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Find Immunology Drugs in Phase III Clinical Development in UNITED STATES

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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): 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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            Lead Product(s): Iloprost

            Therapeutic Area: Immunology Product Name: CIVI030

            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 01, 2020

            Details:

            The AURORA study is a multicenter, double-blind, randomized, placebo-controlled, Phase 3 study evaluating the safety and efficacy of intravenous (IV) iloprost in patients with SSc experiencing symptomatic digital ischemic episodes (symptomatic Raynaud's Phenomenon).

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            Lead Product(s): MDR-101

            Therapeutic Area: Immunology Product Name: MDR-101

            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 30, 2020

            Details:

            The presentation will review the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.

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            Lead Product(s): MDR-101

            Therapeutic Area: Immunology Product Name: MDR-101

            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 September 22, 2020

            Details:

            MDR-101 is being developed to avert transplant kidney rejection by the recipient’s immune system without the need for chronic use of immunosuppressive drugs.

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            Lead Product(s): Avacopan,Rituximab,Azathioprine

            Therapeutic Area: Immunology Product Name: CCX168

            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 17, 2020

            Details:

            The NDA included data from the global, Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group.

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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 September 08, 2020

            Details:

            Topline data showed no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both added to background drug therapy.

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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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