pharmaphorum

OCTOBER 16, 2020

Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. It started human testing of a protein subunit vaccine with partner GlaxoSmithKline last month. Chinese inactivated vaccine safe.

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Trials Vaccination Vaccine Antibody 98

Drug Discovery World

MARCH 26, 2024

For example, progress made in developing gene mutant-specific inhibitors, antibody-drug conjugates (ADC), or cellular therapies. We were excited to unveil data showing that two distinct chemical series exhibit METTL1 inhibition in vitro at low nanomolar concentrations with minimal interference with other RNA and protein methyltransferases.

RNA 64

RNA In-Vivo In-Vitro DNA 64

Pharmaceutical Technology

AUGUST 24, 2022

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 According to the findings, the trial of mRNA-1273.214 met all primary endpoints. At present, a Phase II/III trial of mRNA-1273.222 is progressing. 1 subvariant.

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Vaccination Vaccine Gene Therapy Antibody 130

pharmaphorum

FEBRUARY 9, 2021

million ($22 million) in second-round financing as it prepares to start clinical trials of its lead drug candidate INT-1B3 for solid tumours. The start of dosing in the phase 1/1b trial of the drug has been delayed by the COVID-19 pandemic, but recruitment of the target 80 participants with advanced solid tumours is reported to be ongoing.

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Trials Gene Silencing RNA Gene Expression 59

Delveinsight

SEPTEMBER 23, 2021

The biotech has evolved a T-cell receptor-like antibody to damage a selected immune checkpoint in oncology. 858 Therapeutics closes USD 60 Million series A round to drug RNA modulation. Now, they are ready for their next venture, which is launching RNA biotech 858 Therapeutics with a USD 60 million Series A fundraising.

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RNA Gene Therapy Gene Protein 61

Pharmaceutical Technology

JUNE 8, 2023

The company’s samRNA vector is based on a synthetic RNA molecule derived from a wild-type Venezuelan Equine Encephalitis Virus (VEEV) replicon with the goal of extending the duration and magnitude of immunogen expression to drive potent and durable immune responses. GlobalData is the parent company of Clinical Trials Arena.

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Vaccination Vaccine Immune Response Allergies 130

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Drug Discovery World

OCTOBER 11, 2023

The main presentations will be followed by a panel discussion on how these new approaches – e.g., engineered proteins, antibodies, micro RNA, nanocarriers, antibody drug conjugates – can help address unmet need in oncology.

Research 52

Research Antibody RNA Engineer 52

Drug Discovery World

DECEMBER 21, 2023

Other biotechnologies coming to the fore this year were antibody-drug conjugates and CRISPR gene editing. Regulatory issues and diversity in clinical trials were also important in 2023, as well as the role that artificial intelligence tools like ChatGPT might play. DDW Multimedia Editor Megan Thomas explored three trends in the market.

Gene Therapy 59

Gene Therapy Gene Antibody FDA Approval 59

Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. This system is designed to deliver RNA editing technology or other payloads directly to particular body areas, such as the nervous system or muscle. and Leila Zegna, director of the Kabuki Syndrome Foundation.

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Vaccination Vaccine Gene Therapy RNA 98

The Pharma Data

OCTOBER 25, 2020

The messenger RNA-based vaccine, which is designed to block replication of the coronavirus, was shown to induce neutralizing antibodies and activate T-cells in hamsters and mice. The vaccine is currently being evaluated in phase 1 and 2 human clinical trials. Source link.

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Vaccination Vaccine Immune Response RNA 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. The interim findings are from phase 3 trials in the United Kingdom and Brazil that included more than 11,600 participants. TUESDAY, Dec. 8 in The Lancet. New data posted Tuesday on the U.S. © 2020 HealthDay.

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Vaccination Vaccine Trials Immune Response 52

Pharmaceutical Technology

JULY 5, 2022

On leaving the liver cells, the virus hijacks bits of cell membrane and conceals itself from antibodies that would have isolated the virus before it travelled far through the bloodstream. In addition, the scientists later found that the HAV needs TENT4A/B for its replication.

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Protein RNA Genome Genomics 130

XTalks

NOVEMBER 30, 2023

Over 26 weeks of Sunlenca combined with other antiretroviral drugs, 81 percent of participants achieved HIV RNA suppression, reaching levels low enough to be considered undetectable. Both trials concluded with maintained virologic suppression, and no clinically significant change from baseline in CD4+ cell counts was observed.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

pharmaphorum

JANUARY 7, 2022

NI006 is an antibody that binds to the misfolded forms of the transthyretin protein that form the fibrils, and cause them to be cleared away by immune cells like macrophages. billion on the first nine months of 2021, well ahead of Pfizer’s own forecasts. Tafamidis is thought to work by stabilising the misfolded proteins.

Antibody 116

Antibody Licensing Licensing Protein 116

Drug Discovery World

AUGUST 4, 2023

The top stories: Promontory Therapeutics expands Phase II mCRPC trial Promontory Therapeutics has treated its first patients in France as part of the ongoing Phase II clinical trial of PT-112 in patients with late-stage metastatic castration-resistant prostate cancer (mCRPC).

Drugs 52

Drugs RNA Gene Scientist 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

SEPTEMBER 16, 2020

Both of these vaccines are based on RNA and in phase 3 and phase 1 testing, respectively. Earlier clinical data has shown that the vaccine can stimulate neutralising antibodies against SARS-CoV-2 and was well-tolerated with a transient mild to moderate fever being the main side effect seen in less than 20% of recipients.

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Vaccination Vaccine RNA Trials 86

The Pharma Data

JANUARY 20, 2021

-based Gritstone Oncology is developing a novel COVID-19 vaccine based on adenovirus and messenger-RNA technology designed to combat future variants of the coronavirus. Louis University. . Source link.

Vaccination 52

Vaccination Vaccine RNA Protein 52

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

DECEMBER 1, 2020

The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results. In the trial, BNT162b2 also showed an overall favourable tolerability with no safety concerns reported to date. The first primary objective analysis was based on 170 confirmed cases of COVID-19.

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Vaccination Vaccine RNA Clinical Trials 88

XTalks

JULY 14, 2022

Krystexxa’s expanded approval was based on data from the randomized, controlled MIRROR trial involving adults with uncontrolled gout. Results from the trial showed “significant improvement and sustained response” to Krystexxa with methotrexate (a chemotherapy drug and immune suppressant) compared to Krystexxa alone.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

Roots Analysis

OCTOBER 13, 2023

As a result, in late nineties, the conjugation of drug with biological entities such as antibodies emerged as a possible solution for targeting earlier undruggable entities. However, it was not until 2000 when the first drug conjugate in the form of antibody drug conjugate (ADC) was approved by the USFDA.

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Drugs Antibody RNA Genetics 40

Roots Analysis

DECEMBER 12, 2023

As a result, innovators came up with the idea of magic bullets, antibody drug conjugates (ADCs). It is comprised of three components, namely antibody, drug and linker. The antibody is conjugated to the drug via a linker molecule. The antibody is conjugated to the drug via a linker molecule. Components of an ADC?

Antibody 40

Antibody Manufacturing Drugs RNA 40

pharmaphorum

NOVEMBER 23, 2020

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. Results from trials conducted in the UK and Brazil showed an efficacy of 90% in 2,741 patients receiving the vaccine as a half dose, followed by a full dose at least one month apart.

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Vaccination Vaccine Regulation Protein 105

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

Vaccination 52

Vaccination Vaccine Trials Protein 52

pharmaphorum

OCTOBER 6, 2020

In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted. These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

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Vaccination Vaccine RNA Immune Response 59

pharmaphorum

DECEMBER 23, 2021

The first-in-class, small interfering RNA (siRNA) therapy for cholesterol lowering inhibiting PCSSK9 – the same target as Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Praluent (alirocumab) – but after a lead-in period is dosed only twice a year rather than every month.

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Drugs Sales Antibody FDA Approval 105

World of DTC Marketing

MARCH 16, 2021

Do I have a responsibility to share — on every occasion, random and formal, to family, friends, and strangers alike — my knowledge on the vaccines, monoclonal antibodies, the latest news from the Lancet or JAMA, why RNA is not voodoo, how Phase 4 safety trials are happening as I write…The answer is simple: yes.

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Marketing Vaccination Vaccine RNA 180

pharmaphorum

SEPTEMBER 22, 2022

Le Vert says Osivax’s technology differs, however, as it attacks the virus’ T-cells, making the vaccine more effective in the long term, and that clinical trials have shown promise. When exposed to a virus, one’s immune system develops antibodies in response to foreign antigens, with or without a vaccine.

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Vaccination Vaccine Antibody Clinical Trials 97

pharmaphorum

APRIL 5, 2022

AstraZeneca’s take on the PCSK9 inhibitor – an antisense drug licensed from Ionis six years ago – has cleared a proof-of-concept trial in high-risk patients with high blood cholesterol, but it remains to be seen where it will fit into the increasingly busy category.

Drugs 52

Drugs Antibody Sales FDA Approval 52

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial.

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Protein Vaccination Vaccine Immune Response 126

BioSpace

NOVEMBER 20, 2022

Former Theranos CEO Elizabeth Holmes will serve 11 years in prison on four counts of fraud, according to her sentencing by a federal judge in a California courtroom on Friday afternoon.

Antibody 63

Antibody Medicine Research Clinical Trials 63

pharmaphorum

NOVEMBER 17, 2020

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge.

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Vaccination Vaccine RNA Clinical Trials 77

The Pharma Data

AUGUST 16, 2021

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. The first clinical trial of CV2CoV is expected to start in Q4 2021.

Immune Response 52

Immune Response Vaccination Vaccine Antibody 52

pharmaphorum

NOVEMBER 21, 2022

Bomedemstat (IMG-7289) – an oral lysine-specific demethylase 1 (LSD1) inhibitor – is in multiple phase 2 trials for the treatment of indications including essential thrombocythemia (ET), myelofibrosis (MF), and polycythemia vera (PV). The acquisition is expected to close in the first quarter of 2023.

RNA 59

RNA Clinical Trials Clinical Trials Business Development 59