Containment, Gene, Gene Therapy and Immune Response

?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

JUNE 15, 2022

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. Around 40% of clinical holds are for gene therapy programs.

Gene Therapy

Gene Therapy Gene Clinical Trials Clinical Trials

UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

AUGUST 15, 2022

The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. 1 Omicron variant of concern.

Vaccination

Vaccination Vaccine Immune Response Clinical Trials

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

NOVEMBER 6, 2020

The Burnaby, BC-based company developed the oral DNA-based vaccine using its proprietary bacTRL Gene Therapy Platform, which uses genetically modified bifidobacteria as carriers of genetic vaccine elements on a DNA plasmid. BacTRL Gene Therapy Platform. Related: Red Meat Allergy Test Gets FDA Clearance. “We

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

The democratisation of cell and gene therapy

Drug Discovery World

MAY 29, 2024

Marc Hummersone, Senior Director of Research and Development (R&D) at Astrea Bioseparations, shares insight on the challenges and opportunities in cell and gene therapy (CGT) with DDW’s Megan Thomas. But the unpacked capsid can give rise to an immune response, which is not good for the patient.

Gene Therapy

Gene Therapy Gene Genetics DNA

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

JULY 29, 2022

And we are very prepared and have data that will answer those questions, what would be the advantage of shifting to an Omicron-containing vaccine, whether it's monovalent or bivalent.” Bivalent vaccines work by stimulating an immune response against two different antigens, whereas monovalent vaccines only target one antigen.

Manufacturing

Manufacturing Vaccination Vaccine Packaging

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

DECEMBER 13, 2021

An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

Development

Development Production Immune Response Licensing

Sitting down with Calidi Biotherapeutics

Drug Discovery World

JULY 26, 2022

Indeed, results from the previous Phase I clinical trials of SNV and NNV demonstrated that loading stem cells with oncolytic virus resulted in promising signals of efficacy via both direct lysis of the tumour cells as well as activation of an anti-tumour immune response. Both therapies also had excellent safety profiles.

Gene Therapy

Gene Therapy Clinical Trials Clinical Trials Gene

The path to improved safety of gene-based products

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases.

Production

Production Gene Protein Vaccination

Replimune Announces Pricing of Upsized Public Offering – Oct 22, 2020

The Pharma Data

OCTOBER 21, 2020

Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, today announced the pricing of its public offering of 4,687,500 shares of its common stock at a public offering price of $40.00 BOSTON, Oct. 22, 2020 (GLOBE NEWSWIRE) — Replimune Group, Inc.

Gene Therapy

Gene Therapy Immune Response Sales Gene

Delivering on the promise of gene editing

Drug Discovery World

DECEMBER 15, 2022

As gene editing technologies like CRISPR progress toward clinical study, researchers must continue to advance new approaches and address inherent challenges, explains Jon Chesnut, PhD, Senior Director, Cell Biology R&D, Thermo Fisher Scientific. Early phase clinical trials for gene editing therapies.

Gene Editing

Gene Editing Gene In-Vivo Genome

Optimising AAV capsid purification through improved analytics

Drug Discovery World

FEBRUARY 8, 2023

Svea Cheeseman , Refeyn, explains why better efficiency is needed to advance the production of viral vectors for use in gene therapies. Adeno-associated viruses (AAVs) are a promising, widely used vector for delivering gene therapies. Data were provided by the Cell and Gene Therapy Catapult (London, UK).

Gene Therapy

Gene Therapy Gene Antibody Production

The importance of glycan analysis and characterisation for biopharma

Drug Discovery World

OCTOBER 12, 2022

They are currently working on an extensive InstantPC glycan library that now contains 264 unique glycan structures, while new application methods are being developed. Agilent’s next round of collaboration will look at cell and gene therapy glycan applications. This complexity makes quantification challenging. . References .

Protein

Protein Gene Therapy Antibody Production

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. These data represent the longest period of durability observed to date by a gene therapy for hemophilia B patients.

Gene Therapy

Gene Therapy Vaccination Vaccine Trials

Clinical Catch-Up: December 14-18 | BioSpace

The Pharma Data

DECEMBER 20, 2020

Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. The therapy is remestemcel-L, which contains culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor. Non-COVID-19-Related.

Trials

Trials Gene Therapy Vaccination Vaccine

Necessity Is the Mother of Innovation: Key Trends and Predictions from Biotech Showcase Digital After an Unprecedented Year That Drove Momentous Changes in Healthcare

Pharma Marketing Network

JANUARY 20, 2021

It’s widely acknowledged that optimal vaccine immunity results from engaging both humoral and cellular responses, but less attention has been given to the role of mucosal immunity in protecting against COVID-19, which is surprising considering SARS-CoV-2 enters the human body primarily through the mucosal surfaces of the upper respiratory tract.

Vaccination

Vaccination Vaccine In-Vivo Genetics

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

The Pharma Data

APRIL 27, 2021

MRT5500 (SP0254), an mRNA vaccine candidate against SARS-CoV-2, entered Phase 1/2 to assess safety, immune response and reactogenicity. On January 12, 2021 Sanofi entered into a global licensing agreement with Biond Biologics for BND-22, a novel immune checkpoint inhibitor targeting the ILT2 receptor. Forward-Looking Statements.

Sales

Sales Vaccination Vaccine Medicine

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. This indication is approved under accelerated approval based on tumor response rate and duration of response.

Trials

Trials Hormones Clinical Trials Clinical Trials

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. This indication is approved under accelerated approval based on tumor response rate and duration of response.

Trials

Trials Hormones Clinical Trials Clinical Trials

Clinical Research Informer

?5 Things You Need to Know from Our Recent Gene Therapy Webinar

UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Trending Sources

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

The democratisation of cell and gene therapy

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Sitting down with Calidi Biotherapeutics

The path to improved safety of gene-based products

Replimune Announces Pricing of Upsized Public Offering – Oct 22, 2020

Delivering on the promise of gene editing

Optimising AAV capsid purification through improved analytics

The importance of glycan analysis and characterisation for biopharma

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Clinical Catch-Up: December 14-18 | BioSpace

Necessity Is the Mother of Innovation: Key Trends and Predictions from Biotech Showcase Digital After an Unprecedented Year That Drove Momentous Changes in Healthcare

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

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

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