Tempest Therapeutics, Inc. (Nasdaq: TPST), a
clinical-stage oncology company developing therapies that combine
both targeted and immune-mediated mechanisms, today summarized key
takeaways from the TPST-1120 clinical program provided by Mark
Yarchoan, M.D., associate professor of oncology at Johns Hopkins
School of Medicine, at its June 5th investor event held in
connection with the 2022 American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago, IL. The company also revised its
cash guidance. Dr. Yarchoan also presented the TPST-1120 Phase 1
results in an oral presentation at ASCO on Tuesday, June 7.
Dr. Yarchoan reviewed and discussed TPST-1120
results both as a single agent and in combination with nivolumab in
a webcast presentation that is available on the Tempest website at
https://ir.tempesttx.com. His conclusions include:
- The monotherapy
arm consisted of one of the more challenging groups of tumors to
treat in a Phase 1 trial, e.g., dominated by patients with
late-line pancreatic and cholangiocarcinoma (CCA), where he
considered stable disease a “win.”
- A number of
patients in the monotherapy arm had meaningfully-prolonged stable
disease, showing that TPST-1120 has activity as a monotherapy
-
Two patients with IDH1 mutated CCA, a mutation found in ~15-30% of
intrahepatic CCA, had stable disease extending out to five and ten
months, respectively, vs. less than three months for historical
standard-of-care values, indicating that an IDH1 mutation is a
potential biomarker for patient sensitivity to TPST-1120
-
In the combination arm, two patients with renal cell carcinoma
(RCC) and one with metastatic CCA achieved partial response when
treated with the higher doses of TPST-1120 in combination with
pembrolizumab
- Both RCC
patients had progressed on prior anti-PD1 therapy, providing strong
evidence that TPST-1120 overcomes resistance to anti-PD1
therapy
- The patient
with metastatic CCA had received multiple lines of prior systemic
therapy and was PDL1-negative, mismatch repair proficient, and had
a TMB of less than 10 mutations per megabase, supporting that
TPST-1120 can reprogram the TME in immune-resistant type
cancers
TPST-1120 Monotherapy
Results
In the monotherapy portion of the trial, 19
evaluable patients with late-line treatment-refractory solid
tumors, including pancreatic, cholangiocarcinoma, 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 evaluable patients with heavily-pretreated renal cell carcinoma,
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.
Financial Update
Following the $15 million private investment in
public equity financing completed in April 2022, Tempest’s cash and
cash equivalents are currently expected to be sufficient to fund
its current operating plans into the first quarter of 2024.
About TPST-1120
TPST-1120 is a first-in-class1 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 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.
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,
a DNA repair enzyme that controls activation of 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 about the design, progress, timing, scope and results of
clinical trials, the benefits that may be derived from any product
candidates, or the company’s expected cash runway. 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: success in clinical trials
for our product candidates may not be indicative of the results
that may be obtained in later clinical trials; 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 WheelerWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
Media Contact:
Aljanae Reynolds Wheelhouse Life Science
Advisorsareynolds@tempesttx.com
1 If approved by the FDA
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