Immunology | Phase I Developments

Innovent Biologics

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CHINA China

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Innovent Announces that the First Phase I Clinical Study of Anti-Il-23 Monoclonal Antibody Ibi112 Has Been Administered to A Subject

Lead Product(s): IBI112

Therapeutic Area: Immunology Product Name: IBI112

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 01, 2020

Details:

The study CIBI112A101 is a randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial to evaluate the safety and tolerability in addition with PK/PD of IBI112 when administered as a single subcutaneous or intravenous dose in healthy Chinese subjects.

Cabaletta Bio

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United States

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Cabaletta Bio Announces Publication of Comprehensive Preclinical Study Results for DSG3-CAART in Pemphigus Vulgaris

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.

I-Mab Biopharma

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CHINA China

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I-Mab Begins Plonmarlimab Dosing In Rheumatoid Arthritis Trial

Lead Product(s): Plonmarlimab

Therapeutic Area: Immunology Product Name: TJM2

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 August 17, 2020

Details:

Plonmarlimab is a humanized immunoglobulin G1 (IgG1) antibody that targets the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF), which plays a critical role in autoimmune and inflammatory disease.

TFF Pharmaceuticals

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United States

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TFF Pharmaceuticals Announces $25.9 Million in Financing to Further Advance Its Thin Film Freezing Technology Platform

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.

Aquestive Therapeutics

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United States

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Aquestive Therapeutics Receives FDA Fast Track Designation for AQST-108 for Treatment of Allergic Reactions Including Anaphylaxis

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.

Cynata Therapeutics

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Australia

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Cynata Completes Phase 1 GvHD Clinical Trial Follow-up with Positive Results

Lead Product(s): MCA-derived mesenchymal stem cells

Therapeutic Area: Immunology Product Name: CYP-001

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 July 30, 2020

Details:

The Phase 1 trial, which was the world’s first clinical trial of an allogeneic iPSC-derived MSC product, evaluated the safety and efficacy of CYP-001 for the treatment of patients with steroid-resistant acute graft-versus-host disease (GvHD).

AbSci

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United States

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Alpha Cancer Technologies to License AbSci's SoluPro Strain for the Expression of Alpha-Fetoprotein

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.

Pharmapark

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RUSSIA Russia

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Bio-Thera Solutions Partners with Pharmapark to Market BAT2506 in Russia and other CIS Countries

Lead Product(s): Golimumab

Therapeutic Area: Immunology Product Name: BAT2506

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Pharmapark

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 17, 2020

Details:

Bio-Thera has reached a licensing agreement with Pharmapark LLC, for BAT2506, its golimumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries.

Eisai

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JAPAN Japan

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Eisai Enters Industry-Academia-Government Joint Research Agreement

Lead Product(s): E6742

Therapeutic Area: Immunology Product Name: E6742

Highest Development Status: Phase I Product Type: Undisclosed

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 13, 2020

Details:

In this project, Eisai aims at creating a Japan-originated therapeutic drug for systemic lupus erythematosus (SLE) through industry-academia-government collaboration, using its in-house discovered new oral Toll-Like Receptor (TLR) 7/8 inhibitor E6742.

Cyxone AB

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SWEDEN Sweden

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Cyxone Signs Agreement With Professor Rikard Holmdahl as Senior Scientific Advisor

Lead Product(s): T20K

Therapeutic Area: Immunology Product Name: T20K

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Professor Rikard Holmdahl

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 08, 2020

Details:

The agreement will support Cyxone to develop their drug candidates T20K and Rabeximod and bring them closer to the market.

Find

Find Immunology Drugs in Phase I Clinical Development

Phase I

Product Type

Companies

Innovent Biologics

Innovent Announces that the First Phase I Clinical Study of Anti-Il-23 Monoclonal Antibody Ibi112 Has Been Administered to A Subject

Cabaletta Bio

Cabaletta Bio Announces Publication of Comprehensive Preclinical Study Results for DSG3-CAART in Pemphigus Vulgaris

I-Mab Biopharma

I-Mab Begins Plonmarlimab Dosing In Rheumatoid Arthritis Trial

TFF Pharmaceuticals

TFF Pharmaceuticals Announces $25.9 Million in Financing to Further Advance Its Thin Film Freezing Technology Platform

Aquestive Therapeutics

Aquestive Therapeutics Receives FDA Fast Track Designation for AQST-108 for Treatment of Allergic Reactions Including Anaphylaxis

Cynata Therapeutics

Cynata Completes Phase 1 GvHD Clinical Trial Follow-up with Positive Results

AbSci

Alpha Cancer Technologies to License AbSci's SoluPro Strain for the Expression of Alpha-Fetoprotein

Pharmapark

Bio-Thera Solutions Partners with Pharmapark to Market BAT2506 in Russia and other CIS Countries

Eisai

Eisai Enters Industry-Academia-Government Joint Research Agreement

Cyxone AB

Cyxone Signs Agreement With Professor Rikard Holmdahl as Senior Scientific Advisor