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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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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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