SARS-CoV-2

Infectious Disease Diagnostics for Influenza, RSV and SARS-CoV-2, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, February 14, 2024

TORONTO, Feb. 14, 2024 /PRNewswire-PRWeb/ -- The need for rapid, accessible and portable infectious disease diagnostics for seasonal respiratory diseases like influenza, respiratory syncytial virus (RSV) and SARS-CoV-2 is critical to saving lives. Join an informative webinar focused on in vitro diagnostic development to meet this need, ranging from assay design, the use of bioinformatics in identifying emerging pathogens and optimizing assays, and securing the necessary regulatory approvals that support market access.

Key Points: 
  • In this free webinar, learn about the importance of expertise at all stages of infectious disease diagnostics development.
  • The featured speakers will discuss the value of bioinformatics in the development of infectious disease diagnostics.
  • TORONTO, Feb. 14, 2024 /PRNewswire-PRWeb/ -- The need for rapid, accessible and portable infectious disease diagnostics for seasonal respiratory diseases like influenza, respiratory syncytial virus (RSV) and SARS-CoV-2 is critical to saving lives.
  • Register for this webinar to learn how to effectively take an infectious disease diagnostic assay from initial design stages through regulatory approvals that support market access.

EXPERT SYSTEMS FACILITATES RAPID ADVANCEMENT OF GROUNDBREAKING COVID-19 TREATMENT, TRX01, TO CLINICAL TRIALS WITHIN TWO YEARS

Retrieved on: 
Tuesday, February 13, 2024

ROCKVILLE, Md., Feb. 13, 2024 /PRNewswire/ -- Expert Systems Inc., a private company (ESI), announces the initiation of a first-in-human trial of TRX01 by their partner Trawsfynydd Therapeutics, a private company.

Key Points: 
  • ROCKVILLE, Md., Feb. 13, 2024 /PRNewswire/ -- Expert Systems Inc., a private company (ESI), announces the initiation of a first-in-human trial of TRX01 by their partner Trawsfynydd Therapeutics, a private company.
  • Expert Systems deployed their accelerator platform to engineer this cutting-edge protease inhibitor targeting the SARS-CoV-2 viral main protease (3CL, Mpro) in less than two years.
  • The Phase 1 clinical trial aims to evaluate TRX01's safety, tolerability, and pharmacokinetics in healthy individuals, laying the foundation for potential regulatory approval and broad accessibility for this much needed therapeutic.
  • "Expert Systems' AI-driven rational design methodologies have played a pivotal role in creating superior therapeutics, eliminating the necessity for ritonavir co-administration, marking a major stride in combating this lethal viral disease," commented Bill Farley, CBO at Expert Systems.

MiNK Therapeutics' AgenT-797 Shows Promising Results in the Treatment of Severe Acute Respiratory Distress, Published in Nature Communications

Retrieved on: 
Tuesday, February 6, 2024

These findings show that agenT-797 holds significant promise in improving patient survival and reducing secondary infections, all while maintaining a favorable safety profile.

Key Points: 
  • These findings show that agenT-797 holds significant promise in improving patient survival and reducing secondary infections, all while maintaining a favorable safety profile.
  • ARDS is a life-threatening, rapidly progressive form of respiratory failure, associated with approximately 40% mortality.
  • These data stand in stark contrast compared to 10% survival rate in the in-hospital control group at the same time.
  • The company plans to further advance agenT-797 in patients with viral ARDS through an externally funded, large platform trial.”
    The publication is available at: https://www.nature.com/articles/s41467-024-44905-z .

GeoVax Reports Positive Interim Data From Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster

Retrieved on: 
Tuesday, February 6, 2024

ATLANTA, GA, Feb. 06, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced positive initial safety and immune response findings from its Phase 2 clinical trial at one month following administration of its Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466), was fully enrolled at the end of Sept 2023.

Key Points: 
  • The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year.
  • To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations.
  • The immunological responses measured throughout the study period include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses.
  • We look forward to providing further updates regarding the successful progress of the clinical development of GEO-CM04S1.”

Vaxart Announces Publication in Vaccines of Non-Human Primate Preclinical Data Demonstrating Its Next-Generation Vaccine Candidates Elicit Mucosal and Systemic Immunogenicity and Reduce Viral Shedding after SARS-CoV-2 Challenge

Retrieved on: 
Monday, February 5, 2024

SOUTH SAN FRANCISCO, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the publication of preclinical non-human primate data demonstrating the potential of its COVID-19 vaccine to protect against multiple SARS-CoV-2 variants of concern (VOC)s. The data, which were previously presented at the International Congress of Mucosal Immunology 2022, are reported in the current issue of Vaccines.

Key Points: 
  • “The data published in Vaccines support the potential of our vaccine platform to stimulate potent mucosal cross-reactive IgA responses to multiple VOCs and reduce viral transmission.
  • All three vaccines induced neutralizing antibodies in both the peripheral and mucosal compartments, which was enhanced with a boost immunization.
  • Viral replication and infectious particle shedding were significantly reduced in immunized animals after challenge with beta variant SARS-CoV-2.
  • Vaxart believes these data support the potential for its vaccines to enhance mucosal responses and reduce community transmission, in addition to preventing severe disease.

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

Retrieved on: 
Monday, February 5, 2024

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine.

Key Points: 
  • Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine.
  • ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).
  • “These results further support sa-mRNA’s differentiating attribute to provide prolonged protection against COVID-19 at lower doses,” said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.
  • GMTs against Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than those observed 28 days after the Comirnaty® booster.

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

Retrieved on: 
Monday, February 5, 2024

KING OF PRUSSIA, Pa. and SAN DIEGO, Feb. 5, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154 , the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine. ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).

Key Points: 
  • ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).
  • The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response as compared to Comirnaty for both the original Wuhan strain and Omicron BA.4/5 variant and an advantage in antibody persistence.
  • "These results further support sa-mRNA's differentiating attribute to provide prolonged protection against COVID-19 at lower doses," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.
  • GMTs against Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than those observed 28 days after the Comirnaty® booster.

As Omicron subvariants continue their worldwide transmission, CoVaRR-Net awarded another year of funding

Retrieved on: 
Tuesday, January 30, 2024

Although many discoveries have been made over the past three years, there remain many unanswered questions as subvariants continue to spread and affect people around the world.

Key Points: 
  • Although many discoveries have been made over the past three years, there remain many unanswered questions as subvariants continue to spread and affect people around the world.
  • This is why the Coronavirus Variants Rapid Response Network (CoVaRR-Net) will continue focused activities with a final $6 million in funding from the Canadian Institutes for Health Research (CIHR).
  • “CoVaRR-Net is an academic network that has provided a new model for cooperation in research across Canada,” says CoVaRR-Net Executive Director Dr. Marc-André Langlois.
  • The Canadian Consortium of Academic Biosafety Level 3 ( CCABL3 ) Laboratories, a CoVaRR-Net initiative that unites academic biosafety level 3 laboratories in Canada.

Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2

Retrieved on: 
Wednesday, January 24, 2024

SAN DIEGO, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study.

Key Points: 
  • As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval.
  • We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases.
  • Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine.
  • Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses.

CDC awards Truveta a real-world data contract to study COVID, maternal health, and pediatric care

Retrieved on: 
Monday, January 22, 2024

Truveta will provide real-world data for CDC researchers to conduct respiratory virus surveillance, including COVID-19, as well as data to facilitate studies on maternal health and pediatric care.

Key Points: 
  • Truveta will provide real-world data for CDC researchers to conduct respiratory virus surveillance, including COVID-19, as well as data to facilitate studies on maternal health and pediatric care.
  • Truveta Data will help facilitate the CDC's COVID response and surveillance efforts as it enables CDC scientists to access representative patient-level data, without delays, for statistically significant populations.
  • "As the coronavirus pandemic began ravaging our country and the world, Truveta was formed in 2020 to bring together data that would enable faster answers and better care,” said Truveta CEO Terry Myerson.
  • We are honored that our unique data will help the CDC advance its mission of working 24/7 to save lives and protect people."