pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Valneva is paying 30% of development costs and in return Pfizer will pay tiered royalties starting at 19% and will lead late-stage development.

Vaccination 119

Vaccination Vaccine Bacterium Protein 119

pharmaphorum

DECEMBER 17, 2020

France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR). It is the first publicly announced inactivated COVID-19 vaccine candidate to begin clinical development in Europe.

Vaccination 105

Vaccination Vaccine Trials Immune Response 105

The Pharma Data

NOVEMBER 30, 2020

Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers. to determine efficacy and safety of NVX-CoV2373. Novavax was awarded $1.6

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

Pharmaceutical Technology

FEBRUARY 26, 2023

Cellular Immunotherapy for Non-Small Cell Lung Cancer is under clinical development by Iovance Biotherapeutics and currently in Phase II for Non-Small Cell Lung Cancer. The company operates a research facility in Tampa, Florida. The company also focuses on investigating TIL therapy for treatment of a range of cancer.

Immune Response 100

Immune Response Production Drugs Clinical Trials 100

pharmaphorum

SEPTEMBER 24, 2020

. “These discussions are part of our work to research ways of treating, limiting and hopefully preventing the virus so we can end the pandemic sooner.” That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

Vaccination 98

Vaccination Vaccine Trials Immune Response 98

XTalks

NOVEMBER 6, 2020

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We

Clinical Trials 75

Clinical Trials Clinical Trials Vaccination Vaccine 75

pharmaphorum

AUGUST 5, 2022

MiroBio was set up to develop research by scientific co-founders Simon Davis, professor of molecular immunology at the MRC Weatherall Institute of Molecular Medicine, and Richard Cornall, Nuffield professor of clinical medicine at Oxford University. 7 integrin, with three candidates in early-stage clinical development.

Antibody 105

Antibody Immune Response Development Medicine 105

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

pharmaphorum

NOVEMBER 20, 2022

One standout success we have all benefitted from is vaccine development, with notable vaccines from Pfizer/BioNTech, AstraZeneca, and Moderna. As the world stopped, researchers and stakeholders from across the industry turned their attention to tackling the SARS-CoV-2 virus. But despite this focus, new challenges were ubiquitous.

Vaccination 98

Vaccination Vaccine Development Clinical Development 98

Worldwide Clinical Trials

JUNE 15, 2022

We’ve also seen a decrease in available research nurses, as they have had to be reassigned to COVID patients. It really is—there has been a 10x increase in cell and gene therapies in the clinical development pipeline since 2012. Fewer staff creates many problems, including less bandwidth to meet for reviews and approvals.

Gene Therapy 130

Gene Therapy Gene Clinical Trials Clinical Trials 130

XTalks

SEPTEMBER 5, 2023

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed. What are the major challenges you’re facing right now in vaccine development?

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

The Pharma Data

JANUARY 12, 2021

“The T-cell and NK-cell target discovery approach complements our portfolio aimed at turning cold tumors hot and redirecting the innate immune system to elicit a sustained and durable immune response against tumors. Takeda will assume responsibility for funding all development and commercialization activities.

Development 52

Development Research In-Vivo Genome 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

pharmaphorum

OCTOBER 21, 2022

Hookipa’s proprietary arenavirus platform is based on engineering arenaviruses to carry and deliver virus-specific or tumour-specific genes directly in patients in order to evoke an immune response by T cells, also known as CD8+ T cells.

Licensing 52

Licensing Licensing Immune Response Engineer 52

The Pharma Data

JANUARY 12, 2021

The Israeli-based biotech is dedicated to developing innovative therapies for cancer, based on its proprietary research of newly discovered immune-checkpoints and immune-evasion mechanisms. Ben-Moshe told BioSpace that BND-22 differs from traditional immunotherapy in that it can elicit a more total immune response. . “It

Immune Response 52

Immune Response Clinical Trials Clinical Trials Development 52

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. “Our

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

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.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

JANUARY 3, 2021

We are very honored to have someone of Dr. Zeldis’ caliber lead our scientific research and clinical development teams. Both Jerry and Jeff have proven and successful track records in the design and execution of early and late-stage clinical trials that have evaluated novel immune therapies. GAITHERSBURG, Md.,

Immune Response 40

Immune Response Clinical Trials Clinical Trials Development 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.

Immune Response 40

Immune Response Engineer Medicine Clinical Trials 40

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

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.

Immune Response 52

Immune Response Engineer Licensing Licensing 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.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co.,

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. It’s a very exciting time in gene therapy.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

XTalks

SEPTEMBER 21, 2023

The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. The study, named HVTN 302, is fully supported by the NIAID and is administered by the HVTN, headquartered at the Fred Hutchinson Cancer Research Center in Seattle.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

AavantiBio’s strategic partnership with University of Florida’s Powell Gene Therapy Center provide their foundational research in rare genetic disorders. Sirnaomics is the only biopharma conducting R&D and clinical development in the field of RNAi therapeutics in both the U.S. Source link.

Gene 52

Gene Gene Therapy Medicine Development 52

The Pharma Data

NOVEMBER 9, 2020

announces the first patient treated in the phase 1b/2a clinical trial examining IP-001 in thermally ablated solid tumors. The trial, conducted in collaboration with the Swiss Group for Clinical Cancer Research (SAKK), will assess the safety, tolerability and anti-tumor activity of IP-001 administered intratumorally following tumor ablation.

Immune Response 40

Immune Response Clinical Trials Clinical Trials Trials 40

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 study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

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.

Immune Response 52

Immune Response Trials Development Drugs 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.”

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

MAY 15, 2023

The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Executive Vice President, Research, Gilead Sciences.

DNA 40

DNA Immune Response Medicine Development 40

The Pharma Data

OCTOBER 27, 2020

Mirati Therapeutics is a San Diego -based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. About Mirati Therapeutics.

Sales 52

Sales Immune Response Clinical Development Development 52

The Pharma Data

JULY 6, 2021

billion in clinical development, regulatory and commercial launch-related milestone payments. Alector will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. In another form, people with mutations in the chromosome 9 open reading frame 72 (C9orf72) gene can develop FTD.

Genetics 52

Genetics Gene Antibody Development 52

Pfizer

FEBRUARY 16, 2023

GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development. 5,6 The program was granted Fast Track designation by the U.S.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

OCTOBER 9, 2021

Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib. Deucravacitinib is not approved for use in any country. About Ulcerative Colitis.

Trials 52

Trials Immune Response Dermatology Clinical Trials 52