Immunology | Phase I Developments | UNITED STATES

Cabaletta Bio

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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.

TFF Pharmaceuticals

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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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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.

AbSci

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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.

Emergent BioSolutions

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Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers Form Collaboration for COVID-19 Treatment

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.

AltruBio

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AltruBio Moves Forward with Clinical Development of Neihulizumab in Steroid-Refractory Acute Graft-Vs-Host Disease

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.

Aquestive Therapeutics

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Aquestive Therapeutics Files IND for Pharmacokinetic Clinical Trials of AQST-108

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.

TFF Pharmaceuticals

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TFF Pharmaceuticals Announces First Human Dosing With Tacrolimus Inhalation Powder and Topline Data for Voriconazole Inhalation Powder

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.

Magenta Therapeutics

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Magenta Reports Stem Cell Mobilization and Conditioning Programs Prioritized and Advancing Toward Clinical Milestones

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®.

Celldex Therapeutics

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Celldex’s KIT Inhibitor CDX-0159 Demonstrates Profound, Sustained Dose-dependent Reductions in Plasma Tryptase

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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Cabaletta Bio

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

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

AbSci

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

Emergent BioSolutions

Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers Form Collaboration for COVID-19 Treatment

AltruBio

AltruBio Moves Forward with Clinical Development of Neihulizumab in Steroid-Refractory Acute Graft-Vs-Host Disease

Aquestive Therapeutics

Aquestive Therapeutics Files IND for Pharmacokinetic Clinical Trials of AQST-108

TFF Pharmaceuticals

TFF Pharmaceuticals Announces First Human Dosing With Tacrolimus Inhalation Powder and Topline Data for Voriconazole Inhalation Powder

Magenta Therapeutics

Magenta Reports Stem Cell Mobilization and Conditioning Programs Prioritized and Advancing Toward Clinical Milestones

Celldex Therapeutics

Celldex’s KIT Inhibitor CDX-0159 Demonstrates Profound, Sustained Dose-dependent Reductions in Plasma Tryptase