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Find Immunology Drugs in Phase II Clinical Development

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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): Imlifidase

            Therapeutic Area: Immunology Product Name: Idefirix

            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 24, 2020

            Details:

            Positive data demonstrates potential to increase renal survival in anti-GBM antibody disease and marks an important milestone for expansion of imlifidase outside transplantation.

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            Lead Product(s): Rabeximod

            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 24, 2020

            Details:

            New patent applications have been filed to extend exclusivity on Rabeximod, potentially to 2043. A patent application related to Covid-19 has also been filed.

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            Lead Product(s): PRV-015

            Therapeutic Area: Immunology Product Name: PRV-015

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Provention Bio

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership September 22, 2020

            Details:

            Beyond Celiac has partnered with Provention Bio to provide clinical trial recruitment for the biopharmaceutical company’s Phase 2b PROACTIVE study of PRV-015.

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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): Ziritaxestat

            Therapeutic Area: Immunology Product Name: GLPG1690

            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 11, 2020

            Details:

            Ziritaxestat reached the primary endpoint of the study with a statistically significant change from baseline in the modified Rodnan Skin Score (mRSS) at Week 24, of -8.3 vs -5.7 for placebo.

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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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