Chinook Therapeutics Presents BION-1301 Interim Phase 1/2 Data in Patients with IgA Nephropathy (IgAN) at the 58th ERA-EDTA V...
June 08 2021 - 08:15AM
Chinook Therapeutics, Inc. (Nasdaq: KDNY), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of precision medicines for kidney diseases, today
announced the presentation of data from the ongoing phase 1/2 study
of BION-1301 in patients with IgAN. The findings were presented in
an oral presentation at the 58th European Renal Association –
European Dialysis and Transplant Association (ERA-EDTA) Virtual
Congress.
“We are encouraged by the data we have generated to date for
BION-1301 in patients with IgAN, including the clinically
meaningful reductions in proteinuria observed, as well as safety,
tolerability, PK and mechanistic biomarker responses,” said Alan
Glicklich, M.D., chief medical officer of Chinook Therapeutics.
“The data generated thus far have reaffirmed our belief that
blocking and neutralizing APRIL in patients with IgAN plays a key
role in depleting pathogenic Gd-IgA1 and reducing proteinuria,
demonstrating strong rationale for BION-1301’s disease-modifying
mechanism of action in IgAN.”
FC 040: Interim
Results of Phase 1 and 2 Trials to Investigate the Safety,
Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical
Activity of BION-1301 in Patients with IgA Nephropathy
BION-1301 is a novel anti-APRIL monoclonal antibody currently in
phase 1/2 clinical development for IgAN. Blocking APRIL is a
potential disease-modifying approach to treating IgAN by reducing
circulating levels of galactose-deficient IgA1 (Gd-IgA1) to prevent
the formation of immune complexes that deposit in the glomeruli of
the kidney, causing injury.
Part 3 of the ongoing phase 1/2 multi-center trial (see
www.clinicaltrials.gov, identifier NCT03945318) is evaluating the
safety, tolerability, PK and pharmacodynamics (PD) of BION-1301 in
patients with IgAN in an open-label setting. Patients in Cohort 1
receive an intravenous (IV) dose of 450 mg of BION-1301 every two
weeks for up to 52 weeks. Patients in subsequent cohorts in Part 3
will be dosed subcutaneously.
Key highlights from the oral presentation include the
following:
- BION-1301 has been well-tolerated to date in patients with
IgAN, with no treatment-related adverse events, SAEs,
infusion-related reactions or treatment discontinuations due to
adverse events.
- To date, no anti-drug antibodies (ADAs) have been observed in
patients with IgAN.
- The PK plasma exposures of BION-1301 observed in patients with
IgAN have been consistent with those previously reported in healthy
volunteers and were sufficient to drive rapid, significant and
sustained reductions in free APRIL concentrations, confirming
effective APRIL neutralization by BION-1301.
- BION-1301 has durably reduced serum IgA and IgM levels, and to
a lesser extent IgG levels, highly consistent with the kinetics and
magnitude of immunoglobulin response previously reported in healthy
volunteers.
- BION-1301 treatment has also resulted in significant and
sustained reductions in Gd-IgA1, demonstrating depletion of the
pathogenic IgA variant, and establishing the potential
disease-modifying mechanism of BION-1301 in patients with IgAN by
directly targeting Hit 1 in the multi-hit pathogenesis of
IgAN.
- Ex vivo mesangial cell hyperproliferation, induced by
IgA-containing plasma fractions isolated from patients treated with
BION-1301, was attenuated, suggesting a reduction in circulating
pathogenic IgA-containing immune complexes following BION-1301
treatment.
- BION-1301 demonstrated a clinically meaningful mean reduction
in 24-hour UPCR in the first several patients with IgAN enrolled in
the study. The UPCR reductions began after the first month of
treatment and were evident by three months in patients with
baseline UPCR levels ranging from 530 – 4551 g/g.
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. To help inform future patient
selection for clinical studies of BION-1301, biomarker analysis
from IgAN patient serum in the NURTuRE CKD patient biobank is also
ongoing, integrating patient characteristics, disease progression,
kidney histopathology as well as transcriptomics and proteomic
analysis.
Live Conference Call and WebcastChinook will
host a live conference call and webcast today at 4:00 pm EDT to
discuss the interim data from Part 3 of Chinook’s ongoing phase 1/2
study of BION-1301 in patients with IgAN that was presented at the
58th ERA-EDTA Congress. Members of the Chinook executive team will
be joined by Dr. Jonathan Barratt, the Mayer Professor of Renal
Medicine at University of Leicester.
Conference Call and Webcast DetailsTo access
the call, please dial (844) 309-0604 (domestic) or (574) 990-9932
(international) and provide the Conference ID 2591818 to the
operator.
To access the live webcast, subsequent archived recording and
slides that were developed to complement this and other company
presentations, please visit the Investors section of Chinook’s
website. The archived webcast will remain available for replay on
Chinook’s website for 90 days.
About Chinook Therapeutics, Inc.Chinook
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing precision medicines for kidney diseases. Chinook’s
product candidates are being investigated in rare, severe chronic
kidney disorders with opportunities for well-defined clinical
pathways. Chinook’s lead program is atrasentan, a phase 3
endothelin receptor antagonist for the treatment of IgA nephropathy
and other proteinuric glomerular diseases. BION-1301, an anti-APRIL
monoclonal antibody is being evaluated in a phase 1b trial for IgA
nephropathy. In addition, Chinook is advancing CHK-336, an oral
small molecule LDHA inhibitor for the treatment of primary
hyperoxaluria, as well as research programs for other rare, severe
chronic kidney diseases. Chinook is building its pipeline by
leveraging insights in kidney single cell RNA sequencing,
human-derived organoids and new translational models, to discover
and develop therapeutics with differentiating mechanisms of action
against key kidney disease pathways. To learn more, visit
www.chinooktx.com.
Cautionary Note on Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, including those relating to Chinook’s business, future
operations, advancement of its product candidates and product
pipeline, clinical development of its product candidates, including
expectations regarding cash forecasts and timing of initiation and
results of clinical trials. In some cases, you can identify these
statements by forward-looking words such as “may,” “will,”
“continue,” “anticipate,” “intend,” “could,” “project,” “expect” or
the negative or plural of these words or similar expressions.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results and events to differ materially from those anticipated,
including, but not limited to, our ability to develop and
commercialize our product candidates, including initiation of
clinical trials of our existing product candidates or those
developed as part of the Evotec collaboration, whether results of
early clinical trials, such as those described above for BION-1301,
or preclinical studies will be indicative of the results of future
trials, our ability to obtain and maintain regulatory approval of
our product candidates, our ability to operate in a competitive
industry and compete successfully against competitors that may be
more advanced or have greater resources than we do, our ability to
obtain and adequately protect intellectual property rights for our
product candidates and the effects of COVID-19 on our clinical
programs and business operations. Many of these risks are described
in greater detail in our filings with the SEC. Any forward-looking
statements in this press release speak only as of the date of this
press release. Chinook assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Contact:Noopur LiffickVice President, Investor
Relations & Corporate Communicationsinvestors@chinooktx.com
media@chinooktx.com
Chinook Therapeutics (NASDAQ:KDNY)
Historical Stock Chart
From Feb 2024 to Mar 2024
Chinook Therapeutics (NASDAQ:KDNY)
Historical Stock Chart
From Mar 2023 to Mar 2024