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. You can also use enzymes for product quality assurance, for example, to digest residual nucleic acid in the downstream process, enabling recombinant proteins to meet regulatory guidelines.”.

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Drugs Gene Therapy Production Manufacturing 295

Pharmaceutical Technology

APRIL 28, 2023

Generate Biomedicines has signed a co-development and commercialisation agreement with the University of Texas MD Anderson Cancer Center to expedite the development of new protein therapeutics for oncology using generative AI. TRACTION is a part of the therapeutics discovery division of MD Anderson.

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Development Clinical Trials Clinical Trials Protein 130

pharmaphorum

MARCH 3, 2021

The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation. This allows them to review trial data as it breaks, vastly speeding up the approval process.

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Vaccination Vaccine Regulation Immune Response 130

Scienmag

FEBRUARY 23, 2021

(February 23, 2021) – The Gates Biomanufacturing Facility (GBF) has completed the manufacturing and release of a protein-based biologic under Good Manufacturing Practice for Phase 1 Investigational Drugs for first-in-human clinical trials.

Protein 57

Protein Manufacturing Clinical Trials Clinical Trials 57

Pharmaceutical Technology

APRIL 13, 2023

Clinical-stage biopharmaceutical firm Alentis Therapeutics has raised $105m in a Series C financing round for advancing transformational medicines targeting the CLAUDIN-1 protein. ALE.F02 is being developed for the treatment of advanced kidney, lung and liver fibrosis while ALE.C04 is a potential treatment to target CLDN1-positive tumours.

Medicine 130

Medicine Development Antibody Engineer 130

Pharmaceutical Technology

MARCH 23, 2023

Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics. Adcetris is currently active in multiple clinical trials, including the ECHELON-3 Phase lll study for patients with relapsed or refractory diffuse large B-cell lymphoma.

Licensing 147

Licensing Licensing Sales Trials 147

XTalks

AUGUST 17, 2020

With several biologics in the pipeline, including one in early stage clinical trials for head and neck cancer, the company is positioned to engineer highly specific biologics against immune targets in the body. protein-based biologics) and vaccine treatments. Cell-Based Immunotherapy vs. Immune Biologics.

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Protein Engineer Immune Response In-Vivo 98

Pharmaceutical Technology

NOVEMBER 29, 2022

For this approach, the team leveraged an oncolytic herpes simplex virus for releasing chemokines, which are signalling proteins that aid in attracting immune cells to tumours. These viruses are engineered genetically for killing cancer. GBMs are called “cold” tumours as they lack helpful immune cells.

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Development Research Antibody Engineer 130

The Pharma Data

MARCH 23, 2022

Polymerase is a viral protein that directs how Ebola virus replicates its genome as it infects new hosts. The researchers discovered that Ebola virus polymerase hijacks a cellular protein called GSPT1. To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase.

Protein 52

Protein Genome Genomics Research 52

pharmaphorum

OCTOBER 4, 2022

HER2 is a receptor protein that accelerates cancer cell growth. Based on the level of HER2 receptor protein expressed in patient breast cancer tissue samples, a patient is deemed HER2-positive if a tumour exhibits high levels of HER2.

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FDA Approval Protein Antibody Engineer 105

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 drug candidate is an engineered B-cell modulator. The company offers a proprietary scientific platform that converts native immune system proteins into differentiated, multi-targeted therapeutics.

Protein 100

Protein Engineer Drugs Clinical Trials 100

XTalks

AUGUST 8, 2024

Tecelra is the first cell therapy engineered for a solid tumor cancer in the US, offering a new option for patients with specific genetic markers who have previously undergone chemotherapy. Tecelra works by using the patient’s own immune system to target tumors expressing the melanoma-associated antigen A4 (MAGE-A4) protein on cancer cells.

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Engineer Clinical Trials Clinical Trials FDA Approval 52

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. 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. Vir Biotechnology, Inc.,

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

Scienmag

APRIL 12, 2021

Credit: POSTECH Blood vessels deliver nutrients and oxygen to each organ in our body. They are difficult to completely restore to their original conditions once damaged by myocardial infarction or severe ischemic diseases. This is because various angiogenic growth factors must be applied sequentially in order to restore the vascular structure.

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Protein Research Clinical Trials Clinical Trials 83

The Pharma Data

JULY 22, 2021

(NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. The estrogen receptor is a well-known disease driver in most breast cancers. Chief Executive Officer at Arvinas.

Protein 52

Protein Development HR Hormones 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. Most train the immune system to recognize the RBD, a peptide that is the portion of the SARS-CoV-2 spike protein that binds to the ACE-2 receptor on host cell surfaces. bioRxiv [Preprint].

Protein 52

Protein Vaccination Vaccine Antibody 52

pharmaphorum

SEPTEMBER 16, 2022

A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”. It also bodes well for improving clinical trial success rates. What, then, is the solution?

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Development Research Drugs Clinical Trials 135

The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. About NVX-CoV2373.

Protein 52

Protein Vaccination Vaccine Immune Response 52

Scienmag

MAY 27, 2021

Credit: Chris Pudney, University of Bath A cutting-edge digital tool that will make it cheaper, safer and faster for pharmaceutical companies to predict protein stability – […].

Protein 52

Protein Scientist Medicine Development 52

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.

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Vaccination Vaccine Clinical Trials Clinical Trials 97

pharmaphorum

FEBRUARY 3, 2021

While achieving the Nobel Prize spotlight would have been enough to impress, CRISPR-Cas9 gene editing is part of a growing list of technologies granted Investigational New Drug (IND) applications with early data from clinical trials supporting its safe use in edited cells re-introduced into a patient.

Gene Editing 98

Gene Editing Gene DNA Engineer 98

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

XTalks

JULY 10, 2023

In the case of gMG, certain autoantibodies target specific proteins on the post-synaptic membrane of the neuromuscular junction, thereby impairing synaptic transmission. This disruption takes place at the neuromuscular junction, the site where nerve cells form connections with the muscles they regulate.

FDA Approval 98

FDA Approval Antibody Protein Engineer 98

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is developed based on protein engineering platform. It acts by targeting TGF-beta 1 and 3.

Production 100

Production Vaccination Vaccine Engineer 100

pharmaphorum

JANUARY 29, 2021

California-based Sangamo Therapeutics is one such company that believes in the powerful potential of in vivo genome editing and regulation, together known as genome engineering, and has built up a sizable preclinical pipeline of genome regulation treatments for diseases such as Huntington’s disease and Amyotrophic lateral sclerosis (ALS).

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Gene Editing Gene Gene Therapy In-Vivo 145

XTalks

OCTOBER 20, 2023

Clinical-stage genome editing company Intellia Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a pivotal phase III trial of NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy.

In-Vivo 52

In-Vivo Gene Editing Trials Gene 52

pharmaphorum

JANUARY 10, 2023

BioNTech said the acquisition is part of a strategy to accelerate its pipeline development and support R&D at scale, particularly in oncology, where it currently has 19 clinical-stage programmes and 22 ongoing clinical trials, headed by BNT122 for melanoma and colorectal cancer.

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Vaccination Vaccine Clinical Trials Clinical Trials 116

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

XTalks

AUGUST 8, 2022

The I-ReSToRE platform combines proprietary antibody engineering with MiroBio’s advanced receptor mapping database and visualization tool called Checkpoint Atlas. The acquisition of MiroBio is a testament to the best-in-class discovery engine and highly innovative pipeline they have built.

Immune Response 98

Immune Response Antibody Life Science Engineer 98

pharmaphorum

FEBRUARY 10, 2021

Interim data from a phase 2 trial of Heat’s off-the-shelf cell therapy with Opdivo (nivolumab) showed that patients treated with the duo as a second-line therapy had a survival benefit, particularly in patients who hadn’t previously had checkpoint inhibitor therapy. HS-110 is delivered by intradermal injection once a week.

Engineer 98

Engineer Protein Trials Drugs 98

Scienmag

MAY 24, 2021

The vaccine, made of disease-fighting proteins, could boost efficacy, accelerate production of seasonal flu vaccines Credit: University at Buffalo. — An experimental flu vaccine consisting of billions of tiny spherical sacs that carry infection-fighting proteins throughout the body has proven effective in preclinical studies.

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Vaccination Vaccine Protein Trials 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

STAT News

NOVEMBER 4, 2022

His goal was to find a treatment for his brother’s form of Duchenne muscular dystrophy, which is caused by a mutation that impeded his ability to make a crucial muscle protein called dystrophin. The clinical trial was to be the first time anyone got a gene editing therapy for muscular dystrophy.

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Gene Editing Gene Gene Therapy Scientist 105

pharmaphorum

APRIL 8, 2022

The Dublin-based pharma is paying $15 million upfront for global rights to Werewolf’s WTX-613, a prodrug of the cytokine interferon alfa-2b, which is still back n preclinical development and due to start its first clinical trials next year. Image by Lukas Bieri from Pixabay .

Drugs 105

Drugs Immune Response Licensing Licensing 105

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. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

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Vaccination Vaccine Protein Antibody 52

XTalks

NOVEMBER 30, 2023

Its mechanism of action involves blocking the protein shell (capsid) of the HIV-1 virus, disrupting multiple crucial stages of the viral lifecycle. Both trials concluded with maintained virologic suppression, and no clinically significant change from baseline in CD4+ cell counts was observed. In addition, Vir Biotechnology, Inc.

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FDA Approval Gene Therapy Clinical Trials Gene 111

pharmaphorum

JANUARY 3, 2023

SPK-9001 is a novel, investigation vector containing a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene. The clinical trial participants will be evaluated as part of a long-term study over 15 years.

Gene Therapy 98

Gene Therapy Gene Medicine Trials 98