Details:
Mesoblast remains highly focused on executing on our short term objective to bring remestemcel-L to market for patients with acute respiratory distress syndrome (ARDS) due to COVID-19.
Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: $1,355.0 million Upfront Cash: $50.0 million
Deal Type: Termination December 13, 2021
Details:
Remestemcel-L improved respiratory function to an even greater extent in patients under 65 who received dexamethasone as part of their standard of care at each of days 7, 14, 21, and 30 post-randomization, with OR at Day 30 relative to controls on Dexamethasone alone.
Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2021
Details:
Remestemcel-L reduced mortality through 60 days in the pre-specified population under 65 years old. In these patients the benefit was further increased when remestemcel-L was used with dexamethasone as part of standard of care.
Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2021
Details:
The DSMB noted that the trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment.
Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2020
Details:
Clinical data provided to the FDA supporting the potential of remestemcel-L to address the unmet medical need of COVID-19 ARDS included results from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mt Sinai Hospital in March-April this year.
Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2020
Details:
Addition of remestemcel-L could expand Novartis' respiratory portfolio by adding potential first-in-class ARDS therapy using innovative cell-based technology with platform potential.
Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: $1,355.0 million Upfront Cash: $50.0 million
Deal Type: Collaboration November 19, 2020
Details:
The Phase 3 trial aims to confirm findings from a pilot study at New York’s Mt Sinai Hospital where nine of 12 ventilator-dependent patients were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L within five days.
Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2020
Details:
Independent Data Safety Monitoring Board (DSMB) recommended continuation of the Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection, following completion of trial’s first interim analysis.
Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 04, 2020