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Lead Product(s): Efineptakin alfa
Therapeutic Area: Immunology Product Name: NT-I7
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 February 25, 2021
Details:
The U.S. FDA has cleared its investigational new drug (IND) application for a pilot study evaluating the company’s lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in progressive multifocal leukoencephalopathy (PML).
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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: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2021
Details:
INT301 is an oral mucosal immunotherapy (OMIT) in development for the treatment of peanut allergies. INT301’s unique formulation is designed to desensitize an individual with peanut allergy using a toothpaste delivery system.
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Lead Product(s): Sitaxentan
Therapeutic Area: Immunology Product Name: TMB-003
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 January 12, 2021
Details:
TMB-003 is a locally delivered formulation of sitaxsentan that has the potential to reduce collagen while addressing systemic safety concerns associated with oral administration.
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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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