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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Vaccination Vaccine Trials Immune Response 69

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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Vaccination Vaccine Insulin Trials 103

pharmaphorum

MARCH 11, 2021

Vertex Pharma has made its name with treatment for cystic fibrosis, but has big plans in cell and genetic therapies – and has just chalked up fast-track status from the FDA for a cell-based therapy for diabetes. . That implantable technology was at the heart of the Semma acquisition. ViaCyte also has an unencapsulated version in phase 1/2.

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Gene Editing Insulin Immune Response Gene 98

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

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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XTalks

NOVEMBER 10, 2020

Update (November 11, 2020): Quebec-based biopharmaceutical company Medicago has announced positive results from a Phase I trial of its candidate plant-derived vaccine. Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate.

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Vaccination Vaccine Trials Immune Response 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

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Vaccination Vaccine 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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Vaccination Vaccine Clinical Trials Clinical Trials 97

XTalks

FEBRUARY 19, 2024

The study compared the immune responses evoked by Moderna’s mRNA vaccine to those generated by a previous vaccine candidate, namely, the MF59-adjuvanted glycoprotein B (gB) proten subunit vaccine (gB/MF59) developed by Sanofi. During pregnancy, CMV infection is responsible for causing severe birth defects and brain damage in newborns.

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Vaccination Vaccine Trials Clinical Trials 59

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. Pfizer Inc.

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Immune Response Vaccination Vaccine Clinical Trials 52

Pharma Marketing Network

DECEMBER 21, 2020

Almost two decades after the human genome was sequenced, a trickle of new genetic medicines (i.e., With over 100 late-stage gene therapy trials underway and an increasing number of gene-editing technologies entering trials, it’s clear that this trickle will soon become a torrent.

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Genetics Medicine Gene Therapy Marketing 52

XTalks

MAY 30, 2023

This year has already seen some promising developments, including breakthroughs in understanding the disease’s genetic and environmental triggers and innovative techniques to manage MS symptoms. More than 200 genetic variants have been identified that are more common in people with MS.

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Genetics Research Immune Response Drugs 98

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

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Immune Response Dermatology Clinical Trials Clinical Trials 105

XTalks

JUNE 15, 2022

Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. Clinical Trial Results. This trial included nearly 30,000 adults across over 100 sites in the US and Mexico. Compared to adults, immune responses were approximately two- to three-fold higher in adolescents.

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Vaccination Vaccine Immune Response Protein 59

XTalks

JUNE 9, 2022

What happens when the liver is unable to process bad cholesterol due to genetic factors? It is one of the common genetic causes of premature coronary heart disease. Doortje Reijman, trial investigator and research associate in Pediatric Metabolic Diseases and Nephrology at the Amsterdam University Medical Center.

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Trials Antibody Genetics Gene 52

XTalks

MARCH 13, 2023

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. There are around 300 million people worldwide living with a rare disease.

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Gene Therapy Gene Clinical Trials Clinical Trials 52

Delveinsight

DECEMBER 22, 2020

Vorasidenib is an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 in a Phase III trial in patients with IDH-mutant low-grade glioma, AG-270 is an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor while AG-636 is a novel inhibitor of dihydroorotate dehydrogenase.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technology could potentially modify the amount of a key regulatory protein in the body or treat genetic diseases. The company then utilizes the de-identified records to improve the design of clinical trials and quality of life measurements. and Leila Zegna, director of the Kabuki Syndrome Foundation.

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Vaccination Vaccine Gene Therapy RNA 98

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 is being evaluated in an ongoing Phase 3 trial in the U.K. and Australia. About Matrix-M.

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Protein Vaccination Vaccine Immune Response 52

pharmaphorum

NOVEMBER 30, 2020

Ultimately, titer levels are related to safety, as dosing a patient who has a higher titer level (however that may be defined) is more likely to trigger an immune response to the treatment, an extreme example being the infamous case of Jesse Gelsinger. “As

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Gene Therapy Gene Antibody Clinical Trials 105

pharmaphorum

OCTOBER 6, 2020

In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted. The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

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Vaccination Vaccine RNA Immune Response 59

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

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Vaccination Vaccine Trials Immune Response 40

Cloudbyz

MARCH 5, 2024

They are often used to mimic or enhance natural biological processes, such as immune responses. Immunogenicity : Small Molecules: Generally have a lower risk of inducing an immune response in the body. Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics.

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Development Drugs Immune Response Manufacturing 97

The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. “These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. All cases observed in the vaccine group were mild as defined by the trial protocol.

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Vaccination Vaccine Trials Immune Response 40

pharmaphorum

NOVEMBER 30, 2020

Genmab has axed development of its pipeline cancer drug enapotamab vedotin after it failed to show enough activity in a proof-of-concept trial. Genmab said it will not advance development of the drug after data from expansion cohorts showed it did not meet stringent criteria for proof-of-concept in the early trial.

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Development Drugs Antibody Immune Response 52

pharmaphorum

APRIL 26, 2022

Research into the area is being made possible through advancements in technology, such as being able to sequence genes at scale, allowing researchers to gain more detailed genetic data on the microbiome. 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

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. 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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Clinical Development Vaccination Vaccine Development 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. and globally.”. About NVX-CoV2373. and Australia.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

FEBRUARY 22, 2021

Bluebird Bio’s decision to hit pause on the launch of Zynteglo for beta thalassaemia after two cases of cancer were seen in a clinical trial could see fears over the safety of viral vectors used to deliver gene therapies resurface. . million in Europe.

Gene Therapy 52

Gene Therapy Gene Gene Sequencing Gene Expression 52

Cloudbyz

JULY 31, 2024

These technologies provide insights into genetic, proteomic, and metabolomic profiles, enabling the discovery of biomarkers associated with diseases like cancer, cardiovascular diseases, and neurological disorders. For instance, in oncology, patients with specific genetic mutations (e.g.,

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

The Pharma Data

JANUARY 3, 2021

reports that Scentech-Medical received approval from the Shamir Medical Center ( Asaf Harofe ) Review Board ( Helsinki committee) for a new clinical trial. As part of the trial, the company is verifying the biomarkers that were mapped after its early clinical trials conducted at the Meir Medical Center, in Kfar Saba.

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Clinical Trials Clinical Trials Vaccination Vaccine 40

Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

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Gene Therapy Gene Immune Response In-Vivo 52

The Pharma Data

JULY 6, 2021

PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. ” Arnon Rosenthal, Ph.D.,

Genetics 52

Genetics Gene Antibody Development 52

The Pharma Data

APRIL 8, 2021

Early clinical results are consistent with preclinical studies and suggest THOR-707 (SAR444245) may promote an anti-tumor immune response without alpha-mediated side effects, both alone and in combination with anti-PD-1. Editor’s Note : Sanofi previously entered into an agreement with Merck & Co. About THOR-707 (SAR444245).

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Immune Response Engineer Antibody Genetics 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Regeneron Pharmaceuticals, Inc.

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Antibody Trials Production Clinical Trials 40

The Pharma Data

JANUARY 17, 2021

By exploring multiple therapies across oncology and cardiovascular, genetic, neurological and autoimmune diseases, we are well positioned to bring life-changing treatments to multiple patient populations with critical unmet needs.”. A total of $15.4 References 1. About Ixaka.

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Gene Therapy Gene In-Vivo Genetics 40

XTalks

NOVEMBER 28, 2022

It may be caused by the immune system being triggered by a virus or bacteria that results in an atypical immune response, or genetics play a role in disease development as it is more common in people whose immediate family members have Crohn’s disease. EC Approval of Skyrizi Supported by Global Phase III Trials.

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Trials Immune Response Bacteria Development 52