pharmaphorum

MAY 19, 2022

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. One candidate – mRNA-1644 – has already shown its potential in an earlier phase 1 trial (IAVI G001) run in the US.

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Vaccination Vaccine Trials Immune Response 145

Pharmaceutical Technology

AUGUST 18, 2022

New Zealand’s Medsafe has granted expanded provisional approval for Novavax ’s protein-based Covid-19 vaccine Nuvaxovid (NVX-CoV2373) as a heterologous and homologous booster dose in adults aged 18 years and above. The booster vaccine is indicated for active immunisation for the prevention of Covid-19 in people of this age group.

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Drug Discovery World

SEPTEMBER 25, 2023

Enrolment in a Phase I trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, Maryland, US. With each new universal influenza vaccine candidate and clinical trial, we take another step closer to that goal,” said Acting NIAID Director Hugh Auchincloss.

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Vaccination Vaccine Trials Immune Response 52

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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Vaccination Vaccine Antibody Trials 293

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. .

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Vaccination Vaccine Trials Immune Response 98

XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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Antibody Immune Response Trials Clinical Trials 75

Pharmaceutical Technology

MARCH 31, 2023

Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra. A study involving 765 adults indicate that Bimervax, in addition to reducing antibodies against original SARS-CoV-2 strain, led to higher levels of antibodies against Beta and Omicron variants.

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Vaccination Vaccine Immune Response Antibody 277

Drug Discovery World

FEBRUARY 19, 2024

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

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Vaccination Vaccine Immune Response RNA 52

XTalks

MAY 4, 2023

Celiac disease is an autoimmune disorder that is triggered by the consumption of gluten, a protein found in barley, wheat and rye. When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food.

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Clinical Trials Clinical Trials Trials Immune Response 98

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

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Vaccination Vaccine Protein Antibody 52

Drug Discovery World

JUNE 28, 2023

MinervaX, a Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), has completed enrolment and initial dosing in its Phase I clinical vaccine trial in older adults. The trial is taking place at CEVAC (Centre for Vaccinology), Ghent University, Belgium.

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Clinical Trials Clinical Trials Trials Vaccination 52

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial.

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Protein Vaccination Vaccine Immune Response 126

The Pharma Data

AUGUST 15, 2021

Now, researchers reporting in ACS Central Science have immunized mice with nanoparticles that mimic SARS-CoV-2 by displaying multiple copies of the receptor binding domain (RBD) antigen, showing that the vaccine triggers robust antibody and T cell responses. bioRxiv [Preprint]. 2021 Apr 8:2021.04.08.438884.

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Protein Vaccination Vaccine Antibody 52

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 Vaccination Vaccine Immune Response 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. Results of the Phase 2 trial will inform the Phase 3 protocol.

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Protein Vaccination Vaccine Immune Response 52

pharmaphorum

NOVEMBER 25, 2021

The first patients are now being treated as part of a first-in-human trial of a vaccine, administered as a nasal spray, that aims to slow down the progression of Alzheimer’s disease (AD). Meanwhile researchers in Japan are also running preclinical studies of an intranasal tau vaccine.

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Vaccination Vaccine Trials Immune Response 98

XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8 mg/kg dose with an ORR of 73.6

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FDA Approval Antibody Immune Response Drugs 97

World of DTC Marketing

APRIL 11, 2021

Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome. Antibody tests indicate you had a previous infection and that you may have some level of protection against the virus.

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Drug Discovery World

APRIL 11, 2024

We have noted that cancer patients can develop powerful anti-tumour immune responses that can result in complete cure of the disease and we call these patients ‘elite responders’. By understanding what triggers the adaptive immune response in “elite responders” we have identified new targets and therapeutic antibodies.

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Research Immune Response Antibody Medicine 59

The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

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Antibody Vaccination Vaccine In-Vitro 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

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Antibody Trials Production Clinical Trials 52

XTalks

AUGUST 8, 2022

MiroBio is a private biotech company based in the UK that focuses on developing checkpoint agonist antibodies, which are a new class of therapies that work to restore immune balance in patients with autoimmune and inflammatory diseases. MiroBio’s Research Pursuits.

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XTalks

JUNE 15, 2022

The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. protein that triggers the immune system to generate antibodies against the virus. Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response.

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Vaccination Vaccine Immune Response Protein 59

The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children. Pfizer Inc.

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Immune Response Vaccination Vaccine Clinical Trials 52

pharmaphorum

MAY 27, 2021

GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA emergency approval for antibody sotrovimab, developed with Vir Biotech. “Recent scientific evidence shows that antibodies created against the B.1.351

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Antibody Immune Response Vaccination Vaccine 59

The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. 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.

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Vaccination Vaccine Trials Immune Response 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

MARCH 12, 2021

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. A total of 415 healthy adults 18 years of age and older are expected to be enrolled in the trial across 13 investigational sites.

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Clinical Trials Clinical Trials Trials Vaccination 52

XTalks

OCTOBER 12, 2021

The vaccine was tested in rats and showed strong, immediate and long-lasting immune responses to confer protection against the disease. is an autoantigen, which means it is an endogenous antigen that triggers an immune response in the body. antibodies in the knockout (KO) rats. With the finding that 14-3-3?

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pharmaphorum

AUGUST 11, 2021

South Korea’s SK Bioscience has been given the all-clear to start a phase 3 trial of its COVID-19 vaccine GBP510 that will compare the shot directly with AstraZeneca’s Vaxzevria.

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Vaccination Vaccine Immune Response Trials 98

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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Antibody Vaccination Vaccine Trials 52

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. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

DECEMBER 12, 2023

Human plasma, the clear, liquid portion of blood, is composed of water, electrolytes, nutrients and crucial proteins such as antibodies, clotting factors and albumin. Patients have better quality of life thanks to many Grifols plasma-derived medicines that replace missing or deficient plasma proteins.

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The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. Early tests showed the jab, developed by US biotechnology company Novavax, leads to high levels of virus-fighting antibodies being produced. Image copyright. Image caption.

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Vaccination Vaccine Trials Immune Response 52

pharmaphorum

JANUARY 26, 2022

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 Gilead has been forced to pause recruitment into trials involving the combination while the safety signal is investigated, but subjects already enrolled can continue to be treated, according to a company statement.

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