Preclinical development

AGTC Announces Publication of Preclinical Data that Support the Ongoing Clinical Development of Its XLRP Gene Therapy Program

Retrieved on: 
Tuesday, August 25, 2020

As previously announced , AGTC expects to begin a Phase 2/3 clinical trial of its XLRP gene therapy candidate in the first quarter of 2021.

Key Points: 
  • As previously announced , AGTC expects to begin a Phase 2/3 clinical trial of its XLRP gene therapy candidate in the first quarter of 2021.
  • These newly published preclinical data not only further validate the safety of our therapy but our choice of XLRP transgene for our clinical program.
  • The publication reports data from studies conducted in the RPGR-mutant canine model (XLRPA2), which has been validated as a model for human XLRP due to mutations in the RPGR gene.
  • This significantly expands therapeutic index and guided a starting dose for the ongoing Phase 1/2 clinical trial.

DGAP-News: Immunic, Inc. Announces Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function

Retrieved on: 
Thursday, August 20, 2020

Announces Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function

Key Points: 
  • Announces Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function
    The issuer is solely responsible for the content of this announcement.
  • The phase 1 clinical program includes single and multiple ascending dose parts in healthy volunteers.
  • "Based on strong preclinical data, IMU-856 shows significant therapeutic potential for diseases that are known to be triggered by the disruption of intestinal barrier function."
  • These first two parts of the phase 1 trial are designed to assess the safety, tolerability and pharmacokinetic properties of IMU-856.

Tina Rogers named Senior Scientific Advisor at Sinclair Research

Retrieved on: 
Wednesday, August 12, 2020

Sinclair Research, a leading provider of nonclinical research services, has named Dr. Tina Rogers, PhD, MBA, DABT as Senior Scientific Advisor.

Key Points: 
  • Sinclair Research, a leading provider of nonclinical research services, has named Dr. Tina Rogers, PhD, MBA, DABT as Senior Scientific Advisor.
  • Prior to joining Sinclair Research, Tina held various leadership positions including Vice President of Preclinical Sciences at Altasciences (formerly SNBL USA), Executive Vice President and Director of Research at MPI Research (now Charles River) and Vice President of Drug Development at Southern Research Institute.
  • Tina brings a decades-long successful track record of leading growth initiatives and new service development to Sinclair, said Andy Brown, Vice President of Commercial Operations at Sinclair Research.
  • Sinclair is experienced in all research models and is the leading expert in miniature swine research.

Beyond Air Publishes New Data on Nitric Oxide to Treat M. Abscessus in the Peer-Reviewed Journal Access Microbiology

Retrieved on: 
Monday, August 10, 2020

The patient had an eight-year history of M. abscessus refractory to treatment with multiple drug combinations.

Key Points: 
  • The patient had an eight-year history of M. abscessus refractory to treatment with multiple drug combinations.
  • In vitro susceptibility tests showed a dose-dependent NO effect on M. abscessus susceptibility and significant heterogeneity in response among M. abscessus clinical isolates.
  • These data are in line with our other preclinical and clinical studies, said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.
  • Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made.

Genesis Drug Discovery & Development (GD3) Announces Appointment of Anthony Rohr, as Chief Executive Officer of PharmOptima

Retrieved on: 
Tuesday, August 4, 2020

HAMILTON, N.J., Aug. 4, 2020 /PRNewswire/ -- PharmOptima, a member of Genesis Drug Discovery & Development (GD3), the contract research organization (CRO) arm of Genesis Biotechnology Group (GBG), has announced the appointment of Anthony Rohr as its new Chief Executive Officer.

Key Points: 
  • HAMILTON, N.J., Aug. 4, 2020 /PRNewswire/ -- PharmOptima, a member of Genesis Drug Discovery & Development (GD3), the contract research organization (CRO) arm of Genesis Biotechnology Group (GBG), has announced the appointment of Anthony Rohr as its new Chief Executive Officer.
  • In this capacity, as an expansion of his current role in Business Development, he will provide leadership, oversight, and coordination for the development and management of new preclinical drug discovery platforms.
  • I am also thrilled to be a part of the Genesis Drug Discovery and Development leadership team.
  • GD3 is a fully integrated CRO focused on providing services to support preclinical drug discovery programs from early discovery through preclinical development.

UCB enters into collaboration with Roche to develop antibody treatment for people living with Alzheimer's Disease

Retrieved on: 
Wednesday, July 29, 2020

Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans.

Key Points: 
  • Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans.
  • So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models.
  • Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed.
  • UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB.

UCB enters into collaboration with Roche to develop antibody treatment for people living with Alzheimer's Disease

Retrieved on: 
Wednesday, July 29, 2020

Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans.

Key Points: 
  • Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans.
  • So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models.
  • Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed.
  • UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB.

Salarius Pharmaceuticals Announces Move to New Corporate Offices at Texas Medical Center

Retrieved on: 
Tuesday, July 28, 2020

HOUSTON, July 28, 2020 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting cancers caused by dysregulated gene expression, today announced that it has relocated its corporate operations within the Texas Medical Center in Houston.

Key Points: 
  • HOUSTON, July 28, 2020 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting cancers caused by dysregulated gene expression, today announced that it has relocated its corporate operations within the Texas Medical Center in Houston.
  • In addition to new corporate offices, Salarius has opened a new laboratory space in Johnson & Johnson's JLABS @ TMC where Salarius will pursue internal preclinical research and explore new development paths for seclidemstat, the companys clinical-stage investigational drug candidate.
  • We are excited to announce the move into our new corporate offices as we continue to grow as a company and expand our research and development capabilities, said David Arthur, Chief Executive Officer of Salarius Pharmaceuticals.
  • Our new corporate offices, in particular, the dedicated internal laboratory operations, will allow Salarius to optimize seclidemstats development path more innovatively and efficiently, and ultimately help Salarius achieve its goal of positively impacting patients' lives.

WPD Pharmaceuticals Licensor Announces New Independent In Vitro Testing Confirms Antiviral Activity of WP1122 in Coronavirus

Retrieved on: 
Thursday, July 23, 2020

The testing involved a cell viability assay in the VERO E6 cell line infected with SARS-CoV-2 and compared the therapeutic effects of 2-DG (the active ingredient in WP1122) alone with those of WP1122, a 2-DG prodrug.

Key Points: 
  • The testing involved a cell viability assay in the VERO E6 cell line infected with SARS-CoV-2 and compared the therapeutic effects of 2-DG (the active ingredient in WP1122) alone with those of WP1122, a 2-DG prodrug.
  • In addition, (Moleculin) has also contracted with IITRI to conduct preclinical toxicology testing, which is currently under way.
  • WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage.
  • The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes for most compounds 30 countries in Europe and Asia, including Russia.