Worldwide Clinical Trials

JUNE 15, 2022

The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. We need to consider how to use diverse populations in gene therapy trials. But it’s important we strive to find ways to include diverse patients so trial data can be representative of the wider population.

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Gene Therapy Gene Clinical Trials Clinical Trials 130

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” . PLYMOUTH MEETING, Pa. ,

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DNA Vaccine Vaccination Immune Response 40

pharmaphorum

OCTOBER 2, 2020

Vaccibody, which is also entitled to tiered royalties on sales of any marketed products, will develop the DNA-based individualised neoantigen vaccines until the end of phase 1b. The Roche unit will also bear all costs for trials, filings, manufacturing and marketing after the completion of the phase 1b study.

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Vaccination Vaccine Immune Response Drugs 59

Delveinsight

AUGUST 6, 2020

Zydus starts phase 2 COVID-19 vaccine trial after clearing safety test. Zydus Cadila has finished a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. ZyCoV-D is designed to introduce DNA that encodes for a viral protein into human cells.

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Allergies Vaccine Vaccination Gene Therapy 53

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

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Vaccination Vaccine Trials Immune Response 40

Find Me Cure

OCTOBER 13, 2019

There currently are drugs that do just that but now they’re in clinical trials for metastatic breast cancer as well. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials. An enzyme involved in DNA repair can be the key to making chemotherapy more effective.

Development 52

Development DNA Clinical Trials Clinical Trials 52

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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Gene Therapy Gene Gene Sequencing Gene Expression 52

The Pharma Data

NOVEMBER 18, 2020

. “Based upon our anti-Globo H targeted approaches in cancers of high unmet needs, OBI Pharma is proud to have presentations on the progress of our trial presented at ESMO-Asia 2020 for our novel therapeutic cancer vaccine, OBI-833.” Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients.

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Vaccine Vaccination Immune Response Trials 52

The Pharma Data

AUGUST 6, 2020

Early clinical results showed AstraZeneca’s candidate, AZD1222, triggered both antibody and T-cell immune responses. The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers. The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers.

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Vaccination Vaccine Antibody Licensing 52

The Pharma Data

MAY 15, 2023

Through the acquisition, Gilead gains rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology and MK2 for inflammatory diseases that could enter clinical trials later this year. Executive Vice President, Research, Gilead Sciences. “The Executive Vice President, Research, Gilead Sciences.

DNA 40

DNA Immune Response Medicine Development 40

Cloudbyz

JULY 31, 2024

Liquid biopsies, for example, allow non-invasive monitoring of cancer progression and response to treatment by analyzing circulating tumor DNA (ctDNA) in blood samples. Personalized Post-Treatment Plans: Post-market diagnostics enable the customization of post-treatment care plans based on individual patient responses.

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Gene Therapy Gene Medicine In-Vitro 52

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. About TNX-1800.

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Vaccine Vaccination Development Medicine 40

Camargo

JULY 27, 2021

It is a comprehensive term which encompasses a large variety of therapy products including viral and bacterial vectors, plasmid DNA, human gene editing technology, and patient-specific cellular gene therapy. Additionally, gene editing allows us either to remove or to modify harmful genes. Formulation Considerations.

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Gene Therapy Gene Gene Editing Genetics 238

The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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Vaccination Vaccine Antibody Trials 293

pharmaphorum

SEPTEMBER 14, 2021

Startup Rome Therapeutics has raised $77 million in second-round financing to help mine sequences of DNA – which were dismissed for years as ‘junk’ – for hidden treasure. Much of this repeatome is thought to derive from viruses that embedded in our DNA millions of years ago.

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DNA Immune Response Genome Genomics 52

XTalks

NOVEMBER 30, 2023

The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiating Cabenuva treatment. The Phase I trial for HB-500 is scheduled to start in the first half of 2024.

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FDA Approval Gene Therapy Gene Clinical Trials 111

XTalks

MAY 17, 2024

This pursuit has seen various high-profile failures, such as Merck’s STEP trial in 2007, which was halted early when it failed to prevent HIV infection and, unexpectedly, appeared to increase the risk in some individuals. As a result, further vaccinations within the trial were halted.

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Vaccination Vaccine Research Immune Response 52

The Pharma Data

APRIL 8, 2021

Leadership in DNA damage response demonstrated in multiple presentations for AZD5305, a next-generation PARP1 selective inhibitor. Data for AZD5305 will demonstrate how the next wave of DNA damage response medicines can build on the success of PARP inhibitors, potentially allowing patients to stay on treatment longer.

DNA 52

DNA Medicine Genome Genomics 52

pharmaphorum

OCTOBER 12, 2022

The payload, Del Bourgo tell us, is the therapeutic DNA or RNA sequence that will cure or fix damaged cells. Similar to how we injected mRNA into people to trigger an immune response and train their immune system against COVID-19, genomic medicine repairs cellular or molecular mechanisms that are dysfunctional and cause disease.”.

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Genome Genomics Medicine Development 105

Delveinsight

DECEMBER 13, 2020

Even though clinical trial results were promising, adverse events and serious complications were observed. Unlike a typical virus, hepatitis B’s cccDNA permanently integrates itself into a healthy cell’s DNA. HBV DNA can be integrated into the host genome. First DAAs (telaprevir and boceprevir), used in combination with PegINF-?

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Genotype FDA Approval DNA Drugs 52

Delveinsight

DECEMBER 3, 2020

AMD Patients often have low levels of CD59, which is a protein that protects the retina from damage caused by a vital part of the body’s natural immune response called complement. A phase 3 trial of Ovid Therapeutics’ OV101 in Angelman syndrome has flunked its primary endpoint.

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Gene Therapy Gene Antibody Research 52

The Pharma Data

APRIL 7, 2023

2-5 Philipp Harter, Director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany and principal investigator for the trial, said: “DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer.

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Trials DNA Medicine Development 40

The Pharma Data

JANUARY 20, 2021

Nasdaq: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, including COVID-19, cancer and HPV-associated diseases, today announced the pricing of an underwritten public offering of 17,700,000 shares of its common stock at a public offering price of $8.50

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DNA Containment Immune Response Sales 40

The Pharma Data

JUNE 30, 2021

Approval based on Phase 2 CheckMate -142 trial results showing nearly two-thirds of patients responded to the Opdivo plus Yervoy combination with durable responses observed. Results from the CheckMate -142 trial at minimum follow-up of 46.9 achieving a complete response. CheckMate -142 Efficacy and Safety Results.

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Trials Genome Genomics Containment 52

The Pharma Data

NOVEMBER 29, 2020

HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Phase 2 clinical trial (NCT03629080) to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. Safety and tolerability were evaluated in 69 participants who were enrolled in the trial by the cut-off date.

Vaccine 40

Vaccine Vaccination Clinical Trials Clinical Trials 40

pharmaphorum

JANUARY 10, 2023

Since then, the two partners have developed multiple AI-based applications including a platform for selecting neoantigens for use in individualised cancer vaccines and an early warning system for high risk SARS-CoV-2 variants based on how well they can evade the immune system and their transmissibility.

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Vaccination Vaccine Clinical Trials Clinical Trials 116

The Pharma Data

AUGUST 3, 2021

The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk.

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Antibody Sales Development Production 52

pharmaphorum

AUGUST 27, 2020

The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials. For example, if a company is carrying out clinical trials, then a clinical research organisation is needed to run them. Today researchers are attaching only a portion of the DNA or mRNA of the virus to a harmless molecule.

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Vaccine Vaccination Life Science Clinical Trials 122

Pharmaceutical Technology

NOVEMBER 22, 2022

When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. According to GlobalData, Moderna and BioNTech are currently leading the charge with the highest percentage of mRNA clinical trials, representing 7% and 5% of all mRNA studies, respectively.

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Manufacturing Vaccine Vaccination RNA 130

Roots Analysis

AUGUST 23, 2024

Unveiling The Potential of mRNA Technology mRNA is a single-stranded molecule that relays the genetic instructions needed to make proteins from DNA in the cell nucleus to ribosomes. In theory we could do this for any infectious disease where we know enough about what molecules provoke an effective immune response.

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Protein Vaccination Vaccine Immune Response 40

The Pharma Data

DECEMBER 27, 2020

Even with the holidays among us, there were a number of clinical trial announcements. Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study of monoclonal antibody VIR-7831 for hospitalized adults with COVID-19. Here’s a look. COVID-19-Related. Non-COVID-19-Related.

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Trials Antibody Gene Therapy Gene 52

WCG Clinical

MAY 28, 2024

This proliferative capacity allows a rapid response to an incoming threat, such as a viral infection. T cells and B cells also express specialized antigen receptors that impart specificity to the immune response, directing immune attack against foreign “non-self” targets while sparing “self” targets expressed by healthy tissue.

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In-Vivo Clinical Trials Clinical Trials FDA Approval 40

The Pharma Data

DECEMBER 20, 2020

Many companies appear to be getting their clinical trial news updated ahead of the holidays. CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19. From the initial diagnosis, patients have seven days to attempt to join the trial.

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Trials Gene Therapy Vaccination Vaccine 52

Roots Analysis

MAY 21, 2024

Several LNP-based therapies are currently being evaluated in the clinical trials; majority of these are conducted for treating breast cancer, ovarian cancer and lung cancer. In addition, these can be modified with ligands in order to improve the specificity and selectivity of the gene therapy and reduce off-target effects.

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Drug Delivery Drugs Gene Therapy Bioavailability 40

pharmaphorum

JULY 26, 2022

At a basic level, the virus’s protein ‘coat’ and the enzymes it uses to gain control of the host cell’s DNA mutate frequently, making it difficult to target with therapeutics. The reason there has been, as yet, no effective cure for the condition is due to the complexity of the virus and the way in which it is activated within the body.

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Gene Therapy Protein Vaccination Vaccine 140

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. As of July, the company and its federal partner stated that it is on track to supply between 500 million to 1 billion doses a year at a dose of 100 µg now selected for their Phase III trial.

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Vaccination Vaccine Antibody Life Science 92