FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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            Lead Product(s): FCR001

            Therapeutic Area: Immunology Product Name: FCR001

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 08, 2020

            Details:

            Approval of this IND allows Talaris to initiate a Phase 1/2a trial for the evaluation of Talaris’ novel cell therapy FCR001 in the treatment of diffuse systemic sclerosis, at sites across the U.S., including Duke University and the University of Michigan.

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            Lead Product(s): GP1681

            Therapeutic Area: Immunology Product Name: GP1681

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Richard King Mellon Foundation

            Deal Size: $0.2 million Upfront Cash: Undisclosed

            Deal Type: Funding July 07, 2020

            Details:

            The funding would accelerate the development of CytoAgents' lead drug candidate, GP1681, an investigational new drug to treat “cytokine storm” induced by COVID-19, from the Richard King Mellon Foundation.

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            Lead Product(s): CD45-ADC

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 05, 2020

            Details:

            Single dose of CD45-ADC shown to remove disease-causing cells and halt disease in models of multiple sclerosis, systemic sclerosis and inflammatory arthritis.

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            Lead Product(s): Desmoglein 3 Chimeric AutoAntibody Receptor T cells

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 06, 2020

            Details:

            U.S. FDA has granted Fast Track Designation for DSG3-CAART, the Cabaletta’s lead product for treatment of mucosal pemphigus vulgaris, for improving healing of mucosal blisters in patients with mPV.