pharmaphorum

AUGUST 5, 2022

MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system. 7 integrin, with three candidates in early-stage clinical development.

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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pharmaphorum

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.

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Immune Response Trials Vaccination Vaccine 72

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). log 10 copies/mL for combined doses).

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Antibody Trials Production Clinical Trials 52

Drug Discovery World

FEBRUARY 28, 2024

CRISPR and brain cancer Meanwhile, elsewhere in the US, another exciting development – using CRISPR as a therapeutic approach – has possibilities for tackling brain cancer. The drug, MOv18 IgE (an anti-folate receptor alpha IgE antibody), was developed by researchers at King’s College London. expressing cancers.

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Development Research Drugs Antibody 64

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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Vaccination Vaccine Development Immune Response 52

The Pharma Data

OCTOBER 14, 2020

a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. SAN CARLOS, Calif. , About Apexigen.

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pharmaphorum

NOVEMBER 12, 2020

Fuelled by the positive results, Five Prime promptly announced plans for a public offering to fund further clinical development of bemarituzumab and other pipeline programmes. months with chemotherapy, but hadn’t been reached in the antibody group, which Five Prime said equated to a 42% risk reduction at the data cut-off point.

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Drugs Antibody Immune Response Clinical Development 52

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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pharmaphorum

MARCH 12, 2021

However the companies also expanded their collaboration midway through last year to cover development of mRNA across all infectious disease areas, focusing on the long game once the pandemic has receded. A joint development team is working on a -20C storage temperature for late-stage clinical development and at launch.

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Clinical Trials Clinical Trials Trials Vaccination 52

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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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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Antibody Trials Production Clinical Trials 40

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

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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Vaccination Vaccine Trials Immune Response 52

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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Immune Response Clinical Trials Clinical Trials Development 52

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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Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

DECEMBER 15, 2020

Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3. GBS is responsible for nearly half of all life-threatening infections in newborns. The post Minervax raises €47.4m

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Bacteria Vaccination Vaccine Immune Response 52

The Pharma Data

JANUARY 3, 2021

The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), Santa Casa de Misericórdia de Santos Hospital (Santos, Brazil) and INTRIALS, a world-class, full-service Latin American CRO based in São Paulo, Brazil. . NEW YORK and LONDON, Jan. In a humanized mouse model (NOD/SCID IL2?c-/-),

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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

NOVEMBER 1, 2020

Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease.” In a humanized mouse model (NOD/SCID IL2?c-/-), Forward-Looking Statements.

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Clinical Trials Clinical Trials Antibody Life Science 52

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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Vaccination Vaccine Clinical Trials Clinical Trials 52

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

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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Vaccination Vaccine Antibody Licensing 52

pharmaphorum

AUGUST 17, 2020

It also has a therapy called K-NK003 in early-stage clinical development for patients with acute myeloid leukaemia (AML). In time, the intention is to test the therapy alongside antibodies and vaccines targeting the coronavirus. The cells can then be infused into the patient, mounting an attack against the infection.

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Trials Immune Response Development Clinical Development 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

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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Clinical Trials Clinical Trials Vaccination Vaccine 52

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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Immune Response Engineer Clinical Trials Clinical Trials 40

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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Immune Response Trials Development Drugs 52

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

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Calquence binds covalently to BTK, thereby inhibiting its activity.4,5

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Trials Clinical Trials Clinical Trials Immune Response 52

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

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

NOVEMBER 29, 2020

Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results. The interim immunogenicity analysis also included CMV-neutralizing antibody data assessed from 33 individuals, a subset of the 41 included in the efficacy analysis.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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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Vaccination Vaccine Clinical Trials Clinical Trials 52

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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Clinical Trials Clinical Trials Vaccination Vaccine 76

Drug Discovery World

NOVEMBER 13, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Hiroki Shirai, PhD, Coordinator, RIKEN Center for Computational Science, on: ‘Applying deep learning anomaly detection to antibody structures’.

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Protein Antibody Engineer Scientist 59

XTalks

NOVEMBER 15, 2023

XTALKS WEBINAR: Vaccine Clinical Development: Key Ingredients to Improve Efficiency Live and On-Demand: Monday, November 20, 2023, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn ways to improve the efficiency of vaccine development. The data showed a 98.9

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FDA Approval Vaccination Vaccine In-Vitro 59