May 25, 2023
– Tempest Therapeutics, Inc. (Nasdaq:
TPST), a clinical-stage oncology company developing first-in-classi
therapeutics that combine both targeted and immune-mediated
mechanisms, announced today that Phase 1 clinical trial data for
TPST-1495, the company’s novel dual receptor inhibitor of
prostaglandin (PGE2) signaling, will be presented at the 2023
American Society of Clinical Oncology (ASCO) Annual Meeting to be
held in Chicago from June 2-6, 2023.
The first-in-human Phase 1a/1b, multicenter,
open-label, dose-escalation trial included patients with metastatic
or unresectable solid tumors and treatment-refractory disease with
no remaining standard therapy to confer clinical benefit.
The data showed that in a diverse and
treatment-refractory patient population, treatment with TPST-1495
as a monotherapy and in combination with pembrolizumab resulted in
tumor shrinkage and prolonged stable disease in certain patients,
as well as a durable confirmed partial response (PR) in a
combination therapy patient with microsatellite stable colorectal
cancer (MSS CRC), an indication not normally responsive to
immunotherapy.
The safety profile for TPST-1495 monotherapy on
the recommended once-daily schedule was tolerable, with
predominantly Grade 1-2 treatment related adverse events (TRAEs),
including abdominal pain (17.9% All Grade and 0% Grade 3+), nausea
(20.5% All Grade and 0% Grade 3+), and diarrhea (15.4% All Grade
and 2.6% Grade 3+). For the combination with pembrolizumab, the
most common TRAEs were nausea (29.2% All Grade and 0% Grade 3+),
fatigue (20.8% All Grade and 4.2% Grade 3+) and diarrhea (20.8% All
Grade, 0% Grade 3+). No TRAEs of Grade ≥4 were reported.
On the recommended once-daily schedule, the
disease control rate (DCR) by RECIST v1.1 was 44% for patients on
monotherapy TPST-1495 and 40.9% for patients on TPST-1495 with
pembrolizumab (including a confirmed PR in a patient with MSS CRC
and a stable disease rate of 36.4%).
TPST-1495 also demonstrated near-linear
relationship of exposure-to-dose that was unaffected by combination
therapy, and pharmacodynamic activity was observed in assays of
both immune activation and PGE2 modulation.
“These results from our first-in-human clinical
trial in patients with late-line refractory disease are encouraging
and support a tolerable safety profile and clinical activity of
TPST-1495 as a novel agent targeting the prostaglandin pathway,”
said Sam Whiting, M.D., Ph.D., chief medical officer of Tempest.
“Based on the well-understood biology of PGE2 signaling, we are
enrolling patients in a combination therapy cohort focused on
endometrial cancer, and we are exploring TPST-1495 monotherapy to
treat the high unmet-need inherited cancer syndrome known as
familial adenomatous polyposis, or FAP.”
About TPST-1495
TPST-1495 is an orally-available and potent
small molecule designed to block the receptors EP2 and EP4 in the
prostaglandin pathway, which promote both tumor growth and the
proliferation of suppressive immune cell populations. Several
malignancies are thought to be prostaglandin driven through
expression of high levels of COX-2, the cellular enzyme that
produces PGE2, including endometrial, bladder, breast, colorectal,
and cervical cancers. PGE2 promotes tumor cell growth through EP2
and EP4 signaling and is strongly immune suppressive. Tempest has
conducted multiple IND-enabling studies with peripheral blood
mononuclear cells (PBMCs) from healthy adult donors and in several
mouse tumor models that demonstrate a significant increase in
immune activation and anti-tumor potency by inhibiting both EP2 and
EP4, when compared to EP4-only targeted molecules and non-steroidal
anti-inflammatory drugs (NSAIDS) such as celecoxib.
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 has a diverse portfolio
of novel programs ranging from early research to investigation in a
randomized global study in first-line cancer patients. The
company’s two clinical programs, TPST-1120 and TPST-1495, target
PPARα and EP2/EP4, respectively, and are advancing through trials
designed to study the agents as monotherapies and in combination
with approved agents. Tempest is also developing an orally
available inhibitor of TREX1, a target that controls activation of
the cGAS/STING pathway. Tempest is headquartered in Brisbane,
California. 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 (the “Securities Act”))
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 design, initiation, progress, timing,
scope and results of clinical trials; anticipated therapeutic
benefit and regulatory development of Tempest Therapeutic’s product
candidates; the Company’s ability to deliver on potential
value-creating milestones; the Company’s guidance regarding cash
runway, as well as our operational plans. Forward-looking
statements are based on information available to Tempest
Therapeutics as of the date hereof and are not guarantees of future
performance. Any factors may cause differences between current
expectations and actual results, including: unexpected safety or
efficacy data observed during preclinical or clinical trials;
clinical trial site activation or enrollment rates that are lower
than expected; changes in expected or existing competition; changes
in the regulatory environment; and unexpected litigation or other
disputes. Other factors that may cause actual results to differ
from those expressed or implied are discussed in greater detail in
the “Risk Factors” section of the Company’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2023 and other documents
filed by the Company from time to time with the Securities and
Exchange Commission. 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 Contacts:
Sylvia WheelerWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
Aljanae Reynolds Wheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
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