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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The Pharma Data

APRIL 12, 2023

Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement Biogen Inc. Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ).

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Drug Discovery World

NOVEMBER 9, 2023

DDW Editor Reece Armstrong speaks to Christian Leisner , Chief Executive Officer of antibody therapeutics’ developer CDR-Life about methods to increase access to antigens and improving immunotherapy treatments. RA: Could you discuss the TCR T-cell target MAGE-A4 and what discoveries could be made by targeting this protein?

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Drug Discovery World

FEBRUARY 21, 2024

In October 2023, pharmaceutical company NKGen Biotech released data from its Phase I clinical trial on the use of its investigational natural killer therapy, SNK01, to treat patients with Alzheimer’s disease. This is done without any genetic modification.

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Protein Trials Genetics Antibody 122

Delveinsight

JANUARY 12, 2021

Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year.

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Drug Discovery World

AUGUST 28, 2023

DS: Samsara’s autophagy inducing candidate SAM001 will be the first agent of its class to enter clinical trials. It is the method for removing unwanted debris, e.g., old proteins, and breaking them down so their constituent parts can be used again. DS: What role does genetics play in autophagy? What is autophagy?

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Genetics Protein Genetic Disease Clinical Trials 52

The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

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The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab.

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Drug Discovery World

SEPTEMBER 13, 2023

A Translational Psychiatry publication indicates that SARS-CoV-2 infection, even when unnoticed or asymptomatic, can have an influence on the activation of the Human Endogenous Retrovirus W (W-ENV) protein in psychotic patients, in a context of innate immune inflammation.

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Protein Clinical Trials Clinical Trials Medicine 52

The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S.

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pharmaphorum

OCTOBER 2, 2020

Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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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. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

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XTalks

MAY 1, 2023

This makes Qalsody the first approved treatment to target a genetic cause of ALS. Since SOD1 mutations were first identified as a cause of ALS 30 years ago, the familial ALS community has been searching for genetically targeted treatments. To date, over 200 mutations in the SOD1 gene have been associated with the development of ALS.

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XTalks

JUNE 15, 2022

The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. protein that triggers the immune system to generate antibodies against the virus. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US.

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XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. DMD is a rare genetic disorder that leads to progressive muscle degeneration and weakness. It is injected into a patient’s muscle tissue.

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XTalks

MARCH 28, 2024

For CRC, treatment options that are targeting genetic mutations such as BRAF , KRAS and HER2 have been developed. Furthermore, the introduction of multi-targeted kinase inhibitors and monoclonal antibodies is also being examined as a possible form of therapy. Yang Liu and CFO Abid Ansari – Xtalks Life Science Podcast Ep.

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Gene Editing Life Science Clinical Trials Clinical Trials 59

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , Yancopoulos , M.D.,

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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. Mexico pivotal Phase 3 trial update. and Mexico pivotal Phase 3 trial and manufacturing scale-up. .

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The Pharma Data

NOVEMBER 9, 2020

Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. and globally.”.

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Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. Shape’s RNA editing technology could potentially modify the amount of a key regulatory protein in the body or treat genetic diseases. and Leila Zegna, director of the Kabuki Syndrome Foundation.

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XTalks

SEPTEMBER 2, 2021

The AlzoSure Predict prognostic biomarker Alzheimer’s blood test detects levels of an unfolded conformational variant of the p53 protein in the blood using a proprietary antibody called U-p53AZ. The Diadem AlzoSure Predict assay uses a proprietary antibody, U-p53AZ, to measure blood levels of the unfolded conformational p53 variant.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., combined dose groups; 6.5%

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XTalks

MAY 10, 2023

The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. GSK’s Benlysta (belimumab) is a monoclonal antibody that was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of SLE. What Is the Theme of World Lupus Day 2023?

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Drugs Clinical Trials Clinical Trials Antibody 52

XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

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pharmaphorum

JUNE 16, 2022

The phase 2 API-ADAD study, a pioneering investigation which has been running for more than a decade, looked at crenezumab’s ability to slow or prevent Alzheimer’s symptoms in a population of cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimer’s.

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Trials Licensing Licensing Clinical Trials 111

XTalks

NOVEMBER 30, 2023

Its mechanism of action involves blocking the protein shell (capsid) of the HIV-1 virus, disrupting multiple crucial stages of the viral lifecycle. The FDA’s endorsement of Sunlenca is backed by compelling clinical evidence, demonstrating its efficacy as a viable treatment option. In November 2023, Hookipa Pharma Inc.,

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

pharmaphorum

DECEMBER 1, 2020

The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results. They work by using a short length of genetic code that makes the body produce the “Spike” protein seen on the surface of the SARS-CoV-2 coronavirus.

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Diagnosis is confirmed by a differential complete blood count and genetic testing.

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The Pharma Data

DECEMBER 5, 2020

(NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells.

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The Pharma Data

DECEMBER 13, 2020

As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining its TIME Trial® Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinical trials.

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Clinical Development Medicine Development Antibody 52

pharmaphorum

DECEMBER 21, 2020

As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein. In this case that is the “spike” protein seen on the surface of the coronavirus that it uses to invade host cells.

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pharmaphorum

NOVEMBER 9, 2020

Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier. These cause the body to produce antibodies that neutralise the SARS-CoV-2 virus in the event of an infection.

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pharmaphorum

AUGUST 16, 2020

The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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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. protein-based biologics) and vaccine treatments. Cell-Based Immunotherapy vs. Immune Biologics.

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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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Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

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The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. TAK-019 Clinical Trial.

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