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Global biotechnology leader CSL today announced the official opening of the company's new state-of-the-art research and development (R&D) center in Waltham, Massachusetts.

CSL's global R&D organization has over 2,000 employees in ten countries, contributing to a robust and promising pipeline of novel therapeutic candidates.

The custom-built facility west of Boston will serve as CSL's central hub for current and future vaccine designs, such as cell-based flu shots.

"CSL's growing R&D presence in Waltham is the latest example of our investment in our future – which includes advancing our growing capabilities in disruptive technologies like next-generation mRNA," said Jon Edelman, Senior Vice President of the CSL Vaccines Innovation Unit, in a press release on March 27, 2023.

In addition to Waltham, Massachusetts, the company has an R&D presence helping create an integrated global organization that can conveniently collaborate with institutions everywhere, offer access to professional development opportunities, and enhance external innovation.

"The Waltham site's location and our investment in this world-class facility will provide our talented people with the ideal environment to deliver the breakthroughs that CSL aims to achieve," added Ethan Settembre, Ph.D., Vice President, Research, CSL Vaccines Innovation Unit and site head for this facility.

"We are also excited that this location provides an opportunity for our scientists to collaborate closely with industry and academic partners, allowing greater access to ongoing innovation and talent."

CSL already produces world-class vaccines, such as Flucelvax® Quadrivalent, a cell culture-based flu vaccine, and bird flu vaccines, such as Audenz™ monovalent, adjuvanted, cell-based inactivated influenza (H5N1) subunit vaccine.

Note: This news article is not paid content.

Vaccine Treats: 
Influenza
Image: 
Image Caption: 
CSL Waltham, Massachusetts March 27, 2023
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Boston
Vaccine: 
Flucelvax Quadrivalent Influenza Vaccine
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BioNTech SE today reported financial results as of December 31, 2022, and provided an update on its corporate progress.

In December 2022, BioNTech and Pfizer announced that approximately 2 billion doses of COMIRNATY®  were invoiced globally in 2022 between the two companies.

This includes approximately 550 million doses of the Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine as of mid-December 2022.

And as part of BioNTech's and Pfizer's 2-billion-doses-pledge to support equitable access to medicines, the companies have delivered approximately 1.7 billion doses of COMIRNATY to low- and middle-income countries in line with demand.

The deliveries include the Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine and the original COVID-19 vaccine. 

"Our COVID-19 vaccine revenues, driven by the delivery of our Omicron-adapted bivalent vaccines, have ensured another strong financial performance in 2022," said Jens Holstein, CFO of BioNTech, in a press release on March 27, 2023.

"We believe that the Company's financial success in 2022 will provide a springboard to accelerate and build upon our diversified clinical pipeline and fuel our research and development in the coming years. 

The complete press release is posted at this link.

Vaccine Treats: 
COVID-19
Image: 
Image Caption: 
by Jerzy Górecki
Live Blog Update Author: 
Don Hackett
Location Tags: 
Mainz
Vaccine: 
Comirnaty COVID-19 Vaccine
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Alzamend Neuro, Inc. today announced the completion of the clinical portion of its Phase IIA multiple ascending dose ("MAD") study for dementia related to Alzheimer's.

The topline data is expected to be disclosed in June 2023.

AL001 is a novel lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with dementia-related to mild, moderate, and severe cognitive impairment associated with Alzheimer's.

AL001 can potentially deliver the benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium.

"We strongly believe that AL001's patented ionic cocrystal technology could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million American suffering from Alzheimer's, bipolar disorder, MDD, and PTSD," said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on March 22, 2023.

"We look forward to reporting topline data in June 2023 and further advancing clinical development of this promising potential therapeutic."

Having completed the clinical portion of the MAD study, the resulting pharmacokinetic and statistical data are undergoing evaluation of the safety and tolerability of AL001 under multiple-dose, steady‑state conditions.

This characterizes the maximum tolerated dose in healthy young and elderly subjects and subjects diagnosed with mild to moderate Alzheimer's.

Potentially safe and effective doses will be determined for deployment in planned subsequent Phase IIA clinical trials involving Alzheimer's, bipolar disorder, MDD, and PTSD subjects.

Lithium has been well-characterized for safety and is approved/marketed in multiple formulations for bipolar affective disorders.

AL001 lithium ascending dosing for the MAD cohorts tested incremental fractions of the usual lithium exposure for the treatment of bipolar affective disorder, with the target lithium dose for Alzheimer's treatment expected at a level that will not require therapeutic drug monitoring.

In each of the multiple healthy young/elderly and Alzheimer's cohorts, consisting of 6 active and 2 placebo patients each (as per randomization), multiple ascending doses were administered three times daily for 14 days under fasted conditions up to tolerability/safety limits that included the highest dose permitted per protocol.

As of March 22, 2023, there are no approved vaccines targeting Alzheimer's disease.

Vaccine Treats: 
Alzheimer’s Disease
Image: 
Image Caption: 
by Gerd Altmann
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Atlanta
Vaccine: 
Alzheimer’s Disease Vaccines 2023

JNJ-1802 Dengue Antiviral

JNJ-1802 Dengue Antiviral 2023

Janssen Pharmaceutical Companies JNJ-1802 first-in-class dengue antiviral uses a novel mechanism of action to prevent the interaction between two viral proteins (NS3 and NS4B), thereby stopping the ability of the virus to replicate. JNJ-1802 was shown to be safe and well tolerated in a Phase 1 first-in-human clinical study and is progressing into Phase 2 clinical studies for the prevention and treatment of dengue.

Recent data indicate JNJ-1802 is effective against all four dengue serotypes in mouse models and provides strong protection against two tested serotypes (DENV-1 and -2) in non-human primates. These findings build on research published in the journal Nature in 2021 that first identified the novel mechanism of action from the same chemical series as JNJ-1802.

Janssen Pharmaceutical Companies focuses on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology,  Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

New Jersey-based Johnson & Johnson’s work against dengue is one part of a larger, more than 15-year legacy working to address the burden of Neglected Tropical Diseases, a group of about 20 communicable diseases that affect more than 1.7 billion people in 149 countries around the world. Additionally, the Company launched the Satellite Center for Global Health Discovery at Duke-NUS Medical School in Singapore in June 2022, which is focused on accelerating early-stage discovery research to address the growing challenge of flaviviruses, including dengue. 

JNJ-1802 Indication

JNJ-1802 is indicated to protect people against four dengue serotypes. Current research supports the further clinical development of JNJ-1802 for both the prevention and treatment of dengue. Dengue reinfection is possible due to the presence of four dengue serotypes.

JNJ-1802 News 2023

March 15, 2023 - Janssen Announces Novel Dengue Antiviral Demonstrates Efficacy in Preclinical Data Published in Nature.

October 6, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced the publication of preclinical data in the journal Nature showing that an early-stage compound with a novel mechanism of action could potentially treat all serotypes of dengue fever and provide a period of protection against acquiring the dengue virus.

JNJ-1802 Clinical Trials

Phase 2 clinical trial - Last Update Posted: February 16, 2023.

Phase 2 ClinicalTrials.gov Identifier: NCT04906980 - Last Update Posted: March 15, 2023.

The Phase 1 double-blind, randomized, placebo-controlled study was conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of the novel dengue antiviral compound, which is being developed to prevent dengue. Results from the study show that Janssen’s breakthrough compound administered orally in single or multiple doses, was safe and well-tolerated, with no serious adverse events reported. The preclinical results also demonstrated promising safety data and excellent efficacy at preventing dengue virus infection in mouse and non-human primate models by blocking the interaction between two viral proteins (NS3 and NS4B) that are needed in the replication process of the dengue virus.

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Manufacturer: 
Janssen
Reviewer: 
Robert Carlson, MD
Vaccine: 
JNJ-1802 Dengue Antiviral
Availability: 
N/A
Generic: 
JNJ-1802
Drug Class: 
Antiviral
Clinical Trial Phase I: 
Phase 1 study
Clinical Trial Phase II: 
A Study of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants
Condition: 
Dengue
Last Reviewed: 
Monday, March 20, 2023 - 05:05
Status: 
Candidate
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
0 min read

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced an early-stage antiviral candidate (JNJ-1802) provides strong protection against dengue in non-human primates and mice.

The new data indicate JNJ-1802 is effective against all four dengue serotypes in mouse models and provides strong protection against two tested serotypes (DENV-1 and -2) in non-human primates.

The first-in-class antiviral, which was shown to be safe and well tolerated in a first-in-human clinical study, is progressing into Phase 2 clinical studies for the prevention and treatment of dengue.

"The unprecedented rise in dengue outbreaks throughout the past years offers a glimpse of what lies ahead ....." said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health R&D at Janssen Research & Development, LLC, in a press release on March 15, 2023.

"We know an antiviral will be critical to addressing the unmet needs today and tomorrow."

The peer-review journal Nature published this study: Blocking NS3–NS4B interaction inhibits dengue virus in non-human primates. These findings support the further clinical development of JNJ-1802, a first-in-class antiviral agent against dengue, which is now progressing in clinical studies to prevent and treat dengue.

Vaccine Treats: 
Dengue
Image: 
Image Caption: 
by Andrew from Pixabay
Live Blog Update Author: 
Don Hackett
Location Tags: 
Beerse
Vaccine: 
QDENGA (TAK-003) Dengue Vaccine
Dengue Miami Florida 2023

Dengue Antiviral Candidate Found Efficacious and Safe

JNJ-1802 antiviral targets four dengue serotypes
March 16, 2023
0 min read

The Government of Canada today confirmed its' main priority continues to be protecting the health and safety of Canadians. Throughout the recent pandemic, decisive actions taken empowered Canada to scale up domestic biomanufacturing capacity, which had been in decline for over 40 years.

On March 14, 2023, Adam van Koeverden, Parliamentary Secretary to the Minister of Health and to the Minister of Sport, highlighted in a press release an investment of $2 million to create the Canadian Hub for Health Intelligence & Innovation in Infectious Diseases (HI3).

This support is part of a $10 million investment announced on March 2, 2023, for creating five research hubs as part of Stage 1 of the integrated Canada Biomedical Research Fund and Biosciences Research Infrastructure Fund competition.

The University of Toronto (UofT) leads the Canadian Hub for Health Intelligence & Innovation in Infectious Diseases.

The HI3 hub is led by co-directors Jen Gommerman and Scott Gray-Owen, professors of immunology and molecular genetics, respectively, in the Temerty Faculty of Medicine at U of T. 

It will focus on advancing the concept of "personalized and precise medicine" to influence the development of vaccines, therapeutics, and other public health interventions.

Image: 
Image Caption: 
Canada's HI3 Hub March 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Toronto
Bird flu cases in Europe 2023

Europe's Bird Flu Outbreak Raises Concerns

Avian influenza is spreading in birds, mammals, and infecting people.
March 14, 2023
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The U.K. National History Museum recently reported sea lions in Peru are among the latest victims of a version of the highly pathogenic avian influenza (HPAI) known as bird flu.

The HAPI virus has killed about 3,500 South American sea lions in Peru as of March 9, 2023.

The Peruvian government has reported that since November 2022, around 3% of the country's sea lions have died due to HPAI infections.

Peru, like many South American countries, believes HAPI was brought south by pelicans before jumping into the marine mammals. 

In the Northern Hemisphere, Canada and the United States have reported multiple mammalian fatalities related to bird flu infections.

The United States Department of Agriculture and the World Animal Health Information System reported during March 2023, over 131 HAPI H5N1 detections of wild striped skunks, black bears, raccoons, and red foxes.

  • The California Department of Fish and Wildlife received confirmation on February 15, 2023, that an adult bobcat died from the Eurasian strain of HPAI H5N1.
  • The Colorado Parks and Wildlife confirmed on February 9, 2023, several cases of HPAI in free-ranging wildlife (black bear, skunk, mountain lion).
  • The Montana Department of Fish, Wildlife, and Parks confirmed on January 17, 2023, three juvenile grizzly bears tested positive for HAPI.

While there are no vaccines that protect birds or mammals from H5N1 infections, there are bird flu vaccines for humans.

In the U.S., the Food and Drug Administration authorized CSL Seqirus' Audenz™ vaccine on January 31, 2020, and RAPIVAB® in 2022.

And the U.S. government has financially supported the development of newer bird flu vaccines for people.

Furthermore, the government reminds everyone that annual flu shots are effective against certain types of influenza, but they are not effective against bord flu viruses.

Vaccine Treats: 
Bird Flu
Image: 
Image Caption: 
South American sea lions - by Lars Schlageter
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Peru
Vaccine: 
Audenz Influenza A(H5N1) Vaccine
Texas cruise ships

Norovirus Upsets Spring Break for Cruisers

HIL-214 virus like particle-based bivalent vaccine candidate is conducting research
March 9, 2023