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Abstract: INFO28

A Phase 1/2 Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

  • No subcategory defined

Authors

  • Barratt, Jonathan, University of Leicester, Leicester, Leicestershire, United Kingdom
  • Sorensen, Bess, Chinook Therapeutics Inc, Seattle, Washington, United States
  • Tolentino, Jerlyn C., Chinook Therapeutics Inc, Seattle, Washington, United States
  • Iyer, Sai Prasad N., Chinook Therapeutics Inc, Seattle, Washington, United States
  • Schwartz, Brian S., Chinook Therapeutics Inc, Seattle, Washington, United States
  • King, Andrew J., Chinook Therapeutics Inc, Seattle, Washington, United States
Description

Immunoglobulin A nephropathy (IgAN) is the leading cause of primary glomerulonephritis with limited treatment options, especially for high-risk patients. BION-1301 is a novel humanized monoclonal antibody that blocks a proliferation-inducing ligand (APRIL), a soluble factor that is elevated in patients with IgAN. APRIL promotes the production of pathogenic galactose-deficient IgA1 (Gd-IgA1), leading to immune complex deposition, inflammation, and kidney damage. Blocking APRIL with BION-1301 is a potential disease-modifying approach to treat IgAN.

The primary objective of this Phase 1/2 study (NCT03945318) is to assess the safety and tolerability of BION-1301 in healthy volunteers (HVs) and patients with IgAN and to assess PK, PD, immunogenicity, and preliminary clinical activity and is comprised of 3 parts. The completed Parts 1 and 2 were blinded, placebo-controlled single and multiple ascending dose designs in HVs. The ongoing Part 3 is a multicenter (US, UK, South Korea), multicohort, open-label study in up to 40 patients with IgAN. Patients in Cohort 1 (n=10) receive 450 mg of BION-1301 administered IV every 2 weeks for at least 24 weeks, then transition to 600 mg of BION-1301 SC every 2 weeks for the remainder of a 1-year total treatment duration. Patients in Cohort 2 (up to 30 patients; enrollment ongoing) receive 600 mg of BION-1301 SC every 2 weeks for 1 year. An optional 1-year treatment extension is available to both cohorts with total treatment duration not to exceed 2 years.

Key eligibility criteria for Part 3 include biopsy-verified diagnosis of IgAN within 10 years, total urine protein excretion ≥0.5 g/24h or UPCR ≥0.5 g/g and stable/optimized dose of ACE-I/ARB (or intolerant). eGFR criteria for Cohort 1 was >45 mL/min/1.73 m2 or 30 to 45 mL/min/1.73m2 if kidney biopsy was performed within 2 years. eGFR criteria for Cohort 2, currently enrolling, is ≥ 30 mL/min/1.73 m2.

The current design of the Phase 1/2 study incorporating SC dosing provides improved patient convenience and will enable the generation of extended safety, PK, PD, immunogenicity, and preliminary efficacy data for the use of BION-1301 in patients with IgAN.

Funding

  • Chinook Therapeutics
Abstract: INFO28

A Phase 1/2 Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Barratt, Jonathan, University of Leicester, Leicester, Leicestershire, United Kingdom
  • Sorensen, Bess, Chinook Therapeutics Inc, Seattle, Washington, United States
  • Tolentino, Jerlyn C., Chinook Therapeutics Inc, Seattle, Washington, United States
  • Iyer, Sai Prasad N., Chinook Therapeutics Inc, Seattle, Washington, United States
  • Schwartz, Brian S., Chinook Therapeutics Inc, Seattle, Washington, United States
  • King, Andrew J., Chinook Therapeutics Inc, Seattle, Washington, United States
Description

Immunoglobulin A nephropathy (IgAN) is the leading cause of primary glomerulonephritis with limited treatment options, especially for high-risk patients. BION-1301 is a novel humanized monoclonal antibody that blocks a proliferation-inducing ligand (APRIL), a soluble factor that is elevated in patients with IgAN. APRIL promotes the production of pathogenic galactose-deficient IgA1 (Gd-IgA1), leading to immune complex deposition, inflammation, and kidney damage. Blocking APRIL with BION-1301 is a potential disease-modifying approach to treat IgAN.

The primary objective of this Phase 1/2 study (NCT03945318) is to assess the safety and tolerability of BION-1301 in healthy volunteers (HVs) and patients with IgAN and to assess PK, PD, immunogenicity, and preliminary clinical activity and is comprised of 3 parts. The completed Parts 1 and 2 were blinded, placebo-controlled single and multiple ascending dose designs in HVs. The ongoing Part 3 is a multicenter (US, UK, South Korea), multicohort, open-label study in up to 40 patients with IgAN. Patients in Cohort 1 (n=10) receive 450 mg of BION-1301 administered IV every 2 weeks for at least 24 weeks, then transition to 600 mg of BION-1301 SC every 2 weeks for the remainder of a 1-year total treatment duration. Patients in Cohort 2 (up to 30 patients; enrollment ongoing) receive 600 mg of BION-1301 SC every 2 weeks for 1 year. An optional 1-year treatment extension is available to both cohorts with total treatment duration not to exceed 2 years.

Key eligibility criteria for Part 3 include biopsy-verified diagnosis of IgAN within 10 years, total urine protein excretion ≥0.5 g/24h or UPCR ≥0.5 g/g and stable/optimized dose of ACE-I/ARB (or intolerant). eGFR criteria for Cohort 1 was >45 mL/min/1.73 m2 or 30 to 45 mL/min/1.73m2 if kidney biopsy was performed within 2 years. eGFR criteria for Cohort 2, currently enrolling, is ≥ 30 mL/min/1.73 m2.

The current design of the Phase 1/2 study incorporating SC dosing provides improved patient convenience and will enable the generation of extended safety, PK, PD, immunogenicity, and preliminary efficacy data for the use of BION-1301 in patients with IgAN.

Abstract: INFO28

A Phase 1/2 Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Barratt, Jonathan, University of Leicester, Leicester, Leicestershire, United Kingdom
  • Sorensen, Bess, Chinook Therapeutics Inc, Seattle, Washington, United States
  • Tolentino, Jerlyn C., Chinook Therapeutics Inc, Seattle, Washington, United States
  • Iyer, Sai Prasad N., Chinook Therapeutics Inc, Seattle, Washington, United States
  • Schwartz, Brian S., Chinook Therapeutics Inc, Seattle, Washington, United States
  • King, Andrew J., Chinook Therapeutics Inc, Seattle, Washington, United States
Description

Immunoglobulin A nephropathy (IgAN) is the leading cause of primary glomerulonephritis with limited treatment options, especially for high-risk patients. BION-1301 is a novel humanized monoclonal antibody that blocks a proliferation-inducing ligand (APRIL), a soluble factor that is elevated in patients with IgAN. APRIL promotes the production of pathogenic galactose-deficient IgA1 (Gd-IgA1), leading to immune complex deposition, inflammation, and kidney damage. Blocking APRIL with BION-1301 is a potential disease-modifying approach to treat IgAN.

The primary objective of this Phase 1/2 study (NCT03945318) is to assess the safety and tolerability of BION-1301 in healthy volunteers (HVs) and patients with IgAN and to assess PK, PD, immunogenicity, and preliminary clinical activity and is comprised of 3 parts. The completed Parts 1 and 2 were blinded, placebo-controlled single and multiple ascending dose designs in HVs. The ongoing Part 3 is a multicenter (US, UK, South Korea), multicohort, open-label study in up to 40 patients with IgAN. Patients in Cohort 1 (n=10) receive 450 mg of BION-1301 administered IV every 2 weeks for at least 24 weeks, then transition to 600 mg of BION-1301 SC every 2 weeks for the remainder of a 1-year total treatment duration. Patients in Cohort 2 (up to 30 patients; enrollment ongoing) receive 600 mg of BION-1301 SC every 2 weeks for 1 year. An optional 1-year treatment extension is available to both cohorts with total treatment duration not to exceed 2 years.

Key eligibility criteria for Part 3 include biopsy-verified diagnosis of IgAN within 10 years, total urine protein excretion ≥0.5 g/24h or UPCR ≥0.5 g/g and stable/optimized dose of ACE-I/ARB (or intolerant). eGFR criteria for Cohort 1 was >45 mL/min/1.73 m2 or 30 to 45 mL/min/1.73m2 if kidney biopsy was performed within 2 years. eGFR criteria for Cohort 2, currently enrolling, is ≥ 30 mL/min/1.73 m2.

The current design of the Phase 1/2 study incorporating SC dosing provides improved patient convenience and will enable the generation of extended safety, PK, PD, immunogenicity, and preliminary efficacy data for the use of BION-1301 in patients with IgAN.