Find Immunology Drugs in Phase I Clinical Development in UNITED STATES

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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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            Lead Product(s): Recombinant Human Alpha-fetoprotein

            Therapeutic Area: Immunology Product Name: ACT-101

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Alpha Cancer Technologies

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement July 22, 2020

            Details:

            Under the terms of the agreement AbSci will prepare the hAFP producing E. coli strain for transfer to Alpha Cancer Technologies' CMO of choice for commercial production.

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            Lead Product(s): COVID-19 Hyperimmune Globulin

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: U.S. Department of Defense

            Deal Size: $34.6 million Upfront Cash: Undisclosed

            Deal Type: Collaboration July 08, 2020

            Details:

            Mount Sinai and Emergent to conduct clinical trials to evaluate COVID-HIG for post-exposure prophylaxis of COVID-19 in front-line health care workers and to support a potential Expanded Access Program for military personnel with funding from the U.S. Department of Defense.

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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 July 01, 2020

            Details:

            The results of this single dose study showed that Neihulizumab has an acceptable PK and safety profile in patients with SR-aGVHD involving the skin.

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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 June 29, 2020

            Details:

            Aquestive plans to initiate its PK clinical trials of AQST-108 in a crossover study to compare the pharmacokinetics and pharmacodynamics of epinephrine administered as sublingual film to that of epinephrine administered as an injection.

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            Lead Product(s): Tacrolimus

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 June 29, 2020

            Details:

            The Phase 1 single ascending dose and multiple ascending dose study will assess the safety, tolerability and pharmacokinetics of tacrolimus, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection.

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            Lead Product(s): MGTA-145

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 June 11, 2020

            Details:

            MGTA-145 first-line mobilization program to move into Phase 2 studies in autologous and allogeneic patients in 2020, including allogeneic study in newly announced collaboration with National Marrow Donor Program® (NMDP)/Be The Match®.

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            Lead Product(s): CDX-0159

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 June 06, 2020

            Details:

            CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, consistent with systemic mast cell suppression.

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