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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Drug Discovery World

MAY 30, 2024

DDW Editor Reece Armstrong speaks to Dr Katrina Pollock from the Oxford Vaccine Group at the University of Oxford. Dr Pollock is the Chief Investigator of the LEGACY03 clinical trial, a study aiming to investigate lymph nodes and vaccination responses across age groups. RA: Could you tell us about the LEGACY03 trial?

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Drug Discovery World

JANUARY 10, 2023

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for VAX-24, Vaxcyte’s 24-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease. . The post Breakthrough Therapy designation for pneumococcal disease vaccine appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 27, 2023

HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting. A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing.

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Drug Discovery World

MARCH 27, 2023

The first subjects have been dosed in a Phase I clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor in heart disease. We’re excited to get this first-in-human trial of VXX-401 started.

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Drug Discovery World

APRIL 16, 2023

Personalised mRNA-based cancer vaccine mRNA-4157/V940, in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda) improved recurrence-free survival (RFS) compared with pembrolizumab alone in patients with high-risk melanoma. According to the results of the primary trial analysis, after 18 months, the RFS was 78.6%

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DrugBank

JULY 18, 2024

Vaccines have consistently demonstrated their efficacy in protecting people from infectious diseases. This led to the eradication of smallpox and polio – two debilitating diseases that historically caused global epidemics. Sugars, such as sucrose are common stabilizers in many vaccines.

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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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Drug Discovery World

NOVEMBER 30, 2022

The University of Queensland is set to take a second-generation molecular clamp vaccine to a proof-of-concept human trial. . million to support further development of the re-engineered technology for use in the global response to future disease outbreaks. . The University of Queensland. .

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Drug Discovery World

NOVEMBER 8, 2022

Merck has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing collaboration and license agreement with Moderna. . KEYNOTE-942 is an ongoing randomised, open-label Phase II trial that enrolled 157 patients with high-risk melanoma.

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The Pharma Data

AUGUST 16, 2021

The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.

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Drug Discovery World

AUGUST 16, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s Covid-19 booster vaccine that targets two coronavirus variants. . Known as a bivalent vaccine, Spikevax was approved following data that show it triggers a strong immune response against both Omicron (BA.1)

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Drug Discovery World

MARCH 26, 2024

It is approved in adults and adolescents (12 years of age and older weighing at least 40kg) who are moderate-to-severely immune compromised due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to Covid-19 vaccination.

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The Pharma Data

NOVEMBER 10, 2020

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. microgram or 15-microgram doses of the vaccine candidate, either alone or with an adjuvant.

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Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . The commencement of the trial triggers a $5 million milestone payment to RQ Bio and will enable the company to execute its four scientific programmes focused on viral diseases. .

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Drug Discovery World

MAY 23, 2024

A team of scientists in the US and the UK are combining a genetically modified cold sore virus with a cancer vaccine to treat an aggressive type of brain cancer in children. The research team has already used the virus in a small Phase I trial where responses to the treatment were seen in 11 out of 12 children.

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The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. Overall, the vaccine protected against symptomatic disease in 70% of cases, according to a team led by researchers from Oxford University in England. TUESDAY, Dec. 8 in The Lancet.

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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. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. Some of the vaccines being developed for Covid-19 use either completely new or barely proven technologies.

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Drug Target Review

JANUARY 23, 2024

The current shift focuses on enhancing their efficacy by addressing the crucial need for robust T cell responses, an apparent bottleneck for broader impact. Vaccinations against tumour antigens that are shared between tumours, or tumour antigens that arise from mutations unique to individual tumours, represent promising strategies.

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The Pharma Data

SEPTEMBER 1, 2020

AstraZeneca has started a Phase 3 trial of its experimental coronavirus vaccines in the US, making it the third company to start late-stage trials of a vaccine. . The trial will see participants receive either two doses of the vaccine or a placebo. Photo by Daniel Paquet from Regina, Canada.

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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.

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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. “Our About the Phase 1/2 clinical trial.

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 — Children should be included in clinical trials for a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine at the earliest stages, according to a letter from the president of the American Academy of Pediatrics (AAP), on behalf of more than 67,000 pediatricians and pediatric medical and surgical subspecialists.

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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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Drug Discovery World

JULY 25, 2023

These include two antibodies for modulating immune responses in cancer and autoimmunity, which are being advanced through pharmaceutical partnerships with Novartis and GlaxoSmithKline. It was, at the time, a very small dosing – a few micrograms combined with an antigen, in other words, an adjuvant to a therapeutic vaccine.

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The Pharma Data

SEPTEMBER 4, 2020

The findings have validated confidence in the experimental vaccine, the firm noted. Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, S, prevented severe clinical disease in Syrian golden hamsters when challenged with SARS-CoV-2, the virus that causes COVID-19 in people.

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Drug Target Review

MARCH 1, 2024

This antigen-spreading is critical to long-term protection because tumour often develop with inconsistent antigen expression – equipping the immune response to target many diverse tumour antigens may allow for more complete anti-tumour activity. Dr Haqq holds multiple patents and publications.

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The Pharma Data

OCTOBER 14, 2021

Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Using data from the MS PATHS network in the U.S.,

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The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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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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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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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.

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The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Pfizer-BioNTech COVID-19 Vaccine booster plus placebo.

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

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The Pharma Data

SEPTEMBER 14, 2020

It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives. Prof Martin Landray from the University of Oxford, who is co-leading the Recovery Trial, said: “This is the first type of treatment that’s targeted for this specific virus. ” How will the trial work?

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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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