Find Immunology Drugs in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): Belumosudil

            Therapeutic Area: Immunology Product Name: KD025

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            Belumosudil is being studied in an ongoing double-blind, placebo-controlled Phase 2 clinical trial in adults with SSc. The study is enrolling 60 patients to receive belumosudil 200 mg QD, belumosudil 200 mg BID or placebo for 24 weeks.

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            Lead Product(s): IMVT-1401

            Therapeutic Area: Immunology Product Name: RVT-1401

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 25, 2020

            Details:

            IMVT-1401 was observed to be generally safe and well-tolerated with no serious adverse events (SAEs) and no withdrawals due to adverse events . The drug induced 3.8-point mean improvement on the Myasthenia Gravis Activities of Daily Living scale was statistically significant.

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            Lead Product(s): Nipocalimab

            Therapeutic Area: Immunology Product Name: M281

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 28, 2020

            Details:

            Momenta's novel drug candidate, nipocalimab, has received rare pediatric disease designation from the U.S. FDA for the prevention of hemolytic disease of the fetus and newborn (HDFN). Additionally, FDA granted nipocalimab orphan drug designation in HDFN.

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            Lead Product(s): Epinephrine

            Therapeutic Area: Immunology Product Name: ARS-1

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 13, 2020

            Details:

            Patent approval covers fast-acting decreased dosage level for intranasal administration for type 1 allergic reaction.

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            Lead Product(s): Batoclimab

            Therapeutic Area: Immunology Product Name: HBM9161

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Hudson Bay Capital

            Deal Size: $102.8 million Upfront Cash: Undisclosed

            Deal Type: Series C Financing July 09, 2020

            Details:

            The funds will support a relatively large clinical-phase pipeline spearheaded by an anti-FcRn antibody and a TNF-alpha receptor inhibitor that are on the cusp of registration trials.

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            Lead Product(s): IMVT-1401

            Therapeutic Area: Immunology Product Name: IMVT-1401

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            Based on compelling proof-of-biology for anti-FcRn agents in Myasthenia Gravis (MG), Immunovant has begun preparations to initiate a Phase 3 registrational trial of IMVT-1401 in MG.

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            Lead Product(s): ALPN-101

            Therapeutic Area: Immunology Product Name: ALPN-101

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: AbbVie Inc

            Deal Size: $865‬.0 million Upfront Cash: $60.0 million

            Deal Type: Licensing Agreement June 18, 2020

            Details:

            Alpine Immune Sciences grants AbbVie option to license worldwide rights to ALPN-101, a phase 2-ready, first-in-class dual CD28/ICOS costimulation antagonist, building on AbbVie’s commitment to developing novel therapies in Immunology.

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            Lead Product(s): Nipocalimab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Phase 2 Vivacity-MG Study of Nipocalimab (M281) in Generalized Myasthenia Gravis, met primary endpoint with a strong relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit (p<0.0001).

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            Lead Product(s): ABBV-3373

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 10, 2020

            Details:

            Data show the clinical activity of ABBV-3373 and support advancing the development of the platform in rheumatoid arthritis and initiating clinical studies in other immune-mediated diseases.

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            Lead Product(s): Belumosudil

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $50.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 05, 2020

            Details:

            The proceeds from the offering will be used to advance belumosudil toward a NDA filing with the U.S FDA and support related pre-commercialization activities and provide additional working capital for general corporate purposes.

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