Pharma COVID Roundup: News from J&J, Inovio, and Novavax

The latest on manufacturing and potential treatments for COVID-19 with news from J&J, Inovio, Novavax, Endo International, and the Serum Institute of India.

J&J Reports Positive Phase I/IIa Results for its COVID-19 Vaccine
Johnson & Johnson (J&J) has reported positive results from an interim analysis from an ongoing Phase I/IIa trial for its COVID-19 vaccine candidate, JNJ-78436735.

The company reported that data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults. The ongoing Phase I/IIa trial is designed to study the safety and immunogenicity of the vaccine in single and two-dose schedules. .

Based on these findings, the single dose of the vaccine candidate (5×1010 virus particles) has been selected for further evaluation in a large-scale, multi-country Phase III trial. The company says it also plans on running a Phase III trial of a two-dose regimen of JNJ-78436735 versus placebo later this year (2020). 

J&J says the full set of results will be published once the complete Phase I/IIa trial data are available. .

Source: Johnson & Johnson

FDA Puts Inovio Phase II/III Trial of COVID-19 Vaccine Candidate on Hold
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has been notified by the US Food and Drug Administration (FDA) that its Phase II/III trial of its COVID-19 vaccine candidate, INO-4800, has been placed on partial clinical hold. 

The FDA notified the company that it has additional questions about Inovio’s planned Phase II/III trial of INO-4800, including its Cellectra 2000 delivery device for the vaccine. The company says the hold on the trial is ongoing until the FDA’s questions have been satisfactorily addressed.

Inovio says it is actively working to address the FDA’s questions and plans to respond in October (October 2020), after which the FDA will have up to 30 days to notify Inovio of its decision as to whether the trial may proceed.

The company says this partial clinical hold is not due to the occurrence of any adverse events related to its ongoing expanded Phase I study of INO-4800, which may continue and is not impacted by the FDA’s notification.

Source: Inovio

Endo, Novavax in Fill–Finish Mfg Pact of COVID-19 Vaccine
Par Sterile Products, a subsidiary of Endo International, a generics and specialty pharmaceutical company, has entered into a non-exclusive agreement with Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company. to provide fill–finish manufacturing services at Par’s plant in Rochester, Michigan for NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.

Par Sterile’s Rochester facility has begun production of the NVX-CoV2373 final drug product, with initial batches to be used in Novavax’s Phase III trial in the US. Par Sterile will also fill–finish the NVX-CoV2373 vaccine intended for commercial distribution in the US. Financial and other terms of the agreement were not disclosed.

NVX CoV2373 is a stable, prefusion protein made using Novavax’s recombinant protein nanoparticle technology and includes Novavax’s proprietary saponin-based adjuvant, Matrix M. NVX-CoV2373 is currently in multiple Phase II clinical trials, including: (1) a Phase II clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 that began in August 2020 in the US and Australia; and (2) a Phase IIb clinical trial to assess efficacy that began in South Africa in August 2020. Interim data for these trials are expected before the end of 2020 (as reported on September 25, 2020).

Source: Endo

Serum Institute of India Forms Mfg Pact for COVID-19 Vaccines
The Serum Institute of India (SII), a vaccine manufacturer, has announced a further collaboration with Gavi, a global public health partnership, and the Bill & Melinda Gates Foundation to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low-and middle-income countries (LMICs) as part of the Gavi COVAX AMC, a mechanism within the COVAX Facility.

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 a large portfolio of COVID-19 candidate vaccines using a range of technology platforms and produced by multiple manufacturers. COVAX is led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization (WHO). The Gavi COVAX Advance Market Commitment (AMC) is a financing instrument aimed at supporting the procurement of vaccines.

The new collaboration brings the total number of vaccine doses to be covered by the partnership between SII, Gavi, and the Gates Foundation to an aggregate of up to 200 million doses following an initial agreement for up to 100 million doses announced in August (August 2020).The arrangement provides an option to secure additional doses if the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator sees a need for it.

The new collaboration will provide upfront capital to SII to help it increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification, doses can be distributed at scale to LMICs as part of the Gavi COVAX AMC mechanism as early as the first half of 2021.

The Gavi COVAX AMC, which is currently seeking at least $2 billion in initial seed funding, will meet at least part of the cost of procurement for the vaccine doses. The Gavi Board has agreed upon the final list of 92 countries that will be supported by the Gavi COVAX AMC. Under the new collaboration, AstraZeneca’s candidate vaccine, if successful, will be available to 61 Gavi-eligible countries. Novavax’s vaccine candidate, if successful, will be available to all 92 countries supported by the Gavi COVAX AMC. These countries align with SII’s licensing agreements with the two partners.

The Bill & Melinda Gates Foundation, via its Strategic Investment Fund, will provide at-risk funding of a further $150 million to Gavi, bringing the total funding provided through this collaboration to $300 million.This will be used to support SII to manufacture potential vaccine candidates and for future procurement of vaccines for India and low-and middle-income countries via Gavi’s COVAX AMC. Funding will help accelerate the manufacturing by SII for candidate vaccines licensed from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and WHO prequalification. The vaccines will have a ceiling price of $3 per dose, a price enabled by investments made by partners such as the CEPI, the Bill and Melinda Gates Foundation and SII.

The deal is additional to a memorandum of understanding between AstraZeneca and Gavi, announced in June (June 2020), which will commit an additional 300 million doses of AstraZeneca’s candidate vaccine to the wider COVAX Facility, to be supplied upon licensure or prequalification.

Source: Serum Institute of India

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