also authorized for treating COVID-19.

Lilly received permission for restricted emergency use from India’s Central Drugs Standard Control Organization, a division of India’s Ministry of Health, for baricitinib (2 mg and 4 mg) in combination with remdesivir, Gilead Sciences’ antiviral COVID-19 drug, for treating suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation

Under separate agreements, Cipla, a Mumbai, India-based pharmaceutical company, Sun Pharma, a wholly owned subsidiary of Sun Pharmaceutical Industries, a Mumbai, India-based pharmaceutical company, and Lupin a Mumbai, India-based pharmaceutical company, will manufacture and distribute baricitinib in India.

Source: Cipla, Sun Pharma, and Lupin

Moderna, Australia in Supply Pact for COVID-19 Vaccine
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has entered into a new supply agreement with the government of Australia for 25 million doses of its COVID-19 vaccine.

This agreement includes 10 million doses to be delivered in 2021 and 15 million doses of the company’s updated variant booster vaccine candidate to be delivered in 2022.

Purchase under this agreement is subject to regulatory approval of the vaccine and booster vaccine candidates by the Therapeutic Goods Administration (TGA), the national pharmaceutical regulatory agency in Australia. The company expects to submit an application to the TGA shortly.

The company announced earlier this year (2021) that it also plans to open a commercial subsidiary in Australia in 2021.

Source: Moderna

Novavax, Takeda Update Supply of COVID-19 Vaccine in Japan
Takeda is in the process of establishing vaccine procurement based on technology transfer by Novavax of Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373, and will be responsible for manufacturing and commercialization in Japan.

Takeda will have the capability to manufacture 250 million doses yearly of the vaccine at its manufacturing site in Japan. Japan’s Ministry of Health, Labor and Welfare is in contract discussions with Takeda for the Novavax vaccine with the premise that it will issue an order of 150 million doses.

Distribution of Novavax’s vaccine in Japan by Takeda is expected to begin in late 2021 or early 2022 and will continue into 2022 onwards, considering the likely need to secure vaccines that also protect against COVID-19 variants. 

Source: Novavax

Updates on COVID-19 treatments and vaccines

Roche Gets OK for Regeneron’s COVID-19 Antibody Cocktail in Inda
Roche India has received emergency use authorization in India for REGEN-COV, Regeneron Pharmaceuticals’ antibody cocktail consisting of casirivimab and imdevimab for treating COVID-19. Roche is collaborating with Regeneron to increase global supply of REGEN-COV. Regeneron is responsible for development and distribution in the US, and Roche is primarily responsible for development and distribution outside the US.

The emergency use authorization in India will now enable Roche to import the globally manufactured product batches to India. The product will be marketed distributed in India through a strategic partnership with Cipla, a Mumbai, India-based pharmaceutical company.

The antibody cocktail is currently authorized for emergency use in the US in a 2,400-mg dose for treating mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

Source: Roche India and Cipla

EMA Starts Rolling Review of GSK, Vir Biotechnology COVID-19 Treatment
The European Medicines Agency (EMA) has started a rolling review of data on sotrovimab), a monoclonal antibody for the treatment COVID-19, from GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company.

The review is being carried out by the EMA’s Committee for Human Medicinal Products (CHMP) and will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorization application.

The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of the medicine to prevent hospitalization or death in non-hospitalized patients with COVID-19. The EMA has started evaluating the first batch of data, which come from laboratory and animal studies, in addition to data on the quality of the medicine.

Separately, the CHMP is also reviewing sotrovimab to provide EU-wide recommendations for national authorities that may take evidence-based decisions on the early use of the medicine, ahead of any formal marketing authorization.

An emergency use authorization application for sotrovimab has been submitted to the US Food and Drug Administration. Sotrovimab is also under review by other global regulators, including Health Canada under the expedited interim order application pathway for COVID-19 drugs.

Source: European Medicines Agency, GlaxoSmithKline, and Vir Biotechnology

UK Gov’t Advises on AstraZeneca’s COVID-19 Vaccine for Those Under 40
The UK’s Joint Committee on Vaccination and Immunization (JCVI) has issued advice to the UK government for people under the age of 40 to receive an alternative to Oxford University’s /AstraZeneca’s COVID-19 vaccine.

The JCVI has advised a preference for adults aged 30 to 39 without underlying health conditions to receive an alternative to the Oxford/AstraZeneca COVID-19 vaccine, where available, and only if this does not cause substantial delays in being vaccinated.

This has been considered alongside the latest advice from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on extremely rare cases of concurrent thrombosis (blood clots) and thrombocytopenia (low platelet count) following the first dose of the Oxford/AstraZeneca COVID-19 vaccine. This follows the decision in April (April 2021) to offer a preference for adults aged under 30.

“Our position remains that the benefits of the COVID-19 Vaccine AstraZeneca against COVID-19, with its associated risk of hospitalization and death, continue to outweigh the risks for the vast majority of people,” said Dr. June Raine, MHRA’s Chief Executive in a May 7, 2021 statement. “The balance of benefits and risks is very favorable for older people but is more finely balanced for younger people, and we advise that this evolving evidence should be taken into account when considering the use of the vaccine.”

Source: UK government (recommendation) and UK government (MHRA statement)

WHO Identifies New COVID-19 Variant of Concern in India
The World Health Organization (WHO) has identified the B.1.617 strain of SARS-CoV-2, the virus that causes COVID-19, as a variant of concern in India.

In consultation with the WHO SARS-CoV-2 Virus Evolution Working Group, which aims to detect new mutations quickly and assess their possible impact, WHO has determined that B.1.617 is listed as a variant of concern based on early evidence of phenotypic impacts compared to other circulating virus variants. Full details of the variant of concern and its lineage can be found here.

Source: World Health Organization (press conference) and World Health Organization (weekly epidemiological update)

GSK, CureVac COVID-19 Vaccine Shows Positive Preclinical Results
GlaxoSmithKline (GSK) and CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, have reported CV2CoV, their second-generation COVID-19 vaccine candidate, induces high levels of antigen production as well as strong and dose-dependent immune responses in vaccinated animals.

CV2CoV is in co-development between CureVac and GSK and is based on a new mRNA backbone, which differs from CureVac’s first-generation vaccine candidate, CVnCoV, currently in late-stage clinical testing.

The companies reported that preclinical data in rats immunized with CV2CoV in the dose range of 0.5-40µg demonstrated fast onset of strong immune responses already after the first dose. In addition, the serum of vaccinated animals showed significant cross-neutralization against variants first discovered in Denmark (B.1.1.298), the UK (B.1.1.7) and South Africa (B.1.351). 

CureVac and GSK COVID-19 expanded their collaboration in February 2021 extended to include second-generation vaccines and those with the potential for a multivalent or combination approach to address multiple emerging variants in one vaccine.

Source: CureVac

Inovio Reports Positive Results for COVID-19 DNA Vaccines
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has reported positive data from its Phase II segment of its Phase II/III clinical trial in the US evaluating INO-4800, its first-generation DNA vaccine candidate for COVID-19 and positive preclinical data for INO-4802, its next-generation COVID-19 vaccine candidate against certain variants.

The company reported that INO-4800 was shown to be safe, well-tolerated, and immunogenic in all age groups. The Phase II results informed Inovio’s selection of a 2.0-mg dose for the Phase III segment of the trial.

Inovio plans to file preliminary Phase II results and device data with the US Food and Drug Administration (FDA). Following the submission and FDA concurrence to proceed, the company plans to conduct a global Phase III clinical trial for INO-4800.

The company also reported that INO-4802 induced potent neutralizing antibodies and T cell responses against the original Wuhan strain as well as against B.1.1.7 (UK variant), B.1.351 (South African variant) and P.1. (Brazilian variant) in preclinical models.

The company says that these results show the potential of INO-4802 to induce cross-reactive immune responses against current and emerging viral variants as either a first-line vaccine, or potentially as a boost for individuals previously immunized with various Wuhan-matched vaccines. Phase I/II clinical trials with INO-4802 are planned for this year (2021).

Source: Inovio (Results for original vaccine) and Inovio (results for vaccine against variants)

Novavax Reports Positive Preclinical Data for Combo Flu/COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has reported positive data from a preclinical study of the company’s combination quadrivalent seasonal flu vaccine, NanoFlu, and NVX-CoV2373, the company’s COVID-19 vaccine candidate.

The company reported that the NanoFlu/NVX-CoV2373 combination vaccine demonstrated positive immune responses to both influenza and SARS-CoV-2, the virus that causes COVID-19.

NVX-CoV2373 is being evaluated in two pivotal Phase III trials: (1) a trial in the UK that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and (2) a trial in the US and Mexico that began in December 2020. It is also being tested in two ongoing Phase II studies that began in August 2020: (1) Phase IIb trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa; and (2) a Phase I/II continuation in the US and Australia.

The company also issued an updated protocol for its Phase III trial in the US and Mexico. Final data are expected in the second quarter of 2021.

Source: Novavax (preclinical data) and Novavax (updated protocol)

3M Partners for COVID-19 Vaccine
The Infectious Disease Research Institute (IDRI), a non-profit global health organization, Duke Human Vaccine Institute in Durham, North Carolina, and 3M have collaborated to create a vaccine candidate with potential to provide protection against multiple variants of SARS-CoV2, the virus that causes COVID-19, and other coronaviruses.

Study results show the vaccine candidate, which combines a nanoparticle developed by a Duke-led research team with IDRI’s formulation of 3M’s adjuvant, 3M-052, stimulates increased levels of production of broadly neutralizing antibodies against several strains of coronavirus, including bat coronaviruses.

Results showed the adjuvant component of the vaccine candidate provided a critical boost to induce the robust protection against SARS-CoV-2 and increased production of antibodies that may confer protection against emerging SARS-CoV-2.

Source: Infectious Diseases Research Institute

FDA Vaccines Committee To Hold Meeting on Pediatric Use of COVID-19 Vaccines
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to provide an update on the approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age.

Additionally, the committee will discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.

The FDA intends to issue a notice as soon as possible (as reported on May 12, 2021) with details of the meeting, which will include information about the availability of a public docket for comments.

The meeting will be held on June 10, 2021. The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.

Source: US Food and Drug Administration

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