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

XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 These results came from data from Novavax’s Phase III UK trial where B.1.117

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Protein Vaccine Vaccination Trials 97

Pharmaceutical Technology

OCTOBER 25, 2022

Based on positive data from the open-label, international, randomised, multicentre Phase III HIMALAYA clinical trial, the regulatory agency granted the approval. A human monoclonal antibody, Imfinzi attaches to the PD-L1 protein and hinders the PD-L1 interaction with the PD-1 and CD80 proteins.

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Protein Immune Response Antibody FDA Approval 173

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

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. Plus, clinical trial settings aren’t always the same as real-world settings. But again 90% is not 100%.

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Vaccination Vaccine Clinical Trials Clinical Trials 303

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

Pharmaceutical Technology

NOVEMBER 20, 2022

Health Canada has granted expanded authorisation for Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted) [Nuvaxovid; NVX-CoV2373] as a homologous booster for usage in adults aged 18 and above. Currently, trials are underway to evaluate the immunogenicity and safety of the vaccine administered as a heterologous booster.

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Vaccination Vaccine Immune Response Protein 147

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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Immune Response Vaccine Vaccination Protein 130

BioSpace

NOVEMBER 7, 2022

Researchers from the University of Washington have developed an investigational vaccine that can safely elicit an immune response against the HER2 protein, a key marker in breast cancer.

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Immune Response Vaccination Vaccine Protein 86

Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial.

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Vaccination Vaccine Immune Response Protein 147

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 Vaccine Vaccination Immune Response 126

Pharmaceutical Technology

AUGUST 24, 2022

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. Flow cytometry (FCM) is the primary method scientists use to monitor immune responses in clinical trials, primarily because of its power, speed, and ability to provide a comprehensive view of a disease’s macro-environment.

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Clinical Trials Clinical Trials Trials Development 130

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Clinical Trials Clinical Trials Vaccination Vaccine 75

pharmaphorum

FEBRUARY 22, 2021

In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults. The vaccine is based around an adjuvanted recombinant protein, which will be tested in a new phase 2 study to assess the response including in older adults.

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Vaccination Vaccine Recombinant DNA Technology Trials 89

XTalks

FEBRUARY 29, 2024

Dual-function fusion proteins represent a cutting-edge approach in biopharmaceutical research, offering a promising avenue for the development of novel therapeutics in the treatment of complex diseases such as cancer and autoimmune disorders. The other end activates the CD40 receptor, enhancing the immune system’s ability to fight cancer.

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Protein Development Clinical Trials Clinical Trials 94

pharmaphorum

SEPTEMBER 30, 2020

This first data comes from a descriptive analysis from the seamless phase 1/2/3 trial that Regeneron hopes will hurry the medicine dubbed REGN-COV2 to market. The ongoing double-blind trial measures the effect of adding REGN-COV2 to usual standard of care, compared with usual standard of care. There were no deaths in the trial.

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Antibody Immune Response Trials Protein 135

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. OspA is one of the most dominant surface proteins expressed by the bacteria when present in the ticks that spread the disease.

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Vaccination Vaccine Bacterium Protein 119

pharmaphorum

JANUARY 12, 2021

An injectable/oral ‘prime and boost’ regimen is in a phase 1b study due to conclude in November, according to the clinicaltrials.gov database, and ImmunityBio has said it is also recruiting patients for a phase 2/3 trial. ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.

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Licensing Licensing Vaccination Vaccine 119

Camargo

JULY 27, 2021

Research and development in the area is currently growing at a fast rate, and the National Institute of Health reports hundreds of clinical trials to test gene therapies for different genetic diseases, immune system disorders, oncology treatments, neurogenerative diseases, infectious diseases, and more.

Gene Therapy 238

Gene Therapy Gene Gene Editing Genetics 238

The Pharma Data

AUGUST 16, 2021

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. “In Induction of innate immunity was investigated via specific cytokine markers.

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Immune Response Vaccine Vaccination Antibody 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

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Immune Response 98

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. 1.351 (South African) variants.

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Immune Response Vaccination Vaccine Trials 52

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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Vaccine Vaccination Trials Immune Response 69

pharmaphorum

JULY 18, 2022

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. CanSinoBIO’s inhalant has finished phase three trials in China and is presently undergoing trials in several countries.

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Vaccination Vaccine Development Immune Response 138

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 Protein 98

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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Vaccination Vaccine Immune Response Trials 105

The Pharma Data

JUNE 29, 2021

A sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose. In the UK, Vaxzevria is known as COVID-19 Vaccine AstraZeneca.

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Immune Response Vaccine Vaccination Antibody 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

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. as a potential trigger for rheumatoid arthritis. With the finding that 14-3-3?

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Vaccine Vaccination Research Immune Response 105

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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Vaccine Vaccination Trials Immune Response 52

XTalks

OCTOBER 11, 2024

The vaccine uses recombinant RSV glycoprotein F, stabilized in its prefusion conformation (RSVPreF3), along with GSK’s AS01E adjuvant to boost the immune response — the same adjuvant used in Shingrix, its shingles vaccine, but at a lower dose. Efficacy over the entire study was 62.9

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Vaccination Vaccine Immune Response Trials 103

pharmaphorum

FEBRUARY 9, 2022

While therapeutic cancer vaccines are able to help the body identify particular proteins expressed by cancer cells and then to instigate an immune response. The spokesperson also noted that as the organisations are acting as sponsors of the trials, Vaccitech is able to redirect the funds into other projects.

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Vaccination Vaccine Clinical Trials Clinical Trials 134

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. IGF-1 is an acceptable surrogate endpoint in trials of growth hormone receptor agonists like Somavert, and is preferred for pediatric patient populations.

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Trials Gene Hormones Clinical Trials 98

The Pharma Data

DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology. Source link.

Clinical Trials 52

Clinical Trials Clinical Trials Pharma Companies Vaccination 52

XTalks

DECEMBER 29, 2023

Tarlatamab is an investigational drug currently undergoing clinical trials to assess its efficacy in patients with two distinct types of neuroendocrine cancer: SCLC and neuroendocrine prostate cancer (NEPC). It targets delta-like ligand 3 (DLL3), a protein usually found inside normal cells but abnormally present on the surface of SCLC cells.

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Clinical Trials Clinical Trials FDA Approval Trials 119

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