SARS-CoV-2

Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

Retrieved on: 
torsdag, maj 9, 2024
FDA, CMS, Risk, SARS-CoV-2, Food, Webcast, U.S. FDA, Administration, Research and development, Pre-exposure prophylaxis, COVID-19, Patient, Immunodeficiency, Medicine, Medicare, Clinical trial, HCPCS, Vaccine

“The recent months have been incredibly productive for Invivyd.

Key Points: 
  • “The recent months have been incredibly productive for Invivyd.
  • At the beginning of April, Invivyd announced that PEMGARDA is available for purchase in the U.S. through a network of authorized specialty distributors.
  • The company will begin reporting PEMGARDA net product revenue with its second quarter 2024 financial results.
  • First Quarter 2024 Financial Results:
    Cash Position: Cash and cash equivalents were $189.4 million as of March 31, 2024.

Invivyd to Pursue Rapid Immunobridging Pathway to Potential EUA for Treatment of COVID-19 in Moderately to Severely Immunocompromised People, Based on U.S. FDA Feedback

Retrieved on: 
tisdag, maj 7, 2024
FDA, Immunoglobulin G, COVID-19, Risk, SARS-CoV-2, Pharmacokinetics, RBD, Food, Virology, Chronic lymphocytic leukemia, SVP, CLL, MDCM, Pre-exposure prophylaxis, Patient, Immunodeficiency, Medicine, Infection, Vaccine

This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA.

Key Points: 
  • This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA.
  • The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible.
  • Subsequent to the anticipated submission of an EUA request, Invivyd plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics (PK), and clinical virology.
  • “We are glad to once again align with the FDA on a rapid pathway towards addressing a critical unmet medical need among immunocompromised people who may benefit from alternative approaches to treating their symptomatic COVID-19.

Traws Pharma Completes First Cohort Dosed in Phase 1 Trial for COVID Therapy

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tisdag, maj 7, 2024
Volunteering, Mortality, Cancer, Hope, Safety, SARS-CoV-2, Pharmacokinetics, CDC, COVID19, Ageing, Infection, Pharmaceutical industry

NEWTOWN, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced that it completed dosing in the first cohort of the first-in-human Phase 1 study to evaluate travatrelvir (TRX01), an orally-available protease inhibitor, in development for treatment of COVID19. There have been no safety observations reported.

Key Points: 
  • “COVID-19 remains a significant global health concern, with SARS-CoV-2 infections posing a leading cause of mortality, especially among individuals aged 65 and above,” stated Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma.
  • “Our mission at Traws is to develop novel agents to treat respiratory viral diseases.
  • We expect to report topline data from the Phase 1 study in H2 2024, followed by the initiation of an international Phase 2 safety and efficacy study."
  • Robert R. Redfield, M.D., Chief Medical Officer of Traws Pharma and former director of the US Centers for Disease Control (CDC) added, “Travatrelvir has an exciting and unique profile.

Arcturus Therapeutics Announces First Quarter 2024 Financial Update and Pipeline Progress

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onsdag, maj 8, 2024
Biotechnology, Infectious Diseases, COVID-19, Health, Pharmaceutical, Society, COVID, Investment, Meiji, ARCT, Ornithine transcarbamylase deficiency, Safety, SARS-CoV-2, Travel, European Commission, Research, OTC, Cystic fibrosis, Lyme disease, RNA, MAA, Inborn errors of metabolism, Trial of the century, Vaccine, CDMO, Omicron, SRR, GMT, SAD, Liver, CSL, EMA, JPMorgan Chase, SIMD, Civil service commission, Infection, Messenger, Arcturus Therapeutics, Therapy, European Medicines Agency, Pharmaceutical industry

“Arcturus continues to make encouraging progress in both our vaccine and therapeutics pipeline,” said Joseph Payne, President & CEO of Arcturus.

Key Points: 
  • “Arcturus continues to make encouraging progress in both our vaccine and therapeutics pipeline,” said Joseph Payne, President & CEO of Arcturus.
  • To support this effort, Arcturus along with CDMO partners are on track to deliver the initial 4 million commercial doses of Kostaive in Q3.
  • The Company will share a progress update on the Phase 2 study on July 1, 2024.
  • The expected cash runway extends at least three years based on the current pipeline and programs through the first quarter of fiscal year 2027.

LC-Plasma-based Vaccine Research Selected for SCARDA Project

Retrieved on: 
onsdag, maj 8, 2024
Health, Infectious Diseases, Other Health, Research, Science, Pharmaceutical, Biotechnology, Infection, Kirin Holdings, Christian democracy, Postbiotic, Holding company, SARS-CoV-2, Bacteria, Plasma, Vaccine, Urinary tract infection, Immunization, Research and development, Virus, Kirin, Medical research, Multimedia, AMED, BBRC

We now announce that a proposal for our collaborative research has currently been accepted as a project for research and development into new modalities contributing to vaccine development by the Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA) in the Japan Agency for Medical Research and Development (AMED).

Key Points: 
  • We now announce that a proposal for our collaborative research has currently been accepted as a project for research and development into new modalities contributing to vaccine development by the Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA) in the Japan Agency for Medical Research and Development (AMED).
  • View the full release here: https://www.businesswire.com/news/home/20240507111790/en/
    This research aims at developing an intranasal LC-Plasma vaccine to induce innate immunity for prevention of respiratory virus infection.
  • SCARDA was established at AMED in March, 2022, based on the national strategy, to strengthen strategic research funding and to promote the formation of world-class research and development centers ( https://www.amed.go.jp/en/program/list/21/index.html ).
  • This project is to explore the potential of intranasal LC-Plasma vaccination to prevent respiratory infection with viruses including SARS-CoV-2 and influenza viruses.

Vasomune Therapeutics Announces Poster Presentation at the American Thoracic Society International Conference

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måndag, maj 6, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, TEK tyrosine kinase, ATS, Pneumonia, Safety, SARS-CoV-2, Pharmacokinetics, Conference, PEGylation, Acute respiratory distress syndrome, C40, Patient, National Research Council Canada, American Thoracic Society, Therapy, Risk, Infection, Pharmaceutical industry

Vasomune Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development of AV-001 for the treatment of diseases associated with vascular dysfunction, today announced that the Company will present a Late-Breaking scientific poster at the upcoming 2024 American Thoracic Society (ATS) International Conference taking place May 17-22, 2024, at the Manchester Grand Hyatt, San Diego, CA.

Key Points: 
  • Vasomune Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development of AV-001 for the treatment of diseases associated with vascular dysfunction, today announced that the Company will present a Late-Breaking scientific poster at the upcoming 2024 American Thoracic Society (ATS) International Conference taking place May 17-22, 2024, at the Manchester Grand Hyatt, San Diego, CA.
  • Vasomune’s lead drug candidate AV-001, codeveloped with AnGes Inc, is a first-in-class fully synthetic PEGylated peptide targeting the Tie2 receptor.
  • Activation of the Tie2 receptor plays a critical role in promoting vascular stability, barrier integrity and endothelial quiescence.
  • “Vasomune is grateful to the National Research Council Canada for grant #IRAP-965762 which supported the Phase 1 study.

Infinitopes' Article in Peer-Reviewed Journal Seeks to Unlock the Potential of Cancer Vaccines

Retrieved on: 
torsdag, maj 9, 2024
University, Cancer, HVI, SARS-CoV-2, Human Vaccines & Immunotherapeutics, Vaccine, Cancer vaccine, Disease, Patient, Diagnosis, Pharmaceutical industry

OXFORD, England, May 9, 2024 /PRNewswire/ -- Infinitopes Precision Immunomics, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, today announced the publication of a peer-reviewed article in Human Vaccines & Immunotherapeutics (HVI). The article outlines the current cancer vaccine landscape and the challenges facing vaccine technologies for the treatment of solid tumours to explain the advantages of Infinitopes' combined approach to cancer vaccines: incorporating the right targets and the right vectors, for the right patients at the right time.

Key Points: 
  • The review, entitled "Unlocking Cancer Vaccine Potential: What are the Key Factors?
  • ", was an invited contribution from the editorial team at HVI for inclusion in their special edition on cancer vaccines.
  • The Company co-authored the review in close collaboration with senior academics from the University of Oxford's cancer vaccine programme.
  • Cancer vaccines offer a potential solution to this and, in the past few years alone, we have begun to see some exciting results from different vaccine platforms.

Infinitopes' Article in Peer-Reviewed Journal Seeks to Unlock the Potential of Cancer Vaccines

Retrieved on: 
torsdag, maj 9, 2024
University, Cancer, HVI, SARS-CoV-2, Human Vaccines & Immunotherapeutics, Vaccine, Cancer vaccine, Disease, Patient, Diagnosis, Pharmaceutical industry

OXFORD, England, May 9, 2024 /PRNewswire/ -- Infinitopes Precision Immunomics, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, today announced the publication of a peer-reviewed article in Human Vaccines & Immunotherapeutics (HVI). The article outlines the current cancer vaccine landscape and the challenges facing vaccine technologies for the treatment of solid tumours to explain the advantages of Infinitopes' combined approach to cancer vaccines: incorporating the right targets and the right vectors, for the right patients at the right time.

Key Points: 
  • The review, entitled "Unlocking Cancer Vaccine Potential: What are the Key Factors?
  • ", was an invited contribution from the editorial team at HVI for inclusion in their special edition on cancer vaccines.
  • The Company co-authored the review in close collaboration with senior academics from the University of Oxford's cancer vaccine programme.
  • Cancer vaccines offer a potential solution to this and, in the past few years alone, we have begun to see some exciting results from different vaccine platforms.

NSRI scientists conduct infectious aerosol risk study onboard USNS Mercy

Retrieved on: 
torsdag, maj 2, 2024
University, SARS-CoV-2, Research, Navy, United States Navy, NSRI, Patient, USNS Comfort (T-AH-20), USS Mercy, USNS, Intensive care medicine, COVID-19, Nursing

OMAHA, Neb., May 2, 2024 /PRNewswire/ -- Scientists from the National Strategic Research Institute (NSRI) at the University of Nebraska recently spent nine days at sea on board the U.S. Navy hospital ship, USNS Mercy, to conduct testing for the underway phase of an infectious aerosol risk study.

Key Points: 
  • OMAHA, Neb., May 2, 2024 /PRNewswire/ -- Scientists from the National Strategic Research Institute (NSRI) at the University of Nebraska recently spent nine days at sea on board the U.S. Navy hospital ship, USNS Mercy, to conduct testing for the underway phase of an infectious aerosol risk study.
  • MERCY's secondary mission is to provide full hospital services to support U.S. disaster relief and humanitarian operations worldwide.
  • During the COVID-19 pandemic, the USNS Mercy and its sister hospital ship, USNS Comfort, deployed to Los Angeles and New York City, respectively.
  • The study aims to identify risks associated with infectious airborne pathogens, including SARS-CoV-2, so decision makers can implement strategies to mitigate risks and ensure operational readiness and mission success.

EQS-News: CureVac Announces Financial Results for the Fourth Quarter and Full-Year 2023 and Provides Business Update

Retrieved on: 
fredag, maj 3, 2024
University, Part, CMO, Federal republic, Research, Cancer, Federal Patent Court (Germany), Vaccine, Business, Webcast, BioNTech, District court, Whole genome sequencing, Vaccination, Public, WHO, Hearing loss, Cardiology, Animal, EP 1, Omicron, GSK, Systems biology, Workforce, Infection, Messenger, Federal court, Therapy, Data monitoring committee, Safety, Monroe Dunaway Anderson, CVAC, Justice, RNA, Astrocytoma, Motion, Human, CureVac, Pandemic, GMP, Sąd rejonowy, SARS-CoV-2, Business development, Epitope, MD, Acuitas Therapeutics, DSMB, Ageing, Patent, Patient, Neurology, Operating cost, H5N1, MD Anderson Cancer Center, PPA, Interim, MBA, Antigen, COVID-19, Amgen

ET / 3 p.m. CET

Key Points: 
  • ET / 3 p.m. CET
    TÜBINGEN, Germany/BOSTON, USA – April 24, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced financial results for the fourth quarter and full-year 2023 and provided a business update.
  • “We closed out 2023 on a sturdy footing and are poised to advance strongly through 2024 with strategic initiatives to make CureVac fit-for-purpose.
  • Thaminda Ramanayake was appointed to the CureVac Management Team as Chief Business Officer effective June 1, 2024.
  • Mr. Ramanayake joins CureVac from Affini-T Therapeutics, where he served as Chief Business Officer and was responsible for creating the company’s business development organization.