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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): Lenzilumab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Humanigen

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration September 15, 2020

            Details:

            Collaboration to expand lenzilumab manufacturing capacity in advance of potential Emergency Use Authorization in 2020.

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            Lead Product(s): Tadekinig alfa

            Therapeutic Area: Immunology Product Name: r-hIL-18BP

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: AB2 Bio

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration October 29, 2020

            Details:

            Tadekinig alfa is a novel IL-18 binding protein in pivotal Phase 3 testing for orphan disease IL-18 driven monogenic Hemophagocytic Lymphohistiocytosis (HLH). WuXi Biologics to undertake commercial scale manufacturing to support U.S. market launch.

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            Lead Product(s): Grass MATA MPL

            Therapeutic Area: Immunology Product Name: Grass MATA MPL

            Highest Development Status: Phase III Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2020

            Details:

            Allergy Therapeutics announces start of key exploratory field study in advance of pivotal Phase III Grass trial;Breakthrough study design to deliver for the first time cutting edge scientific concepts in the Allergy field to optimize SCIT trial results.

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            Lead Product(s): Voclosporin,Mycophenolate Mofetil

            Therapeutic Area: Immunology Product Name: ISA247

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 22, 2020

            Details:

            Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care.

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            Lead Product(s): Lenabasum

            Therapeutic Area: Immunology Product Name: JBT-101

            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 October 21, 2020

            Details:

            Abstract titled "Preliminary Baseline Subject Demographics and Disease Characteristics in a Phase 3 Clinical Trial of the Safety and Efficacy of Lenabasum in Dermatomyositis".

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            Lead Product(s): Mavorixafor

            Therapeutic Area: Immunology Product Name: X4P-001

            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 October 08, 2020

            Details:

            Mavorixafor is a potential first-in-class, once-daily, oral, small molecule antagonist of chemokine receptor CXCR4, currently being investigated in a global pivotal Phase 3 clinical trial, 4WHIM, for the treatment of WHIM syndrome.

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            Lead Product(s): Omalizumab

            Therapeutic Area: Immunology Product Name: CT-P39

            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 October 08, 2020

            Details:

            The Korean drug authority has given clearance to Celltrion's CT-P39 to start a phase 3 clinical trial in Korea. CT-P39 is a protein replica of Xolair, aimed at being a more affordable solution to allergic asthma and chronic spontaneous urticaria.

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            Lead Product(s): Efgartigimod

            Therapeutic Area: Immunology Product Name: ARGX-113

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Argenx BVBA

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration October 06, 2020

            Details:

            Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme's ENHANZE® drug delivery technology for three additional targets upon nomination for a total of up to six targets under the existing and newly expanded collaboration.

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            Lead Product(s): FCR001

            Therapeutic Area: Immunology Product Name: FCR001

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

            Partner/Sponsor/Collaborator: Surveyor Capital

            Deal Size: $115.0 million Upfront Cash: Undisclosed

            Deal Type: Series B Financing October 06, 2020

            Details:

            Proceeds to support ongoing Phase 3 registration trial of Talaris’ lead product candidate FCR001 in living donor kidney transplant, and additional Phase 2 trials next year in autoimmune disease and organ transplant.

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