IND Enabling

Talaris Therapeutics

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United States

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CAMBODIA PHAR-MED 2020

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FDA Approves Talaris Therapeutics’ IND for Its Allogeneic Cell Therapy FCR001 to Be Evaluated in Patients With a Severe Form of Scleroderm...

Lead Product(s): FCR001

Therapeutic Area: Immunology Product Name: FCR001

Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 08, 2020

Details:

Approval of this IND allows Talaris to initiate a Phase 1/2a trial for the evaluation of Talaris’ novel cell therapy FCR001 in the treatment of diffuse systemic sclerosis, at sites across the U.S., including Duke University and the University of Michigan.

CytoAgents

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United States

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CytoAgents Receives Funding to Accelerate COVID-19 Clinical Trials for Cytokine Storm Treatment From Richard King Mellon Foundation

Lead Product(s): GP1681

Therapeutic Area: Immunology Product Name: GP1681

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Richard King Mellon Foundation

Deal Size: $0.2 million Upfront Cash: Undisclosed

Deal Type: Funding July 07, 2020

Details:

The funding would accelerate the development of CytoAgents' lead drug candidate, GP1681, an investigational new drug to treat “cytokine storm” induced by COVID-19, from the Richard King Mellon Foundation.

Magenta Therapeutics

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United States

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Magenta Therapeutics Presents Data Supporting Immune Reset for Autoimmune Diseases

Lead Product(s): CD45-ADC

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2020

Details:

Single dose of CD45-ADC shown to remove disease-causing cells and halt disease in models of multiple sclerosis, systemic sclerosis and inflammatory arthritis.

Cabaletta Bio

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United States

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Cabaletta Bio Receives FDA Fast Track Designation for DSG3-CAART for the Treatment of Mucosal Pemphigus Vulgaris

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

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 06, 2020

Details:

U.S. FDA has granted Fast Track Designation for DSG3-CAART, the Cabaletta’s lead product for treatment of mucosal pemphigus vulgaris, for improving healing of mucosal blisters in patients with mPV.

Polyneuron Pharmaceuticals

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Switzerland

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Polyneuron Receives Approval to Begin Clinical Study With PN-1007 in Anti-MAG Neuropathy

Lead Product(s): PN-1007

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2020

Details:

Regulatory authorities in France, the Netherlands and the UK have approved the clinical trial application for a phase I/IIa study of PN?1007 for the treatment of anti-MAG neuropathy.

Shenzhen Chipscreen Biosciences

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CHINA China

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Chipscreen Biosciences's Original New Drug CS12192: Investigational New Drug (IND) Application Accepted

Lead Product(s): CS12192

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 24, 2020

Details:

CS12192 showed significant efficacy in multiple autoimmune disease models in preclinical studies.

Revive Therapeutics

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CANADA Canada

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Revive Provides Update on its Clinical Development Plan for Cannabidiol in the Treatment of Autoimmune Hepatitis

Lead Product(s): Cannabidiol

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 18, 2020

Details:

Revive is currently in the process of preparing its Investigational New Drug (“IND”) application for submission to the U.S. Food and Drug Administration (“FDA”) for CBD in the treatment of AIH.

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Companies

Talaris Therapeutics

FDA Approves Talaris Therapeutics’ IND for Its Allogeneic Cell Therapy FCR001 to Be Evaluated in Patients With a Severe Form of Scleroderm...

CytoAgents

CytoAgents Receives Funding to Accelerate COVID-19 Clinical Trials for Cytokine Storm Treatment From Richard King Mellon Foundation

Magenta Therapeutics

Magenta Therapeutics Presents Data Supporting Immune Reset for Autoimmune Diseases

Cabaletta Bio

Cabaletta Bio Receives FDA Fast Track Designation for DSG3-CAART for the Treatment of Mucosal Pemphigus Vulgaris

Polyneuron Pharmaceuticals

Polyneuron Receives Approval to Begin Clinical Study With PN-1007 in Anti-MAG Neuropathy

Shenzhen Chipscreen Biosciences

Chipscreen Biosciences's Original New Drug CS12192: Investigational New Drug (IND) Application Accepted

Revive Therapeutics

Revive Provides Update on its Clinical Development Plan for Cannabidiol in the Treatment of Autoimmune Hepatitis