Broad Institute

OCTOBER 11, 2023

By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA. As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014.

Research 137

Research Immune Response Clinical Trials Therapies 137

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.

Clinical Trials 52

Clinical Trials Vaccine Pharma Companies Trials 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.

Vaccine 52

Vaccine Trials Immune Response Clinical Trials 52

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) The Company announced topline preprint study results from this Phase 1/2a sub-study on July 1, 2021.

Immune Response 52

Immune Response Vaccine Clinical Trials FDA 52

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

JANUARY 25, 2021

In a surprise move, Merck announced that it is giving up on its two coronavirus vaccine candidates after seeing a subpar immune response and shifting its focus to a pair of investigational coronavirus treatments. Initial efficacy data are anticipated in the first quarter and the phase 2/3 trials are expected to wrap up in May.

Vaccine 52

Vaccine Immune Response Trials Clinical Trials 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. JUNE 22 , 2021. 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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

JANUARY 25, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. And safety outcomes were similar in the REGN-COV2 dose groups and the placebo group.

Immune Response 52

Immune Response Treatment Clinical Trials Hospitals 52

The Pharma Data

JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . DalCor Pharmaceuticals initiated the Phase II dal-COVID trial of dalcetrapib for COVID-19.

Vaccine 52

Vaccine Clinical Trials Immune Response Trials 52

The Pharma Data

DECEMBER 12, 2020

Sanofi and GlaxoSmithKline (GSK) have decided to push back the phase 2b trial of their adjuvanted COVID-19 vaccine after finding it produced only a weak immune response in older patients, delaying the potential delivery of a vaccine that could contribute to the mass vaccination effort in the U.S. to vaccinate on demand.

Vaccine 52

Vaccine Immune Response Trials Research 52

The Pharma Data

JANUARY 22, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group.”. Martin Berman-Gorvine.

Immune Response 52

Immune Response Clinical Trials Hospitals Trials 52

Drug Target Review

JANUARY 15, 2024

Onchilles Pharma has translated this breakthrough research into a proprietary set of therapeutics and plans to start first-in-human clinical trials for its first programme, N17350, in 2024 in skin cancers, head and neck cancer, and triple-negative breast cancer. 2021 May 7;0(0). Reference 1. Cui C, Chakraborty K, Tang XA, et al.

Treatment 105

Treatment Immune Response Therapies Clinical Trials 105

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.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

AUGUST 3, 2021

Revenue in the second quarter of 2021 increased 23 percent, driven by volume growth of 22 percent. – Revenue from all key products grew in the quarter and 2021 year-to-date. . – Revenue from all key products grew in the quarter and 2021 year-to-date. – 2021 EPS guidance updated to be in the range of $6.73

Production 52

Production Marketing Research DNA 52

The Pharma Data

JANUARY 19, 2021

With this kind of a start, 2021 may be scorching. TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. It is now in a Phase I/IIa trial for adult NSCLC with EGFRex20ins mutations.

Small Molecule 52

Small Molecule Trials Laboratories Immune Response 52

The Pharma Data

SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. Dr. Camillo Porta. Thursday, September 16, 8:30 CEST.

Research 52

Research Immune Response Treatment Trials 52

The Pharma Data

AUGUST 6, 2020

Under the pact, AZ will transfer the vaccine’s technology to BioKangtai, which will in return reserve enough capacity to make at least 100 million doses of the shot by the end of 2020 and expand to 200 million doses per year by the end of 2021. The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers.

Vaccine 52

Vaccine Licensing Licensing Immune Response 52

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

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 Virus Vaccine Pharmacokinetics 52

The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.

Clinical Trials 52

Clinical Trials Trials Immune Response Vaccine 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.

Vaccine 52

Vaccine Trials Immune Response Virus 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

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. ” Dr.

Vaccine 52

Vaccine Trials Virus RNA 52

The Pharma Data

SEPTEMBER 2, 2021

The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc.

Clinical Trials 52

Clinical Trials Trials Vaccine Virus 52

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. Using data from the MS PATHS network in the U.S.,

Vaccine 52

Vaccine Therapies Immune Response Disease 52

The Pharma Data

FEBRUARY 22, 2021

New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults. If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021. Results of the Phase 2 trial will inform the Phase 3 protocol.

Vaccine 52

Vaccine Immune Response Trials Clinical Trials 52

PLOS: DNA Science

OCTOBER 12, 2023

Can they deliver healing genes without triggering an overactive immune response? The details are disturbingly reminiscent of the famous case of Jesse Gelsinger , who died from a ferocious immune response to experimental gene therapy in September 1999. An immune response is two-tiered.

Therapies 69

Therapies Immune Response DNA Virus 69

The Pharma Data

JULY 6, 2021

Sanofi highlights scientific innovations in the field of rare blood disorders at I STH 2021. New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. FDA for ITP.

Therapies 52

Therapies Pharmacokinetics Treatment RNA 52

The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. Preliminary results from that trial are expected in the third quarter ( DID , March 15 ). ? 14, 2020 ). Jason Scott. Source link.

Vaccine 40

Vaccine Immune Response RNA Virus 40

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

Vaccine 40

Vaccine Trials Clinical Trials Immune Response 40

Codon

JULY 14, 2024

However, this dropped under 10% in 2021. 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. Data from Rousseau G.F.

Production 140

Production Clinical Trials Trials Therapies 140

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. TUESDAY, Jan. Half were randomly chosen to receive two separate IV infusions of 100 million stem cells, while the others received a placebo IV.

Immune Response 52

Immune Response Hospitals Clinical Trials Trials 52

The Pharma Data

DECEMBER 8, 2020

With the proceeds, Qu Biologics will complete stage 1 of the RESTORE Phase 2 clinical trial for patients with moderate to severe Crohn’s disease and its Phase 2 Study to assess activation of anti-cancer immune response in colon cancer. “We

Immune Response 52

Immune Response Clinical Trials Disease Trials 52

The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Progress on implementation of the Corporate Social Responsibility strategy. Change at CER.

Vaccine 52

Vaccine Production FDA Disease 52

The Pharma Data

DECEMBER 7, 2020

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon. Jason Scott. Source link.

Vaccine 52

Vaccine Immune Response Clinical Trials Trials 52

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 is being evaluated in an ongoing Phase 3 trial in the U.K. and Australia. About Matrix-M.

Vaccine 52

Vaccine Government Immune Response Clinical Trials 52