TPST TEMPEST THERAPEUTICS INC

Tempest Presents New Data at the SITC 2024 Spring Scientific Meeting Supporting Potent Anti-tumor Activity of TPST-1120 in Multiple Cancer Types

Tempest Presents New Data at the SITC 2024 Spring Scientific Meeting Supporting Potent Anti-tumor Activity of TPST-1120 in Multiple Cancer Types

BRISBANE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) 2024 Spring Scientific Meeting highlighting preclinical data showing potent anti-tumor activity in several cancer models treated with TPST-1120 alone or with immune checkpoint inhibitors. The presentation covered experimental results that corroborated clinical biomarker data from patients with advanced solid tumor cancers treated in a Phase 1 trial with TPST-1120 showing increased expression of select immune-related genes and elevated plasma Free Fatty Acid (FFA) levels associated with clinical response. TPST-1120 is an oral, selective PPAR⍺ antagonist in clinical development that has shown promising results, including positive data from a randomized study in first-line hepatocellular carcinoma (HCC) patients compared to the standard of care.

“Data presented at the SITC Spring Scientific Meeting bolster our mechanistic understanding of PPARα blockade in cancer patients and reinforce a basis for the ongoing late-stage clinical development of TPST-1120,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest. “Based on positive Phase 1 and 2 data, we are planning a pivotal study in patients with first-line liver cancer, and we also look forward to evaluating the potential of TPST-1120 in additional cancer indications.”

In preclinical models of liver, colon and pancreatic cancer, TPST-1120 elicited a greater than 50% inhibition of tumor growth with enhanced inhibition observed in liver and colon cancer models when co-administered with anti-PD-1. In addition, biomarker results from the Phase 1 clinical trial of TPST-1120 in multiple solid tumor indications showed statistically significant, exposure-dependent elevations in expression levels of multiple immune-related genes, and patients exhibiting objective responses displayed increased circulating free fatty acids (FFA), both of which are in-line with the proposed TPST-1120 mechanism of action. Clinical response and biomarker findings support that inhibition of PPARα may be an effective therapeutic strategy for the treatment of cancer.

These findings complement positive data reported in October 2023 from a global randomized phase 1b/2 study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC. The differentiating data showed clinical superiority of the TPST-1120 arm across multiple study endpoints and relevant biomarker-defined patient subpopulations when compared to atezolizumab and bevacizumab alone, the standard of care in first-line HCC.

About TPST-1120

TPST-1120 is an oral, small molecule, selective PPAR⍺ antagonist. Tempest’s data suggest that TPST-1120 treats cancer by targeting tumor cell metabolism directly, as well as by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In a Phase 1 clinical trial in patients with heavily-pretreated advanced solid tumors, TPST-1120 as monotherapy and in combination with the PD-1 inhibitor nivolumab demonstrated tumor reduction (including RECIST responses) and biomarker modulation. In a global randomized phase 1b/2 study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced hepatocellular carcinoma (HCC), the TPST-1120 arm showed clinical superiority across multiple study endpoints when compared to atezolizumab and bevacizumab alone, the standard of care. TPST-1120 is wholly-owned by Tempest.

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 .

Investor & Media Contacts

Sylvia Wheeler

Wheelhouse Life Science Advisors

Aljanae Reynolds

Wheelhouse Life Science Advisors

i If approved by the FDA



EN
12/03/2024

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on TEMPEST THERAPEUTICS INC

 PRESS RELEASE

Tempest Reports Second Quarter 2025 Financial Results and Provides Bus...

Tempest Reports Second Quarter 2025 Financial Results and Provides Business Update Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in ChinaGranted orphan drug designation from the European Medicines Agency (EMA) for amezalpat for the treatment of patients with HCCPresented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual MeetingGranted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP) BRISBAN...

 PRESS RELEASE

Tempest Receives Clearance to Proceed with Pivotal Trial of Amezalpat ...

Tempest Receives Clearance to Proceed with Pivotal Trial of Amezalpat Combination Therapy for First-Line HCC in China Builds on clearances already received by FDA and EMAChina has the largest population of patients with hepatocellular carcinoma in the world BRISBANE, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received approval from the National Medical Products Administration (NMPA) ...

 PRESS RELEASE

Tempest Announces $4.6 Million Registered Direct Offering of Common St...

Tempest Announces $4.6 Million Registered Direct Offering of Common Stock BRISBANE, Calif., June 11, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that it has entered into a definitive agreement with a single institutional investor for the purchase and sale in a registered direct offering of 739,000 shares of its common stock (or common stock equivalents), at an offering price of $6.25 per share of common stock (or commo...

 PRESS RELEASE

Tempest Receives Orphan Drug Designation from the European Medicines A...

Tempest Receives Orphan Drug Designation from the European Medicines Agency for Amezalpat for the Treatment of Patients with HCC EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment optionsThe multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for amezalpat combination therapy across multiple study endpoints, including overall survival in both the entire population ...

 PRESS RELEASE

Tempest Reports First Quarter 2025 Financial Results and Provides Busi...

Tempest Reports First Quarter 2025 Financial Results and Provides Business Update Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual MeetingGranted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP)Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of FAPGranted both Orphan Drug & Fast Track designations by FDA for Amezalpat (TPST-1120) for the treatment of patients with hepatocellular carcinoma (HCC) BRISBANE, Calif., May 13...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch