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. Vaxzevria was co-invented by the University of Oxford and its spin-out company, Vaccitech.

Immune Response 52

Immune Response Vaccination Vaccine Antibody 52

pharmaphorum

JULY 27, 2022

Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. Clinical data show strong neutralising antibody responses against Omicron BA.1,

Protein 122

Protein Immune Response Vaccination Vaccine 122

The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

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. Source link.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

Successful TIL therapy depends on the infusion product containing tumour-reactive T cells that, on infusion, generate an anti-tumour immune response that causes disease regression. The use of engineered immune cytokines that selectively induce the expansion of TILs is being investigated as an alternative to IL-2 stimulation.

Immune Response 246

Immune Response In-Vivo Production Manufacturing 246

Pharmaceutical Technology

MARCH 31, 2023

Moreover, these events also have ramifications for planned clinical trials. Eligibility for the UK’s National Health Services (NHS) booster programmes in England is restricted to those ages 75 years and above or individuals with weakened immune systems. The NHS will be using Covid-19 vaccines manufactured by Pfizer, Moderna and Sanofi.

Vaccination 277

Vaccination Vaccine Immune Response Antibody 277

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.

Vaccination 69

Vaccination Vaccine Trials Immune Response 69

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

MAY 7, 2021

Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. Earlier results from a more complete analysis of trial data shared in March confirmed a high level efficacy of 86.3 1.351 variant.

Protein 77

Protein Vaccination Vaccine Trials 77

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. 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. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

OCTOBER 5, 2022

Called NGoXIM, the vaccine is based on gonococcal OMVs combined with sustained-release microspheres containing recombinant human IL-12, supplied Intravacc’s US partner Therapyx, which are designed to boost the immune response to the antigens.

Vaccination 98

Vaccination Vaccine Immune Response Bacterium 98

Worldwide Clinical Trials

JUNE 15, 2022

The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. We need to consider how to use diverse populations in gene therapy trials. But it’s important we strive to find ways to include diverse patients so trial data can be representative of the wider population.

Gene Therapy 130

Gene Therapy Gene Clinical Trials Clinical Trials 130

XTalks

OCTOBER 24, 2024

In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis. Nutrient-rich foods containing omega-3 fatty acids, prebiotics and curcumin could also help improve immune function and alleviate symptoms.

Research 92

Research Dermatology Clinical Trials Clinical Trials 92

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.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

Pharmaceutical Technology

NOVEMBER 22, 2022

According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”. Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

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. First Trial Results for First mRNA Influenza Vaccine. Mixed Results.

Vaccination 90

Vaccination Vaccine Immune Response Antibody 90

The Pharma Data

DECEMBER 11, 2020

The University of Oxford has regularly appeared in our updates since July 2020, as its team of researchers leads an ongoing clinical trial for the Covid-19 vaccine. More recently, the university has released news of its collaboration with Thermo Fisher Scientific as it looks to discover an immune Covid-19 response pre- and post-vaccination.

Antibody 52

Antibody Vaccination Vaccine Containment 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. and Australia.

Protein 52

Protein Vaccination Vaccine Immune Response 52

pharmaphorum

SEPTEMBER 14, 2021

The Cambridge, Massachusetts biotech is focusing specifically on the 60% of DNA sequences that repeat themselves hundreds or thousands of times in the genome, known as the ‘repeatome’, that could contain targets for cancer and autoimmune disorders.

DNA 52

DNA Immune Response Genome Genomics 52

STAT News

NOVEMBER 3, 2022

The early-stage study, which is being sponsored by BioNTech, aims to evaluate safety, tolerability, and immunogenicity, or the ability to generate an immune response. The trial is being conducted in the U.S. and the companies aim to enroll 180 volunteers between the ages of 18 and 64.

Vaccination 97

Vaccination Vaccine Drug Delivery Systems Sales 97

pharmaphorum

SEPTEMBER 25, 2020

DKN-01 is an antibody drug targeting the Dickkopf-1 (DKK1) protein, which is overexpressed in some forms of G/GEJ adenocarcinoma and is thought to be involved in tumour growth as well as dampening down the immune response against the cancer.

Immune Response 72

Immune Response Trials Drugs Containment 72

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies. Product Type-Specific Analysis.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

NOVEMBER 14, 2020

In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel. The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated.

Clinical Trials 40

Clinical Trials Clinical Trials Vaccination Vaccine 40

XTalks

NOVEMBER 23, 2020

Severe cases of the infection did not occur among trial participants, nor were any hospitalizations reported. The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

Vaccination 79

Vaccination Vaccine Clinical Trials Clinical Trials 79

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.

Vaccination 52

Vaccination Vaccine Trials Protein 52

Roots Analysis

AUGUST 23, 2024

The idea behind mRNA vaccines is to use this natural process to incite an immune response: inject patients with a synthetic mRNA strand encoding a particular antigen – usually a protein, or part of a protein, recognized by the immune system – and their cells will produce the antigen in situ.

Protein 40

Protein Vaccination Vaccine Immune Response 40

The Pharma Data

APRIL 8, 2022

Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immune responses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications.

Immune Response 52

Immune Response In-Vivo Genetic Analysis Research 52

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

Vaccination 111

Vaccination Vaccine Immune Response Trials 111

The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.” About PREVENT-19.

Vaccination 40

Vaccination Vaccine Trials Immune Response 40

The Pharma Data

NOVEMBER 9, 2020

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. and globally.”.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Roots Analysis

JANUARY 6, 2022

Myeloid cells represent a group of cells containing granulocytes, monocytes, macrophages, mast cells and dendritic cells, which play a key role in innate immunity. Over time, many research studies have shown that myeloid cells can interact with the immune system and aid in generating an appropriate anti-tumor immune response.

Immune Response 52

Immune Response Clinical Trials Clinical Trials Marketing 52

The Pharma Data

DECEMBER 8, 2020

The efficacy rating followed an interim report of ongoing human trials conducted in that country, CNBC reported. In August, the company reported the vaccine candidate triggered antibody-based immune responses in early and mid-stage trials. The vaccine was also demonstrating a strong safety profile.

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

APRIL 11, 2021

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Surgery was rarely canceled due to adverse events, only affecting two patients in each arm of the trial.

Trials 52

Trials Immune Response Genome Genomics 52

The Pharma Data

OCTOBER 9, 2021

Novartis will present 41 abstracts from a wide-ranging multiple sclerosis (MS) portfolio, including new data on Kesimpta ® (ofatumumab) and Mayzent ® (siponimod) Novartis will be commencing Phase III pivotal trials investigating remibrutinib in RMS.

Immune Response 52

Immune Response Vaccination Vaccine Medicine 52

XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. In the trial, the vaccine was injected directly into the lymph nodes of type 1 diabetic individuals. The DIAGNODE-2 Trial.

Vaccination 77

Vaccination Vaccine Insulin Trials 77

The Pharma Data

MARCH 8, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

Trials 52

Trials Immune Response Clinical Trials Clinical Trials 52