XTalks

NOVEMBER 15, 2024

These RXR receptors play a key role in regulating transcription pathways involved in inflammation and immune responses, among other cancer hallmarks, to modulate the tumor microenvironment. Tamibarotene is a selective agonist of retinoic acid receptor alpha/beta, with potential binding to retinoid X receptors (RXR).

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Trials HR Immune Response FDA Approval 105

XTalks

MAY 13, 2025

Xtalks Clinical Edge : Issue 4 OncoC4’s Approach to Immuno-Oncology Trials Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials.

Antibody 52

Antibody Clinical Trials Clinical Trials Immune Response 52

XTalks

MAY 23, 2025

A second approach comes from Tiziana Life Sciences, which is investigating intranasal foralumab, a fully human anti-CD3 monoclonal antibody. Delivered via the nasal route, it activates regulatory immune responses while avoiding systemic immunosuppression.

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XTalks

DECEMBER 30, 2024

has announced promising Phase IIb results for cenerimod, an investigational drug targeting immune system dysfunction in moderate-to-severe systemic lupus erythematosus (SLE). SLE is an autoimmune disease where the immune system attacks healthy tissues, causing inflammation, pain and potential organ damage. Viatris Inc.

Immune Response 52

Immune Response Gene Expression Drugs Trials 52

XTalks

DECEMBER 29, 2023

Tarlatamab is an investigational drug currently undergoing clinical trials to assess its efficacy in patients with two distinct types of neuroendocrine cancer: SCLC and neuroendocrine prostate cancer (NEPC). As a bispecific T-cell engager immunotherapy, tarlatamab directs the patient’s T cells to attack cancer cells exhibiting DLL3.

Clinical Trials 119

Clinical Trials Clinical Trials FDA Approval Trials 119

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. A scheme providing £500 payments to people self-isolating has been extended in England until the summer.

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Vaccine Vaccination Development Life Science 105

pharmaphorum

JULY 18, 2022

MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, The inhalant version.

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Vaccine Vaccination Development Immune Response 138

XTalks

JANUARY 8, 2021

Both vaccines demonstrated an effectiveness of about 95 percent in Phase III clinical trials. Others have voiced concern that clinical trials have not evaluated half doses nor different dosing schedules. The agency says, “These are all reasonable questions to consider and evaluate in clinical trials.

Vaccine 144

Vaccine Vaccination Clinical Trials Clinical Trials 144

XTalks

MAY 22, 2025

Xtalks Clinical Edge : Issue 4 Sernova’s Approach to Cell Therapy for Type 1 Diabetes Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials.

Clinical Research 52

Clinical Research Insulin Research Hormones 52

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Having its own checkpoint inhibitor to combine with its ADCs rather than from other companies would make things easier to coordinate in clinical trials.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 10, 2020

Phase1b/2 clinical study to be conducted in the United States and several European countries. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. Tiziana Life Sciences January 9, 2020 Press Release ( [link] ). . Crohn’s Disease Therapeutics Market Size $4.7 and Europe.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

XTalks

AUGUST 13, 2020

As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.

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Vaccine Vaccination Trials Clinical Trials 89

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Having its own checkpoint inhibitor to combine with its ADCs rather than from other companies would make things easier to coordinate in clinical trials.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 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. All except for Adstiladrin were cleared for rare disease indications.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

pharmaphorum

JULY 20, 2021

The phase 3 trial being run in support of approval is using a two-shot regimen, with the first dose targeting the original SARS-CoV-2 virus and the second targeting beta (B.1.351) 1.351) variant first identified in South Africa. The post EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine appeared first on.

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XTalks

NOVEMBER 23, 2020

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. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

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Vaccine Vaccination Clinical Trials Clinical Trials 97

pharmaphorum

NOVEMBER 29, 2022

Number of on-going clinical trials: 14. T cells are known to mediate anti-tumor immune responses. For that reason, they have become the key target of immune checkpoint therapies, like PD-(L)1 agents. Locations: 3 (US HQ, Korea office, Korea R&D center). Number of employees: 90+ (as of Oct. Creation: Jan.

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Clinical Trials Clinical Trials Trials Engineer 105

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.

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. In the majority of cases, the risk of VAED is brought to light during preclinical stages or early clinical trial phases.

Vaccine 96

Vaccine Vaccination Development Clinical Trials 96

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.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

XTalks

NOVEMBER 22, 2022

In clinical trials, the treatment delayed stage 3 disease onset for about two years compared with the placebo. Tzield’s FDA approval was based on safety and efficacy data from a randomized, double-blind, event-driven, placebo-controlled trial involving 76 patients with stage 2 type 1 diabetes.

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Insulin Drugs FDA Approval Immune Response 97

XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. There were no significant safety findings reported through day 29. Mixed Results.

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Vaccine Vaccination Immune Response Antibody 98

XTalks

JULY 28, 2021

While Merck’s previous shot, Pneumovax 23, defends against 23 serotypes and has been on the market for almost four decades, the immune responses it generates are not as durable as Prevnar 13. This is why Pfizer’s Prevnar 13 has dominated the pneumonia vaccine space for more than a decade.

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FDA Approval Vaccine Vaccination Immune Response 89

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. How the Type 1 Diabetes Vaccine Works. islet cells of the organ, giving rise to the disease. cells of the pancreas.

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Vaccine Vaccination Insulin Trials 103

XTalks

JANUARY 20, 2021

While diseases like celiac are associated with inappropriate activation of the immune system triggered by food antigens, this is not the case in IBS. In a normal, healthy intestine, foods do not trigger immune responses and so in a patient with IBS, something else must activate the response. Mouse and Human Studies.

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Immune Response Research Allergies Protein 52

XTalks

JUNE 15, 2022

Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. Clinical Trial Results. Results from the PREVENT-19 pediatric expansion trial showed that the vaccine was also effective in adolescents aged 12 to 17 years. NVX-CoV2373 also includes an adjuvant called Matrix-M.

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Vaccine Vaccination Immune Response Protein 59

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

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Vaccine Vaccination Trials Clinical Trials 59

XTalks

JULY 2, 2021

The CDC says that while “clinical trials that study the safety of COVID-19 vaccines and how well they work in pregnant people are underway or planned … based on how these vaccines work in the body, experts believe they are unlikely to pose a risk for people who are pregnant.”.

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Vaccine Vaccination Protein Immune Response 105

XTalks

MAY 30, 2023

Novel treatments: Ongoing research into new treatments for MS include novel immunomodulatory drugs that aim to modulate or suppress the immune response that attacks the myelin sheath in MS. Clinical trials have shown that HSCT can halt disease progression in some people with aggressive forms of MS, although it is a high-risk procedure.

Genetics 98

Genetics Research Immune Response Drugs 98

XTalks

NOVEMBER 10, 2020

Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate. Adjuvants are used to help stimulate stronger vaccine immune responses. Based on the encouraging Phase I data, Medicago says it plans to proceed with its Phase II/III trials.

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Vaccine Vaccination Trials Immune Response 52

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

JANUARY 3, 2021

Weber is a renowned melanoma specialist and leading immunotherapy translational and clinical scientist. Both will help NexImmune advance current early-stage clinical trials and will guide Company’s translational efforts to develop new immunotherapy products. GAITHERSBURG, Md.,

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Immune Response Clinical Trials Clinical Trials Development 40

XTalks

MAY 16, 2025

Instead of advancing to late-stage trials, it will conduct early sponsor-led studies to assess Apitoxs role in MS symptom management. Preclinical data suggest that bee venom components may modulate immune responses linked to the disease. Apimeds licenses its core technology from Apimeds Korea, a subsidiary of Inscobee Inc.,

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Licensing Licensing Immune Response Trials 52

XTalks

NOVEMBER 10, 2020

The early data is for one of four COVID-19 vaccines currently being tested in clinical trials by the companies as part of Pfizer’s BNT162 mRNA-based vaccine program called ‘Project Lightspeed’ for SARS-CoV-2, the virus causing the current global pandemic. Related: Moderna’s COVID-19 Vaccine Fast-Tracked to Phase II Trials.

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Vaccine Vaccination Trials Clinical Trials 75

The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. ” Findings from the Phase 1 Clinical Trial. mg and 2.0

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DNA Vaccine Vaccination Immune Response 40

The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ — Cytiva , a global life sciences leader, is supporting Clover Biopharmaceuticals , a global clinical-stage biotechnology company, to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate. SHANGHAI , Nov. About Cytiva.

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Vaccine Vaccination Manufacturing Life Science 52

XTalks

FEBRUARY 3, 2021

These vaccine productions had gone through the regular steps starting with three clinical trials, publishing the trial results then manufacturing the vaccine. Herd Immunity and Equitable Access to COVID-19 Vaccines. The safety of the vaccines is continuously monitored.”.

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Vaccine Vaccination Immune Response Manufacturing 98