Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq:
TERN), a clinical-stage biopharmaceutical company developing a
portfolio of small-molecule product candidates to address serious
diseases, including oncology, non-alcoholic steatohepatitis (NASH)
and obesity, today announced the U.S. Food and Drug
Administration’s (FDA’s) clearance of the Company’s Investigational
New Drug application and the design of the CARDINAL Trial, Terns’
global Phase 1 clinical trial to evaluate the safety, tolerability,
pharmacokinetics (PK) and efficacy of TERN-701 in participants with
chronic myeloid leukemia (CML). TERN-701 is the Company’s
proprietary, allosteric BCR-ABL tyrosine kinase inhibitor (TKI),
designed to target the BCR-ABL myristoyl pocket.
“Allosteric BCR-ABL inhibitors comprise a novel class of therapy
for CML that has been shown to have superior efficacy and improved
safety compared to active-site inhibitors in prior studies. We are
particularly pleased with our Phase 1 trial design for TERN-701 as
it will recruit chronic CML patients who experienced treatment
failure on at least one prior second-generation TKI. This will
allow us to offer a novel investigational allosteric inhibitor to
CML patients in as early as their second line of therapy, where
there are currently no approved allosteric inhibitors,” said Emil
Kuriakose, MD, chief medical officer-oncology at Terns
Pharmaceuticals.
“Importantly, we were able to leverage emerging early clinical
data from the ongoing Phase 1 trial in China conducted by our
partner, Hansoh, to inform the dose selection for the CARDINAL
Trial. This enables us to accelerate our study and the overall
development of this molecule, while enhancing our ability to best
dose optimize TERN-701 for patients with CML.”
“We are excited to continue the clinical development momentum of
TERN-701, which we believe can offer a valuable alternative to the
only FDA-approved allosteric BCR-ABL TKI for CML. We are
well-positioned to report initial data from this global Phase 1
trial in the second half of 2024,” continued Dr. Kuriakose.
Phase 1 CARDINAL Trial DesignThe CARDINAL Trial
is a global, multicenter, open-label, two-part Phase 1 clinical
trial to evaluate the safety, PK, and efficacy of TERN-701 in
participants with previously treated CML. Part 1 is the dose
escalation portion of the trial that will evaluate once-daily
TERN-701 monotherapy in approximately 24-36 adults living with CML
to be enrolled in up to five dose cohorts. Participants will have
chronic phase CML with confirmed BCR-ABL and a history of treatment
failure or suboptimal response to at least one second generation
TKI (nilotinib, dasatinib or bosutinib). Participants who are
intolerant to prior TKI treatment (including asciminib) are also
allowed. The primary endpoints for Part 1 are the incidence of dose
limiting toxicities (DLTs) during the first treatment cycle, and
additional measures of safety and tolerability. Secondary endpoints
include TERN-701 PK and efficacy assessments, such as hematologic
and molecular responses as measured by the change from baseline in
BCR-ABL transcript levels. The starting dose is 160 mg QD
(once-daily) with dose escalations as high as 500 mg QD and the
option to explore a lower dose of 80 mg QD.
Part 2 is the dose expansion portion of the trial that will
enroll approximately 40 patients, randomized to once-daily
treatment with one of two doses of TERN-701 to be selected based on
data from Part 1. The primary endpoint of the dose expansion
portion of the trial is efficacy, measured by hematologic and
molecular responses. Secondary endpoints include safety,
tolerability and PK. The overall objective of the CARDINAL Trial is
to select the optimal dose(s) of TERN-701 to move forward to a
potential pivotal trial in chronic phase CML.
The CARDINAL Trial plans to enroll at sites in the U.S., Europe
and other Terns global territories. Global site identification and
trial start-up activities are ongoing, with the first patient
screening expected in December 2023. More information about the
TERN-701 global Phase 1 (CARDINAL Trial) trial may be found on
clinicaltrials.gov when available.
About TERN-701TERN-701 is Terns’ proprietary,
oral, potent, allosteric BCR-ABL TKI specifically targeting the
BCR-ABL myristoyl pocket, which is in clinical development for
chronic myeloid leukemia. Allosteric TKIs, which bind to the
myristoyl-binding pocket, represent a novel treatment class for CML
and have the potential to address the shortcomings of active-site
TKIs, including off-target activity and limited efficacy against
active site resistance mutations. TERN-701 aims to address the
limitations of active-site TKIs with the goal of achieving improved
tumor suppression through a combination of potent activity against
BCR-ABL including a broad range of mutations and improved safety
and tolerability profiles. Terns anticipates initiation of the
CARDINAL Trial, a global Phase 1 trial for TERN-701, in the second
half of 2023, with potential interim top-line readouts from initial
cohorts in 2024. Hansoh’s Phase 1 trial (NCT05367700) evaluating
the tolerability, efficacy, and pharmacokinetics of once-daily
TERN-701 (HS-10382) for CML in China is ongoing.
About Chronic Myeloid LeukemiaCML is a cancer
that occurs when the blood-forming cells of the bone marrow
overproduce white blood cells. In the United States, CML is an
orphan indication with approximately 8,930 new cases expected to be
diagnosed in 2023. As of 2020, the latest year for which statistics
are available, an estimated 66,366 people are either living with or
in remission from CML.i Since the introduction of tyrosine kinase
inhibitor (TKI) therapy in 2001, CML has been transformed from a
life-threatening disease to a life-long chronic condition for most
patients. Despite improvements in outcomes with active-site
targeting TKIs, many patients do not achieve long-term disease
control with these therapies due to resistance or intolerance,
leading patients to cycle through prior generation treatments. As a
result, physicians and patients are seeking additional efficacious
therapies for people whose tolerability, co-morbidity and/or
drug-drug interaction profiles change over time, limiting their
available treatment options, quality of life and the effectiveness
of mainstay therapies. Allosteric BCR-ABL TKIs are the only class
of drug to show efficacy and tolerability benefits over active-site
TKIs, and represent an important advancement in the treatment of
CML.
About Terns PharmaceuticalsTerns
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
developing a portfolio of small-molecule product candidates to
address serious diseases, including oncology, NASH and obesity.
Terns’ pipeline includes two clinical stage development programs
including an allosteric BCR-ABL inhibitor and a THR-β agonist, and
preclinical small-molecule GLP-1 receptor agonist and GIPR
modulator programs. For more information, please visit:
www.ternspharma.com.
Cautionary Note Regarding Forward-Looking
Statements This press release contains forward-looking
statements about Terns Pharmaceuticals, Inc. (the “Company,” “we,”
“us,” or “our”) within the meaning of the federal securities laws,
including those related to the Company’s expectations of timing and
potential results of the clinical trials and other development
activities of the Company and its partners, including timelines
related to the TERN-701 Phase 1 trial; the potential indications to
be targeted by the Company with its small-molecule product
candidates; the therapeutic potential of the Company’s
small-molecule product candidates, including the potential for its
product candidates such as TERN-701 to be safe and efficacious; the
potential for the mechanisms of action of the Company’s product
candidates to be therapeutic targets for their targeted
indications; the potential utility and progress of the Company’s
product candidates in their targeted indications, including the
clinical utility of the data from and the endpoints used in the
Company’s and its partner’s clinical trials; the Company’s clinical
development plans and activities, including the results of any
interactions with regulatory authorities on its programs; the
Company’s expectations regarding the profile of its product
candidates, including efficacy, tolerability, safety, metabolic
stability and pharmacokinetic profile and potential differentiation
as compared to other products or product candidates; the Company’s
plans for and ability to continue to execute on its current
development strategy, including potential combinations involving
multiple product candidates; and the impact of new legislation and
regulatory developments on the Company’s plans for its product
candidates, such as the effect of the Inflation Reduction Act of
2022. All statements other than statements of historical facts
contained in this press release, including statements regarding the
Company’s strategy, future financial condition, future operations,
future trial results, projected costs, prospects, plans, objectives
of management and expected market growth, are forward-looking
statements. In some cases, you can identify forward-looking
statements by terminology such as “aim,” “anticipate,” “assume,”
“believe,” “contemplate,” “continue,” “could,” “design,” “due,”
“estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,”
“positioned,” “potential,” “predict,” “seek,” “should,” “target,”
“will,” “would” and other similar expressions that are predictions
of or indicate future events and future trends, or the negative of
these terms or other comparable terminology. The Company has based
these forward-looking statements largely on its current
expectations, estimates, forecasts and projections about future
events and financial trends that it believes may affect its
financial condition, results of operations, business strategy and
financial needs. In light of the significant uncertainties in these
forward-looking statements, you should not rely upon
forward-looking statements as predictions of future events. These
statements are subject to risks and uncertainties that could cause
the actual results and the implementation of the Company’s plans to
vary materially, including the risks associated with the
initiation, cost, timing, progress, results and utility of the
Company’s current and future research and development activities
and preclinical studies and clinical trials. These risks are not
exhaustive. For a detailed discussion of the risk factors that
could affect the Company’s actual results, please refer to the risk
factors identified in the Company’s SEC reports, including but not
limited to its Annual Report on Form 10-K for the year ended
December 31, 2022. Except as required by law, the Company
undertakes no obligation to update publicly any forward-looking
statements for any reason.
Contacts for Terns
InvestorsJustin Nginvestors@ternspharma.com
MediaJenna UrbanBerry & Company Public
Relationsmedia@ternspharma.com
i Arber DA, Orazi A, Hasserjian RP, et al. International
consensus classification of myeloid neoplasms and acute leukemias:
integrating morphologic, clinical, and genomic data. Blood.
2022:140(11);1200-1228
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