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By Rachel Arthur
Contact

August 30, 2021
– Last updated on
August 30, 2021 at 17:44 GMT

Related tags:
COVID-19 vaccine, Scancell, Novavax, Sanofi, Gsk

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Vaccines from big names like Pfizer / BioNTech, Moderna, AstraZeneca and Johnson & Johnson continue to increase production and sales. However, according to the WHO vaccine tracker, there are still 112 COVID-19 vaccine candidates in clinical development and 184 in preclinical development.

These range from technologies such as mRNA and non-replicating viral vectors to DNA and live attenuated virus vaccines – as well as those looking for an alternative to needle administration.

We take a look at some of the candidates coming through the pipeline; the difference they hope to make from legal and legal vaccines; and its development schedule.

Valneva announced this month that the company has begun ongoing filing for its COVID-19 vaccine candidate VLA2001 in the UK.

VLA2001 is currently in a Phase 3 regulatory phase in the UK Study, Cov-Compare (VLA2001-301), for which topline results are currently expected at the beginning of the fourth quarter of 2021.

Valneva takes a “proven” approach with its inactivated candidate. The vaccine is expected to meet the standard cold chain requirements of 2 degrees to 8 degrees Celsius.

The manufacturing process for VLA2001 is already at its final industrial scale and the company started commercial production in January 2021, around the Optimize the schedule for possible deliveries of the vaccine. The UK government has ordered 100 million doses for delivery in 2021 and 2022, with the option to purchase an additional 90 million doses by 2025.

Akston Biosciences has its second generation protein subunit COVID-19 vaccine candidate, AKS -452, entered into a phase 1/2 study this month.

The phase I study showed that AKS-452 is safe and well tolerated; with the candidate achieving a seroconversion rate of 100% with both 90 microgram single-dose therapy and 45 microgram two-dose therapy. The AKS-452 has been shown to be at 25 ° for at least six months Celsius (77 ° Fahrenheit) storage-stable and maintains its effectiveness at 37 ° Celsius (99 ° Fahrenheit) for one month: ideal for distribution in countries with limited infrastructure.

The vaccine candidate of the second generation of mRNA COVID-19 from CureVac and GSK has shown improved immune response and protection over the first-generation candidate, according to the results of a preclinical study published this month.

CV2CoV was developed with specially optimized non-coding regions to provide improved mRNA Translation to show increased and extended protein expression compared to the mRNA backbone of the first generation.

In an animal model it was shown that CV2CoV according to information The company induces broad antibody and cellular immune responses that are very similar to the breadth of immune responses observed after infection with SARS-CoV-2.

There were immune responses against the original SARS-CoV-2 virus and the questionable beta – and Delta variants and the Lambda variant of interest found.

Arcturus from San Diego, a mRNA company in the clinical stage that focuses on vaccines against infectious diseases of the liver and rare respiratory diseases, is developing two COVID-19 in parallel Candidates: ARCT-021 (its lead candidate) and ARCT-154 (targeting variants of concern, including the Delta variant). The vaccines were manufactured using Arcturus ‘STARR mRNA technology.

Arcturus’ lead mRNA COVID-19 vaccine candidate, ARCT-021, is currently in a phase 2 study in the US and Singapore, with data expected in the second half of 2021.

Meanwhile, its manufacturing partner in Vietnam, Vinbiocare, received clinical trial application (CTA) approval from the Vietnamese Ministry of Health this month to move the variant-focused ARCT-154 into a phase 1/2 / 3 study to bring. The randomized, observer-blind, placebo-controlled design is sponsored and funded by Vinbiocare (a subsidiary of Vingroup, the country’s largest private industrial conglomerate).

Preclinical research suggests immunizing non-human primates with ARCT-154 against neutralizing antibodies causes worrying SARS-CoV-2 variants, including the delta variant (protection was highest against alpha, followed by delta, gamma and then beta).

If the clinical trial proves successful in interim evaluations, will The Vietnamese Ministry of Health is expected to receive the Emergency Use Approval (EUA) by the end of the year.

NVX-CoV2373 is a protein-based vaccine candidate that was developed from the genetic sequence of the first SARS-CoV-2 strain. It was developed using Novavax’s recombinant nanoparticle technology to generate antigens from the coronavirus spike (S) protein and is formulated with Novavax’s saponin-based Matrix-M adjuvant to boost the immune response and produce high levels of neutralizing antibodies to stimulate.

NVX-CoV2373 is evaluated in two approval-relevant phase 3 studies: a study in Great Britain, which shows an effectiveness of 96.4% against the original virus strain, 86.3% against the alpha variant (B. .1.1.7) and showed a total effectiveness of 89.7%; and the PREVENT-19 study in the US and Mexico, which showed 100 percent protection against moderate and severe illness and an overall effectiveness of 90.4%.

It is also being tested in two ongoing Phase 2 studies that began in August 2020: a phase 2b study in South Africa that showed a total of 55% effectiveness in HIV-negative participants and 48.6% effectiveness against a newly emerging escape variant first described in South Africa and a continuation of phase 1/2 in the US and Australia.

Novavax is working to complete ongoing approval for approval from the European Medicines Agency (EMA) in the third quarter of 2021. Novavax and the Serum Institute of India have jointly applied for emergency approval in India, Indonesia and the Philippines.

NVX-CoV2373 is stored at 2 to 8 ° C and is stable, so that the existing channels of the vaccine Supply chain can be used for distribution.

Sanofi and GSK started a clinical phase 3 study in May for an adjuvanted recombinant protein COVID-19 vaccine candidate. A two-tier design evaluates vaccine formulations against both the original D.614 virus and B.1.351. The schedule states that the vaccine could be approved / approved in the fourth quarter of 2021 – subject to positive Phase 3 results and regulatory reviews.

Sanofi is also working on the development of a second COVID-19 mRNA vaccine based on its work with Translate Bio – which it took over this month – with a phase 1/2 study, the results of which are expected in the third quarter of 2021.

Scancell is evaluating the safety and immunogenicity of the two vaccine candidates SCOV1 and SCOV2 and evaluates different doses of vaccine administered by two alternative routes of injection using needle-free systems. The company selected PharmaJet needle-free injection systems to either deliver the vaccine by intradermal injection using the PharmaJet Tropis needle-free injection system; or via intramuscular administration with the PharmaJet Stratis system.

Needle-free injectors use a narrow stream of fluid to penetrate the skin and deliver vaccines and other drugs to the required tissue depth. Both PharmaJet systems have been clinically proven with a wide range of vaccines including delivery of DNA products. According to the company, the injection systems are easy to use, eliminate needlestick injuries, and have the potential to extend vaccination coverage to those with fear of needles.

Scancell’s preclinical studies have confirmed that PharmaJet’s delivery of its vaccines has strong immune responses to S and N antigens induced (meanwhile, PharmaJet’s technology is used with the plasmid DNA vaccine from Zydus Cadila, which has just received the EUA from the Drug Controller General of India).

The vaccine candidates are expected in the second half of the year Enter a Phase 1 study in South Africa in 2021. As soon as the safety data are available, a study in the UK will give the vaccine as a booster to people who are already with two approved COVID-19. Vaccinations are fully vaccinated.

In addition to evaluating virus-neutralizing antibodies, Scancell will also analyze T-cell responses to the N-protein in the studies, which will provide additional information and data on the potential benefits of SCOV1 and SCOV2 against future SARS- CoV-2 variants will supply.

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Related topics:
Organic developments,
COVID-19

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Similar title :
In the pipeline : What the next wave of COVID-19 vaccines could look like

Ref: https://www.biopharma-reporter.com