XTalks

NOVEMBER 5, 2024

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 is advancing novel nasal spray-based hydrogels with two innovative platforms: Capture and Contain (C&C) and Trap and Target (T&T). Polyrizon Ltd., million in gross proceeds.

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Drug Delivery Drugs Immune Response Allergies 111

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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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.

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Protein Vaccine Vaccination Trials 97

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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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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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.

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Immune Response Vaccine Vaccination Antibody 52

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.

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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.

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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.

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Vaccine Vaccination Immune Response Bacterium 98

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.

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Development Production Immune Response Licensing 161

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

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Vaccine Vaccination Immune Response Trials 111

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.

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Vaccine Vaccination Clinical Trials Clinical Trials 97

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.

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Clinical Trials Clinical Trials Trials Immune Response 52

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.

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Vaccine Vaccination Immune Response Antibody 98

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.

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Vaccine Vaccination Insulin Trials 103

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.

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Manufacturing Vaccine Vaccination RNA 130

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.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

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.

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Clinical Trials Clinical Trials Vaccine Vaccination 76

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.

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Immune Response Trials Drugs Containment 72

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.

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Clinical Trials Clinical Trials Vaccine Vaccination 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.

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Vaccine Vaccination Drug Delivery Systems Sales 97

pharmaphorum

APRIL 26, 2022

As more research has been conducted, closer and unexpected links have been found between the microbiome of the gut, as one example, and other areas of the body, such as brain health and the immune system. In the trial, Seres announced that the product candidate had met its primary endpoint, showing a statistically significant 30.2%

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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.

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Antibody Vaccine Vaccination 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.

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Protein Vaccine Vaccination 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

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.”.

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Vaccine Vaccination Clinical Trials Clinical Trials 52

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Cell-Based Immunotherapy vs. Immune Biologics. Immune system modulators (i.e.

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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.

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Vaccine Vaccination 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.

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Trials Immune Response Genome Genomics 52

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.

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Immune Response In-Vivo Genetic Analysis Research 52

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.

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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.

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Trials Immune Response Clinical Trials Clinical Trials 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. The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Trials Production 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

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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Clinical Development Vaccine Vaccination Development 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.

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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.

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