Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.

Development 161

Development Production Immune Response Licensing 161

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 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

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Protein Vaccination Vaccine Immune Response 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. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

AUGUST 15, 2021

Now, researchers reporting in ACS Central Science have immunized mice with nanoparticles that mimic SARS-CoV-2 by displaying multiple copies of the receptor binding domain (RBD) antigen, showing that the vaccine triggers robust antibody and T cell responses.

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Protein Vaccination Vaccine Antibody 52

The Pharma Data

NOVEMBER 9, 2020

“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally.”. and Australia.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

MAY 7, 2021

Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. 1.351 variant.

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Protein Vaccination Vaccine Trials 97

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , Yancopoulos , M.D.,

Antibody 52

Antibody Medicine Production Trials 52

XTalks

APRIL 26, 2021

Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial. At six months, 29.5

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Vaccination Vaccine Immune Response Trials 105

pharmaphorum

AUGUST 16, 2020

The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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Vaccination Vaccine Immune Response Trials 111

The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Phase1b/2 clinical study to be conducted in the United States and several European countries. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. Billion by 2025.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

DECEMBER 8, 2020

In August, the company reported the vaccine candidate triggered antibody-based immune responses in early and mid-stage trials. That diverse population was considered a benefit for the clinical study. The vaccine was also demonstrating a strong safety profile.

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., combined dose groups; 6.5%

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Antibody Trials Production Clinical Trials 40

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

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Antibody Vaccination Vaccine Trials 52

The Pharma Data

NOVEMBER 30, 2020

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. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

XTalks

MAY 1, 2023

XTALKS WEBINAR: Patient-Centricity in Clinical Trials Sites — The Trinity of Patient, Sites and Sponsors Live and On-Demand: Monday, June 12, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how the Patient Concierge program increases study participants’ engagement and decreases dropout.

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FDA Approval Gene Genetics Protein 89

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

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

DECEMBER 13, 2020

SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response. SYNB1891 is being evaluated in a Phase 1 clinical trial.

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Immune Response Engineer Containment Clinical Trials 40

The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units.

Vaccination 52

Vaccination Vaccine Antibody Protein 52

The Pharma Data

MARCH 8, 2021

Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta (IL-1?) Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses 9,10. 6 , 7 and neutralizes IL-1? By neutralizing IL-1?, Disclaimer.

Trials 52

Trials Immune Response Containment Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. This press release features multimedia. Graphic: Business Wire).

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Vaccination Vaccine Immune Response Protein 52

Pharmaceutical Technology

AUGUST 24, 2022

The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1% Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies.

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Clinical Trials Clinical Trials Trials Development 130

The Pharma Data

OCTOBER 21, 2020

The active IND enables the Company to initiate the first-in-human clinical trial to assess safety and efficacy of ADI-001 in NHL patients. T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of “off-the-shelf” ?? “We T cell therapy in NHL patients. Forward-Looking Statements.

Immune Response 40

Immune Response Engineer Containment Clinical Trials 40

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. About Pneumococcal Disease.

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Vaccination Vaccine Immune Response Containment 52

The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As The information contained in this release is as of September 7, 2020.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 15, 2021

About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S., 7 It is able to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.

FDA Approval 52

FDA Approval Vaccination Vaccine Licensing 52

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Cell-Based Immunotherapy vs. Immune Biologics. Immune system modulators (i.e.

Protein 98

Protein Engineer Immune Response In-Vivo 98

Delveinsight

JANUARY 22, 2021

There are newer agents coming to the market, for instance, Fc receptor via monoclonal IgG antibodies mechanism, BTK [Bruton tyrosine kinase] inhibition, and so on, however, the real challenge lies in the compliance in terms of patients perspectives such as cost and tolerance.

Marketing 65

Marketing Drugs Antibody Compliance 65

The Pharma Data

MARCH 16, 2021

1.351 carries another spike mutation E484K, which appears to evade the body’s immune response, possibly diminishing vaccine efficacy. 1 has been circulating in the Amazon region as of late 2020 and is thought to evade immunity generated after infection by other variants. 2,3 Another variant, B.1.351, 4 Variant P.1,

Antibody 52

Antibody Clinical Trials Clinical Trials Vaccination 52

The Pharma Data

AUGUST 20, 2020

The companies are continuing to analyze data from the Phase 1 trials in the U.S. T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. This press release features multimedia. View the full release here: [link].

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover’s COVID-19 vaccine candidate and will fund the development, including the Phase 2/3 trial, through licensure. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

Vaccination 52

Vaccination Vaccine Trials Protein 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, Empowering Life.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

Licensing 52

Licensing Licensing Vaccination Vaccine 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech appreciate the continued participation of the approximately 44,000 trial volunteers and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Empowering Life. www.sanofi.com.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. The information contained in this release is as of December 10, 2020. About the Phase 2/3 Study.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

JULY 21, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of July 21, 2021. Procedures should be in place to avoid injury from fainting. myocarditis and pericarditis.

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Manufacturing Vaccination Vaccine Clinical Trials 52