CoronaTcP (PepGNP-Covid19) / Gylden Pharma - LARVOL DELTA

The critical role of artificial intelligence and bioinformatics in accelerating peptide-based vaccine discovery for tackling global infectious diseases. (PubMed, Brief Bioinform) - "This review contextualizes the historical trajectory of peptide-based vaccinology, from early linear epitope discoveries in the 1960s to multi-epitope constructs and clinically tested candidates such as UB-612 and PepGNP-Covid19...Major challenges in immunoinformatics include performance limitations in epitope prediction tools, complexities in HLA mapping, and the necessity for manual intervention in data pipelines. Artificial intelligence-driven models, including deep learning and interpretable machine learning, promise to overcome these challenges by improving prediction accuracy, reducing errors, and supporting global epidemic response efforts such as CEPI's 100 Days Mission and the WHO R&D Blueprint."

Journal • Review • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | N=30 ➔ 60

Enrollment change • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=60 ➔ 30

Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Apr 2026 ➔ Aug 2026

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland. (PubMed, BMC Infect Dis) - P1 | "The favourable safety profile and cellular responses observed support further development of PepGNP-Covid19."

Clinical • Journal • P1 data • Fatigue • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD69 • CD8 • TNFRSF9

Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19) (clinicaltrials.gov) - P1/2 | N=110 | Not yet recruiting | Sponsor: Gylden Pharma Ltd | Trial completion date: Oct 2024 ➔ Dec 2026 | Trial primary completion date: Mar 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Emergex Vaccines signs Collaboration Agreement with Brazil’s Bio-Manguinhos/Fiocruz for the Development of a COVID-19 Vaccine (GlobeNewswire) - "Emergex Vaccines Holding Limited...today announces that it has signed a collaboration and development agreement with the Institute of Technology on Immunobiologicals...of the Oswaldo Cruz Foundation (Fiocruz) in Brazil to develop a COVID-19 vaccine...The agreement provides a framework under which both parties will work together to progress certain immunotherapeutic programmes, including a vaccine candidate for COVID-19, through a regulatory pathway for the Brazilian National Health Service....Emergex will also support the performance of studies, including clinical trials, and to manufacture, market, promote and distribute certain infectious diseases vaccines...Emergex has already completed preclinical development work..."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Emergex Vaccines and George Mason University Identify T-Cell Epitopes Presented by SARS-Cov-2 Infected Cells (GlobeNewswire) - "First detailed, empirical analysis of Class 1 epitopes presented by SARS-Cov-2 infected cells which define the T-Cell repertoire necessary for cytotoxic T-Cell function; MHC expression library provides an accurate basis for COVID-19 T-Cell vaccine and related diagnostics development; Emergex Vaccines Holding Limited...today announces the determination of a Class I MHC expression library, or ligandome, for SARS-Cov-2 infected cells, in collaboration with George Mason University....Clinical trials of the first Emergex COVID-19 vaccine candidate are intended to start in Q4 2020."

Licensing / partnership • New trial • Preclinical • Infectious Disease • Novel Coronavirus Disease