Find Immunology Drugs in Phase III Clinical Development

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            Lead Product(s): Sutimlimab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 14, 2020

            Details:

            Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. If approved, sutimlimab would be the first and only approved treatment for these patients.

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            Lead Product(s): Mavorixafor

            Therapeutic Area: Immunology Product Name: AMD11070

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 02, 2020

            Details:

            Publication infoms about a comprehensive safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy data of mavorixafor from an ongoing Phase 2, dose-escalation study in adult patients with genetically confirmed WHIM syndrome.

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            Lead Product(s): Upadacitinib

            Therapeutic Area: Immunology Product Name: Rinvoq

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 25, 2020

            Details:

            The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.

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            Lead Product(s): Nipocalimab

            Therapeutic Area: Immunology Product Name: M281

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Johnson & Johnson

            Deal Size: $6,500.0 million Upfront Cash: $6,500.0 million

            Deal Type: Acquisition August 19, 2020

            Details:

            This acquisition gives Johnson & Johnson a major entry point into a new class of drugs. Momenta’s FcRn inhibitor, nipocalimab, has the potential to transform treatment of autoantibody-driven autoimmune diseases.

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            Lead Product(s): Filgotinib

            Therapeutic Area: Immunology Product Name: GS-6034

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 18, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA).

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            Lead Product(s): SAR442168

            Therapeutic Area: Immunology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: $3,680.0 million Upfront Cash: $3,680

            Deal Type: Acquisition August 17, 2020

            Details:

            The acquisition expands and accelerates development of Sanofi's BTK inhibitors consisting ‘168, rilzabrutinib and PRN473 Topical, across multiple indications.

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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): Viaskin peanut

            Therapeutic Area: Immunology Product Name: DBV712

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 04, 2020

            Details:

            Food and Drug Administration has issued a Complete Response Letter regarding the Company’s Biologics License Application for investigational Viaskin™ Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.

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            Lead Product(s): Filgotinib

            Therapeutic Area: Immunology Product Name: Jyseleca

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Galapagos

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 24, 2020

            Details:

            The CHMP positive opinion is supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs, which included 4,544 RA patient-years of experience with filgotinib.

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            Lead Product(s): Ruxolitinib

            Therapeutic Area: Immunology Product Name: Jakafi

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 23, 2020

            Details:

            Jakafi® demonstrated superior overall response rate in patients with steroid-refractory chronic graft-versus-host disease (GVHD) at Week 24 compared to best available therapy.

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