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Find Immunology Drugs in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): Mavrilimumab

            Therapeutic Area: Immunology Product Name: KPL-301

            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 October 26, 2020

            Details:

            Mavrilimumab is an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha. In the Phase 2 giant cell arteritis trial, mavrilimumab was superior to placebo on the primary and secondary efficacy endpoints.

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            Lead Product(s): KZR-616

            Therapeutic Area: Immunology Product Name: KZR-616

            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 October 23, 2020

            Details:

            KZR-616 is a first-in-class selective immunoproteasome inhibitor with the potential to impact multiple drivers of immune-mediated diseases and inflammation. PRESIDIO is a Phase 2 placebo-controlled cross-over trial to evaluate KZR-616 for the treatment of PM and DM.

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            Lead Product(s): Mavrilimumab

            Therapeutic Area: Immunology Product Name: KPL-301

            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 October 06, 2020

            Details:

            The primary efficacy endpoint by Week 26 in all patients treated with Mavrilimumab was statistically significant. The secondary efficacy endpoint of sustained remission at Week 26 in all treated patients was also statistically significant.

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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: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 30, 2020

            Details:

            Batoclimab, a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and lead to the treatment of pathogenic IgG-mediated autoimmune diseases. Earlier studies show Batoclimab is well tolerated​ and can rapidly reduce total IgG.

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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 30, 2020

            Details:

            The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of patients with cGVHD who failed two or more lines of systemic therapy.

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            Lead Product(s): Rilzabrutinib

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 17, 2020

            Details:

            The multicenter Phase 2A trial is anticipated to enroll approximately 25 patients with active IgG4-RD in two arms, rilzabrutinib with glucocorticoids or glucocorticoids only.

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            Lead Product(s): Mavrilimumab

            Therapeutic Area: Immunology Product Name: KPL-301

            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 September 15, 2020

            Details:

            Mavrilimumab is a monoclonal antibody inhibitor targeting granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα).

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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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