RNA glioblastoma vaccine shows promise in first human trial
pharmaphorum
MAY 2, 2024
A personalised vaccine for the aggressive brain cancer glioblastoma developed has shown encouraging signs of efficacy in its first human trial.
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BioNTech targets infectious diseases for vaccine development
Pharmaceutical Technology
MARCH 28, 2023
Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer. In response to the lower vaccine sales forecasts, BioNTech shares opened at 3.9%
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BioNTech’s RNA vaccine sparks potential in pancreatic cancer
Pharmaceutical Technology
MAY 11, 2023
Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later.
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Merck and Moderna partner to develop and sell cancer vaccine
Pharmaceutical Technology
OCTOBER 14, 2022
German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs.
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Beyond Covid-19: the disruptive potential of RNA-based therapeutics
Pharmaceutical Technology
MARCH 1, 2023
The Covid-19 pandemic led to massive developments and scientific advances within the field of messenger ribonucleic acid (mRNA) vaccines. Pfizer /BioNTech and Moderna’s mRNA-based vaccines were the first to receive emergency use authorisation (EUA) out of all other Covid-19 vaccines under development in late 2020.
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UTMB and HDT Bio receive US funding for vaccine development
Pharmaceutical Technology
NOVEMBER 30, 2022
in a project agreement from the US government for developing self-amplifying RNA (saRNA) vaccine technology against advanced and emergent viral threats. Development of vaccines to Phase I trials under the five-year $59m prototype project comprises additional $28.4m in milestone payments.
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HIV vaccines suffer setbacks but new approaches could turn the tide
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. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.
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The future of RNA-based Therapeutics and Vaccines: Introducing advanced, Unrivalled Treatment Approaches
Roots Analysis
NOVEMBER 6, 2023
RNA-based therapeutics have completely revolutionized the healthcare segment, greatly influencing the study and treatment of human diseases by conferring precise targeting ability to therapeutic modalities. The below figure presents the distribution of next generation RNA-based therapeutics and RNA-based vaccines, based on type of molecule.
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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run
Pharmaceutical Technology
AUGUST 2, 2022
Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Following the demonstration at Samsung, the clinical trial of GreenLight’s Covid-19 booster vaccine is anticipated to commence this year.
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BioNTech Founders Predict Cancer Vaccine Is Only Years Away
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2022
The husband-and-wife team who co-founded BioNTech, the biotechnology company that partnered with Pfizer to develop an effective messenger-RNA (mRNA) shot against COVID-19, has predicted that a cancer vaccine could be widely available within the next decade.
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Merck makes circular RNA play with $3.5bn Orna alliance
pharmaphorum
AUGUST 16, 2022
Merck & Co has ramped up its involvement in the RNA category, partnering with US biotech Orna Therapeutics in a deal valued at up to $3.5 billion, consummating a relationship that first started in 2018 and spanned a range of mRNA-based vaccines for infectious diseases. billion, including $150 million upfront.
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HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India
Pharmaceutical Technology
JUNE 30, 2022
HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac. The vaccine leverages self-amplifying RNA (saRNA), which can replicate itself after administration and could be effective at very low doses. HDT Bio CEO Steve Reed said: “Our saRNA vaccine is a game-changer.
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The Future of Vaccine Development
VirTrial
OCTOBER 25, 2023
Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries.
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Eli Lilly Pursues RNA Editing in New Partnership with ProQR
XTalks
SEPTEMBER 13, 2021
With RNA therapies being the next hot thing in genetic medicine, Eli Lilly is joining the RNA editing race by partnering with Netherlands-based ProQR Therapeutics NV (Nasdaq: PRQR), a biotech company developing RNA-based therapies for rare genetic diseases with a focus on blinding disorders of the retina.
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Alnylam Files Lawsuits Against Pfizer and Moderna Over Patent Infringement of RNA Delivery Technology
XTalks
MARCH 21, 2022
Credited as a pioneering RNA interference (RNAi) therapeutics company, Alnylam Pharmaceuticals is taking Pfizer and Moderna to court, claiming that the companies’ use of the lipid nanoparticle (LNP)-based RNA delivery technology in their mRNA COVID-19 vaccines infringes on a patented technology.
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China’s NMPA grants EUA to CSPC Pharmaceutical’s Covid-19 vaccine
Pharmaceutical Technology
MARCH 23, 2023
China’s National Medical Products Administration (NMPA) has granted emergency use authorisation (EUA) for CSPC Pharmaceutical Group’s messenger RNA (mRNA) vaccine, SYS6006, to treat Covid-19. The independently developed SYS6006 vaccine has been designed to target some major Omicron variants. in clinical trials.
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mRNA universal influenza vaccine enters clinical trials
Drug Discovery World
MAY 18, 2023
A clinical trial of an experimental universal influenza vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) has begun enrolling volunteers at Duke University in Durham, North Carolina.
Moderna seeks FDA EUA for Covid-19 booster vaccine
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 5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above.
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Positive initial results for srRNA rabies vaccine
Drug Discovery World
FEBRUARY 19, 2024
Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).
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Using AI to design RNA-based medicines
Drug Discovery World
APRIL 11, 2023
US-based start-up Atomic AI is using artificial intelligence (AI) to design more intelligent RNA-targeted and RNA-based medicines. The technology can also generate synthetic data sets, or make human trials more efficient, by identifying the most suitable patients, predicting outcomes and optimising dosages and regimens of drugs.
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Arexvy Becomes World’s First RSV Vaccine
XTalks
MAY 5, 2023
This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). RSV is a negative-strand RNA virus that was first identified in 1955.
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What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?
XTalks
OCTOBER 26, 2023
The best way to prevent the flu is by getting vaccinated every year. The CDC and the World Health Organization (WHO) recommend annual flu vaccination for most people, especially those at high risk of serious complications, like pregnant women, elderly individuals, children and people with certain chronic health conditions.
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BioNTech, CureVac claim bulk of Germany’s €750m COVID-19 vaccines fund
pharmaphorum
SEPTEMBER 16, 2020
In May, Germany pledged to provide up to €750 million ($889 million) in funding to support vaccines against COVID-19, and the main recipients have now been revealed – BioNTech, CureVac and IDT Biologika – which are all German biotechs. Both of these vaccines are based on RNA and in phase 3 and phase 1 testing, respectively.
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Risk adjusted net present value: What is the current valuation of Moderna’s MRNA-0184?
Pharmaceutical Technology
JUNE 6, 2023
According to Globaldata, it is involved in 1 clinical trial, which is ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. MRNA-0184 Overview mRNA-0184 is under development for the treatment decompensated heart failure.
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Merck gets on board with Moderna cancer vaccine in $250m deal
pharmaphorum
OCTOBER 12, 2022
Shares in Moderna were ticking upwards today after Merck & Co took up an option on a personalised RNA-based cancer vaccine with a payment of $250 million. As we all know, cancer vaccines have had a rough history. The post Merck gets on board with Moderna cancer vaccine in $250m deal appeared first on.
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GSK poaches Pfizer exec Dormitzer as new vaccines R&D chief
pharmaphorum
NOVEMBER 30, 2021
GlaxoSmithKline has found a replacement for head of vaccines R&D Emmanuel Hanon, who left the company for a US biotech earlier this year, hiring Phil Dormitzer from Pfizer. His most recent role at Pfizer was chief scientific officer for RNA and viral vaccines, a position he held for more than six years. Phil Dormitzer.
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Reconfiguring COVID and influenza vaccines for long-term effectiveness
pharmaphorum
SEPTEMBER 22, 2022
Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. The technology. The technology.
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Pfizer’s RSV Vaccine Abrysvo Is a New Step for RSV Prevention
XTalks
JUNE 5, 2023
Pfizer has announced that its respiratory syncytial virus (RSV) vaccine, Abrysvo, has received approval from the US Food and Drug Administration (FDA). Abrysvo, the bivalent RSV prefusion F (RSVpreF) vaccine, is intended for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older.
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Shape Therapeutics-Roche’s Deal; AllStripes Raises $50M; Datavant-Real Chemistry’s Partnership; BlueWillow’s Nasal Vaccine
Delveinsight
AUGUST 26, 2021
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. Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks.
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Sanofi preps trials of second COVID-19 shot, as Russia approves another
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.
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Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients
pharmaphorum
NOVEMBER 9, 2020
As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.
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US launches clinical trial for pandemic preparation
Drug Discovery World
JULY 19, 2022
An early-stage clinical trial has been launched in the US investigating a vaccine against Nipah virus infection. . The clinical trial has been launched by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate an investigational vaccine to prevent infection with Nipah virus. Fauci, M.D.
Novavax delays COVID vaccine filings until Q3
pharmaphorum
MAY 11, 2021
Novavax has finally provided some clarity about when its long-awaited COVID-19 vaccine will be ready, saying regulatory filings in the US, UK and Europe are due in the third quarter. The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data.
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Pfizer begins US pilot delivery programme for COVID-19 vaccine
pharmaphorum
NOVEMBER 17, 2020
Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.
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UK faces “V-Day” and largest ever vaccination programme
pharmaphorum
DECEMBER 7, 2020
Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary Matt Hancock reportedly came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.
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Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate
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. “Our MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.
Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
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.
Novavax provides 1.1 billion COVID shots to global vaccine drive
pharmaphorum
FEBRUARY 19, 2021
billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available to poorer countries. Novavax has signed a deal to provide 1.1
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Key Trends in the Life Sciences to Look Forward to in 2022
XTalks
DECEMBER 22, 2021
The development and widespread adoption of new technologies is key to revolutionizing the way we diagnose, prevent, treat and manage disease. The RNA Revolution: From mRNA Vaccines to RNA Editing. The age of RNA is officially here, and it’s here to stay as more than a passing life science trend. RNA in the Making.
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Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate
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.
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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet
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. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.
Gritstone Oncology Devising COVID-19 Vaccine Targeting Future Strains | 2021-01-21
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.
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Sanofi to acquire Translate Bio; advances deployment of mRNA technology across vaccines and therapeutics development
The Pharma Data
AUGUST 3, 2021
Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.
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Sinovac raises $515m to boost production of potential COVID-19 vaccine
pharmaphorum
DECEMBER 7, 2020
China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.
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