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Find Clinical Drug Pipeline Developments & Deals by Mesoblast

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Gastroenterology Product Name: Ryoncil

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Cleveland Clinic

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 21, 2020

            Details:

            Mesoblast intends to confirm the potential for remestemcel-L to induce luminal healing and early remission in a wider spectrum of diseases with severe inflammation of the gut, in addition to steroid-refractory aGVHD. The trial has been commenced at the Cleveland Clinic.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Immunology 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 October 01, 2020

            Details:

            While the ODAC of the FDA voted that the available data support the efficacy of remestemcel-L in children with SR-aGVHD, the FDA suggests that Mesoblast conduct at least one more study in adults and/or children to provide further proof of the effectiveness of remestemcel-L.

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            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

            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.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Immunology 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 August 14, 2020

            Details:

            Oncologic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL™) in pediatric patients with steroid-refractory acute graft versus host disease.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Infections and Infectious 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 06, 2020

            Details:

            The protocol was filed with the United States Food and Drug Administration (FDA) and provides physicians with access to remestemcel-L for an intermediate-size patient population1 under Mesoblast’s existing Investigational New Drug (IND) application.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2020

            Details:

            The post-hoc analysis from a randomized, placebo-controlled Phase 2 trial in COPD showed that remestemcel-L significantly improved respiratory and functional clinical outcomes in patients with elevated levels of the inflammatory biomarker C-reactive protein (CRP).

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 May 25, 2020

            Details:

            Trial results underpin Mesoblast’s Biologics License Application to seek approval of its product candidate RYONCIL for pediatric steroid-refractory acute graft versus host disease, which has been accepted for priority review by the USFDA.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $90.0 million Upfront Cash: Undisclosed

            Deal Type: Financing May 13, 2020

            Details:

            A significant portion of the net proceeds will be used to scale-up manufacturing of remestemcel-L for the treatment of critically ill patients suffering with diseases caused by cytokine release syndromes associated with high mortality, particularly COVID-19 ARDS.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase II/ 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 30, 2020

            Details:

            Company initiated Phase 2/3 randomized trial to confirm whether its allogeneic mesenchymal stem cell therapy remestemcel-L provides a survival benefit in moderate/severe ARDS due to COVID-19.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

            Recipient: Cardiothoracic Surgical Trials Network

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership April 08, 2020

            Details:

            This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN).

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