Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage
oncology company developing therapies that combine both targeted
and immune-mediated mechanisms, today announced positive results
from its Phase 1 clinical trial of TPST-1120, a first-in-class1
PPARα antagonist, as a single agent and in combination with
nivolumab in patients with advanced solid tumors. The results will
be presented in an oral presentation at the 2022 American Society
of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, by Mark
Yarchoan, M.D., associate professor of oncology at Johns Hopkins
School of Medicine.
Dr. Yarchoan commented, “The anti-cancer activity
observed in these late-stage solid tumor patients is encouraging,
particularly in light of their treatment history and the difficult
nature of the tumor types. Based on the clinical activity observed
with monotherapy, and the responses observed with combination
therapy in patients with prior progression on checkpoint inhibitor
therapy, a tolerable safety profile and distinct mechanism of
action, I see significant potential in multiple tumor types and
look forward to the ongoing development of TPST-1120.”
Sam Whiting, chief medical officer of Tempest,
added, “We are excited to see these positive TPST-1120 results in
Tempest’s first presentation of clinical data, especially given the
advanced stage and treatment histories of these patients. We look
forward to presenting these data at ASCO and the continued
development of TPST-1120 in the ongoing first-line randomized study
in patients with hepatocellular carcinoma.”
_______________1 If approved by the FDA
TPST-1120 Monotherapy Results
In the monotherapy portion of the trial, 19
patients with late-line treatment-refractory solid tumors,
including pancreatic, cholangiocarcinoma (CCA), and colorectal
cancers, were treated with oral twice-daily TPST-1120. The results
showed that 53% (10/19) of patients experienced clinical benefit in
the form of disease control, including tumor shrinkage in 21% of
the patients. Two patients with late-line CCA, an aggressive tumor
type and disease setting usually unresponsive to therapy, including
IO therapies, achieved durable stable disease and one of the
patients achieved durable tumor shrinkage.
TPST-1120 and Nivolumab Combination
Therapy Results
In the combination therapy portion of the trial,
15 patients with heavily-pretreated renal cell carcinoma (RCC),
hepatocellular carcinoma (HCC) and CCA were treated with oral
twice-daily TPST-1120 and the anti-PD-1 therapy, nivolumab. All of
the HCC and RCC patients had received an approved anti-PD-1 therapy
in at least one prior line of therapy and discontinued that
treatment due to disease progression. Promising objective responses
(RECIST v1.1) were observed in two patients with late-line RCC who
had previously progressed on anti-PD-1 therapy without an objective
response (ORR 50%, n=2/4, in evaluable RCC patients). A third
RECIST response was observed in a patient with late-line, heavily
pre-treated CCA, a tumor type generally not responsive to anti-PD-1
alone.
Notably, all three responders were treated at
the two highest doses of TPST-1120 (ORR 30%, 3/10).
Safety
TPST-1120 was well tolerated as both a
monotherapy and in combination with nivolumab. The majority of the
treatment-related adverse events were Grade 1 and 2, and included
nausea, fatigue and diarrhea. No dose-limiting toxicities were
reported during dose escalation.
ASCO Events
Presentations Details
Title: A phase 1 study of
TPST-1120 as a single agent and in combination with nivolumab in
subjects with advanced solid tumors
Session Typer/Title: Oral
Abstract Session, Developmental Therapeutics – Molecularly Targeted
Agents and Tumor Biology Session Date and Time:
Tuesday, June 7, 2022; 9:45 a.m. - 12:45 p.m. CDT Abstract
Number: 3005
Title: A phase 1 study of
TPST-1495 as a single agent and in combination with pembrolizumab
in subjects with solid tumors
Session Type/Title: Poster
Session, Developmental Therapeutics – Immunotherapy Session
Date and Time: Sunday, June 5, 2022; 8:00 a.m. – 11:00
a.m. CDT Abstract Number: TPST2696
Tempest Investor Event
Tempest will host and webcast an investor event
in conjunction with the ASCO Annual meeting on Sunday, June 5, 2022
at 6:30 a.m. CDT. Company management will be joined by key thought
leaders:
Mark Yarchoan, M.D. Associate Professor of
Oncology Johns Hopkins Sidney Kimmel Comprehensive Cancer
Center
Susanna V. Ulahannan, M.D., MMEd Assistant
Professor of Medicine Associate Director, Oklahoma TSET Phase 1
Program Stephenson Cancer Center at the University of Oklahoma
Jason Luke, M.D. Associate Professor of Medicine
Director - Immunotherapy and Drug Development Center UPMC Hillman
Cancer Center
Toni K. Choueiri, M.D. Director, Lank Center for
Genitourinary Oncology, Dana Farber Cancer Institute Jerome and
Nancy Kohlberg Chair and Professor of Medicine, Harvard Medical
School
To access the live or archived recording of the
investor event, please visit the investor section of the Tempest
website at https://ir.tempesttx.com.
About TPST-1120
TPST-1120 is a first-in-class2 oral selective
PPAR⍺ antagonist with a dual mechanism designed to target both
tumor cells directly and suppressive immune cells in the tumor
microenvironment. Both types of targeted cells are dependent on
fatty acid metabolism, which is regulated by the PPAR⍺
transcription factor. In extensive non-clinical studies, TPST-1120
as a monotherapy and in combination with other anti-cancer drugs
resulted in significant reductions in tumor growth and stimulation
of durable anti-tumor immunity. In addition to the study being
presented at ASCO, in collaboration with F. Hoffmann La Roche,
TPST-1120 is also advancing through a randomized, first-line,
global, Phase 1b/2 clinical study in combination with the
standard-of-care regimen of atezolizumab and bevacizumab in
patients with advanced or metastatic hepatocellular carcinoma.
_______________2 If approved by the FDA
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage
oncology company advancing small molecules that combine both
tumor-targeted and immune-mediated mechanisms with the potential to
treat a wide range of tumors. The company’s two novel clinical
programs are TPST-1120 and TPST-1495, antagonists of PPARα and
EP2/EP4, respectively. Both TPST-1120 and TPST-1495 are advancing
through clinical trials designed to study both agents as
monotherapies and in combination with other approved agents.
Tempest is also developing an orally-available inhibitor of TREX-1
designed to activate selectively the cGAS/STING pathway, an innate
immune response pathway important for the development of anti-tumor
immunity. Tempest is headquartered in South San Francisco. More
information about Tempest can be found on the company’s website at
www.tempesttx.com.
Forward Looking Statements
This press release contains forward-looking
statements (including within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended, and Section 27A of the
Securities Act of 1933, as amended concerning Tempest Therapeutics,
Inc. These statements may discuss goals, intentions, and
expectations as to future plans, trends, events, results of
operations or financial condition, or otherwise, based on current
beliefs of the management of Tempest Therapeutics, as well as
assumptions made by, and information currently available to,
management of Tempest Therapeutics. Forward-looking statements
generally include statements that are predictive in nature and
depend upon or refer to future events or conditions, and include
words such as “may,” “will,” “should,” “would,” “could,” “expect,”
“anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,”
“intend,” and other similar expressions. All statements that are
not historical facts are forward-looking statements, including any
statements regarding the timing and selection of development
candidates, dose selection or commencement of, or availability of
data from, clinical trials or the benefits that may be derived from
any products. Forward-looking statements are based on information
available to Tempest Therapeutics as of the date hereof and are not
guarantees of future performance. Actual results could differ
materially from those contained in any forward-looking statement as
a result of various factors, including, without limitation: our
inability to successfully or timely develop our product candidates;
our inability to realize any benefits from any current or future
products; and our failure to realize any commercial or market
benefit from current or future products, if any. These and other
risks are described in greater detail in the Form 10-Q filed by
Tempest Therapeutics with the Securities and Exchange Commission on
May 13, 2022. Except as required by applicable law, Tempest
Therapeutics undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise. These forward-looking statements should not be relied
upon as representing Tempest Therapeutics’ views as of any date
subsequent to the date of this press release and should not be
relied upon as prediction of future events. In light of the
foregoing, investors are urged not to rely on any forward-looking
statement in reaching any conclusion or making any investment
decision about any securities of Tempest Therapeutics.
Investor Contact:
Sylvia Wheeler Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Media Contact:
Aljanae Reynolds Wheelhouse Life Science Advisors
areynolds@tempesttx.com
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