The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.

Immune Response 52

Immune Response Vaccine Clinical Trials FDA 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.

Disease 64

Disease Immune Response Clinical Trials Treatment 64

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

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. We look forward to sharing initial results by year-end. ”. “

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

Drug Target Review

OCTOBER 17, 2024

While its involvement in the do-not-eat-me signal from cancer has inspired therapeutic development of this pathway for oncology, the function of the innate immune checkpoint we identified in 2009 1 extends to both innate and adaptive immune responses. Biomarkers are the holy grail of clinical trials. References Chen GY.,

Immune Response 52

Immune Response Clinical Trials Trials Therapies 52

Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials? Therapies that showed promise in healthy cell models may fail to achieve desired clinical outcomes in patients.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

The Pharma Data

APRIL 11, 2021

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Surgery was rarely canceled due to adverse events, only affecting two patients in each arm of the trial.

Trials 52

Trials Treatment Immune Response Clinical Trials 52

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. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials 52

Trials Vaccine Virus Pharmacokinetics 52

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. The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.” About PREVENT-19.

Vaccine 40

Vaccine Trials Disease Immune Response 40

The Pharma Data

NOVEMBER 14, 2020

In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel. The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated.

Clinical Trials 40

Clinical Trials Vaccine Trials Pharmaceutical Companies 40

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

Vaccine 52

Vaccine Trials Virus RNA 52

The Pharma Data

MARCH 31, 2023

months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death by 32%, demonstrating a landmark three-year event-free survival (EFS) rate of 57% with Opdivo with chemotherapy compared to 43% with chemotherapy alone (Hazard Ratio [HR], 0.68; 95% Confidence Interval [CI], 0.49 With median follow up of 41.4

Trials 40

Trials Treatment Clinical Trials Immune Response 40

Alta Sciences

JANUARY 11, 2024

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. However, there are significant challenges associated with the successful development of these complex, leading-edge therapies.

Therapies 52

Therapies Immune Response Disease Virus 52

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

JANUARY 5, 2021

5, 2021 — Stem cells derived from a baby’s umbilical cord can help save the lives of the sickest COVID-19 patients, results from a small new clinical trial suggest. The therapy also proved safe, with no infusion-related serious adverse events. TUESDAY, Jan.

Immune Response 52

Immune Response Hospitals Clinical Trials Trials 52

The Pharma Data

OCTOBER 9, 2021

Novartis will present 41 abstracts from a wide-ranging multiple sclerosis (MS) portfolio, including new data on Kesimpta ® (ofatumumab) and Mayzent ® (siponimod) Novartis will be commencing Phase III pivotal trials investigating remibrutinib in RMS.

Immune Response 52

Immune Response Vaccine Treatment Therapies 52

The Pharma Data

MARCH 8, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

Immune Response 52

Immune Response Clinical Trials Trials Treatment 52

The Pharma Data

DECEMBER 8, 2020

The efficacy rating followed an interim report of ongoing human trials conducted in that country, CNBC reported. In August, the company reported the vaccine candidate triggered antibody-based immune responses in early and mid-stage trials. The vaccine was also demonstrating a strong safety profile.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 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.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

MARCH 9, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

Treatment 52

Treatment Immune Response Trials Clinical Trials 52

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.

DNA 40

DNA Vaccine Clinical Trials Immune Response 40

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.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

DECEMBER 13, 2020

Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. SYNB1891 is being evaluated in a Phase 1 clinical trial. CAMBRIDGE, Mass. , 14, 2020 /PRNewswire/ — Synlogic, Inc.

Immune Response 40

Immune Response Treatment Engineering Clinical Trials 40

The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies 3 ,4. NEW YORK and LONDON, Nov.

Clinical Trials 40

Clinical Trials Science Disease Trials 40

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

Vaccine 40

Vaccine Trials Pharmaceutical Companies Clinical Trials 40

The Pharma Data

OCTOBER 14, 2021

Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Immune response was measured using immunoglobulin G (IgG) assays. Approximately 92 percent of participants in the analysis received an mRNA vaccine.

Vaccine 52

Vaccine Therapies Immune Response Disease 52

The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. Almirall S.A.’s

Trials 40

Trials Clinical Trials Small Molecule Disease 40

The Pharma Data

JANUARY 3, 2021

This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. The last patients in the trial received their final dose on 21 December 2020. The topline data from the trial is expected to be available in January 2021.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

The Pharma Data

MARCH 29, 2022

Application based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer.

Treatment 52

Treatment Clinical Trials Trials Immune Response 52

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

Clinical Development 52

Clinical Development Vaccine Clinical Trials Immune Response 52

The Pharma Data

DECEMBER 11, 2020

. “There will be no distinction made, in part because we think there’s no adverse event that will occur, and also the protection from the vaccine actually may be more long-lived, of longer duration than that you get from the natural infection.” The trials included some people who had already been infected.

Vaccine 52

Vaccine Immune Response Virus Trials 52

Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

Production 131

Production Clinical Trials Trials Therapies 131

The Pharma Data

SEPTEMBER 3, 2020

The data, published today in Nature Medicine , demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge.

Vaccine 52

Vaccine Disease Immune Response Pharmaceutical Companies 52

The Pharma Data

SEPTEMBER 10, 2021

POSEIDON Phase III trial showed the addition of a short course of tremelimumab to Imfinzi plus chemotherapy improved patient outcomes without an increase in treatment discontinuation. Number of patients with event (%) 3. Number of patients with event (%) 5. Grade 3 or 4 treatment-related adverse events were experienced by 51.8%

Treatment 52

Treatment Immune Response Trials Clinical Trials 52

The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil.

Clinical Trials 52

Clinical Trials Trials Medical Schools Hospitals 52