Rise Therapeutics Announces FDA Clearance of its IND Application to Initiate a Phase 1 Study of an Oral Immunotherapy for the Treatment of Ulcerative Colitis

Published on : Published by : BioBuzz Media

Rise Therapeutics Announces FDA Clearance of its IND Application to Initiate a Phase 1 Study of an Oral Immunotherapy for the Treatment of Ulcerative Colitis 31 January 2023
Rockville, Maryland, January 31st, 2023 – Rise Therapeutics, a biopharmaceutical company engaged in developing novel oral synthetic biology medicines, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a Phase 1 clinical trial of its lead program candidate, R-3750.
R-3750 is a synthetic biology-based cellular immunotherapy being developed for the treatment of Inflammatory Bowel Disease (IBD). Optimized for intestinal delivery of a key microbiome-associated immune regulatory molecule whose natural role is to control host immune function, R-3750 is an oral therapy that has the potential to treat the underlying immunological basis of gastrointestinal-associated inflammatory disease. R-3750 leverages Rise Therapeutics’ proprietary drug delivery platform to orally deliver targeted biological therapy that engages a specific receptor expressed on dendritic cells, reducing inflammation and inducing colonic immune homeostasis. As a result, R-3750 improves gut membrane barrier integrity reestablishing a normal microbiome composition.
 The Phase 1 trial will be a single and repeat dose study assessing the safety and tolerability, drug exposure, and clinical…

First Participant Infused with Potential HIV Cure Enters Phase 1 Clinical Trials via American Gene Technologies AGT103-T

HIV Cure
Published on : Published by : Alex Keown

One year after receiving the green light from the FDA to initiate a Phase I study of an HIV gene therapy, American Gene Technologies (AGT) has infused the first patient. AGT103-T is designed as a cure for the disease that has wreaked havoc across the globe since the 1980s.

Rockville’s Integrated BioTherapeutics Inc. Awarded $16.3M Contract from the National Institute of Allergy and Infectious Diseases to Develop a Treatment for Marburg Virus Disease

Published on : Published by : BioBuzz Media

Integrated BioTherapeutics Inc. (IBT), a Maryland biotechnology company specializing in emerging infectious diseases, announced today the receipt of a contract valued at up to $16.3 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop IBT-T03H, a monoclonal antibody for treatment of Marburg virus disease (MVD). MVD is caused by either of two marburgviruses, Marburg virus and Ravn virus, and has reemerged several times since it was initially described in 1967. IBT-T03H, discovered in collaboration with the University of Maryland, has been shown in preclinical studies to be protective against both Marburg and Ravn virus.