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Find Immunology Drugs in Phase I Clinical Development in UNITED STATES

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            Lead Product(s): ADX-914

            Therapeutic Area: Immunology Product Name: ADX-914

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: OrbiMed Advisors

            Deal Size: $60.0 million Upfront Cash: Undisclosed

            Deal Type: Series B Financing October 29, 2020

            Details:

            Proceeds from the Series B financing will support the advancement of ADX-914 through demonstration of proof-of-mechanism and propel the company’s groundbreaking tissue-targeted complement regulation platform.

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            Lead Product(s): Tacrolimus

            Therapeutic Area: Immunology Product Name: TFFTAC-LAC

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 20, 2020

            Details:

            Company completes dosing of three cohorts with Tacrolimus Inhalation Powder for direct-to-lung delivery of a Thin Film Freezing dry-powder product for prevention of lung transplant rejection.

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            Lead Product(s): Cetirizine HCl

            Therapeutic Area: Immunology Product Name: Ceteric Allergy Gummy

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 15, 2020

            Details:

            SGC scientists have developed a suite of technologies that enable the incorporation of various drug compounds into a novel gummy matrix, thus solving drug solubility, stability, and taste issues.

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            Lead Product(s): GP1681

            Therapeutic Area: Immunology Product Name: GP1681

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Novotech

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 13, 2020

            Details:

            The new clinical trial is designed to evaluate the use of GP1681 as a potential new medicine to treat the severe immune response to COVID-19.

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            Lead Product(s): CDX-0159

            Therapeutic Area: Immunology Product Name: CDX-0159

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 13, 2020

            Details:

            First patient has been dosed in its randomized, double-blind Phase 1b study of CDX-0159 in patients with chronic spontaneous urticaria. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor and inhibits its activity.

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            Lead Product(s): Neihulizumab

            Therapeutic Area: Immunology Product Name: AbGn-168H

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2020

            Details:

            The trial is a multi-dose study of Neihulizumab in SR-aGVHD and follows its successful Phase 1a single-dose study which demonstrated a 77% response rate.

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            Lead Product(s): STMC-103H

            Therapeutic Area: Immunology Product Name: STMC-103H

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Khosla Ventures

            Deal Size: $30.0 million Upfront Cash: Undisclosed

            Deal Type: Series B Financing September 22, 2020

            Details:

            The latest round of capital will go towards supporting clinical proof of concept (POC) trials testing the efficacy of their lead LBP product, STMC-103H.

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

            Therapeutic Area: Immunology Product Name: DSG3-CAART

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 25, 2020

            Details:

            The manuscript, titled “Antigen-specific B-cell depletion for precision therapy of mucosal pemphigus vulgaris,” includes the preclinical data that enabled the DSG3-CAART IND submission and opening of the DesCAARTesTM clinical trial.

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            Lead Product(s): Tacrolimus

            Therapeutic Area: Immunology Product Name: Tac-Lac

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Jefferies LLC

            Deal Size: $25.9 million Upfront Cash: Undisclosed

            Deal Type: Financing August 11, 2020

            Details:

            Net proceeds from the financing will be used to accelerate the expansion of the company’s internal development portfolio beyond its programs for Voriconazole and Tacrolimus inhalation powders.

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            Lead Product(s): Epinephrine

            Therapeutic Area: Immunology Product Name: AQST-108

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2020

            Details:

            The FDA has granted the Aquestive's AQST-108 Fast Track designation, "first of its kind" oral sublingual film formulation that delivers systemic epinephrine to treat allergic reactions, including anaphylaxis, using the proprietary Aquestive PharmFilm ® technologies.

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