Bronchoalveolar lavage

GRI Bio Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom

Retrieved on: 
Monday, March 4, 2024

LA JOLLA, CA, March 04, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the UK.

Key Points: 
  • The MHRA is the UK regulatory authority, a government agency, for medicines and medical devices.
  • The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents.
  • “We are pleased to receive authorization from the MHRA and take a step in the global expansion of our clinical development for GRI-0621.
  • We are focused on driving this program forward and generating important data readouts this year,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

bioAffinity Technologies News Update

Retrieved on: 
Wednesday, February 21, 2024

bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, provides a summary of recent Company news.

Key Points: 
  • bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, provides a summary of recent Company news.
  • Lung Innovations Network’s multidisciplinary team focuses on affordable, innovative and individualized care by incorporating new technologies and research into an evidence-based practice.
  • National Sales Director Dallas Coleman announced that Cole Koeppen has joined bioAffinity Technologies as Pulmonary Sales Executive for CyPath® Lung in North Texas.
  • Bansal’s experience as both clinician and researcher demonstrates his commitment to innovative healthcare and the best possible outcome for his patients,” bioAffinity Technologies President and CEO Maria Zannes said.

GRI Bio Commences Patient Enrollment in Phase 2a Biomarker Study Evaluating Lead Program GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis (“IPF”)

Retrieved on: 
Tuesday, December 5, 2023

LA JOLLA, CA, Dec. 05, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the initiation of patient enrollment in the Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. Patient dosing is expected imminently. Interim data from the Phase 2a biomarker study is expected in the first half of 2024 and topline results are expected in the second half of 2024.

Key Points: 
  • Interim data from the Phase 2a biomarker study is expected in the first half of 2024 and topline results are expected in the second half of 2024.
  • IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream.
  • “The start of enrollment marks another important step forward for GRI as we continue to execute our clinical development plans for our lead program, GRI-0621.
  • We are pleased to meet this significant milestone and remain focused on the successful execution of this Phase 2a study.

GRI Bio (NASDAQ: GRI) Announces FDA Clearance of IND for Lead Program GRI-0621, a Type 1 Invariant NKT (“iNKT”) Antagonist for the Treatment of Idiopathic Pulmonary Fibrosis (“IPF”)

Retrieved on: 
Monday, November 27, 2023

LA JOLLA, CA, Nov. 27, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug (“IND”) application for GRI-0621 for the treatment of IPF. The Company plans to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, on track to commence before year end.

Key Points: 
  • The Company plans to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, on track to commence before year end.
  • “Clearance of our IND application for GRI-0621 represents a significant milestone for the Company and for our innovative pipeline of NKT cell modulators.
  • Our team has worked tirelessly to meet our planned milestones and I am proud of the continued progress made.
  • Click here to watch a brief video from the GRI Bio management team discussing the IND clearance and the meaning of this milestone for the Company’s GRI-0621 development program.

Avelo, VIVOLTA, and BLINK Win €1.5M Eurostars Grant to Develop New Solution for Diagnosing Lower Respiratory Tract Infections

Retrieved on: 
Thursday, October 26, 2023

The project will span two years and lay the foundation for market launch in 2027.

Key Points: 
  • The project will span two years and lay the foundation for market launch in 2027.
  • The solution will be the world’s first breath-based system capable of fast, accurate, and specific diagnosis of LRTIs, and will be simple-to-use for maximum adoption around the world.
  • Joining forces with VIVOLTA and BLINK will help us to develop and validate our AveloCollect breath sampling kit, which has the potential to revolutionize the field of respiratory medicine.
  • After adding the breath sample from the AveloCollect device, the Respirex cartridge can be rapidly analyzed in BLINK’s first-of-its-kind point-of-care analyzer, the BLINK ONE.

GRI Bio Presents Translational Data Demonstrating Connection Between NKT Cells and the Pathogenesis of Idiopathic Pulmonary Fibrosis (IPF) at the 2023 Pittsburgh-Ireland International Lung Conference

Retrieved on: 
Thursday, October 19, 2023

LA JOLLA, CA, Oct. 19, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the presentation of translational data at the 2023 Pittsburgh-Ireland International Lung Conference: Precision Medicine in Lung Diseases: From Cellular Mechanisms to Clinical Phenotypes held October 16-17, 2023 at the RCSI University of Medicine and Health Sciences in Dublin, Ireland. The abstract titled “Altered NKT cell populations in the airways of patients with IPF,” was presented in a poster presentation by collaborator Emily Calamita of Dr. Adam Byrne’s laboratory.

Key Points: 
  • IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream.
  • Natural killer T (NKT) cells are a subset of innate-like T lymphocytes that recognize lipid antigens, by expressing the T-cell receptor (TCR) Vα24-Jα18 chain.
  • Upon activation, NKT cells produce numerous cytokines, including those that have been shown to drive IPF pathogenesis.
  • In animal models of lung fibrosis, NKT cells have been shown to drive IPF pathology.

GRI Bio Announces Partnership with the Respiratory Translational Research Collaboration to Advance Leading NKT Regulation Technology Targeting Earlier in the Inflammatory Cascade to Modulate Disease Progression

Retrieved on: 
Tuesday, October 17, 2023

LA JOLLA, CA, Oct. 17, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced it has entered into a collaboration with the UK consortia, National Institute for Health and Care Research Respiratory Translational Research Collaboration (“NIHR Respiratory TRC”) to advance its leading NKT regulation technology to treat inflammatory, fibrotic and autoimmune diseases.

Key Points: 
  • Together with the NIHR Respiratory TRC, GRI Bio will design and execute complex multi-center studies that accelerate research for the benefit of respiratory disease patients.
  • “As a Company, we are dedicated to revolutionizing the way that inflammatory, fibrotic and autoimmune diseases like IPF are treated.
  • The establishment of this collaboration represents another important step forward as we work to advance our clinical development programs.
  • The NIHR Respiratory TRC offers cutting-edge translational research that we believe will assist in executing clinical studies underpinned by excellent scientific rigor.

GRI Bio (NASDAQ: GRI) Provides Business Outlook and Highlights Upcoming Milestones for Innovative Pipeline of NKT Cell Modulators

Retrieved on: 
Monday, May 22, 2023

LA JOLLA, CA, May 22, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today provided a business outlook and highlighted upcoming milestones for its innovative pipeline of NKT cell modulators in development.

Key Points: 
  • Rapidly advancing clinical pipeline in potential high-value inflammatory, fibrotic and autoimmune diseases
    LA JOLLA, CA, May 22, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today provided a business outlook and highlighted upcoming milestones for its innovative pipeline of NKT cell modulators in development.
  • “We believe our leading NKT platform technology represents a compelling opportunity with the potential for significant value creation.
  • GRI Bio’s lead program, GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human Type I, iNKT cells.
  • GRI Bio’s second asset in development, GRI-0803, is a novel activator of human Type 2 NKT cells.

Spexis reports solid safety and pharmacokinetics results from first-in-human study with inhaled murepavadin, a novel macrocycle compound

Retrieved on: 
Monday, January 9, 2023

ALLSCHWIL, Switzerland, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced the successful completion of the first-in-human clinical trial with novel class antibiotic murepavadin, delivered via the oral inhalation route (iMPV). iMPV is a macrocycle compound derived from Spexis’ proprietary platform and specifically targets the outer membrane of Pseudomonas aeruginosa (P. aeruginosa) including activity against highly resistant strains. P. aeruginosa is the key pathogen in cystic fibrosis (CF) lung infections. The study was supported by the European Innovative Medicines Initiative (IMI).

Key Points: 
  • iMPV is a macrocycle compound derived from Spexis’ proprietary platform and specifically targets the outer membrane of Pseudomonas aeruginosa (P. aeruginosa) including activity against highly resistant strains.
  • The study was supported by the European Innovative Medicines Initiative (IMI).
  • In Part B, single doses of 75 mg, 150 mg, and 300 mg were evaluated in nine subjects per cohort.
  • The pharmacokinetics (PK) of iMPV were assessed in blood samples and in epithelial lining fluid (ELF) obtained by bronchoalveolar lavage.

IMUNON Presentation at World Vaccine & Immunotherapy Congress Highlights PLACCINE Preclinical Proof of Concept and Key Competitive Advantages

Retrieved on: 
Thursday, December 1, 2022

PLACCINE is IMUNONs non-viral, non-device plasmid DNA-based vaccine modality targeting multiple antigens from a single vector.

Key Points: 
  • PLACCINE is IMUNONs non-viral, non-device plasmid DNA-based vaccine modality targeting multiple antigens from a single vector.
  • In addition, the data presented showed that IMUNONs plasmid DNA vaccine yielded comparable yet more durable antigen expression than either the protein or a commercial mRNA vaccine.
  • We are delighted to share preclinical proof of concept along with highlighting key competitive advantages to a global audience of vaccine and immunotherapy leaders, said Dr. Corrine Le Goff, IMUNONs President and Chief Executive Officer.
  • IMUNON assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.