XTalks

NOVEMBER 6, 2020

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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The Pharma Data

MAY 16, 2021

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. High immune response after a single dose in patients with prior infection shows strong booster potential. For media and investors only. Issued: London UK. About the Phase 2 study.

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Immune Response Vaccine Vaccination Trials 52

The Pharma Data

FEBRUARY 22, 2021

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults. government in order to accelerate its development and manufacturing.

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pharmaphorum

JULY 18, 2022

“It is programmed and coded for the production of the full-length spike protein of the coronavirus. It then elicits an immune response against that spike protein. When you have mucosal immunity, the immunoglobulins called IgAs start neutralising the virus at the point of entry. The inhalant version.

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Cloudbyz

MARCH 5, 2024

Biologics: Biologics are large, complex molecules, often proteins, that are produced using living cells. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.

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pharmaphorum

AUGUST 11, 2021

The vaccine – based on a self-assembling protein nanoparticle that displays 60 copies of the SARS-CoV-2 spike protein – is formulated with GlaxoSmithKline’s vaccine adjuvant, designed to boost the immune response.

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The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

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Protein Vaccine Vaccination Immune Response 52

pharmaphorum

AUGUST 23, 2021

Ahmedabad-based Zydus Cadila has said it expects to launch ZyCoV-D in late September or early October, and expects to be able to manufacture around 100-120 million doses a year, with around 10 million available at launch. Proponents of the approach claim that DNA vaccines may have advantages over other technologies like mRNA.

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pharmaphorum

DECEMBER 22, 2020

There is no evidence to suggest the new strain causes more serious illness, but it does show variations in the “spike” protein that the virus uses to infect cells – the same protein that the Pfizer/BioNTech shot uses to confer immunity. The likelihood that our vaccine works … is relatively high.”.

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The Pharma Data

DECEMBER 20, 2020

SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology. In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021. Source link.

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XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. These strains of the virus were recommended by the World Health Organization (WHO).

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The Pharma Data

APRIL 15, 2022

Each serum was tested simultaneously for its neutralizing titer against recombinant SARS-CoV-2 (with USA-WA-1/2020 genetic backbone) bearing the wild-type SARS-CoV-2 spike protein and theOmicron spike. The 50% neutralizing geometric mean titer (GMT) against Omicron was 993 (after three doses), compared to 27 after two doses.

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Immune Response Vaccine Vaccination Clinical Trials 52

pharmaphorum

FEBRUARY 24, 2021

Changes in the “Spike” protein targeted by nearly all the vaccines approved or in development could also lead to more infectious variants, such as the strain that emerged in Kent and is now prevalent across most of the UK. If vaccines need updating, the FDA expects that manufacturing information will remain generally the same.

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pharmaphorum

SEPTEMBER 15, 2020

The UK has also agreed to invest in Valneva’s manufacturing plant in Livingston, Scotland, to help scale up production of the vaccine, with the investment serving as a credit for future vaccine supply. The hope is that directly targeting the cells lining the airways may stimulate a more effective immune response against SARS-CoV-2.

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XTalks

NOVEMBER 23, 2020

Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials. As a manufacturing partner for Oxford’s vaccine, AstraZeneca is ramping up its production capabilities as it plans to make up to three billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.

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The Pharma Data

SEPTEMBER 2, 2020

The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology. Sanofi and GSK are currently scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection.

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The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. ” Clover’s COVID-19 S-Trimer vaccine was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company’s proprietary Trimer-Tag © technology. SHANGHAI , Nov.

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pharmaphorum

MARCH 17, 2022

.” Both Pfizer’s BioNTech-partnered Comirnaty and Moderna’s SpikeVax vaccines use LNPs to carry mRNA coding for the SARS-CoV-2 spike protein. After dosing, the LNPs deliver the mRNA sequence into cells, which is then used by cellular machinery to manufacture the viral protein and stimulate an immune response.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

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The Pharma Data

SEPTEMBER 30, 2021

Our results show that the candidate vaccine formulation is safe, produces rapid immune responses – within seven days – and elicits comprehensive immunity against SARS-CoV-2,” said Varadarajan. A fundamental limitation of intramuscular vaccines is that they’re not designed to elicit mucosal immunity.

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XTalks

NOVEMBER 10, 2020

Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate. Adjuvants are used to help stimulate stronger vaccine immune responses. These are very promising results. Plant-Based Vaccine Technology.

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The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

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Clinical Development Vaccine Vaccination Development 52

pharmaphorum

JANUARY 8, 2021

While the manufacturer can submit further evidence following this first draft guidance, there is a chance interim funding could be discontinued if NICE comes to the same conclusions in final draft guidance. Opdivo is a monoclonal antibody that binds to the PD-1 receptor, blocking its interaction with the PD-L1 and PD-L2 proteins.

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The Pharma Data

JUNE 26, 2021

The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies or protein degradation. Source link: [link].

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Clinical Trials Clinical Trials Vaccine Vaccination 52

Delveinsight

AUGUST 6, 2020

ZyCoV-D is designed to introduce DNA that encodes for a viral protein into human cells. By ordering human cells to make the protein, ZyCoV-D could cause an immune response against the coronavirus. In a new study that is published in Science, the team displayed that one soluble receptor protein, sACE2.v2.4,

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies or protein degradation. About Translate Bio. Source link:[link].

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Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates.

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The Pharma Data

OCTOBER 25, 2020

In parallel we are scaling up our manufacturing capability with our strategic partners, Lonza and Rovi, to address this global health emergency by delivering a safe and effective vaccine to the people of Qatar and around the world.”. On Thursday, October 22, Moderna completed enrollment of the Phase 3 COVE study. About Moderna.

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The Pharma Data

SEPTEMBER 25, 2020

Novavax are using traditional methods – proteins from the coronavirus that cannot replicate in the body and a chemical, called an adjuvant, to boost the immune response. ” The vaccine will be manufactured in Stockton-on-Tees. ” Follow James on Twitter.

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The Pharma Data

JUNE 25, 2021

Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.

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Pfizer

FEBRUARY 16, 2023

This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick.

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The Pharma Data

DECEMBER 23, 2020

Cellular (T cell) response were observed to multiple regions of the spike protein including the RBD region. 74% had measurable cellular responses at the 1.0 mg dose group demonstrated cellular responses. The 1.0 mg and 2.0 mg dose group and 84% demonstrating neutralizing antibodies in the 2.0

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DNA Vaccine Vaccination Immune Response 40

The Pharma Data

APRIL 22, 2023

The current COVID-19 vaccines are designed to trigger an antibody response to the SARS-CoV-2 spike protein, which is vulnerable to mutations that could make the vaccine less effective over time. These epitopes elicit an immune response from a broad selection of T cells, ensuring a sustained coverage of future variants.

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The Pharma Data

JULY 6, 2021

New research will also be presented on Eloctate ® Antihemophilic Factor (Recombinant), Fc Fusion Protein, Sanofi’s extended half-life factor VIII therapy for people with hemophilia A. BTK is involved in innate and adaptive immune responses and is a signaling molecule in immune mediated diseases. ePoster Abstract # OC48.2

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The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

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