SOUTH SAN FRANCISCO, Calif. - Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, announced that the U.S. Patent and Trademark Office has issued multiple patents covering composition of matter for the company's therapeutic product candidate TPST-1495, an orally available small molecule designed to selectively block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway.
'We have shown in pre-clinical studies that our approach to inhibit signaling through both EP2 and EP4 receptors with our TPST-1495 dual antagonist confers significantly increased potency compared to single EP4 inhibitors, as well as improvement over other prostaglandin-inhibition approaches including NSAIDs, and could represent an important evolution in the targeting of this pathway in oncology,' said Tom Dubensky, president of Tempest. 'Prostaglandin signaling drives a wide range of cancers as well as resistance to immune checkpoint inhibitor therapies, so we are excited about the potential of our ongoing clinical evaluation of TPST-1495. The intellectual property portfolio covering TPST-1495 and its uses is important to protect the differentiated properties of this molecule.'
The patent portfolio now includes U.S. Patent Numbers 10,968,201 and 11,066,405, as well as a number of pending applications in the United States and other markets outside of the United States. The pending applications cover compositions of matter and methods of use, which further strengthen Tempest's intellectual property for the combined inhibition of EP2 and EP4 prostaglandin PGE2 receptor signaling.
About TPST-1495
TPST-1495 is an orally-available small molecule designed to block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway, while sparing the homologous but differentially active EP1 and EP3 receptors. PGE2 signaling through EP2 and EP4 has been observed both to enhance tumor progression and promote immune suppression. Tempest has conducted head-to-head preclinical studies comparing TPST-1495 to single antagonists of EP2 and EP4 and observed significantly enhanced activity of TPST-1495 in both overcoming PGE2-mediated suppression of human immune cells in vitro, as well as significantly increased anti-tumor activity in mouse models of human colorectal cancer. Tempest is currently evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and possible anti-tumor activity of TPST-1495 in a multicenter Phase 1a/1b dose and schedule optimization study in subjects with advanced solid tumors, with the potential to expand in indications known to be prostaglandin-driven, including colorectal cancer, or CRC, and in a tumor indication-agnostic, biomarker-selected cohort.
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage oncology company advancing small molecules that combine both targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors. The company's two novel clinical programs are TPST-1495 and TPST-1120, antagonists of EP2/EP4 and PPAR?, respectively. Both TPST-1495 and TPST-1120 are advancing through Phase 1 studies designed to study both agents as monotherapies and in combination with other approved agents. In collaboration with F. Hoffman La Roche, TPST-1120 is also advancing through a first line, global, randomized Phase 1b/2 clinical study evaluating TPST-1120 in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with advanced or metastatic hepatocellular carcinoma. Tempest is also developing an orally available inhibitor of TREX-1 designed to activate selectively 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 (the 'Securities Act')) concerning Tempest Therapeutics, Inc. ('Tempest'). 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, as well as assumptions made by, and information currently available to, management of Tempest. 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', 'potentially,' and other similar expressions. All statements that are not historical facts are forward-looking statements, including: any statements regarding the progress, scope or timing of the development and evaluation in clinical trials of our product candidates; the benefits that may be derived from any future products or the commercial; or market opportunity with respect to any of our future products. Forward-looking statements are based on information available to Tempest 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: our inability to successfully or timely develop our product candidates; our inability to realize any benefits from any future products; and our failure to realize any commercial or market benefit from future products, if any. These and other risks are described in greater detail in the Form 10-Q filed by Tempest with the Securities and Exchange Commission on August 12, 2021. Except as required by applicable law, Tempest 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's 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.
Contact:
Investor
Sylvia Wheeler
Wheelhouse Life Science Advisors
E: swheeler@wheelhouselsa.com
Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
E: areynolds@wheelhouselsa.com
TEMPEST THERAPEUTICS, INC. 
