Full Press Release Details
Tempest Unveils New Survival Data for Amezalpat (TPST-1120) in Randomized First-Line HCC Study
Demonstrating a Six-Month Improvement over Control Arm
Brisbane, CA, June 20, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today announced new positive data
from the ongoing global randomized Phase 1b/2 clinical study in which amezalpat2 (TPST-1120), Tempest s PPAR antagonist, delivered a six-month
improvement in median overall survival ( OS ) advantage when combined with atezolizumab and bevacizumab in a comparison to atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic
hepatocellular carcinoma ( HCC ).
We are thrilled by these new survival data that build on the already meaningful data released in the
fall showing the improvement of the amezalpat arm over atezolizumab and bevacizumab control across all study endpoints, said Stephen Brady, president and chief executive officer of Tempest. These new data come after 10 more months of follow-up since the last data analysis and show not only a strong hazard ratio of 0.65 favoring the amezalpat arm, but also a six-month improvement in the median overall
survival with half the patients still in survival follow up, as well as observation of a survival advantage across key populations results that we believe put amezalpat in a strong position for a successful pivotal Phase 3.
At the cutoff date of February 14, 2024, the new data from 40 patients randomized to the amezalpat arm
and 30 patients randomized to the control arm show:
The earlier top-line data analysis, dated April 20, 2023, had a median follow up of 9.2 and 9.9 months for the
amezalpat and control arms, respectively, and showed:
ORR was determined by RECIST v1.1, and confirmed responses included at least two scans. Tempest retains all product rights to amezalpat.
Conference Call & Webcast Information
will host a webcast conference call today, June 20, 2024 at 8:30am ET.
To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. The live webcast and audio archive of the presentation may be accessed on the investor section of the
Tempest website at https://ir.tempesttx.com/. The webcast will be available for replay for 30 days.
About the Randomized Clinical Trial
The Phase 1b/2 global randomized HCC study is part of Roche s Morpheus program and evaluates amezalpat in combination with atezolizumab and
bevacizumab versus atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC not previously treated with systemic therapy. The trial randomized 70 patients to receive either amezalpat with atezolizumab +
bevacizumab or a contemporaneous control arm of atezolizumab + bevacizumab alone at approximately 25 sites worldwide, including in the United States, Europe, and Asia. The primary efficacy endpoint was confirmed objective response rate, and key
secondary endpoints including PFS and OS. Under the terms of the clinical collaboration agreement, Roche is managing the study operations for this global, multicenter trial and Tempest retains all product rights.
About Amezalpat (TPST-1120)
Amezalpat is an oral, small
molecule, selective PPAR antagonist. Tempest s data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global
randomized phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints when compared to atezolizumab and
bevacizumab alone, the standard of care. These randomized data were supported by positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors.
About Hepatocellular Carcinoma
HCC is an aggressive
cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030.3 Every year, more than 900,000 people worldwide are diagnosed with HCC.4 Incidence and mortality are highest in East Asia and are increasing in parts of Europe and the US.5 In the US, HCC represents the fastest-rising
cause of cancer-related death.3
Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C
infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these
Even if diagnosed in the early stage, an estimated
70-80% of people with early-stage HCC experience disease recurrence following surgery.7 Early recurrence is associated with poorer prognosis and shorter
survival.5,8 Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of recurrence.6
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted
and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is
headquartered in Brisbane, California. More information about Tempest can be found on the company s website at www.tempesttx.com.
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. ( Tempest Therapeutics ). 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 in this release regarding the therapeutic benefit and regulatory development of amezalpat and the favorable results of clinical trials. 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. 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 9, 2024. 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.
Wheelhouse Life Science
Wheelhouse Life Science Advisors