MRNA Archives - Medical Design Sourcing

Can BioNTech’s BNT165b1 malaria vaccine stand up to Oxford’s R21?

Malaria parasite connecting to a red blood cell [Image courtesy of NIAID]

The mRNA vaccine company BioNTech (Nasdaq:BNTX) has begun a Phase 1 study of BNT165b1, a multi-antigen malaria vaccine candidate that belongs to its BNT165 malaria program.

Researchers at Oxford University are farther along with their R21/Matrix-M vaccine. A recently completed Phase 3 trial focused on R21. It could win licensure in 2023.

In a Phase 2 study published in The Lancet, a booster of the R21 vaccine continued to offer strong protection against malaria one year after primary vaccination with three doses. In addition, the vaccine met the World Health Organization’s Malaria Vaccine Technology Roadmap standard of providing at least 75% efficacy.

Oxford University is working with the Serum Institute of India to develop the R21 vaccine.

Researchers at Oxford University were also instrumental in developing the …

Why BioVectra has big mRNA biomanufacturing ambitions

Founded in 1970, BioVectra is a CDMO with specialties in microbial fermentation, complex chemistry and biologics. The company is looking to bolster its mRNA manufacturing capability.

In November 2021, the Canadian company announced its intent to build a new $79.6 million facility dedicated to producing and manufacturing mRNA vaccines and therapeutics. The initiative resulted from a joint private-public investment from the company and federal and provincial governments in Canada.

In April, BioVectra broke ground on the 36,000 ft2 mRNA Vaccine and Biomanufacturing Center located at its campus in Charlottetown, a city on Prince Edward Island.

The funding from the Canadian government followed after officials reached out to BioVectra with the intent of building up domestic manufacturing capability for mRNA- and plasmid-DNA-based vaccines.

Government officials ultimately decided to invest in BioVectra’s expansion, which will be structured into th…

Amazon Web Services is powering medtech innovation: Its chief medical officer explains

Dr. Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]

It doesn’t get any bigger than Amazon in the world of cloud computing.

The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Dr. Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

In the following interview, Kass-Hout explains how Moderna was born in the cloud and how the company has used cloud computing to scale mRNA technology.

Get the full story from our sister site, Medical Design …

BioNTech 2021 revenue surges 39x year over year

The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021.

Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth.

In 2020, BioNTech’s revenues were €482.3 million.

“Looking back, 2021 was an exceptional year during which BioNTech had a momentous impact on human health and the global economy with our first approved vaccine based on our mRNA technology,” said Dr. Ugur Sahin, BioNTech CEO, in a news release.

The company plans on using the recent cash infusion to boost R&D spending by roughly 50%. In all, the company plans on spending between €1.4 billion to €1.5 billion in R&D in 2022.

It seeks to advance various programs, including the development of mRNA-based immunotherapies, cell therapies and bi-specific antibodies. The company will also invest in regenerative medicine and autoimmune diseases.

BioNTech also plans t…

Moderna says its mRNA Access program could help with the next pandemic

Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases.

“It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships.

“mRNA Access was born of the idea that we are stewards of our platform, and by allowing researchers to access that platform, and leverage the preclinical, clinical, regulatory and manufacturing capabilities that we’ve created, we could accelerate the development of novel vaccines,” Bennett said.

Get the full story from our sister site, Drug Discovery & Development.

A closer look at Honeywell’s and Wallvax Biotech’s mRNA COVID-19 vaccine plant partnership

Walvax and Honeywell partnered to build China’s first mRNA COVID-19 vaccine plant.

Walvax (SHE: 300142) recently formed a strategic collaboration with Honeywell (Nasdaq: HON) that led to the construction of China’s first mRNA COVID-19 vaccine production plant.

The company has been working since 2017 to become a leading vaccine R&D company, recounted Shawn Opatka, vice president, life sciences, Honeywell Process Solutions. “Their goals accelerated the construction of a digital-enabled center for vaccine production, and vision for a smart factory,” he said.

When building the mRNA vaccine plan, Walvax used Honeywell’s intelligent plant technology to enable the digital production and operation of the smart plant.

First, the companies collaborated on deploying a supervisory control and data acquisition (SCADA) system pilot for other projects. “Since then, H…

NIH to launch clinical trial of three mRNA HIV vaccines

HIV virus image courtesy of NIAID

The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences.

The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA.

The three HIV vaccine candidates were developed by scientists at the Scripps Consortium for HIV/AIDS Vaccine Development (CHAVD) and the International AIDS Vaccine Initiative (IAVI) Neutralizing Antibody Center at Scripps.

NIAID is a division within the National Institutes of Health (NIH).

Moderna (Nasdaq: MRNA) manufactured the vaccines for the HVTN 302 trial with an NIAID-backed contract.

Similar to mRNA-based COVID-19 vaccines, each of the HIV vaccine candidates will be based on the spike protein found on the surface of the vir…

Sanofi details €2B plan to make France an mRNA leader

French drugmaker Sanofi (Nasdaq:SNY) said it would spend €935 million between 2022 and 2026 to produce mRNA-based vaccines.

That funding is part of a larger €2 billion initiative to accelerate its mRNA development capability, Sanofi explained on its French-language website.

The company plans to use the funds to ramp up its lipid nanoparticle production capability and identify six candidate mRNA vaccines.

To commemorate the investment, French Prime Minister Jean Castex and Sanofi CEO Paul Hudson arrived at the company’s planned Evolutive Vaccines Facility plant in Neuville, France, on March 7.

The Neuville site will ultimately house equipment for multiple vaccine and biological platforms.

To date, Sanofi has been left on the sidelines as Pfizer (NYSE:PFE), BioNTech (Nasdaq:BNTX) and Moderna (Nasdaq:MRNA) have raked in billions of dollars of mRNA-based vaccine sales.

Last year, Pfizer raked in $36.8 billion in COVID-19 vaccine sales al…

CueVac and GSK launch Phase 1 trial of mRNA-based flu vaccine

CureVac (NSDQ:CVAC) and GSK (NYSE:GSK) have announced the dosing of the first participant in a Phase 1 study of a multivalent influenza vaccine built on a second-generation mRNA backbone. The study is based in Panama and will enroll approximately 240 subjects.

CVAC shares increased 2.27% to $19.34 in mid-day trading.

At various points last year, however, the company’s stock was trading over $100 per share on enthusiasm about the company’s first-generation COVID-19 vaccine. However, the shares later tanked after the company announced that interim vaccine efficacy was 47% in the Phase 2b/3 study.

The company’s second-generation COVID-19 vaccine remains in pre-clinical development.

Its influenza vaccine candidate has multiple non-chemically modified mRNA constructs related to four different influenza strains.

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are also developing mRNA-based influenza vaccines.

Investors were dis…

7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory.

Researchers are now exploring dozens of new possibilities for the mRNA platform.

Here, we summarize several areas where mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

Merck KGaA, Darmstadt, Germany acquires Exelead to bolster mRNA offerings

Merck KGaA, Darmstadt, Germany, has announced that it has signed a definitive agreement to purchase Exelead (Indianapolis), a biopharma contract development and manufacturing organization (CDMO). Not to be confused with the similarly named Merck & Co., the German company will pay roughly $780 million in the acquisition.

Exelead specializes in creating lipid nanoparticle and pegylated formulations. Exelead has fared well during the pandemic. mRNA-based therapies are in high demand, and Pfizer tapped the company to help make its COVID-19 vaccine. (Additionally, Merck KGaA, Darmstadt, Germany has supplied lipids to bolster Pfizer-BioNTech COVID-19 vaccine production.)

“Novel modalities, particularly mRNA, present a highly attractive business opportunity as pharma and biotech pipelines are increasingly building on them beyond COVID-19,” said Belén Garijo, CEO of Merck KGaA, Darmstadt, Germany, in a press release.

The acquisition of Exelead will allow the…

Moderna doses the first patient with its mRNA Epstein-Barr virus vaccine candidate

Moderna (NSDQ:MRNA) has dosed the first volunteer in the Phase 1 Eclipse study of mRNA-1189, an Epstein-Barr virus vaccine candidate.

The study will take place at roughly 15 sites in the U.S. and involve approximately 272 healthy adults between the ages of 18 and 30.

The study will be randomized, observer-blind, placebo-controlled and involve a range of doses.

Epstein-Barr virus (EBV) is one of the most common viruses, representing one of the viruses that cause infectious mononucleosis (mono). EBV is also linked to a heightened risk of multiple sclerosis and some cancers and autoimmune diseases.

EBV seroprevalence tends to rise with age, affecting 90–95% of adults.

“Adolescents who develop infectious mononucleosis are frequently absent from school for weeks and even months at a time, impacting the quality of their education and their families,” said Stéphane Bancel, Moderna CEO, in a press release.

Pfizer (NYSE:PFE) and BioNTech (NSD…