The Pharma Data

DECEMBER 20, 2020

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. . SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology. Source link.

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Drug Target Review

NOVEMBER 6, 2023

These options are creating opportunities to develop more sophisticated, novel combination regimens for patients. For example, combining IO agents with ADCs to mount a two-pronged attack against cancer by activating an anti-cancer immune response and directly killing cancer cells may drive stronger and more durable responses in the clinic.

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The Pharma Data

JANUARY 12, 2021

Ben-Moshe told BioSpace that BND-22 differs from traditional immunotherapy in that it can elicit a more total immune response. . “It It is a new immune checkpoint that is expressed on three different immune cells: Macrophages, [Natural Killer] NK cells, and T cells. [It]

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We and our collaborators are steadfast in our commitment to the development of safe, effective and accessible COVID-19 vaccines for the global population.”. S-Trimer is intended to be adjuvanted.

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Alta Sciences

JUNE 11, 2024

Milton also highlighted which assessments are optional for the development of gene therapies and how eliminating them could save sponsors time and money, while listing those that are essential to consider, including shedding, biodistribution , and cellular immune response assays and neutralizing antibody assays.

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Alta Sciences

JANUARY 11, 2024

However, there are significant challenges associated with the successful development of these complex, leading-edge therapies. The in vivo nonclinical study of cell and gene therapies includes a thorough understanding of on-and-off-target activity, immune responses, and other adverse events just to name a few.

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The Premier Consulting Blog

APRIL 18, 2024

As in all nonclinical drug development programs, the goal is to identify potential safety issues in humans. This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product. Can you identify a safe AND efficacious clinical dose?

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Conversations in Drug Development Trends

JUNE 21, 2024

Clinical researchers are currently working to streamline TIL production and enhance treatment outcomes by more efficiently regulating immune responses — such as combination therapy with checkpoint inhibitors.

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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. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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The Pharma Data

DECEMBER 28, 2020

.” The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. About Moleculin Biotech, Inc. Moleculin Biotech, Inc.

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The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Food and Drug Administration (FDA). S-Trimer is intended to be adjuvanted. About Trimer-Tag© Technology.

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The Pharma Data

JULY 6, 2021

The collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. ” Arnon Rosenthal, Ph.D.,

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The Pharma Data

OCTOBER 25, 2020

The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S.

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DrugBank

FEBRUARY 12, 2025

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. This necessitates exploring alternative strategies to expedite drug discovery and optimize resource allocation.

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Drug Target Review

DECEMBER 5, 2024

Determining the ratio of full, partially filled, and empty capsids is considered a Critical Quality Attribute (CQA) for AAV gene therapy products, and is a factor that must be monitored and controlled, as higher empty capsid contents in gene therapies poses risks of triggering an immune response and adverse events in the clinic (Figure 1).

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Drug Target Review

FEBRUARY 14, 2025

The KEGG Pathway database provides insights into metabolic pathways, genetic interactions and disease mechanisms, which are crucial for understanding how a dataset can inform our understanding of complex biological phenomena such as signal transduction, cell proliferation, or immune responses.

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The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone.

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The Pharma Data

JANUARY 4, 2021

Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells. The pipeline development is leveraged through the Company’s proprietary target discovery engine called “DIAMOND.” The Company maintains offices in Houston, Texas. Forward-Looking Statements.

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The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

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Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. The new draft guidance can be broken into three main parts.

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Broad Institute

OCTOBER 11, 2023

The drugs work by blocking a protein, PD-1 — which helps keep immune responses in check — and stimulating the immune system to attack tumors. The team studied the immune response to CRISPR and designed a new technology that they published in 2021 — a way of removing immune-triggering molecules from CRISPR-edited cells.

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Drug Target Review

JULY 7, 2023

Antibodies protect us by attaching to molecules on those invaders (known as antigens) and triggering our body’s natural immune response to destroy them. This can create an abnormal immune response that attacks the cells of our bodies and contributes to the development of autoantibody diseases.

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Drug Target Review

JANUARY 15, 2024

To be therapeutically useful, antigenic peptides must be presented in a way that allows immune responses to destroy cancer cells without causing unacceptable damage to healthy tissue. Therefore, therapeutically useful tumour antigens represent a tiny fraction of the genes expressed by a tumour cell.

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The Pharma Data

MARCH 9, 2021

inhibition,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis. Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses 9,10. Canakinumab is a first-in-class interleukin-1beta (IL-1?)

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The Pharma Data

MARCH 8, 2021

inhibition,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis. Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses 9,10. Canakinumab is a first-in-class interleukin-1beta (IL-1?)

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The Pharma Data

SEPTEMBER 8, 2021

“Since immune checkpoint inhibitors were introduced more than a decade ago, they have played a transformational role in treating cancers with high unmet need, and most importantly, helping people with cancer live longer,” said Samit Hirawat, M.D. executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? Finally, in either scenario, sponsors should consider adverse effects directly related to the product’s interaction with a biological component of the immune system (e.g.,

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Conversations in Drug Development Trends

MARCH 12, 2024

These markers can inform treatment response and help reduce patient radiation exposure by reducing the need for repeated imaging assessments in clinical trials.

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Drug Target Review

OCTOBER 2, 2023

These peptides are a vital part of the immune system’s display-recognition mechanism that enables T cells to distinguish between self and non-self-antigens, recognizing intruders to initiate immune responses.

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DrugBank

FEBRUARY 26, 2025

Developing Antimicrobial Peptides and Biomolecules In addition to traditional small-molecule antibiotics, researchers are exploring the potential of antimicrobial peptides (AMPs) and other biomolecules. AMPs disrupt bacterial membranes, making them less susceptible to resistance development.

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The Pharma Data

DECEMBER 20, 2020

The primary endpoints of the study include safety and overall response rate, while secondary endpoints include progression-free survival, overall survival and immune response correlates. Kenilworth, N.J., The study will enroll approximately 90 patients at up to 20 centers in the United States.

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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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PLOS: DNA Science

SEPTEMBER 5, 2024

Targeted cancer drugs developed to treat one type of cancer often expand, with further testing, to treat other types, based on molecular similarities. This removes the cancer’s blocking of the immune response, so that T cells can fight the cancer.

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SugarCone Biotech

MAY 28, 2019

Importantly, these papers fit into a new contextual framework and cap a series of studies that have come out over the last year or so that have enriched our understanding of how the immune system and tumor cell populations interact. is focused on the response of sarcomas to immunotherapy ( [link] ). The paper by Cabrita et al.

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The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk. futility analysis). .

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