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Lead Product(s): Lentivirus-Hematopoietic Stem Cell
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 August 24, 2020
Details:
Expression Therapeutics has developed a promising and potentially curative gene therapy candidate for familial hemophagocytic lymphohistiocytosis (HLH) type 3 (FHL3).
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Lead Product(s): Tivozanib
Therapeutic Area: Immunology Product Name: Fotivda
Highest Development Status: IND Enabling Product Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: $433.5 million Upfront Cash: $25.0 million
Deal Type: Agreement August 05, 2020
Details:
The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an investigational new drug (IND) application for tivozanib in a non-oncology indication being developed by Kyowa Kirin.
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Lead Product(s): Epinephrine
Therapeutic Area: Immunology Product Name: BRYN-NDS1C
Highest Development Status: IND Enabling Product Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $26.0 million Upfront Cash: Undisclosed
Deal Type: Financing August 04, 2020
Details:
Proceeds from the financing will be used to fund the remaining development and regulatory approval activities, and pre-launch commercialization program for BRYN-NDS1C, Bryn's bi-dose epinephrine nasal spray.
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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.
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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.
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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.
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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.
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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.
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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.
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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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