Drug Patent Watch

DECEMBER 9, 2024

Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immune response, can be highly variable and impact the safety and efficacy of the drug. Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product.

Biosimilars 89

Biosimilars Clinical Trials Immune Response Trials 89

Drug Discovery Today

APRIL 15, 2021

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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Clinical Trials Vaccine Trials Immune Response 113

SCIENMAG: Medicine & Health

JUNE 12, 2023

Peer-reviewed / Randomised Controlled Trial / People Study of healthy US adults found that a single dose of the VLA1553 vaccine candidate was generally safe, well tolerated and provokes an immune response.

Immune Response 66

Immune Response Vaccine Trials Disease 66

The Pharma Data

OCTOBER 22, 2020

AstraZeneca’s COVID-19 vaccine candidate, AZD1222, currently being evaluated in phase 3 global trials, delivers a strong immune response, according to a new UK study. Source link.

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Immune Response Vaccine Trials Research 52

The Pharma Data

AUGUST 16, 2021

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. “In Induction of innate immunity was investigated via specific cytokine markers.

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Immune Response Vaccine Virus RNA 52

Plenge Gen

APRIL 7, 2020

Repurposing of approved therapies is the fastest way to impact patients today, as these medicines have regulatory approval to enable investigator-initiated trials and have a manufacturing process to ensure drug supply. appeared first on Plenge Gen @rplenge.

Immune Response 52

Immune Response Disease Clinical Trials Drugs 52

The Pharma Data

MAY 16, 2021

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. 1.351 (South African) variants.

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Immune Response Vaccine Trials Treatment 52

Drug Target Review

MAY 23, 2025

As the biotech sector races to improve the tolerability of these revolutionary treatments, Poolbeg Pharma has a novel solution: an oral therapy, POLB 001, to block the development of CRS, by limiting inflammation without affecting the anti-cancer immune responses that are vital for effective immunotherapies.

Immune Response 52

Immune Response Therapies Treatment Clinical Trials 52

ASPET

SEPTEMBER 12, 2023

Significance Statement This first-in-human clinical trial of KPL-404, a fully humanized IgG4 monoclonal antibody, was designed with two independent (by route of administration) placebo-controlled single-ascending-dose-level groups, one with four intravenous single-dose cohorts and another with two subcutaneous single-dose cohorts.

Pharmacokinetics 100

Pharmacokinetics Immune Response Trials Clinical Trials 100

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. Based on the promising phase 1 data, the company plans to proceed with a phase 2/3 clinical trial. “We

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Immune Response Vaccine Clinical Trials Virus 40

Conversations in Drug Development Trends

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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Research Clinical Trials Therapies Immune Response 52

The Pharma Data

NOVEMBER 2, 2020

German biopharma company CureVac announced yesterday that its COVID-19 vaccine hopeful generated immune responses and was generally well-tolerated in phase 1 trial participants, lending support for a pivotal trial before year’s end. Source link.

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Vaccine Trials Immune Response Research 52

Alta Sciences

FEBRUARY 19, 2025

These interactions may disrupt protein function, trigger immune responses, or contribute to other toxicological risks. to ligands or linkers) may elicit immune responses. Immunogenicity: While oligonucleotides are typically non-immunogenic, modifications or conjugations (e.g.,

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

Drug Target Review

FEBRUARY 9, 2024

Additionally, ADSCs possess immunomodulatory properties, enabling them to modulate immune responses and promote tissue healing. What experimental models and assays are commonly used to assess the therapeutic potential of stem cells, and how well do these models predict the outcomes observed in later-stage clinical trials?

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Therapies Immune Response Clinical Trials Treatment 105

The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Moderna started a large-scale Phase 3 trial last month that will test the vaccine’s safety and effectiveness on 30,000 people with results expected in October.

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Vaccine Immune Response Clinical Trials Virus 90

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.

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Vaccine Trials Immune Response Virus 52

The Pharma Data

SEPTEMBER 25, 2020

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 responses were similar across the age groups studied, including older adults.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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. . In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021. Source link.

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Clinical Trials Vaccine Pharma Companies Trials 52

The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. The interim findings are from phase 3 trials in the United Kingdom and Brazil that included more than 11,600 participants. TUESDAY, Dec. 8 in The Lancet. New data posted Tuesday on the U.S. © 2020 HealthDay.

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Vaccine Trials Immune Response RNA 52

SugarCone Biotech

JUNE 10, 2024

Targeting 4-1BB remained of interest to the immuno-oncology field as cell culture experiments and tumor models in mice suggested that robust anti-tumor immune responses could be triggered by anti-4-1BB antibody therapies. This is the T cell type most closely associated with anti-tumor immune responses. One more question.

Immune Response 88

Immune Response Production Regulations Clinical Trials 88

The Pharma Data

DECEMBER 23, 2020

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. This Phase IIa trial follows a preliminary study conducted by Prof.

Clinical Trials 52

Clinical Trials Trials Research Immune Response 52

The Pharma Data

DECEMBER 14, 2020

The randomized trial of the two-dose vaccine is expected to enroll more than 35,000 participants aged 18 and up at sites throughout Europe and Latin America. Participants will also be monitored in a yearlong study following the trial’s conclusion that will collect additional data to help assess the vaccine’s duration of effectiveness.

Vaccine 52

Vaccine Trials Immune Response RNA 52

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. Conor Kavanagh. Source link.

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Vaccine Trials Immune Response Virus 52

The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate.

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Vaccine Trials Immune Response Clinical Trials 52

The Pharma Data

JUNE 26, 2021

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. JUNE 22 , 2021.

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Clinical Trials Vaccine Trials Immune Response 52

Drug Target Review

JUNE 6, 2023

Natural killer (NK) cells are another immune cell type that, as the name suggests, also have potent cell-killing activity, and have a well-known role in the anti-tumour immune response. In the context of a tumour microenvironment, Tregs are often present in high numbers, preventing an effective immune response to the tumour.

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Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

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. The Novavax jab is only the second to enter large scale trials in the UK; the other has been developed by the University of Oxford.

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Vaccine Trials Immune Response Virus 52

DrugBank

MARCH 12, 2025

Once delivered into the body, the mRNA instructs cells to produce these antigens, which are then presented to the immune system. This process triggers a robust immune response, enabling the immune system to recognize and attack cancer cells. Another challenge is the potential for unintended immune responses.

Vaccine 97

Vaccine Treatment Clinical Trials Therapies 97

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.

Immune Response 52

Immune Response Vaccine Clinical Trials Virus 52

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. About the Phase 1/2 clinical trial.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

Drug Target Review

NOVEMBER 17, 2023

NK cells are among the front line of protection from infected and abnormal cells as part of the ‘innate immune response’. They recognise ‘cell stress molecules’ on the surface of infected, old, injured and cancerous cells without the need for complex pre-stimulation signals of the adaptive immune system (eg, T cells).

Therapies 118

Therapies Clinical Trials Cell Biology Trials 118

The Pharma Data

OCTOBER 23, 2020

A solidarity clinical trial “is one of the largest international randomized trials for Covid-19 treatments, enrolling almost 12,000 patients in 500 hospital sites in over 30 countries”, according to the World Health Organization (WHO), which launched the trail with a number of partners.

Trials 52

Trials Immune Response Hospitals Clinical Trials 52

Drug Target Review

NOVEMBER 17, 2023

NK cells are among the front line of protection from infected and abnormal cells as part of the ‘innate immune response’. They recognise ‘cell stress molecules’ on the surface of infected, old, injured and cancerous cells without the need for complex pre-stimulation signals of the adaptive immune system (eg, T cells).

Therapies 103

Therapies Clinical Trials Immune Response Trials 103

The Pharma Data

OCTOBER 25, 2020

German drugmaker CureVac said preclinical studies of its COVID-19 vaccine candidate, CVnCoV, showed the vaccination prompted a successful immune response. The vaccine is currently being evaluated in phase 1 and 2 human clinical trials. Source link.

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Vaccine Immune Response RNA Clinical Trials 52

Drug Target Review

SEPTEMBER 9, 2024

Additionally, ‘1104 increases the number of activated regulatory T and B cells, which help modulate the immune response and maintain immune tolerance, preventing the immune system from entering overdrive. As such, ‘1104 uniquely affects both the effector and regulatory arms of the immune response.

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Disease Immune Response Clinical Trials Treatment 64

The Pharma Data

MARCH 25, 2021

today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. About RELATIVITY-047 (CA224-047). Source link:[link].

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Trials Clinical Trials Immune Response Therapies 52

The Pharma Data

JUNE 25, 2021

To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively.

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Vaccine Trials Immune Response Virus 52