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Intranasal delivery of AstraZeneca COVID-19 vaccine fails to generate strong immune response

BioPharma Reporter

Intranasal delivery of ChAdOx1 nCoV-19 failed to induce either a consistent mucosal antibody response or a strong systemic immune response, according to results from a Phase 1 clinical trial released today.

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The Lancet Respiratory Medicine: Clinical trial finds inhaled immune response protein increases odds of recovery for hospitalised COVID-19 patients

Scienmag

Inhaled delivery of a formulation of a key protein involved in the immune response – interferon beta-1a – to hospitalised COVID-19 patients in the UK reduced the odds that they would develop severe disease or die from SARS CoV-2 infection. Peer-reviewed / Randomised Controlled Trial / People Inhaled delivery of a formulation of a key […].

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Vaccine-induced immune response to omicron wanes substantially over time

The Pharma Data

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substantially within 3 months, according to new clinical trial data.

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Early data shows Russia’s Sputnik V COVID-19 vaccine produces immune response

Pharma Phorum

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. The vaccine also produced a T-cell response within 28 days, a secondary outcome.

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Pfizer and BioNTech Announce Updated Clinical Data for Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Substantially Higher Immune Response in Adults Compared to the Original COVID-19 Vaccine

The Pharma Data

Pfizer and BioNTech Advertise streamlined Clinical Data for OmicronBA.4/BA.5- Immune responses againstBA.4/BA.5

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Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11

NY Times

your-feed-science Children and Childhood Coronavirus (2019-nCoV) Vaccination and Immunization Moderna Inc New England Journal of Medicine Coronavirus Omicron Variant Clinical Trials Disease Rates Teenagers and Adolescence Drugs (Pharmaceuticals) Food and Drug Administration United States

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Flow cytometry: advantages in immunotherapy clinical trials

Pharmaceutical Technology

More than three decades ago, scientists at the National Cancer Institute began exploring ways to fight cancer using the patient’s immune system. Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies.

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Triggering tumor antiviral immune response in triple negative breast cancer

Scienmag

14, 2021) – Researchers at Baylor College of Medicine have discovered how therapeutics targeting RNA splicing can activate antiviral immune pathways in triple negative breast cancers (TNBC) to trigger tumor cell death and signal the body’s immune response. Medicine & Health Breast Cancer cancer Cell Biology Clinical Trials Genetics Medicine/Health Pharmaceutical ScienceHOUSTON – (Jan.

RNA 41
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UK partners with BioNTech on clinical trials of mRNA cancer therapies

Pharma Phorum

The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim.

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Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study

The Pharma Data

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.

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Medicago Says COVID-19 Vaccine Candidate Triggers Promising Immune Response | 2020-11-10

The Pharma Data

Canadian biopharmaceutical company Medicago has announced that its investigational COVID-19 vaccine generated “significant antibody and cellular immune responses” after two doses in all subjects in an early-stage clinical trial. Based on the promising phase 1 data, the company plans to proceed with a phase 2/3 clinical trial. “We The interim analysis from the phase 1 trial has been published online at the preprint server, medRxiv.

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Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

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. He explained that by taking the vaccine orally “allows for a mucosal response in the intestine that can trigger signals to eliminate viruses in the body.”. COVID-19 Clinical Trials.

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The Lancet: Phase 2 trial of Oxford COVID-19 vaccine in healthy older adults finds it is safe and provokes immune response

Scienmag

Older adults are at a disproportionate risk of severe COVID-19 disease, so it is essential that any vaccine adopted for use against SARS-CoV-2 is effective in this group Peer-reviewed / Randomised Controlled Trial / People **There will be a UK Science Media Centre briefing at 10.15am UK time on Thursday 19th November about this study. […].

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The Lancet Infectious Diseases: Chinese vaccine candidate based on inactivated SARS-CoV-2 virus appears safe and induces an immune response in healthy volunteers, preliminary study finds

Scienmag

Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate (CoronaVac) involved more than 700 healthy volunteers aged 18-59 years recruited in China between 16 April and 5 May 2020 Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate (CoronaVac) involved more than 700 healthy volunteers aged 18-59 years recruited in China […].

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Medicxi’s Portfolio Company MiroBio to be Acquired by Gilead

XTalks

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. PD-1 is a potent immune inhibitory receptor.

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Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

The Pharma Data

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.

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Statement on Data Published in PLOS Medicine on Tolerability and Immune Response of Johnson &.

The Pharma Data

Data published in PLOS Medicine demonstrated that the Johnson & Johnson (the Company) Ebola vaccine authority, Zabdeno ® (Ad26.ZEBOV) and Mvabea ® (MVA-BN-Filo), was well permitted and convinced a robust vulnerable response in both healthy grown-ups and grown-ups living with HIV. The Innovative Medicines Initiative (IMI) handed backing through the IMI Ebola Programme to support a number of colleges that initiated multiple clinical trials and other vaccine development conditioning.

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The Lancet Infectious Diseases: Preliminary results find vaccine candidate based on inactivated SARS-CoV-2 virus is safe and induces an immune response in healthy volunteers

Scienmag

Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate was carried out in China between 29 April and 30 July 2020 and involved more than 600 healthy volunteers. Peer reviewed / Randomised clinical trial / People The Lancet Infectious Diseases: Preliminary results find vaccine candidate based on inactivated SARS-CoV-2 virus is safe and […].

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Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age

The Pharma Data

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.

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NIH launches clinical trial of mRNA Nipah virus vaccine

The Pharma Data

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched an early-stage clinical trial evaluating an investigational vaccine to prevent infection with Nipah virus.

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COVID-19 vaccine candidate, tested at UAB, will start Phase 1 clinical trial

Scienmag

Preclinical tests at UAB last year showed potent systemic and mucosal immune responses in mice after a single intranasal dose. Chemistry AND Physics Clinical Trials Immunology/Allergies/Asthma Infectious/Emerging Diseases Medicine/Health Pharmaceutical Science Vaccines Virology

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Gene Therapy Clinical Trials for Rare Diseases: 5 Key Takeaways from FDA’s Recent Town Hall

XTalks

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases.

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Moderna to Seek Authorization of Its Coronavirus Vaccine for Young Children

NY Times

The company said the vaccine produced a strong immune response in children younger than 6, but proved only about 40 percent effective in preventing symptomatic Covid-19.

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Sanofi/Translate start clinical trial of mRNA COVID shot

Pharma Phorum

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. Clinical trial participants will receive one dose of MRT5500, or two doses 21 days apart.

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Demonstrated a Durable Immune Response and Elicited Dual Mechanisms of Protection Against Delta and Other SARS-CoV-2 Variants of Concern in Data Published in New England Journal of Medicine

The Pharma Data

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) of Beth Israel Deaconess Medical Center suggest maturation of B-cell response without further boosting.

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Scancell announces positive Phase 1 data for needle-free COVID-19 vaccines

BioPharma Reporter

Scancell has reported preliminary immunogenicity data from its Phase 1 COVIDITY clinical trial: with the plasmid DNA based COVID-19 vaccine candidates inducing immune responses when delivered via needle-free tech.

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Inotrem’s COVID-19 Phase IIa Clinical Trial Declared “National Priority Research” by the French Government’s Clinical Trial Council

The Pharma Data

In the context of a substantial amount of COVID-19-related research and the launch of numerous clinical trials, the French government created this steering committee to prioritize and accelerate high potential clinical trials. 24, 2020 07:00 UTC.

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Company profile: NeoImmuneTech

Pharma Phorum

Number of on-going clinical trials: 14. Amplifying and reinvigorating persistent T cell immunity has become a much-needed path to enhance anti-tumor efficacy. T cells are known to mediate anti-tumor immune responses. NeoImmuneTech, Inc. CEO: Dr Se Hwan Yang, PhD.

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Pfizer Announces Start of Phase 3 Clinical Trial in Adults.

The Pharma Data

The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older.

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NIH begins clinical trial evaluating second COVID-19 booster shots in adults

The Pharma Data

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. director of the Hope Clinic at the Emory Vaccine Center in Atlanta, and Angela Branche, M.D.,

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UK Pharma Company Scancell Selects COVID-19 Vaccine for Clinical Trials | 2020-12-21

The Pharma Data

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. .

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Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

The Pharma Data

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.

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Akston Biosciences Launches Phase I/II Clinical Trial of Second-Generation COVID-19 Vaccine

Drug Discovery Today

First subjects dosed with AKS-452, COVID-19 vaccine candidate in the Netherlands trial the vaccine is shelf-stable for 4 months at 25 degrees Celsius (77° Fahrenheit). 176 volunteers will participate in the clinical trial the safety and immune response read-outs expected in Q2 2021

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Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Pharma Data

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 Response Data.

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Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

The Pharma Data

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.

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Another COVID-19 Vaccine Candidate Begins Final Clinical Trials

The Pharma Data

29, 2020 — Vaccine maker Novavax, along with federal health researchers, announced Monday that a phase 3 trial will begin on the safety and effectiveness of another COVID-19 vaccine — the fifth shot to reach this final stage of development. TUESDAY, Dec.

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COVID-19 vaccine development: Setback for Sanofi and GSK candidate, University of Queensland and CSL abandon trial

BioPharma Reporter

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

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New Research Shows IBS Symptoms May be Caused by Gut Infections

XTalks

Researchers at KU Leuven in Belgium have found a potential mechanism underlying irritable bowel syndrome (IBS) that involves activation of immune cells primed by past gastrointestinal infections. Moreover, the response did not induce symptoms typical of a food allergy.

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Johnson & Johnson Expands Phase 2a Clinical Trial of COVID-19 Vaccine Candidate to Include Adolescents

The Pharma Data

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Clinical Trails

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Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes

XTalks

In clinical trials, the treatment delayed stage 3 disease onset for about two years compared with the placebo. There are three stages of type 1 diabetes with stage 3 being the step at which a clinical diagnosis is made.

Insulin 88
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Edible Cholera vaccine made of powdered rice proves safe in phase 1 human trials

Scienmag

The first human trial has shown no obvious side effects and a good immune response. Study points towards role of gut microbiome in vaccine effectiveness Credit: Image by Dr. Hiroshi Kiyono, CC BY 4.0

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UK will start first COVID-19 challenge study “within a month”

Pharma Phorum

The aim of the study is to find the smallest amount of SARS-CoV-2 that is needed to cause an infection, see how the immune system reacts to the virus, and to assist in the development of new treatments and vaccines.

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Regeneron’s Evkeeza (evinacumab) Reduces Cholesterol Levels in Children with Homozygous Familial Hypercholesterolemia (HoFH) in Phase III Trial

XTalks

APOB is responsible for synthesizing LDL while PCSK9 facilitates its degradation. Doortje Reijman, trial investigator and research associate in Pediatric Metabolic Diseases and Nephrology at the Amsterdam University Medical Center. The Trial.