NIAID

Exavir Therapeutics Receives $3M Award from NIH / NIAID to Advance Ultra-Long-Acting Integrase Inhibitor XVIR-110

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화요일, 8월 22, 2023
White House, Federal Government, AIDS, Public Policy, Government, Health, Infectious Diseases, Pharmaceutical, Biotechnology, Therapy, HIV, National Institute of Allergy and Infectious Diseases, Pharmacokinetics, CYP3A, CNS, Patient, Central nervous system disease, NIAID, IND, NIH, Infection, Foundation for the National Institutes of Health, Conditional sentence, Pharmaceutical industry

Exavir Therapeutics, a company dedicated to transforming the lives of patients with chronic viral infections and CNS disorders with ultra-long-acting therapeutics, today announced that the company has received a $3M award from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institute of Health (NIH), to support the development of XVIR-110.

Key Points: 
  • Exavir Therapeutics, a company dedicated to transforming the lives of patients with chronic viral infections and CNS disorders with ultra-long-acting therapeutics, today announced that the company has received a $3M award from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institute of Health (NIH), to support the development of XVIR-110.
  • XVIR-110 is an ultra-long-acting HIV integrase inhibitor with a preclinical profile that suggests best-in-class potential for HIV pre-exposure prophylaxis (PrEP), and for HIV treatment as the cornerstone of a next-generation multi-drug regimen.
  • “We are thankful for the NIH’s support of American companies and innovative biotechnology, particularly in an area like HIV / AIDS that affects so many millions of people worldwide,” said Alborz Yazdi, co-founder and CEO of Exavir.
  • “This award speaks to XVIR-110’s transformative potential, but also the importance of American agencies and public-private partnerships in improving population health outcomes.

Veopoz™ (pozelimab-bbfg) Receives FDA Approval as the First Treatment for Children and Adults with CHAPLE Disease

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금요일, 8월 18, 2023
ACIP, Priority review, Vaccination, National Institute of Allergy and Infectious Diseases, Prevalence, Face, Regeneron Pharmaceuticals, Attenuated vaccine, Infection, Advisory Committee on Immunization Practices, Fast Track, Medicine, National Institutes of Health, Bangladesh Technical Education Board, Neisseria meningitidis, Immune system, Meningococcal disease, Patient, Risk, CD55, Blood, NIAID, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Health insurance coverage in the United States, BLA, NIH, Food, C5, Disease, Pharmaceutical industry, Vaccine

TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has approved Veopoz™ (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for CHAPLE. With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg BLA have been addressed. FDA action on the aflibercept 8 mg BLA is expected in the next few weeks.

Key Points: 
  • With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg BLA have been addressed.
  • FDA action on the aflibercept 8 mg BLA is expected in the next few weeks.
  • Veopoz was reviewed under Priority Review, and the Company received a Rare Pediatric Disease Priority Review voucher upon approval.
  • Veopoz was previously granted Rare Pediatric Disease designation, Orphan Disease designation and Fast Track designation.

Pluri’s PLX-R18 Increases Blood Cell Counts and Reduces Need for Transfusions in a Phase I Study: Results Published in Nature Bone Marrow Transplantation

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수요일, 8월 16, 2023
Graft-versus-host disease, System, University, Acute radiation syndrome, Nature, ARS, Marketing, Cellular, University of Kansas Health System, HCT, Pluri Inc., Cell, PLUR, Cytopenia, Regeneration, Patient, University of Kansas Medical Center, TASE, Blood, Vein graft failure, NIAID, Placentalia, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Vaccine, Pharmaceutical industry

As described in the article, in a successful Phase I first-in-human study which achieved its primary endpoint, patients with incomplete hematopoietic recovery post-hematopoietic cell transplantation (HCT) were treated with escalating doses of Pluri’s cell therapy, PLX-R18.

Key Points: 
  • As described in the article, in a successful Phase I first-in-human study which achieved its primary endpoint, patients with incomplete hematopoietic recovery post-hematopoietic cell transplantation (HCT) were treated with escalating doses of Pluri’s cell therapy, PLX-R18.
  • Low levels of blood cells (cytopenia) post-HCT can persist despite adequate engraftment of donor cells.
  • Pluri’s PLX-R18 cells secrete a large array of hematopoietic factors which promote regeneration, maturation, and differentiation of hematopoietic cells and stimulate their migration to peripheral blood.
  • As a groundbreaking, first-in-class solution, PLX-R18’s capacity to augment hematopoietic system recovery and effectively manage diverse cytopenia holds immense promise.”

Lundquist Principal Investigator Dr. Michael Yeaman Awarded $11.5 Million NIAID/HHS Grant for Innovative Research To Understand and Solve Persistent Bloodstream Infections

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화요일, 8월 15, 2023
Vaccine, Infection, DNA, Duke University Hospital, Centers for Disease Control and Prevention, Genetics, TLI, Epigenomics, Public, National Institute of Allergy and Infectious Diseases, MRSA, Immunity, Biomedical Research, Hope, Research, Antimalarial medication, Staphylococcus, Doctor of Philosophy, Bangladesh Technical Education Board, CDC, Harbor–UCLA Medical Center, Molecular medicine, Principal investigator, Division, Risk, Immune system, Nightfall and Other Stories, Biological engineering, NIAID, Principal, UCLA, United States Department of Health and Human Services, NIH, Bloodstream infections, Pharmaceutical industry, Health, Medicine, U19

In turn, defining such patterns will enable new ways to predict individuals at risk of such persistent infections, and inform best antibiotic regimens for cures.

Key Points: 
  • In turn, defining such patterns will enable new ways to predict individuals at risk of such persistent infections, and inform best antibiotic regimens for cures.
  • The focus of this U19 is on infections caused by the bacterium Staphylococcus, including methicillin-resistant S. aureus (MRSA) and the invasive fungus, Candida.
  • Dr. Yeaman and team made previous discoveries that laid essential groundwork for this project to find new ways to prevent and treat persistent bloodstream infections.
  • “We will use state-of-the-art technologies in synergistic research to understand human-pathogen interactions driving persistence,” said Dr. Yeaman.

TFF Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update

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화요일, 8월 15, 2023
COPD, Insurance, Calendar, British Aerospace EAP, EAP, Conference call, TFF, SARS-CoV-2, SBIR, National Institute of Allergy and Infectious Diseases, Clinical trial, CRADA, Pharmacokinetics, G&A, Voriconazole, Temperature, Respiratory syncytial virus, Bangladesh Technical Education Board, Medication, Research and development, DARPA, ET, RSV, Patent, Patient, Chronic pulmonary aspergillosis, Administration, NIEHS, Roflumilast, Corporation, PPB, NIAID, R, Leidos, General Administration of Sport of China, Conference, Infection, Pharmaceutical industry, Vaccine, Fine chemical, Security (finance), Cryptocurrency

“We continue to make solid progress in our Phase 2 trials of TFF VORI and TFF TAC and expect to announce initial data by the end of 2023,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals.

Key Points: 
  • “We continue to make solid progress in our Phase 2 trials of TFF VORI and TFF TAC and expect to announce initial data by the end of 2023,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals.
  • We’ve also launched our EAP for TFF VORI and partnered with Durbin to implement the program across several countries.
  • For the quarter ended June 30, 2023, compared to quarter ended June 30, 2022
    Cash Position: as of June 30, 2023, TFF Pharmaceuticals reported cash and cash equivalents of $7.7 million.
  • Net Loss: TFF Pharmaceuticals reported a net loss for the second quarter of 2023 of $5.0 million, compared to a net loss of $8.7 million for the comparable period in 2022.

Trethera Receives NIH Grant for Preclinical Development in the Pediatric Neurologic Disease Acute Disseminated Encephalomyelitis

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월요일, 8월 14, 2023
Transfer, Central nervous system, STTR, Stanford University, Marketing, Mumps, National Institute of Allergy and Infectious Diseases, Fever, Spinal cord, Pathology, Cancer, Brain, COVID, Inflammation, Multiple sclerosis, Viral disease, Patient, Cranial nerves, Autoimmune disease, Coma, ADEM, NIAID, FDA, IND, NIH, Infection, Consciousness, Disease, Pharmaceutical industry, Neuro

Trethera’s first-in-class small molecule, TRE-515, holds the only FDA Orphan Drug designation for Acute Disseminated Encephalomyelitis (ADEM), an acute neurologic disease principally of children.

Key Points: 
  • Trethera’s first-in-class small molecule, TRE-515, holds the only FDA Orphan Drug designation for Acute Disseminated Encephalomyelitis (ADEM), an acute neurologic disease principally of children.
  • ADEM is an autoimmune disease that can present with fever and difficulty walking as well as loss of consciousness and coma.
  • The grant will advance IND enabling studies for a disease where no approved therapies currently exist.
  • Furthermore, should the FDA approve TRE-515 for commercial use in ADEM, Trethera would be eligible for a pediatric priority review voucher.

Thermo Fisher Scientific Selected as the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) for the U.S. National Institute of Allergy and Infectious Diseases

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목요일, 8월 10, 2023
Infectious Diseases, Health, Clinical Trials, United States Department of Health and Human Services, National Institute of Allergy and Infectious Diseases, United Network for Organ Sharing, PPD, Maintenance, U.S. Department of Defense Strategy for Operating in Cyberspace, Human services, Office of Inspector General, U.S. Department of Health and Human Services, Quality of life, Research, Thermo Fisher Scientific, Bangladesh Technical Education Board, Science, Transplant, CLIA, Patient, Manuscript, Overmyer Network, Kidney, Federation, NIAID, Plasma protein binding, Mindful Scientific Inc., Infection, Pharmaceutical industry, Dentistry

The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the United States.

Key Points: 
  • The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the United States.
  • This center will offer a broad range of support services critical to the design, development, execution and analysis of NIAID transplantation clinical trials and research.
  • Thermo Fisher’s PPD clinical research business has three decades of experience successfully delivering clinical research services to governmental agencies, contractors and nonprofits.
  • The content of this announcement is solely the responsibility of Thermo Fisher Scientific and does not necessarily represent the official views of the National Institutes of Health.

Gritstone bio Reports Second Quarter 2023 Financial Results and Provides Corporate Updates

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수요일, 8월 9, 2023
KRAS, Chemistry, Congress, Lance, Patient, SLATE, Collaboration, Infection, Maintenance, Monitoring, Vaccination, Gritstone bio, Immunity, Research, Melinda French Gates, Gilead, ECCMID, CORAL, NCI, Vaccine, DNA, AACR, COVID-19, African, Cancer, NAB, Immunotherapy, Messenger, Government, Friends, National Cancer Institute, Bill & Melinda Gates Foundation, European, NIAID, Partnership, Circulating tumor DNA, Drug development, CRC, HIV, CMC, Clinical trial, Nature Communications, PCV, Cryptocurrency, Pharmaceutical industry, Neoplasm, Gritstone

EMERYVILLE, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today reported financial results for the second quarter ended June 30, 2023 and provided recent corporate and clinical updates.

Key Points: 
  • Molecular response, or reduction in ctDNA, is the primary efficacy endpoint for the Phase 2 portion of the GRANITE trial.
  • Gritstone delivered multiple presentations detailing advances in neoantigen prediction capabilities and cancer vaccine programs at the 2023 American Association for Cancer Research (AACR 2023, in April 2023).
  • Gritstone expects to initiate a randomized Phase 2 clinical trial within SLATE (“off-the-shelf” neoantigen vaccine program) in 2024.
  • Gritstone expects to share additional data from the CORAL-CEPI and CORAL-BOOST studies in Fall 2023.

Tonix Pharmaceuticals Completes Clinical Phase of PREVAIL Proof-of-Concept Study of TNX-102 SL for the Treatment of Fibromyalgia-Type Long COVID

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월요일, 8월 7, 2023
Tonix Pharmaceuticals, Therapy, Arthralgia, Cluster analysis, Sleep, DSM-IV codes, SL, Brain, Infection, COVID, CFS/ME, Bangladesh Technical Education Board, Quality, Pain, Myalgia, Back pain, Translational medicine, Patient, Quality of life, Fibromyalgia, National Institute of Allergy and Infectious Diseases, NIAID, FDA, CFS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NIH, Food, Fatigue, Pharmaceutical industry, Long COVID

CHATHAM, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL as a potential treatment for fibromyalgia-type Long COVID. Topline results for the PREVAIL study are expected in the third quarter of 2023.

Key Points: 
  • “Approximately 40% of U.S. Long COVID patients have fibromyalgia-like multi-site pain symptoms based on our observational studies of Long COVID patients from the TriNetX claims database,”2,3 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • We have termed this subgroup, ‘Fibromyalgia-type Long COVID.’ Given our encouraging results with TNX-102 SL as a potential treatment for fibromyalgia4, we are testing TNX-102 SL as a bedtime medicine for the management of Fibromyalgia-type Long COVID.
  • In their recent publication, cluster analysis of the symptom frequencies in the RECOVER study identified four subgroups of Long COVID patients.
  • We believe that daily pain has the potential to be an endpoint for registrational studies in fibromyalgia-like long COVID.”

Vir Biotechnology Provides Corporate Update and Reports Second Quarter 2023 Financial Results

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목요일, 8월 3, 2023
HIV Vaccine Trials Network, GSK, Corporate Affairs, EASL, Sotrovimab, HIV, Investment, Influenza, Marketing, Conference call, Head, Hook effect, National Institute of Allergy and Infectious Diseases, COVID-19, Hepatitis, PEG, CHB, MBA, Infection, Bill & Melinda Gates Foundation, Bangladesh Technical Education Board, JJI, Congress, Conditional sentence, Patient, Vir, SAN, HPV, Bill, European Association of Urology, AI, NIAID, Johnson & Johnson, Viral hepatitis, Vaccine, CHD, HCMV, Conference, Pharmaceutical industry, Cryptocurrency, Dietary supplement, Management

ET, Aug. 3, 2023 –

Key Points: 
  • ET, Aug. 3, 2023 –
    SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the second quarter ended June 30, 2023.
  • Vir expects the Phase 1 trial for VIR-1388, a novel T cell vaccine for the prevention of HIV, to begin dosing in Q3 2023.
  • In June, Sasha Damouni Ellis joined Vir as Executive Vice President and Chief Corporate Affairs Officer.
  • Revenues: Total revenues for the quarter ended June 30, 2023, were $3.8 million compared to $(40.6) million for the same period in 2022.