HHS awards more than $1 billion to advance next-gen COVID-19 vaccines and therapeutics

The U.S. Department of Health and Human Services (HHS) has awarded $1.4 billion to support vaccine clinical trials to test new, more effective and longer-lasting COVID-19 vaccines. In all, Project NextGen is a $5 billion initiative from Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the program is to identify and address strengths and weaknesses of current COVID-19 therapies and vaccines, as well as the back the development of next-gen COVID-19 vaccines and therapies

The latest funding announcement announced allots $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody and another $100 million to spark innovation of novel vaccine and therapeutic technologies. 

Towards next-gen COVID-19 vaccines and therapies

Regeneron alone received $326 million under the program, dubbed Project NextGen. The funding for the Tarrytown, New York–bas…

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Phase 3 trial shows donanemab reduces Alzheimer’s symptoms by 35%

According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries.

Another monoclonal antibody, Leqembi (lecanemab) recently won FDA approval for Alzheimer’s disease treatment after showing a statistically significant 27% reduction in decline on the Clinical Dementia Rating Scale in trials.

Donanemab is an investigational plaque-clearing antibody similar to lecanemab and aducanumab, which controversially notched FDA approval in 2021 based on its plaque reduction despite inconsistent clinical efficacy data.


The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated that donanemab, an investigational drug, significantly slowed cognitive and fun…

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The recent FDA thumbs-up for Beyfortus could kickstart a new chapter in RSV prevention

Respiratory syncytial virus (RSV) is a common cause of severe lower respiratory tract infections like pneumonia and bronchiolitis in infants and young children. Traditionally there have been no approved treatments for RSV infections, with care being largely supportive. But the landscape is quickly changing.

The FDA recently approved Beyfortus (nirsevimab), the first immunoprophylactic to prevent RSV disease in newborns, infants and toddlers. On the RSV vaccine front, FDA also approved GSK‘s (NYSE:GSK) Arexvy. Other RSV vaccine candidates are waiting in the wings.

A shift in the RSV treatment landscape

Beyfortus is a monoclonal antibody developed by AstraZeneca and Sanofi that provides protection against RSV with a single intramuscular injection. It is the first innovation in RSV prevention in over two decades. Until recently, the only preventive therapy on the market was Synagis, a monoclonal antibody used to help prevent serious lung disease from RSV in …

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FDA authorization of vilobelimab signals new opportunities for drug developers in inflammatory diseases

The FDA has granted InflaRx (Nasdaq:IFRX) emergency use authorization (EUA) for the monoclonal antibody Gohibic (vilobelimab) to treat critically-ill COVID-19 patients. The company’s shares were up yesterday almost 84% to $3.77. Today, its shares jumped an additional 62% to $6.10.

The EUA represents a significant advance for the Jena, Germany–based company, which on March 31, 2022, encountered a setback related to the antibody. At that time, the company announced that vilobelimab failed a topline readout for critically ill intubated patients suffering from COVID-induced pneumonia in the phase 2/3 PANAMO study. Later, however, InflaRx reported in a predefined analysis without site-stratification that vilobelimab significantly decreased all-cause mortality at 28 days. While the initial protocol did not require site-stratification, the company amended the protocol based on regulators’ recommendations.

Regulatory nod for vilobelimab could spark new developments …
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Leyden Labs closes $140M in Series B funding

After announcing a licensing deal for CR9114, a monoclonal antibody for influenza A and B from Janssen (NYSE:JNJ), Leyden Labs has won $140 million in Series B funding.

Amsterdam-based Leyden Labs plans on developing an intranasal spray based on CR9114.

Leading the round were Casdin Capital and GV (formerly Google Ventures).

Leyden plans on using the most recent funding round to advance its pipeline dedicated to targeting a range of respiratory viruses.

In March, Leyden Labs won €40 (approximately $45) million in Series A financing in a round led by GV.

The company notes that its total fundraising is approximately $200 million.

The most recent funding round “underscores our investors’ belief that Leyden Labs’ platform can generate cornerstone products to combat respiratory diseases,” said Koenraad Wiedhaup, a founder and CEO of Leyden Labs, in a press release. “The ongoing COVID-19 pandemic teaches us we need to expand our arsenal of…

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GSK and Vir file for EUA for intramuscular administration of sotrovimab to treat COVID-19

GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab.

Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of developing severe COVID-19.

Sotrovimab won emergency use authorization (EUA) in the U.S. in May 2021. In addition, it won EU marketing authorization as an early COVID-19 therapy in December 2021.

The companies note that data from the Phase 3 COMET-TAIL trial found that 500-mg intramuscular injection of the monoclonal antibody was non-inferior to intravenous injection.

Interim data from that trial was published in The New England Journal of Medicine last year. Final data were published as a pre-print on medRxiv. GSK and Vir Biotechnology anticipate that the full data will be publi…

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REGEN-COV lowers risk of symptomatic COVID-19 infections by 81% in study

Regeneron’s (NSDQ:REGN) REGEN-COV remains one of the most effective monoclonal antibody therapies in reducing the risk of serious COVID-19 infections and resulting hospitalizations and deaths. A study recently published in the New England Journal of Medicine found that the drug effectively prevented COVID-19 disease in household contacts of individuals infected with the novel coronavirus.

When delivered subcutaneously, REGEN-COV was 81.4% effective at reducing the risk of symptomatic infections and led to a 92.6% reduction of symptomatic infections after the first week.

Consisting of the monoclonal antibodies casirivimab and imdevimab, REGEN-COV also appeared to accelerate the recovery of COVID-19-infected individuals. In recipients who received the drug, symptoms resolved two weeks faster than in placebo recipients.

Study investigators also found that the drug was generally well-tolerated.

“This peer-reviewed NEJM publication demonstrates that RE…

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Immunotherapy against cancer: Challenge and opportunities

Image from Wikipedia.

With some of the recently developed drugs showing unprecedented response rates and consistent improvement in overall survival in some indications, we face the dawn of a new era in anticancer research. New therapeutic targets, novel classes of products, booming and competing pipelines, innovative statistical methods, and a changing regulatory environment are all features of this new era.  

More than ever, we need clinical trials that can incorporate the required innovations into their design, conduct, infrastructure and analysis. Fortunately, specialist CROs stand ready to take what they have learned from the past 10 years of oncology drug development and apply it to the new world in which we find ourselves. 

These CROs already know how to meet the challenges of segmented study populations and an increasingly competitive development landscape, how to implement complex and adaptive…

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HHS halts distribution of Lilly’s bamlanivimab/etesevimab antibody cocktail

U.S. government authorities have decided to immediately pause the distribution of Eli Lilly’s bamlanivimab and etesevimab over concerns that the monoclonal antibody cocktail is ineffective against some SARS-CoV-2 variants.

CDC recently concluded that the Gamma variant (P.1) and the Beta variant (B.1.351) make up 11% of COVID-19 infections. They are also continuing to become more dominant, as is the Delta variant (B.1.617.2). CDC has determined that the Delta variant is possibly less responsive to some monoclonal antibody treatments.

The Beta and Gamma variants are significantly less responsive to bamlanivimab and etesevimab than other viral lineages.

Bamlanivimab and etesevimab image courtesy of Lilly.

FDA is recommending Regeneron’s REGEN-COV and GSK’s sotrovimab as more robust antibody therapies.

In related news, FDA recently granted emergency use authorization to tocilizumab, a monoc…

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How lupus clinical trials are evolving

A high magnification micrograph of histomorphologic changes in a lymph node resulting from systemic lupus erythematosus (SLE). Image from Wikipedia.

In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities.

Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus erythematosus (SLE). SLE is the most common form of lupus. The PDUFA date for anifrolumab is September 30, 2021, according to the Antibody Society.

A fully human monoclonal antibody, anifrolumab binds to subunit 1 of the type I interferon receptor, potentially calming the impact of pro-inflammatory cytokines involved in lupus.

Anifrolumab has shown promise in SLE patie…

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Anifrolumab data promising for systemic lupus erythematosus

AstraZeneca (LON:AZN) has announced that a new posthoc analysis of data from the TULIP Phase 3 clinical trials of anifrolumab showed promise in patients with systemic lupus erythematosus (SLE), the most common type of lupus. Anifrolumab is a monoclonal antibody that blocks the activity of interferons such as interferon-α and interferon-β. If approved, anifrolumab would be a first-in-class type I interferon inhibitor.

The most recent clinical trial data demonstrated that anifrolumab led to consistent skin rash and arthritis improvements in patients with moderate to severe SLE compared to placebo.

“Arthritis and rash are the most common and persistent problems in lupus and often have a significant impact on a person’s life,” said Joan Merrill, Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Research Program, U.S., in a statement. The data from the recent analysis indicate that anifrolumab was “consistently effective using three different…

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U.S. government classifies threat levels of SARS-CoV-2 variants

Image courtesy of Wikipedia

The number of SARS-CoV-2 variants with enhanced transmissibility and resistance to antibodies is increasing, prompting the U.S. government to issue guidance on how to classify them.

The criteria divide variants into three categories including the following:

Variant of interest: This virus type has genetic markers that have been linked to a potentially increased risk. Examples include mutations that could change how the virus enters cells and responds to antibodies from vaccination or infection. Such a virus could also potentially enhance transmissibility or disease severity. Variant of concern: This class includes variants with evidence of increased transmissibility, severe disease or reduction in neutralization by antibodies from infection or vaccination. Such a variant may also pose a higher risk of eluding testing. See the table below for examples. Variant of high conseque…
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