Immune Response, In-Vivo and Manufacturing - Clinical Research Informer

ESMO 2022: the evolution of TIL therapy – a highly promising approach

Pharmaceutical Technology

SEPTEMBER 14, 2022

As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. The overall response rate (ORR) for TILs was 48.8% for Yervoy, with complete response (CR) rates of 20.2% versus 21.4% respectively.

Immune Response

Immune Response In-Vivo Production Manufacturing

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

FEBRUARY 27, 2024

TILs are immune cells that attack and penetrate tumors. The immune cells in both cases are then infused back into the patient. Amtagvi is approved for the treatment of unresectable or metastatic melanoma following prior treatment with a PD-1 inhibitor and a BRAF inhibitor if the tumor harbors a BRAF V600 mutation.

FDA Approval

FDA Approval Manufacturing In-Vivo Trials

Ixaka (formerly Rexgenero) Launches as an Integrated Cell and Gene Therapy Company

The Pharma Data

JANUARY 17, 2021

Joe Dupere, CEO of Ixaka, commented: “Ixaka’s broad offering of integrated cell and gene therapy capabilities, encompassing cell-based products and an innovative in vivo gene delivery platform, provides a strong foundation for our ambitions to become a leader in cell and gene therapies. A total of $15.4

Gene Therapy

Gene Therapy Gene In-Vivo Genetics

Verily – Janssen collaboration; Enhancing the response in pancreatic cancer; Avrobio gene therapy eradicates toxic substrate; Gut microbiome responsible for Multiple Sclerosis

Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

Gene Therapy

Gene Therapy Gene Immune Response In-Vivo

Taking an ‘upside-down’ approach to mRNA delivery

pharmaphorum

JANUARY 17, 2023

Once its potential as a means of stimulating an immune response had been established, attention quickly turned to where else the technology could provide a therapeutic solution. In addition, the construction of a specialised manufacturing facility for mRNA vaccines was agreed.

Vaccination

Vaccination Vaccine In-Vivo In-Vitro

The challenges and trends of cell & gene therapies

Drug Discovery World

SEPTEMBER 6, 2022

Speaking about emerging opportunities, Carlo Russo, CEO of Genenta, says that whilst “immuno-oncology treatment has been very successful in treating patients suffering from blood cancer,” its success has been limited “by the durability of the responses”. billion, compared to $19.9 million price point per dose.

Gene Therapy

Gene Therapy Gene Manufacturing Medicine

T-cell vaccine for COVID-19 may last longer than current vaccines

The Pharma Data

APRIL 22, 2023

Such a vaccine may provide long-lasting immunity against future emerging variants and could be used as a model for other seasonal viral diseases like the flu. “This means that vaccine manufacturers will have to keep creating new vaccines that target new variants, and people have to keep getting these new vaccines,” he said.

Vaccination

Vaccination Vaccine Protein Antibody

How mice with humanised immune systems are advancing cell-based immunotherapy

Drug Discovery World

JULY 22, 2022

Immunotherapies have become more popular due to their ability to trigger and train the patient’s immune system to recognise and attack tumour cells, provide strong immune responses, and reduce the severity of adverse side effects generally associated with chemotherapies. Jespersen et al.

In-Vivo

In-Vivo Engineer In-Vitro Antibody

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

The Pharma Data

DECEMBER 10, 2020

In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.

Vaccination

Vaccination Vaccine Immune Response Protein

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

XTalks

AUGUST 17, 2020

Immunotherapy continues to be a burgeoning field, with immune-based therapies being among the leading treatments being developed in oncology and autoimmunity. Cell-Based Immunotherapy vs. Immune Biologics. Immunotherapy involves leveraging components of the immune system (i.e. Immune system modulators (i.e.

Protein

Protein Engineer Immune Response In-Vivo

AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development

The Pharma Data

JANUARY 11, 2021

Xiaomin Fan, Founder, President and CEO of AvantGen, “Even with the recent Emergency Use Authorization of multiple vaccines, we believe there remains an urgent need for potent antibody therapies and prophylactics for immunocompromised patients who cannot mount an adequate immune response either to the vaccine or to subsequent viral infection.

Antibody

Antibody Licensing Licensing Development

HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

The Pharma Data

NOVEMBER 29, 2020

Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results. Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

RRx-001: Jack of all trades, master of…many

Drug Discovery World

FEBRUARY 2, 2023

Bryan Oronsky , Chief Development Officer at EpicentRx, discucsses how one drug sourced from the defense and aerospace industry, could have many potential disese targets. A late-stage clinical trial in head and neck cancer for the treatment of severe oral blistering or oral mucositis caused by radiation therapy is planned.

Manufacturing

Manufacturing Clinical Trials Clinical Trials Drugs

What to expect from PEGS Europe 2023: Day 3

Drug Discovery World

NOVEMBER 13, 2023

Enkelejda Miho, PhD, Professor, University of Applied Sciences and Arts Northwestern Switzerland, and Managing Director, aiNET, on: ‘The singular immune response to dengue and machine learning identification of antibodies in high-throughput sequences’.

Protein

Protein Antibody Engineer Scientist

Tezepelumab granted Priority Review by U.S. FDA

The Pharma Data

JULY 8, 2021

Many patients with severe asthma have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.(2,6,9) Amgen (NASDAQ:AMGN) announced that the U.S. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca. Reese, M.D., About Severe Asthma.

Allergies

Allergies Trials In-Vivo Medicine

What to expect from PEGS Europe 2023: Day 1

Drug Discovery World

NOVEMBER 8, 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. Luncheon presentations will be given by Andrew Bradbury, MB BS, PhD, Chief Scientific Officer, Specifica, and Stefanie Kall, Ph.D.,

Antibody

Antibody Engineer Protein Scientist

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

Progress on implementation of the Corporate Social Responsibility strategy. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent ® and Vaccines. Specialty Care sales grew 15.3%, due to strong Dupixent ® performance (+45.6% to €1,047 million) and oncology launches.

Sales

Sales Vaccination Vaccine Medicine

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

The Pharma Data

OCTOBER 26, 2020

The purpose of this exploratory Phase 1b/2 trial was to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor in a heterogeneous group of patients with aggressive, recurrent and/or metastatic HPV16-positive cancers. An overall response rate of 23.5%

Vaccination

Vaccination Vaccine Trials Containment

Clinical Research Informer

ESMO 2022: the evolution of TIL therapy – a highly promising approach

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

Trending Sources

Ixaka (formerly Rexgenero) Launches as an Integrated Cell and Gene Therapy Company

Verily – Janssen collaboration; Enhancing the response in pancreatic cancer; Avrobio gene therapy eradicates toxic substrate; Gut microbiome responsible for Multiple Sclerosis

Taking an ‘upside-down’ approach to mRNA delivery

The challenges and trends of cell & gene therapies

T-cell vaccine for COVID-19 may last longer than current vaccines

How mice with humanised immune systems are advancing cell-based immunotherapy

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development

HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

RRx-001: Jack of all trades, master of…many

What to expect from PEGS Europe 2023: Day 3

Tezepelumab granted Priority Review by U.S. FDA

What to expect from PEGS Europe 2023: Day 1

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

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