Tempest Therapeutics Starts Phase I/Ib Clinical Trial with First-in-Class PPAR Alpha Antagonist

–Company strengthens board of directors and scientific advisory board
with appointments of Mike Raab and Benjamin Cravatt–

SAN FRANCISCO–(BUSINESS WIRE)–Tempest Therapeutics Inc., a clinical-stage biotechnology company
developing a broad portfolio of first-in-class immunomodulatory small
molecules targeting diverse cancers, today announced that the first
patient has been dosed with TPST-1120 in a Phase I/Ib trial to treat
advanced solid tumor malignancies.

PPAR (peroxisome proliferator-activated receptor) alpha is a nuclear
transcription factor that regulates fatty acid oxidation and lipid
metabolism in the tumor microenvironment (TME). TPST-1120 is a PPAR
alpha antagonist that has a two-pronged mechanism, targeting both tumor
cells and suppressive immune cells in the TME dependent on fatty acid
metabolism, driving a metabolic shift to glycolysis and facilitating the
development of a tumor-specific effector immune cell response. In
extensive animal studies, TPST-1120 therapy used as a single agent or in
combination with other anti-cancer drugs resulted in significant
reductions in tumor growth and stimulation of durable anti-tumor
immunity.

The U.S. Phase I trial (NCT03829436) is enrolling patients with advanced
solid tumors. The open-label, dose-escalation and dose-expansion study
is testing oral twice-daily TPST-1120 as monotherapy and in combination
with marketed cancer drugs such as PD-1 inhibitors, anti-EGFR antibodies
or chemotherapy. Primary outcome measures of the trial include assessing
safety and tolerability and establishing a dose range for expanded
studies at specified TPST-1120 doses. Secondary outcome measures include
pharmacokinetics, mechanism-based biomarkers and objective response rate.

“Today represents an exciting moment for Tempest, as we transition to a
clinical-stage company that is advancing first-in-human therapies
targeting new pathways to induce anti-cancer immunity. Ultimately, we
hope that our new approaches to treat cancer will provide benefit to
patients,” said Ginna Laport, MD, CMO of Tempest.

To help facilitate the transition to a clinical-stage company, Tempest
has made key appointments to its board of directors with the appointment
of Mike Raab, and to its scientific advisory board with the appointment
of Benjamin Cravatt, Ph.D.

Mr. Raab is president and CEO of Ardelyx Inc., a publicly traded
biotechnology company focused on cardiorenal diseases. He previously was
a partner at New Enterprise Associates, where he spent 15 years in
commercial and operating leadership roles in the biotech and
pharmaceutical industries. Before NEA, he was SVP of therapeutics and
general manager of the renal division at Genzyme Corp. where he launched
and oversaw the sales growth of sevelamer, the leading phosphate binder
to treat hyperphosphatemia, with over $1 billion in worldwide sales in
2013. Mike also was instrumental in the worldwide launch of Genzyme’s
therapies for Gaucher disease, Ceredase and Cerezyme.

Dr. Cravatt is a professor in the Skaggs Institute for Chemical Biology
and Gilula Chair Chemical Biology at The Scripps Research Institute. His
research group is interested in understanding the roles that enzymes
play in physiological and pathological processes, especially as pertains
to the nervous system and cancer. Dr. Cravatt is a co-founder and
scientific advisor of multiple biotechnology companies.

“Mike Raab and Ben Cravatt are widely recognized leaders in pharma and
biotechnology drug development, and each will provide significant
guidance and insights to facilitate Tempest’s continuing success,” said
Tom Dubensky, Ph.D., president and CEO of Tempest.

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biotechnology company advancing
small molecules that modulate anti-tumor immunity pathways. The company
has a balanced and deep pipeline consisting of first-in-class and
potential best-in-class small molecule therapeutics that modulate
distinct immune response pathways relevant to mounting an effective
anti-tumor response. Tempest’s backers include Versant Ventures, F-Prime
Capital, Quan Capital, Lilly Asia Ventures, Foresite Capital and Eight
Roads Ventures.

Contacts

Steve Edelson
[email protected]
415-801-8088