BARDA

Esperovax Awarded $1M for Development of an Oral COVID-19 RNA Vaccine under the HHS Project NextGen Initiative

Retrieved on: 
Tuesday, October 3, 2023
BLUE, Nextgen, Biomedical Advanced Research and Development Authority, University, Public, Johnson & Johnson, COVID-19, Anglo-Scandinavian, Infection, RNA, The Blue Knight, Development, Investigational New Drug, Animal, UTHealth School of Dentistry, BARDA, Disease, Vaccine

PLYMOUTH, Mich., Oct. 3, 2023 /PRNewswire/ -- Esperovax, a U.S.-based preclinical biopharmaceutical company and a BLUE KNIGHT™ resident company, is receiving an award for $ 1 M to further develop a yeast-based oral COVID-19 RNA vaccine candidate as part of the BLUE KNIGHT™ QuickFire Challenge : Accelerating Project NextGen.

Key Points: 
  • PLYMOUTH, Mich., Oct. 3, 2023 /PRNewswire/ -- Esperovax, a U.S.-based preclinical biopharmaceutical company and a BLUE KNIGHT™ resident company, is receiving an award for $ 1 M to further develop a yeast-based oral COVID-19 RNA vaccine candidate as part of the BLUE KNIGHT™ QuickFire Challenge : Accelerating Project NextGen.
  • This award will support critical studies aimed at demonstrating vaccine safety and immunoprotection in orally vaccinated animals challenged with different COVID-19 virus variants.
  • Esperovax is collaborating with Dr. Slobodan Paessler at the University of Texas Medical Branch – Galveston to conduct these studies.
  • Blue Knight, a joint initiative between Johnson & Johnson Innovation – JLABS (JLABS) and the Biomedical Advanced Research and Development Authority (BARDA), collaborates with companies to accelerate innovation against emerging health security threats.

Vir Biotechnology Awarded BARDA Funding to Support Development of Antibody Platform Technologies for Global Infectious Disease Threats

Retrieved on: 
Tuesday, October 3, 2023
OT, United States Department of Health and Human Services, ASPR, Office of Inspector General, U.S. Department of Health and Human Services, Nextgen, Biomedical Advanced Research and Development Authority, Therapy, CBRN, HHS, Human services, OTA, COVID-19, Infection, Administration for Strategic Preparedness and Response, Hope, MBA, Research, Government, Wind, Administration, Development, Division, SAN, BARDA, Radiation, Vaccine, Hook effect

SAN FRANCISCO, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), has awarded Vir approximately $50 million in new funding to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions to widen the applicability of mAbs in COVID-19 and in pandemic preparedness and response.

Key Points: 
  • “We are grateful to the U.S. government for its continued support of our innovative technological approaches in mAb research and development as we seek to optimize mAb delivery.
  • Such delivery could widen the breadth of administration options and shorten development and manufacturing timelines.
  • The new investment falls under Vir’s existing Other Transaction Authority (OTA), a multi-year contract BARDA awarded Vir in 2022 .
  • This OTA allows for a potential total investment of up to $1 billion to support Vir’s development of future pandemic influenza mAbs as well as the potential development of up to 10 emerging infectious disease or CBRN medical countermeasure candidates.

Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole

Retrieved on: 
Monday, October 2, 2023
SAB, ASPR, US Foods, Prescription Drug User Fee Act, Partnership, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, Administration for Strategic Preparedness and Response, LR, NDA, CABP, Ceftobiprole, ABSSSI, GAIN, Administration, Development, Patient, PDUFA, Infection, Fungal infection, FDA, Safety, BARDA, TARGET, Pharmaceutical industry, Allschwil, New Drug Application

Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024

Key Points: 
  • Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024
    Ad hoc announcement pursuant to Art.
  • 53 LR
    Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the antibiotic ceftobiprole, which was submitted to the FDA on August 3rd this year.
  • The FDA has set April 03, 2024, as the Prescription Drug User Fee Act (PDUFA) goal date.
  • Basilea is planning to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the PDUFA goal date.

ModeX Therapeutics Secures BARDA Contract to Develop Novel Multispecific Antibodies Against Viral Infectious Disease Threats

Retrieved on: 
Thursday, September 28, 2023
United States Department of Health and Human Services, DNA, Biomedical Advanced Research and Development Authority, Epstein–Barr virus, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, HHS, SARS-CoV-2, Human services, Public, Infection, COVID-19, MSTAR, Administration for Strategic Preparedness and Response, DRS, Research, Antibody, Bangladesh Technical Education Board, Modex, Messenger, Vaccine Research Center, Administration, Development, OPKO Health, Merck, BARDA, Virus, NIH, Vaccine

The awarded funding will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX proprietary MSTAR technology.

Key Points: 
  • The awarded funding will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX proprietary MSTAR technology.
  • Additional funding of up to $109 million may be available from BARDA upon achieving particular milestones to develop multispecific antibodies targeting other viral pathogens such as influenza.
  • “We are excited to partner with BARDA to advance the potential of our MSTAR multispecific antibody platform as a versatile solution to major viral threats,” said Drs.
  • Gary Nabel and Elias Zerhouni, Co-Founders of ModeX and, respectively, President, Chief Executive Officer of ModeX and President of OPKO.

Spectral MD Awarded BARDA Project BioShield Contract Valued at $149 Million for AI-Driven DeepView® Burn Wound Imaging Technology

Retrieved on: 
Thursday, September 28, 2023
United States Department of Health and Human Services, ASPR, Trauma, MDAI, Surgeon, Biomedical Advanced Research and Development Authority, Office of Inspector General, U.S. Department of Health and Human Services, Hospital, Marketing, Human services, Policy, Eye, Administration for Strategic Preparedness and Response, Burn, Spectral, SMD, Administration, Development, Triage, MD, Patient, Physician, Algorithm, American Burn Association, BMCI, Artificial intelligence, Diagnosis, United, FDA, BARDA, Skin, Wound healing, Pharmaceutical industry, Medical imaging, Nursing

The contract is for the advanced development of the DeepView® System, the Company’s AI-driven burn wound imaging technology, to be used at emergency departments, trauma centers and burn centers, for both routine burn care and as a medical countermeasure for use in burn mass casualty incidents (BMCI).

Key Points: 
  • The contract is for the advanced development of the DeepView® System, the Company’s AI-driven burn wound imaging technology, to be used at emergency departments, trauma centers and burn centers, for both routine burn care and as a medical countermeasure for use in burn mass casualty incidents (BMCI).
  • Previously in 2013 and 2019, SMD was awarded BARDA contracts totaling $123 million, of which $101 million has been committed to date.
  • Together with this new contract, it brings the total potential support from BARDA to nearly $251 million.
  • For the first time, there will be an accurate and objective solution in burn wound healing assessment to guide treatment.

Basilea announces New England Journal of Medicine publication of phase 3 data on ceftobiprole for the treatment of Staphylococcus aureus bacteremia

Retrieved on: 
Thursday, September 28, 2023
SAB, ASPR, Staphylococcus, The New England Journal of Medicine, US Foods, Biomedical Advanced Research and Development Authority, Microbiology, MSSA, HHS, Clostridioides, Daptomycin, Overalls, Infection, Survival, MRSA, Administration for Strategic Preparedness and Response, Duke University School of Medicine, Associate, Staphylococcus aureus, Ceftobiprole, NEJM, ABSSSI, Clostridioides difficile infection, Administration, Development, Patient, Fungal infection, Disease, Mortality, Bacteria, BARDA, Food, Methicillin-resistant Staphylococcus aureus, New Drug Application, Pharmaceutical industry, Vaccine, Allschwil, Medicine

ERADICATE is the largest registrational study for SAB conducted to date and ceftobiprole showed similar clinical benefit compared to daptomycin, which is a standard of care antibiotic in the treatment of SAB.

Key Points: 
  • ERADICATE is the largest registrational study for SAB conducted to date and ceftobiprole showed similar clinical benefit compared to daptomycin, which is a standard of care antibiotic in the treatment of SAB.
  • Using a pre-defined non-inferiority margin of 15%, treatment with ceftobiprole was non-inferior to daptomycin with overall treatment success achieved in 69.8% of patients in the ceftobiprole group compared to 68.7% in the daptomycin group.
  • The results for the primary study outcome were consistent in key subgroups, including patients with either methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA).
  • Ceftobiprole was generally well tolerated and showed a safety profile consistent with previous phase 3 studies and the post-marketing experience.

MediciNova Announces Results of Studies under BARDA Contract to Develop MN 166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury

Retrieved on: 
Thursday, September 28, 2023
ASPR, Code, ALI, Human services, United States Department of Health and Human Services, White lung, Development, MCM, Chlorine, Tokyo Stock Exchange, Biomedical Advanced Research and Development Authority, Acute respiratory distress syndrome, Standard Market Design, BARDA, Safety, Pharmaceutical industry

Two different nonclinical models were used to investigate the potential clinical utility of MN-166 (ibudilast) for the treatment of chlorine-induced lung damage.

Key Points: 
  • Two different nonclinical models were used to investigate the potential clinical utility of MN-166 (ibudilast) for the treatment of chlorine-induced lung damage.
  • The primary endpoint was the pulmonary function measure PaO2/FiO2, which is the ratio of arterial oxygen partial pressure to fractional inspired oxygen.
  • In the pilot design single-dose treatment regimen, the test subjects were treated only once after the Cl2 gas challenge was completed.
  • There is a great unmet medical need for treatments for chlorine gas exposure as there is no drug approved specifically for this indication.

Gritstone bio Awarded BARDA Contract to Conduct Comparative Phase 2b Study Evaluating Next-Generation Vaccine Candidate for COVID-19 Valued at up to $433 Million

Retrieved on: 
Wednesday, September 27, 2023
Vaccine, United States Department of Health and Human Services, Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Health, Nextgen, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Fred Hutchinson Cancer Research Center, SARS-CoV-2, Human services, Gritstone bio, COVID-19, Infection, Federal, Messenger, Assistant, Government, Development, Trust, Controversies regarding COVID-19 contracts in the United Kingdom, NIAID, CORAL, BARDA, Safety, Pharmaceutical industry, Gritstone

EMERYVILLE, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, announced today that it was awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study evaluating Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate containing Spike plus other viral targets to protect against COVID-19. The agreement, which is valued at up to $433 million, was awarded as part of ‘Project NextGen,’ an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19.

Key Points: 
  • Under the contract, Gritstone bio will conduct a 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of the Gritstone next-generation COVID-19 vaccine candidate with an approved COVID-19 vaccine.
  • Preparations for the study are underway, and execution of the study will be fully funded by BARDA.
  • CORAL was designed to address these limitations by inducing durable neutralizing antibody and T cell-based immunity against current and future SARS-CoV-2 variants.
  • We are excited about this opportunity to work alongside BARDA and look forward to initiating the Phase 2b study (CORAL-BARDA) in the first quarter of 2024.

Crossject reports financial results and business highlights for first half of 2023

Retrieved on: 
Tuesday, September 26, 2023
BPI, Biomedical Advanced Research and Development Authority, Office of Inspector General, U.S. Department of Health and Human Services, Marketing, ISO, Human services, Paris-Saclay University, MBA, Research, Doctor of Philosophy, Caisse, Certification, Administration, Seizure, Development, IDD, Patient, INSEAD, Administration for Strategic Preparedness and Response, Supervisory board, ISIN, BNP, Groupe Caisse d'Épargne, Caregiver, FDA, BARDA, Shock (mechanics), Environment, Pharmaceutical industry, Pharmacy, Euronext

"Crossject has made substantial progress so far in 2023 as we move our portfolio of drugs for use in rescue therapies further towards the market," said Patrick Alexandre, President of the Executive Board of Crossject.

Key Points: 
  • "Crossject has made substantial progress so far in 2023 as we move our portfolio of drugs for use in rescue therapies further towards the market," said Patrick Alexandre, President of the Executive Board of Crossject.
  • "Since the beginning of the year, we strengthened further our financial position by cashing in €8 million from the €14 million non-dilutive financing.
  • Crossject cashed in early 2023 €8 million, in addition to €4 million at the end of 2022, from a combined non-dilutive financial transaction of €14 million to accelerate the company's development.
  • Crossject and IDD, its long-term regulatory partner, have officially joined this 3-year-long research program with a total budget of €800,000.

Chrysalis Receives FDA Approval to Initiate Clinical Trials with Chrysalin™ (TP508)

Retrieved on: 
Tuesday, September 26, 2023
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Acute respiratory distress syndrome, Tissue, Pupa, US Foods, Radiation, Biomedical Advanced Research and Development Authority, Bone fracture, University, Office of Inspector General, U.S. Department of Health and Human Services, Human services, Safety, National Institute of Allergy and Infectious Diseases, Infection, Brain, COVID, Inflammation, Lung, Pulmonary fibrosis, UTMB, Fibrosis, Development, Ischemia, Patient, Diagnosis, Chronic radiation syndrome, Carney, NIAID, Trauma, UTHealth School of Dentistry, BARDA, IND, Food, White lung, Pharmaceutical industry

Chrysalis BioTherapeutics, Inc. announced today that the US Food and Drug Administration (FDA) has given the company permission to initiate human clinical trials aimed at treating acute lung failure.

Key Points: 
  • Chrysalis BioTherapeutics, Inc. announced today that the US Food and Drug Administration (FDA) has given the company permission to initiate human clinical trials aimed at treating acute lung failure.
  • Other animal studies show potential TP508 benefit in treating acute lung injury, chronic smoke inhalation, and mitigating radiation effects on brain and other tissues.
  • “TP508 is a natural regenerative peptide that accelerates tissue repair and revascularization while modulating the inflammatory response.
  • Chrysalis is using UTMB, Houston-area, and national advisors to advance TP508 for treating pulmonary indications.