Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical
company focused on the discovery, development and commercialization
of precision medicines for kidney diseases, today announced a
focused oral presentation on zigakibart (BION-1301) will be
presented on Friday, June 16, 2023 at the 60th ERA Congress being
held virtually and live in Milan, Italy.
“The strong data we will be presenting at the ERA Congress from
the ongoing phase 1/2 study of zigakibart continue to demonstrate
its disease-modifying potential in patients with IgAN,” said Eric
Dobmeier, president and chief executive officer of Chinook
Therapeutics. “In addition to sustained reductions in mechanistic
biomarkers and correlating clinically meaningful proteinuria
reductions observed in patients with IgAN with a wide range of
baseline proteinuria levels, the phase 1/2 study has provided us
additional key learnings that we look forward to implementing in
the phase 3 BEYOND trial, including dose, schedule and route of
administration and patient selection.”
Updated Interim Results of a Phase 1/2 Study of
Zigakibart (BION-1301) in Patients with IgA
Nephropathy
Zigakibart is a novel anti-APRIL monoclonal antibody currently
in phase 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).
Updated data from both Cohorts 1 and Cohort 2 will be presented
from Part 3 of the ongoing phase 1/2 multi-center trial (see
www.clinicaltrials.gov, identifier NCT03945318) evaluating the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD)
and clinical responses of open-label zigakibart treatment in
patients with IgAN.
Key highlights from the presentation include the
following:
Patients in Cohort 1 initially received a 450mg intravenous (IV)
dose of zigakibart every two weeks. After at least 24 weeks of IV
dosing, patients in Cohort 1 transitioned to a 600 mg subcutaneous
(SC) dose every two weeks for a total treatment duration of up to
two years. Cohort 1 enrolled 10 patients, of which two patients
withdrew from the study for reasons unrelated to study drug, and
eight patients continued receiving treatment.
Patients in Cohort 2 are receiving a SC dose of 600 mg of
zigakibart every two weeks for a total treatment duration of up to
two years. Cohort 2 enrolled 30 patients, of which three patients
were discontinued for not meeting the eligibility criterion of
having biopsy-confirmed IgAN, and 27 patients continued receiving
treatment.
Baseline 24-hour Urine Protein Excretion
(g/day)
- The median baseline 24-hour urine protein excretion for
patients enrolled in Cohort 1 was 1.2 g/day, with a range of 0.7 –
6.5 g/day, and the median baseline 24-hour urine protein excretion
for patients enrolled in Cohort 2 was 1.1 g/day, with a range of
0.3 – 7.0 g/day. With a median baseline 24-hour urine protein
excretion for patients enrolled in both Cohorts 1 and 2 of 1.1
g/day, this population represents patients with IgAN at high risk
of kidney disease progression.
Safety and Tolerability
- As of the May 8, 2023 data cutoff, zigakibart has been well
tolerated, with no deaths or treatment discontinuations due to
adverse events. Of all 40 patients enrolled in both Cohorts 1 and
2:
- All infections have been Grade 1 or 2 in severity and only one
subject had infections deemed treatment-related (Grade 1 viral
upper respiratory tract infection and influenza).
- There were no anti-drug antibodies observed in any
patients.
- Two patients had IgG levels that fell below 3 g/L. One patient
in Cohort 1 required protocol-mandated withholding of study drug.
The patient reached end-of-treatment prior to re-initiation of
study drug. One patient in Cohort 2 had IgG levels below 3g/L at
their week 12 follow-up after permanent discontinuation due to not
meeting eligibility criteria for having biopsy-confirmed IgAN. No
infections were reported in either patient while their IgG levels
were below 3g/L.
- There were 16 injection site reactions (ISRs) reported from a
total of 875 SC doses administered (<2%). All ISRs were Grade 1
or Grade 2.
- One serious adverse event occurred (amnesia) that was not
treatment-related and did not result in interruption of study
drug.
Mechanistic Biomarkers
- Zigakibart treatment resulted in rapid and sustained
reductions in IgA, pathogenic Gd-IgA1, IgM and to a lesser extent
IgG, in patients with IgAN. Zigakibart’s effects on mechanistic
biomarkers were highly consistent between Cohorts 1 and 2 (see
figures below).
https://www.globenewswire.com/NewsRoom/AttachmentNg/6608e190-53ad-4117-b6da-e521a2f9acef
https://www.globenewswire.com/NewsRoom/AttachmentNg/baac3459-0bf7-4b0d-8ffe-36e05158951f
24-hour UPCR
- Zigakibart treatment resulted in sustained, clinically
meaningful proteinuria reductions in patients with IgAN across a
wide range of baseline proteinuria levels.
- In the combined Cohorts 1 and 2, zigakibart demonstrated mean
reductions in 24-hour urine protein creatinine ratio (UPCR) of 20%
in 33 patients at 12 weeks of treatment, 39% in 33 patients at 24
weeks of treatment, 67% in 17 patients at 52 weeks of treatment,
67% in seven patients at 76 weeks of treatment and 72% in five
patients at 100 weeks of treatment (see figure below).
https://www.globenewswire.com/NewsRoom/AttachmentNg/dca0b8df-b710-4f2c-b410-33f8aeafaf01
Overviews of the phase 3 BEYOND and phase 2 ASSIST trials are
also being presented as focused oral presentations (digital poster
with 3-minute presentation) on Friday, June 16, 2023. A moderated
oral presentation (6-slide presentation) on research regarding the
impact of maladaptive tubular epithelial cells on disease
progression in chronic kidney diseases will be presented on Friday,
and a free communication presentation (10-minute live oral
presentation) on initial data from the phase 1 study of CHK-336 in
healthy volunteers will be presented Saturday, June 17, 2023.
Focused Orals:
Abstract Title: |
Updated Interim Results of a
Phase 1/2 Study of BION-1301 in Patients with IgA Nephropathy |
Presenting Author: |
Jonathan Barratt, PhD,
FRCPUniversity of Leicester & Leicester General Hospital,
Leicester, UK |
Session: |
Glomerular &
Tubulo-interstitial Diseases |
Date/Time: |
Friday, June 16, 2023 at 8:30 –
9:45 am CEST |
Location: |
Focused Oral Room 2 |
|
|
Abstract Title: |
A Phase 3, Randomized,
Double-blind, Placebo-controlled Study of BION-1301 in Adults with
IgA Nephropathy |
Presenting Author: |
Vlado Perkovic, MBBS, PhD, FRACP,
FASNUniversity of New South Wales, Sydney, New South Wales,
Australia |
Session: |
Glomerular &
Tubulo-interstitial Diseases |
Date/Time: |
Friday, June 16, 2023 at 12:00 –
1:15 pm CEST |
Location: |
Focused Oral Room 9 |
|
|
Abstract Title: |
ASSIST Study Design: A
Randomized, Double-blind, Placebo-controlled, Crossover Study of
Atrasentan in Patients with IgA Nephropathy (IgAN) on
Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) |
Presenting Author: |
Hiddo J. L Heerspink, PhD,
PharmDUniversity Medical Center Groningen, Groningen,
Netherlands |
Session: |
Glomerular &
Tubulo-interstitial Diseases |
Date/Time: |
Friday, June 16, 2023 at 8:30 –
9:45 am CEST |
Location: |
Focused Oral Room 2 |
Free Communication:
Abstract Title: |
CHK-336, A First-in-Class Orally
Administered LDH Inhibitor: Safety, PK and Target Engagement in a
First-in-Human Phase 1 Healthy Volunteer Study |
Presenting Author: |
Vincent Tong, PhDChinook
Therapeutics |
Session: |
Something Rare, Something
Special |
Date/Time: |
Saturday, June 17, 2023 at 12:00
– 1:15 pm CEST |
Location: |
Amber 3 & 4 |
Moderated Oral:
Abstract Title: |
Accumulation of Maladaptive
Tubular Epithelial Cells (TECs) is Ubiquitous in Chronic Kidney
Diseases and Represents a Common Initiating Mechanism of Disease
Progression |
Presenting Author: |
Eric Olson, PhDChinook
Therapeutics |
Session: |
Moderated Orals 1.4 |
Date/Time: |
Friday, June 16, 2023 at 5:00 –
6:15 pm CEST |
Location: |
Amber 6 |
Once presented, all five presentations can be found in the
Scientific Publications section of Chinook’s website. For more
information on these and other abstracts, please visit the 60th ERA
Congress website.
Due to the pending acquisition of Chinook by Novartis AG, the
investor conference call and webcast previously scheduled for
Friday, June 16, 2023 at 8:15 am EDT (2:15 pm CEST) during the ERA
Congress has been cancelled.
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 proteinuric glomerular diseases. Zigakibart (BION-1301), an
anti-APRIL monoclonal antibody, is being evaluated in a phase 1/2
trial for IgA nephropathy. CHK-336, an oral small molecule LDHA
inhibitor for the treatment of hyperoxalurias, is in phase 1
development. In addition, Chinook’s research and discovery efforts
are focused on building a pipeline of precision medicines for rare,
severe chronic kidney diseases with defined genetic and molecular
drivers. Chinook is leveraging insights from kidney single cell RNA
sequencing and large CKD patient cohorts that have been
comprehensively panomically phenotyped, with retained biosamples
and prospective clinical follow-up, to discover and develop
therapeutic candidates with mechanisms of action targeted against
key kidney disease pathways. To learn more, visit
www.chinooktx.com.
Forward-Looking Statements In addition to
historical information, this communication contains forward-looking
statements within the meaning of applicable securities law,
including statements regarding the advancement of its product
candidates and product pipeline, and the clinical development of
its product candidates, including expectations regarding the
results of clinical trials. In addition, when used in this
communication, the words “will,” “expects,” “could,” “would,”
“may,” “anticipates,” “intends,” “plans,” “believes,” “seeks,”
“targets,” “estimates,” “looks for,” “looks to,” “continues” and
similar expressions, as well as statements regarding our focus for
the future, are generally intended to identify forward-looking
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communication involves risks and uncertainties that could cause
actual results to differ materially from these forward-looking
statements. Factors that might cause or contribute to such
differences include, but are not limited to: expected revenues,
cost savings, synergies and other benefits from the proposed merger
might not be realized within the expected time frames or at all and
costs or difficulties relating to integration matters, including
but not limited to employee retention, might be greater than
expected; the requisite regulatory approvals and clearances for the
proposed transaction may be delayed or may not be obtained (or may
result in the imposition of conditions that could adversely affect
the combined company or the expected benefits of the proposed
merger); the requisite approval of Company stockholders may be
delayed or may not be obtained, the other closing conditions to the
proposed merger may be delayed or may not be obtained, or the
merger agreement may be terminated; business disruption may occur
following or in connection with the proposed merger; Novartis or
Chinook’s businesses may experience disruptions due to
transaction-related uncertainty or other factors making it more
difficult to maintain relationships with employees, other business
partners or governmental entities; the milestones for the proposed
CVRs may not be achieved; the possibility that the proposed merger
is more expensive to complete than anticipated, including as a
result of unexpected factors or events; and diversion of
management’s attention from ongoing business operations and
opportunities as a result of the proposed merger or otherwise.
Additional factors that may affect the future results of Novartis
and Chinook are set forth in their respective filings with the U.S.
Securities and Exchange Commission (the “SEC”), including in the
most recently filed annual report of Novartis on Form 20-F,
subsequently filed Current Reports on Form 6-K and other filings
with the SEC, which are available on the SEC’s website at
www.sec.gov, and Chinook’s most recently filed Annual Report on
Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K and other filings with the SEC, which are
available on the SEC’s website at www.sec.gov. The risks described
in this communication and in Novartis and Chinook’s filings with
the SEC should be carefully reviewed. Undue reliance should not be
placed on these forward-looking statements, which speak only as of
the date they are made. Novartis and Chinook undertake no
obligation to publicly release any revisions to the forward-looking
statements or reflect events or circumstances after the date of
this communication, except as required by law.
Additional Information and Where to Find It In
connection with the proposed merger between Novartis and Chinook,
Novartis and Chinook intend to file relevant materials with the
SEC, including a preliminary and definitive proxy statement to be
filed by Chinook. The definitive proxy statement and proxy card
will be delivered to the stockholders of Chinook in advance of the
special meeting relating to the proposed merger. CHINOOK’S
STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN
ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS
FILED BY EACH OF NOVARTIS AND CHINOOK WITH THE SEC IN CONNECTION
WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE THEREIN
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors
and security holders will be able to obtain a free copy of the
proxy statement and such other documents containing important
information about Novartis and Chinook, once such documents are
filed with the SEC, through the website maintained by the SEC at
www.sec.gov. Novartis and Chinook make available free of charge at
the Novartis website and Chinook’s website, respectively (in the
“Investors” section), copies of materials they file with, or
furnish to, the SEC. The contents of the websites referenced above
are not deemed to be incorporated by reference into the proxy
statement.
Participants in the Solicitation This document
does not constitute a solicitation of proxy, an offer to purchase
or a solicitation of an offer to sell any securities. Novartis,
Chinook and their respective directors, executive officers and
certain employees may be deemed to be participants in the
solicitation of proxies from the stockholders of Chinook in
connection with the proposed merger. Information regarding the
special interests of these directors and executive officers in the
proposed merger will be included in the definitive proxy statement
referred to above. Security holders may also obtain information
regarding the names, affiliations and interests of the Novartis
directors and executive officers in the Novartis Annual Report on
Form 20-F and Form 20-F/A for the fiscal year ended December 31,
2022, which were filed with the SEC on February 1, 2023, and May
15, 2023, respectively. Security holders may obtain information
regarding the names, affiliations and interests of Chinook’s
directors and executive officers in Chinook’s Annual Report on Form
10-K for the fiscal year ended December 31, 2022, which was filed
with the SEC on February 27, 2023, and its definitive proxy
statement for the 2023 annual meeting of stockholders, which was
filed with the SEC on April 28, 2023. To the extent the holdings of
Chinook’s securities by Chinook’s directors and executive officers
have changed since the amounts set forth in Chinook’s definitive
proxy statement for its 2023 annual meeting of stockholders, such
changes have been or will be reflected on Statements of Change in
Ownership on Form 4 filed with the SEC. Additional information
regarding the interests of such individuals in the proposed merger
will be included in the definitive proxy statement relating to the
proposed merger when it is filed with the SEC. These documents
(when available) may be obtained free of charge from the SEC’s
website at www.sec.gov, the Novartis website at
https://www.novartis.com and Chinook’s website at
https://www.chinooktx.com. The contents of the websites referenced
above are not deemed to be incorporated by reference into the proxy
statement.
Investor Contact:
Noopur Liffick, MPH
Senior Vice President, Investor Relations & Corporate Communications
investors@chinooktx.com
Media Contact:
Kelly North
Senior Manager, Investor Relations & Corporate Communications
media@chinooktx.com
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