Tempest Presents New Data at the SITC 2024 Spring Scientific Meeting Supporting Potent Anti-tumor Activity of TPST-1120 in Multiple Cancer Types
Tempest Therapeutics, Inc. presents promising preclinical data at SITC 2024 Spring Scientific Meeting for TPST-1120, a selective PPAR⍺ antagonist showing potent anti-tumor activity in various cancer models. Positive Phase 1 and 2 results support late-stage clinical development in liver cancer patients, with plans for pivotal study. Data indicates inhibition of PPAR⍺ as an effective cancer treatment strategy.
Tempest Therapeutics' revelation of preclinical data and Phase 1 clinical trial results at the SITC 2024 Spring Scientific Meeting is a significant stride in the field of oncology, particularly for targeted cancer therapies. The data underscores the potential of TPST-1120 as a PPARα antagonist, which is a novel approach in cancer treatment. PPARα, or Peroxisome Proliferator-Activated Receptor Alpha, is a nuclear hormone receptor that plays a role in the metabolism of fat and glucose, as well as cellular proliferation and differentiation. By inhibiting PPARα, TPST-1120 may disrupt cancer cell metabolism and enhance the immune system's ability to fight tumors.
Importantly, the reported increase in expression of immune-related genes and elevated plasma Free Fatty Acid levels in response to TPST-1120 treatment could indicate a robust immune-mediated anti-tumor response. This is particularly intriguing as it suggests a dual mechanism of action: direct tumor growth inhibition and immune system modulation. The greater than 50% inhibition of tumor growth in liver, colon and pancreatic cancer models and enhanced inhibition when combined with anti-PD-1 therapy, suggests that TPST-1120 could be a valuable addition to the current immunotherapy landscape.
The data presented by Tempest Therapeutics not only showcases the efficacy of TPST-1120 in preclinical models but also its potential translational value in clinical settings. The positive Phase 1 and 2 data provide a strong foundation for the planned pivotal study in first-line liver cancer patients. The exposure-dependent biomarker changes observed in the Phase 1 trial are particularly promising, as they offer a quantifiable measure of the drug's mechanism of action. This could facilitate the stratification of patients who are most likely to benefit from TPST-1120, thereby personalizing treatment approaches.
Moreover, the randomized study data from October 2023 that demonstrated clinical superiority of TPST-1120 in combination with atezolizumab and bevacizumab over the standard of care in advanced hepatocellular carcinoma patients is a testament to the drug's potential. It is important to note that biomarker-defined patient subpopulations were considered, which is a modern approach in clinical research that aims to improve the precision and efficacy of cancer treatments. These findings could have significant implications for the future of oncology therapeutics and the approach to treating various solid tumor cancers.
From a market perspective, the advancements in TPST-1120's clinical development could be a catalyst for investor interest in Tempest Therapeutics. The oncology drug market is highly competitive and the introduction of a new therapeutic with a novel mechanism of action could disrupt the current market dynamics, especially in the hepatocellular carcinoma segment. The decision to advance to a pivotal study indicates confidence in the drug's efficacy and safety profile, which is crucial for investor sentiment.
Furthermore, the potential for TPST-1120 to be evaluated in additional cancer indications expands its market reach and could lead to multiple revenue streams upon successful approval and commercialization. The company's strategic focus on leveraging clinical biomarker data to support the drug's development is also a positive sign, as it may lead to a more streamlined regulatory process and potentially faster market entry. The long-term impact on Tempest Therapeutics' stock will depend on the outcomes of the late-stage trials and the subsequent steps towards commercialization, but the current data points to a positive trajectory.
03/12/2024 - 08:00 AM
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 www.tempesttx.com
Investor & Media Contacts
Sylvia Wheeler
Aljanae Reynolds
i If approved by the FDA
What was highlighted in the poster presentation at the SITC 2024 Spring Scientific Meeting?
The poster presentation showcased preclinical data demonstrating potent anti-tumor activity in various cancer models treated with TPST-1120 alone or in combination with immune checkpoint inhibitors.
What are the key findings from the Phase 1 trial with TPST-1120?
The Phase 1 trial results showed increased expression of select immune-related genes and elevated plasma Free Fatty Acid (FFA) levels associated with clinical response in patients with advanced solid tumor cancers.
What is TPST-1120 and its role in cancer treatment?
TPST-1120 is an oral, selective PPAR⍺ antagonist that has shown promising results in inhibiting tumor growth in liver, colon, and pancreatic cancer models, particularly when co-administered with anti-PD-1.
What are the future plans for TPST-1120 based on the presented data?
Based on positive Phase 1 and 2 data, Tempest Therapeutics plans to conduct a pivotal study in patients with first-line liver cancer and explore the potential of TPST-1120 in other cancer indications.
What was the outcome of the global randomized phase 1b/2 study of TPST-1120 in combination with atezolizumab and bevacizumab?
The study reported clinical superiority of the TPST-1120 arm over atezolizumab and bevacizumab alone in first-line patients with advanced HCC, across multiple study endpoints and relevant biomarker-defined patient subpopulations.
