November 8, 2019

Tempest Therapeutics’ Oncology Programs Presented at Society of Immunotherapy for Cancer Annual Meeting

South San Francisco, CA – November 8, 2019 - Tempest Therapeutics, Inc., a clinical-stage biotechnology company developing a broad portfolio of first-in-class small molecule therapeutics that combine both precision and immune-mediated mechanisms, today announced presentations featuring the company’s novel lead oncology programs at the Society for Immunotherapy of Cancer (SITC) annual meeting in National Harbor, MD.

TPST-1120 – Selective PPARα Antagonist (Phase 1)

Tom Dubensky, Ph.D., Tempest’s chief executive officer, and John Powderly, M.D. president of Carolina BioOncology Institute, will present a Phase 1/1b trials-in-progress poster for TPST-1120, a first-in-class antagonist against peroxisome proliferator-activated receptor alpha (PPARα). TPST-1120 is designed to target the key transcription factor and block a metabolic pathway integral to both tumor growth and suppressive immune cells, which results in a durable anti-cancer effect. The trial is a dose escalation and expansion study consisting of both monotherapy arms to evaluate single agent activity as well as combination arms to evaluate synergy with chemotherapy and immunotherapy agents.  The primary and secondary endpoints include safety, tolerability and anti-cancer activity of TPST-1120 in multiple tumor types, including renal, liver, pancreatic, lung, breast and colorectal cancers. The trial is underway and actively recruiting patients at multiple centers in the U.S.

TPST-1495 – Dual EP2-4 Antagonist (IND YE19)

TPST-1495, a first-in-class EP2-EP4 dual antagonist that selectively blocks prostaglandin-mediated tumor growth and immune suppression, is being debuted in a second poster to be presented by Chan Whiting, Ph.D., senior vice president, research and development at Tempest, along with Dr. Dubensky. The poster provides preclinical evidence in both human immune cell and in tumor-bearing studies of the significantly-enhanced potency of this dual antagonistic approach with TPST-1495, as compared to single EP4 antagonists in clinical development by several groups. In addition, the data support combination synergy with immune checkpoint inhibitor antibodies. Early next year, Tempest plans to initiate a Phase 1/1b dose escalation and expansion trial in multiple tumors dependent on the EP2/4 pathway, such as MSS colorectal cancer, bladder, head and neck and breast cancer in 2020.

Oral Presentation: Tom Dubensky, CEO Tempest, to discuss STING

In an oral presentation entitled “STING at a Crossroads: Untapped Potential for Innate Immunity,” Dr. Dubensky will review the STING pathway’s role as a critical mediator of cancer immunity and the potential to elicit broad and potent anti-cancer activity through systemic activation of this pathway. In his presentation, Dr. Dubensky will summarize limitations of intratumoral approaches and introduce second generation oral small molecules that are designed for broad innate immune activation through the STING pathway. Tempest is advancing a research program designed to target and inhibit TREX-1, which is known to limit STING activation and is upregulated in response to inflammation and chemotherapy and radiation therapy. 

“This is an important time for Tempest as we advance two promising first-in-class oral small molecule oncology drug candidates in development,” said Tom Dubensky, Ph.D., chief executive officer of Tempest.  “Our programs are differentiated and leverage new insights in oncology to combine both precision medicine and modulation of immune suppression. Our clinical strategy is to demonstrate single agent activity in addition to synergy with other anti-cancer agents.  We believe these are essential elements to elucidate early promise in development and ultimately for success to offer patients new anti-cancer therapies.”

The company’s SITC presentations will be available at www.tempesttx.com/publications after the conference.

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biotechnology company advancing small molecules that combine both precision and immune-mediated mechanisms to modulate anti-tumor pathways with the potential to target a wide range of tumors.  TPST-1120, currently being evaluated in a Phase 1a/1b study in patients with advanced solid malignancies, is a first-in-class, orally available small molecule that blocks the activity of a transcription factor known as PPARα, which regulates a broad set of genes required for fatty acid oxidation (FAO), a metabolic pathway.  TPST-1120 has a two-pronged anti-cancer effect, inhibiting the growth of both metastatic tumors that are reliant on FAO and designated immune cell populations that prevent immune recognition and tumor rejection. TPST-1495 is a first-in-human orally available small molecule that blocks two receptors, EP2 and EP4, which bind to prostaglandin (PGE2) and initiate signaling that promotes tumor growth and proliferation of suppressive immune cell populations.  Several cancer types are thought to be prostaglandin driven, including colorectal cancer, pancreatic cancer, and head and neck cancer.  Signaling through both EP2 and EP4 has been shown to promote tumor growth.  In preclinical studies, TPST-1495 has significantly increased potency compared to single EP4 antagonists in clinical development.  Tempest anticipates evaluating TPST-1495 in patients with advanced cancers in early 2020.

Tempest, headquartered in South San Francisco, is supported by key healthcare investors, including Versant Ventures, F-Prime Capital (Fidelity), Quan Capital, Lilly Asia Ventures, Foresite Capital and Eight Roads Ventures. More information about Tempest can be found on the company’s website at www.tempesttx.com.

Contacts

Sylvia Wheeler
swheeler@wheelhouselsa.com

Alex Santos
asantos@wheelhouselsa.com