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. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S). Immune Response Data.

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pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains. ” Vaxzevria added almost $4 billion to its revenues last year, including $1.8

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The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800.

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pharmaphorum

OCTOBER 6, 2020

The CHMP begun its review of the vaccine, known as BNT162b2 based on preliminary results from pre-clinical and early clinical studies. These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

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The Pharma Data

SEPTEMBER 2, 2020

The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology. First results are expected early December and, if positive, will pave the way for initiation of a Phase III trial in the same month.

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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. Senior Vice President and Head of Global Clinical Development at Regeneron.

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The Pharma Data

JANUARY 12, 2021

The novel immune checkpoint inhibitor Sanofi deemed worthy of such an investment is BND-22, a humanized IgG4 antagonist antibody targeting the Ig-like transcript 2 (ILT2) receptor, an inhibitory receptor expressed on both innate and adaptive immune cells. It is being developed for the treatment of solid tumors.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

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The Pharma Data

AUGUST 6, 2020

Early clinical results showed AstraZeneca’s candidate, AZD1222, triggered both antibody and T-cell immune responses. China has several home-grown COVID-19 vaccines in clinical development. One problem with Ad5-nCoV is that many people already have pre-existing immunity against the human adenovirus.

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pharmaphorum

JANUARY 4, 2023

The hypothesis is that it will induce immune tolerance by stimulating anti-inflammatory regulatory T- (Treg) cells and cytokines that dampen down the immune response. It already has a pipeline of drug candidates in this area, including IRAK4 inhibitor GS-5718 that has advanced into early clinical development for lupus and RA.

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The Pharma Data

JUNE 25, 2021

CureVac and GSK expect to progress the second-generation vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. About CVnCoV.

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Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level.

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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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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. Synlogic’s President and Chief Executive Officer.

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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. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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The Pharma Data

JULY 6, 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels.

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XTalks

JUNE 9, 2022

Evkeeza — generically known as evinacumab — is a monoclonal antibody. Yancopoulos said, “ VelocImmune provides perhaps the most powerful and efficient way of generating fully human monoclonal antibodies that are ready for clinical testing. These antibodies bind strongly to their target and provide a robust immune response.

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The Pharma Data

JANUARY 21, 2021

The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI). The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

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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.

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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. The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR ?? T cell products,” said Chen Schor, President and Chief Executive Officer of Adicet. “We

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The Pharma Data

JANUARY 19, 2021

Other products include CLNB-049, a bispecific antibody against FLT3 and CD3 and CLN-619, a monoclonal antibody that simulates NK and T-cell responses. The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

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The Pharma Data

SEPTEMBER 9, 2020

The BNT162b2 vaccine candidate induced SARS-CoV-2 neutralizing antibodies in rhesus macaques, pseudovirus neutralizing antibodies in mice, and strong, antigen-specific CD4+ and CD8+ T cells in mice and macaques. producing CD8+ T cell responses, which is thought to promote an anti-viral effect.

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The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. Monoclonal Antibodies. Anti-CD40L Antibody.

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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. P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease.

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The Pharma Data

OCTOBER 14, 2020

Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. CHATHAM, N.J., Ilya Trakht, Ph.D.,

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The Pharma Data

AUGUST 20, 2020

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. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

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The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone.

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Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine.

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Pfizer

FEBRUARY 16, 2023

While VLA15 is still under investigation, to date the companies have been encouraged by the data from the Phase 2 clinical studies, which demonstrated strong immunogenicity and acceptable safety and tolerability profiles. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

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Pfizer

JULY 8, 2022

Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. A two-dose primary series of the vaccine (30-µg dose) elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, GMTs) in an earlier analysis.

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Roots Analysis

OCTOBER 30, 2023

The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than five transfer RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical). The primary target indications for tRNA therapeutics include genetic and oncological disorders.

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The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. About the Phase 2/3 Study.

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Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).

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Pharmaceutical Technology

JUNE 28, 2022

Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). An iADC merges an antibody with a small molecule compound that elicits immunogenic cell death, and an immune-activating molecule.

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The Pharma Data

DECEMBER 11, 2020

A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S., The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.

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