BioSpace

APRIL 25, 2024

The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.

Genetic Engineering 92

Genetic Engineering Engineer Clinical Trials Clinical Trials 92

STAT News

JULY 11, 2022

Then it was almost instantly derailed by the death of an 18-year-old clinical trial volunteer named Jesse Gelsinger after he received a genetically engineered virus that had been developed to treat his rare liver condition.

Gene 111

Gene Gene Therapy Genetic Engineering Engineer 111

BioSpace

DECEMBER 6, 2021

Proof of concept for the Genetically Engineered Microbial Medicines (GEMM) platform came in a recent first-in-human, Phase I trial.

Genetic Engineering 77

Genetic Engineering Bacteria Engineer Genetics 77

Pharmaceutical Technology

APRIL 26, 2023

This marks the first-ever designation for genetically modified gamma-delta T cell therapies. INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is the company’s DeltEx chemotherapy-resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology.

Genetic Engineering 130

Genetic Engineering Drugs Genetics Engineer 130

pharmaphorum

SEPTEMBER 11, 2022

It is the first time that a cell therapy for solid tumours has been tested in a phase 3 trial, and the first time that the approach has been directly compared with standard second-line immunotherapy in melanoma. ” The post ESMO: TIL therapy improves on Yervoy in melanoma trial appeared first on.

Trials 105

Trials Genetic Engineering Immune Response Engineer 105

Pharmaceutical Technology

JUNE 29, 2022

In September 2021, GlobalData figures revealed there to be 1,320 industry-sponsored regenerative medicine and advanced therapy trials ongoing worldwide. Novozymes has a long legacy of enzyme discovery and the ability to genetically engineer these speciality enzymes to be superior. And it’s within the family – Novozymes!”.

Drugs 295

Drugs Gene Therapy Production Manufacturing 295

pharmaphorum

NOVEMBER 1, 2021

Delytact (teserpaturev) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) that was approved for marketing in Japan earlier this year, and received pricing approval in August at 1.43 million yen (around $12,500) per dose, according to a Pharma Japan report.

Genetic Engineering 122

Genetic Engineering Clinical Trials Clinical Trials Trials 122

Pharmaceutical Technology

MARCH 2, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The therapeutic candidate comprises allogeneic NK cells genetically engineered to express chimeric antigen receptors (CAR-NK) targeting cells CD33.

Gene Editing 100

Gene Editing Genetic Engineering Engineer Clinical Trials 100

Pharmaceutical Technology

AUGUST 17, 2022

These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets. In order to offer complete process development, quality control and regulatory services, cGMP manufacturing for pre-clinical and Phase I/II clinical trials, AGC will use its worldwide network.

Manufacturing 130

Manufacturing Gene Therapy Genetic Engineering Gene 130

XTalks

NOVEMBER 23, 2020

Severe cases of the infection did not occur among trial participants, nor were any hospitalizations reported. The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

Vaccine 97

Vaccine Vaccination Clinical Trials Clinical Trials 97

Velocity Clinical Research

OCTOBER 3, 2024

.” All Velocity sites are fully prepared to support cell and gene therapy (CGT) clinical trials. Read the full press release: [link] The post Nick Spittal Comments on Velocity’s Membership With Advarra’s Gene Therapy Ready Site Network appeared first on Velocity Clinical Research.

Gene Therapy 52

Gene Therapy Gene Genetic Engineering Clinical Research 52

Pharmaceutical Technology

MAY 2, 2023

Chimeric antigen receptor T-cell (CAR-T) therapies are the only genetically modified cell therapies to have received regulatory approval, and they are currently utilised in relapsed/refractory settings. There is currently a rich and diverse IO pipeline that aims to address these unmet needs, with 703 IO products currently in clinical trials.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

pharmaphorum

JANUARY 10, 2022

The opt-in has been prompted by the results of a phase 2 trial of ensovibep (MPO420), which showed that a single intravenous dose of the drug was able to not only reduce viral load in non-hospitalised COVID-19 patients over eight days, but also cut the risk of hospitalisation or death by 78% versus placebo.

Trials 52

Trials Drugs Antibody Genetic Engineering 52

pharmaphorum

NOVEMBER 6, 2020

Novartis’ Ilaris (canakinumab) has failed to produce results in a phase 3 trial, which tested whether it could improve COVID-19 patients’ survival chances without need for mechanical ventilation. The key secondary endpoint was to reduce the COVID-19-related death rate during the four week period after trial treatment.

Trials 40

Trials Genetic Engineering Licensing Licensing 40

Pharmaceutical Technology

FEBRUARY 15, 2023

Innovation S-curve for the pharmaceutical industry Gene splicing using nucleases is a key innovation area in the pharmaceutical industry Nucleases play a fundamental role in the field of recombinant DNA technology, or genetic engineering. Nucleases are enzymes that hydrolytically cleave the phosphodiester backbone of DNA.

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Gene Splicing Gene DNA Recombinant DNA Technology 130

pharmaphorum

JANUARY 26, 2023

Yescarta – a CD19-directed genetically modified autologous T-cell immunotherapy investigated in the ZUMA-1 trial – is the first chimeric antigen receptor (CAR) T-cell therapy recommended for routine use on the NHS in England , meaning that for the first time eligible patients will be able to access CAR-T cell therapy in the long-term.

Genetic Engineering 96

Genetic Engineering Engineer Genetics Drugs 96

XTalks

JULY 31, 2020

The study developed and researched microbe-controlled and genetically-engineered mice to understand the healing response in the intestine when receiving specific signals from bacteria. If we can influence these interactions, we may be able to control many diseases that are impacted by our microbiome or diet,” she says.

Bacteria 98

Bacteria Genetic Engineering Engineer Research 98

Pharmaceutical Technology

APRIL 5, 2023

And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials. We have the emergence of this new pillar of medicine, which is out of the lab and beyond clinical trials now. But there is that significant challenge.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

WCG Clinical

NOVEMBER 17, 2023

Since then, however, certain genetic engineering technologies (e.g., For example, two trials testing genetically identical genome-edited cell therapies – one engineered with a viral vector, and one without – can differ in their IBC review requirements because of how the cells were modified rather than what they have become.

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. Gene Delivery Systems Genetic material, in the form of DNA or RNA, does not easily enter cells without the aid of a delivery system.

Engineer 52

Engineer Genetics Clinical Research Research 52

NY Times

FEBRUARY 22, 2021

Two patients in a gene therapy study developed cancer years after treatment. It is not clear whether the therapy was responsible.

Gene Therapy 54

Gene Therapy Trials Research Gene 54

Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. However, simply having an IBC is much different than actively managing the IBC review process as part of an overall strategy to streamline trial activation.

Gene Therapy 52

Gene Therapy Gene Research Genetic Engineering 52

pharmaphorum

FEBRUARY 18, 2021

Researchers from the University of Texas Medical Branch based their findings on lab tests using SARS-CoV-2 coronaviruses that were genetically engineered to have the same mutations as those in the strain that is causing scientists so much concern.

Immune Response 52

Immune Response Genetic Engineering Vaccination Vaccine 52

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Only after these trials are successful can sponsors seek market approval for mRNA-based products.

Vaccine 52

Vaccine Vaccination Protein Antibody 52

The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look. COVID-19-Related. Non-COVID-19-Related.

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Gene Therapy Trials Gene Clinical Trials 52

The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. “These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. All cases observed in the vaccine group were mild as defined by the trial protocol.

Vaccination 40

Vaccination Vaccine Trials Immune Response 40

Advarra

AUGUST 8, 2023

Gene therapy involves the transfer of engineered genetic materials to human research subjects. These studies were previously considered to be highly experimental and limited to early phase trials at a handful of highly specialized academic medical centers.

Gene Therapy 52

Gene Therapy Gene Research Genetics 52

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

Clinical Development 52

Clinical Development Vaccine Vaccination Development 52

pharmaphorum

JULY 27, 2021

When the GPR75 researh was published, Regeneron’s chief scientific officer George Yancopoulos, described the mutations as a “genetic superpower” that “provides hope in combating global health challenges as complex and prevalent as obesity.”

Gene 52

Gene Drugs Genetic Engineering Genetics 52

The Pharma Data

NOVEMBER 9, 2020

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. and globally.”. About NVX-CoV2373. and Australia. billion from the U.S. government.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

Bioengineer

JULY 21, 2021

Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry’s most widely read publication worldwide. Mary Ann Liebert, Inc., A complete list of the firm’s 90 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc.,

Genetic Engineering 52

Genetic Engineering Development Engineer Genetics 52

The Pharma Data

DECEMBER 16, 2020

NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

Protein 52

Protein Vaccination Vaccine Immune Response 52

Bioengineer

JULY 19, 2021

The researchers at the CNIO created two genetically engineered mouse models that lacked KRAS4B and expressed the KRAS4A variant only, both with and without the G12V mutation (KRAS4AG12V). Our results suggest that for therapies to be effective, the two KRAS isoforms should be targeted.” ” KRAS genes in embryonic development.

Research 52

Research Gene Genetic Engineering Genetics 52

Bioengineer

JULY 15, 2021

Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry’s most widely read publication worldwide. Mary Ann Liebert, Inc., publishers (https:/ / www. liebertpub. com/ ) website.

Nurses 52

Nurses Genetic Engineering Engineer Genetics 52

XTalks

MARCH 28, 2024

Early clinical trials have shown promising results and this therapy could become a valuable addition towards CRC treatment in the future. Gene Editing and CAR T-Cell Therapy Genetic engineering technologies, such as CRISPR-Cas9, are providing newer potential avenues for cancer treatment.

Gene Editing 59

Gene Editing Life Science Clinical Trials Clinical Trials 59

Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. Preparing for unforeseeable release with a small spill kit.

Production 52

Production Containment Biohazard Biohazard 52

The Pharma Data

OCTOBER 27, 2020

He is also a principal investigator and a translational chair on several institutional and cooperative group clinical trials exploring novel immunotherapy combinations in gynecologic cancers and other solid tumors. He has led several investigator-initiated trials from phase 1 through phase III. Dean A.

Antibody 40

Antibody Genetic Engineering Engineer Development 40