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Details:
BION-1301 is a humanized IgG4 monoclonal antibody that blocks APRIL, a TNF-family cytokine believed to be implicated in IgAN and other indications, from binding to its receptors.
Lead Product(s): BION-1301
Therapeutic Area: Nephrology Product Name: BION-1301
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 05, 2022
Details:
BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1/2 clinical development for patients with IgAN. Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).
Lead Product(s): BION-1301
Therapeutic Area: Nephrology Product Name: BION-1301
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Evotec
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
BION-1301 has been well-tolerated to date in patients with IgAN, with no treatment-related adverse events, serious adverse events, infusion-related reactions or treatment discontinuations due to adverse events.
Lead Product(s): BION-1301
Therapeutic Area: Immunology Product Name: BION-1301
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2021
Details:
Cohort 2 in Part 3 of the ongoing phase 1/2 study will soon begin enrolling patients with IgAN utilizing subcutaneous administration of BION-1301.
Lead Product(s): BION-1301
Therapeutic Area: Immunology Product Name: BION-1301
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2021
Details:
Poster presentation on BION-1301 including Gd-IgA1 biomarker data in healthy volunteers from Parts 1 and 2 of the ongoing phase 1b study of BION-1301 and data from the phase 1 IV to SC bioavailability study in healthy volunteers.
Lead Product(s): BION-1301
Therapeutic Area: Immunology Product Name: BION-1301
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2021
Details:
Part 3 of the Phase 1 multi-center trial is evaluating the safety and tolerability of BION-1301 in two cohorts of 20 total adult subjects with IgA nephropathy in an open-label multiple dose design.
Lead Product(s): BION-1301
Therapeutic Area: Immunology Product Name: BION-1301
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
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