All Data
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Lead Product(s): Orelabrutinib
Therapeutic Area: Immunology Product Name: ICP-022
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 November 02, 2020
Details:
This will be a randomized, double-blind, placebo-controlled and multi-center phase II Study in Relapsing-Remitting multiple sclerosis patients (RRMS). Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell lymphomas and autoimmune indications.
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Lead Product(s): IN-001
Therapeutic Area: Immunology Product Name: IN-001
Highest Development Status: IND Enabling Product Type: Small molecule
Partner/Sponsor/Collaborator: HLK Pharmacin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
The Phase 1 single dose study in healthy volunteers will compare IN-001 orally dissolving tablet (epinephrine prodrug) vs the current standard of care, EPIPEN (epinephrine injection).
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Lead Product(s): INT301
Therapeutic Area: Immunology Product Name: INT301
Highest Development Status: IND Enabling Product Type: Large molecule
Partner/Sponsor/Collaborator: Intrommune Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 20, 2020
Details:
Based on this deal, Circuit Clinical will oversee the early clinical development of Intrommune’s lead drug, INT301, including a Phase 1b study planned for Q4 2020 and Q1 2021.
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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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