Bio Pharma Dive

OCTOBER 1, 2020

Worrisome immune responses had led the FDA to halt Solid's study. Now, the agency will permit Solid to continue after the biotech made adjustments to its manufacturing and patient enrollment procedures.

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pharmaphorum

FEBRUARY 8, 2022

With the safety of gene therapies thrown into the spotlight by a series of FDA clinical holds, Astellas has said that an interim readout in a phase 1/2 trial of its Pompe disease candidate AT845 hasn’t found any cause for concern. The post Astellas says Pompe gene therapy clears safety hurdle appeared first on.

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Drug Discovery World

SEPTEMBER 6, 2022

DDW Editor Reece Armstrong looks at the cell and gene therapy landscape, examining the challenges facing developers and the trends we can expect to see throughout the year. . There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. million price point per dose.

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Pharmaceutical Technology

NOVEMBER 16, 2022

A custom-made viral vector and cell therapy centre of excellence, ElevateBio BaseCamp has an end-to-end process development and existing Good Manufacturing Practice (cGMP) production expertise for research, clinical and commercial cell and gene therapies and regenerative treatments.

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Pharmaceutical Technology

AUGUST 1, 2022

They intend to develop vaccines that provide lasting immune responses compared to existing vaccines. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Furthermore, the parties will collaborate on the joint development of systems that accelerate the latest designs into clinical usage.

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Pharmaceutical Technology

MARCH 20, 2023

The collaboration, under a sponsored research agreement, will focus on mRNA vaccines that can help in modulating the normal immune response of the body for the treatment of certain autoimmune diseases as well as allergic conditions. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

JULY 5, 2022

It attaches to CD19, an antigen expressed on B-cells, and CD3 receptor on T-cells to stimulate and recruit T-cells to CD19-expressing tumours, where they can induce an immune response. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

JUNE 21, 2023

The vaccine produced significantly higher immune responses when given as a booster. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. It is given intra-dermally via a needle-free injection device. Clinical findings had showed the need to develop variant-specific vaccines.

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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. .

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Delveinsight

DECEMBER 22, 2020

FDA Puts uniQure’s Hemophilia B Gene Therapy on Leash. In a recent, uniQure faced backlash after its hemophilia B gene therapy got hit with clinical hold by the USFDA. . The Hemophilia B market has several therapies, however, no therapy has been able to kill the disease from its root.

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The Pharma Data

JANUARY 17, 2021

LONDON–( BUSINESS WIRE )– Ixaka Ltd , an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. The new business will continue to develop Ixaka’s proprietary technologies – concentrated multi-cell therapies (MCTs) and targeted nanoparticle (TNP) therapeutics.

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Pharmaceutical Technology

AUGUST 15, 2022

MHRA chief executive Dr June Raine said: “I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

MAY 24, 2023

Morphogenesis’s technologies include Immune Fx (IFx) personalised cancer vaccines and tumour microenvironment (TME) modulators. IFx has been designed to activate an innate immune response against tumour antigens that are patient-specific. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Drug Discovery World

MARCH 19, 2024

AT-108 is a first-in-class, off-the-shelf gene therapy that directly reprogrammes tumour cells into antigen-presenting dendritic cells, ultimately leading to a personalised anti-tumour immune response.

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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

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pharmaphorum

NOVEMBER 30, 2020

Cure Rare Disease’s Rich Horgan discusses the importance of preclinical NAbs screening and helping rare disease patients better understand their eligibility for gene therapies. In serious cases, higher levels of pre-existing NAbs can even cause a dangerous immune reaction when such therapies are administered.

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Drug Discovery World

MARCH 12, 2024

A collaboration with an academic partner of such prominence not only provides an increased scientific understanding but also puts Elicera on the map in an ecosystem that includes thought leaders in clinical cell and gene therapy.

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Pharmaceutical Technology

DECEMBER 1, 2022

As per the deal, the combined company will focus on developing three cancer therapies, which originated from Thomas Jefferson University (TJU) in the US and South Korea-based Innobation Bio. It can induce immune responses against Guanylyl Cyclase C (GCC) expressing colorectal, pancreatic, gastric and oesophageal cancers.

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XTalks

NOVEMBER 30, 2023

More Investigational Therapies for HIV Are on the Way American Gene Technologies, a pioneering biotech company headquartered in Rockville, Maryland, has released promising results from its Phase I trial of AGT103-T, a gene therapy designed for individuals with chronic HIV disease. In November 2023, Hookipa Pharma Inc.,

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Delveinsight

AUGUST 26, 2021

Shape Therapeutics inks gene therapy deal with Roche worth up to USD 3 Billion. Seattle biotech firm Shape Therapeutics has signed a deal potentially exceeding USD 3 billion with pharma giant Roche to bolster the development of gene therapies for Alzheimer’s and Parkinson’s disease.

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pharmaphorum

FEBRUARY 22, 2021

Bluebird Bio’s decision to hit pause on the launch of Zynteglo for beta thalassaemia after two cases of cancer were seen in a clinical trial could see fears over the safety of viral vectors used to deliver gene therapies resurface. . million in Europe.

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pharmaphorum

JUNE 28, 2022

. “iADCs hold promise well beyond the existing success of ADCs,” said Sutro’s chief executive William Newell, pointing to the technology’s ability to bind two separate components to a tumour-targeting antibody – one that delivers a cell-killing payload and another that can help drive an immune response.

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Cloudbyz

MARCH 6, 2024

For example, monoclonal antibodies, a type of biologic, can selectively bind to specific targets such as proteins or cells involved in disease processes, thereby modulating immune responses or inhibiting disease progression.

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Camargo

DECEMBER 13, 2021

Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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Drug Discovery World

NOVEMBER 30, 2022

Exosomes are emerging as an effective, non-viral chassis for genetic medicines, as they are non-toxic, efficient at delivering RNA cargoes into cells and able to do so without eliciting an immune response. .

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Delveinsight

AUGUST 6, 2020

By ordering human cells to make the protein, ZyCoV-D could cause an immune response against the coronavirus. Taysha raises USD 95 Million to take 4 CNS gene therapies into the clinic. Taysha Gene Therapies has raised USD 95 million to take four gene therapies into humans.

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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.

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pharmaphorum

NOVEMBER 2, 2022

The promise in the self-assembling RNA technology lies in its potential to achieve a strong immune response using a lower dose of antigen than the current generation of mRNA shots, although it is generally a larger molecule and may be more challenging to deliver.

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Delveinsight

SEPTEMBER 23, 2021

858’s drug candidates include proteins, which regulate RNA and immune response. Novartis is expanding its optogenetics portfolio with the acquisition of gene therapy company Arctos Medical. Mutations can cause IRDs in more than 100 genes. The financial terms of the deal were not revealed.

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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.

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Advarra

JANUARY 11, 2024

As researchers continue to identify better cellular targets and expand and improve upon immunotherapy approaches, they become better able to predict patient response and better able to learn from cancer cells’ attack strategies. These advancements are part of a larger effort to make cancer research more precise and more effective.

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pharmaphorum

JULY 20, 2022

Shares in VBL Therapeutics have lost around 78% of their value in pre-market trading after the company reported a phase 3 trial of its lead gene therapy VB-111 for ovarian cancer failed a pivotal trial. The post VBL craters as ovarian cancer gene therapy fails phase 3 test appeared first on.

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Pharma Marketing Network

DECEMBER 21, 2020

those that modify the expression of an individual’s genes or repair abnormal genes) has entered clinical practice, including 11 RNA therapeutics, 2 in vivo gene therapies, and 2 gene-modified cell therapies. greater safety, transient and reversible effect on gene expression). References. March 2020.

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Drug Discovery World

MARCH 13, 2023

GenSight Biologics has revealed pooled safety data from five clinical studies of lenadogene nolparvovec (Lumevoq), the largest cohort of ND4-LHON (Leber hereditary optic neuropathy) patients studied after gene therapy treatment. The post Five-year data show gene therapy safe for ND4-LHON appeared first on Drug Discovery World (DDW).

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Pharmaceutical Technology

JULY 29, 2022

Bivalent vaccines work by stimulating an immune response against two different antigens, whereas monovalent vaccines only target one antigen. 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.”

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The Pharma Data

OCTOBER 27, 2020

Former Sarepta Therapeutics executive Bo Cumbo left to launch his new gene therapy company, AavantiBio, with a $107 million Series A. AavantiBio’s strategic partnership with University of Florida’s Powell Gene Therapy Center provide their foundational research in rare genetic disorders. AavantiBio .

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The Pharma Data

JANUARY 18, 2021

Use of AAVnerGene capsid library provided to Neurophth for ophthalmic gene therapy. Next Generation AAVs enhance gene therapies by increasing transduction efficiency and specificity while reducing immune responses and cost. WUHAN, China and NEWARK, DE. ,

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