January 30, 2020
Tempest Therapeutics Announces FDA Clearance of Investigational New Drug Application for TPST-1495 and Welcomes New Investors
– TPST-1495 is a selective dual antagonist of both EP2 and EP4 prostaglandin receptors
– Lyfe Capital and Rock Springs Capital Management join investor syndicate
South San Francisco, CA – January 30, 2020 - Tempest Therapeutics, Inc., a clinical-stage oncology company developing therapeutics that combine both precision and immune-mediated mechanisms, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for TPST-1495, a small molecule dual antagonist of the prostaglandin receptors EP2 and EP4.
“We are excited about the differentiated potential of TPST-1495 to treat a broad range of patients with prostaglandin-driven tumors,” said Tom Dubensky, Ph.D., chief executive officer of Tempest. “We believe the ability to block both EP2 and EP4 receptor downstream signaling will be an important differentiator from other agents in clinical development that target this pathway and may result in increased benefit to patients.”
FDA clearance of the IND enables Tempest to initiate its planned Phase 1a/1b clinical trial in patients with advanced solid tumors. The dose escalation phase of the trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of TPST-1495 as a monotherapy and in combination with a checkpoint inhibitor. Following completion of the dose escalation phase, additional patients will be enrolled in an expansion cohort at the maximum tolerated dose. Although the clinical trial will allow participation of patients with any solid tumor histology, Tempest intends to focus evaluation of TPST-1495 in patients with microsatellite stable colorectal cancer (MSS CRC) given the mechanism of action of this first-in-human investigational agent.
Tempest also announced that healthcare investors Lyfe Capital and Rock Springs Capital Management have made equity investments in the company.
“We appreciate the support of both our existing and new investors, which speaks to the potential of Tempest’s programs to bring new treatment options to patients with cancer,” offered Stephen Brady, president and chief operating officer of Tempest. “With the company’s current capital, we’re positioned to aggressively execute a strategy to demonstrate both single agent and combination activity with our two lead drug candidates, TPST-1120 and TPST-1495.”
About TPST-1495
TPST-1495 is a potent small molecule designed to block the receptors EP2 and EP4 in the prostaglandin pathway, which promote both tumor growth and proliferation of suppressive immune cell populations. Several cancer types are thought to be prostaglandin driven, including MSS CRC. TPST-1495 is differentiated from other prostaglandin-targeted programs in development because it targets both EP2 and EP4 to the exclusion of EP1 and EP3, which Tempest believes is an important distinction for oncology. Tempest has conducted multiple IND-enabling studies with PBMCs from healthy adult donors and in several preclinical tumor models that demonstrate a significant increase in anti-tumor potency through inhibiting both EP2 and EP4.
About Tempest Therapeutics
Tempest is a clinical-stage biotechnology company advancing small molecules that combine both precision and immune-mediated mechanisms to modulate anti-tumor pathways. In addition to TPST-1495, the company is progressing TPST-1120, a second novel small molecule that selectively antagonizes the PPARα transcription factor. TPST-1120 has a two-pronged anti-cancer effect, inhibiting the growth of the tumors directly, as well as designated suppressive immune cell populations that prevent immune recognition and tumor rejection. TPST-1120 is currently being evaluated in a Phase 1a/1b study in patients with advanced solid malignancies.
Tempest is headquartered in South San Francisco and supported by notable healthcare investors Versant Ventures, F-Prime Capital, Quan Capital, Lilly Asia Ventures, Foresite Capital, Eight Roads Ventures, Lyfe Capital and Rock Springs Capital Management. More information about Tempest can be found on the company’s website at www.tempesttx.com.
Contacts
Sylvia Wheeler
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Alex Santos
asantos@wheelhouselsa.com