Tempest Therapeutics, Inc. is a clinical-stage oncology company, which engages in the development and discovery of small molecule drugs for the treatment of cancer. The company was founded in 2011 and is headquartered in Brisbane, CA.
Clinical Trials
3
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
2
66.7%
Not yet recruiting
1
33.3%
No approval data available
- Tempest Therapeutics has entered an exclusive option agreement with Hebei Senlang Biotechnology to license a CD7-targeted lentiviral vector platform and in vivo CAR-T product candidates. - The lead asset is a BCMA/GPRC5D dual-targeting in vivo CAR-T candidate in Phase 1 dose escalation for relapsed or refractory multiple myeloma. - Early clinical observations at the highest evaluable dose show in vivo CAR-T generation and expansion, with no Grade 3 or higher cytokine release syndrome or ICANS as of August 25, 2026. - The deal complements Tempest's existing CD7-targeted lipid nanoparticle in vivo CAR-T platform, which is planned to enter the clinic later this year.
- Tempest Therapeutics announced an all-stock acquisition of dual-targeting CAR-T programs from Factor Bioscience, including the clinical-stage CD19/BCMA dual-CAR T program TPST-2003 designed for extramedullary disease patients. - The transaction will extend Tempest's operational runway to mid-2027 and expand its pipeline beyond existing programs amezalpat and TPST-1495, with Factor's investment commitment providing additional funding support. - TPST-2003 has completed Phase 1 trials in relapsed multiple myeloma patients with data expected in 2026, and Tempest plans to pursue U.S. registrational studies starting in 2027. - Upon closing expected in early 2026, Factor Bioscience CEO Matt Angel will become Tempest's President and CEO, while current CEO Stephen Brady will transition to Chairman.
- DelveInsight's 2025 pipeline report reveals over 50 active companies developing 52+ advanced liver cancer therapies, indicating strong industry commitment to addressing this challenging malignancy. - Recent regulatory milestones include Tempest Therapeutics receiving FDA fast track and orphan drug designations for amezalpat, while Bayer initiated Phase I trials for targeted alpha radiopharmaceutical BAY 3547926. - The pipeline features diverse therapeutic approaches including immunotherapy combinations, targeted therapies, and novel mechanisms like STAT3 inhibitors and CAR-T cell therapies. - Advanced liver cancer affects patients with disease spread beyond the liver, requiring systemic treatments focused on slowing progression and maintaining quality of life with median survival often limited to months.
- Tempest Therapeutics is conducting a Phase 3 clinical trial evaluating TPST-1120 combined with atezolizumab and bevacizumab versus standard care in patients with unresectable or metastatic hepatocellular carcinoma. - TPST-1120 is an orally administered competitive antagonist of PPARα that aims to extend patient survival when combined with the current standard treatment regimen. - The randomized, quadruple-masked study is set to begin recruitment in November 2024, with collaboration from Hoffmann-La Roche highlighting its potential industry impact. - The company is also conducting the Morpheus-Liver Phase II study examining neoadjuvant plus adjuvant treatment with atezolizumab and bevacizumab, expected to complete in 2025.
- Biotech funding dropped 57% to $2.7 billion in May 2025, marking one of the worst funding periods in three years according to Jefferies investment bank analysis. - Trump administration policies including FDA mass layoffs, proposed NIH budget cuts, and unclear drug pricing plans have created significant uncertainty among biotech investors. - Public biotech companies raised only $1.1 billion in May while burning through approximately $4.5 billion monthly on average, creating a dangerous cash flow gap. - Several biotech companies including iTeos and Third Harmonic Bio have announced plans to liquidate assets and shut down operations due to the challenging funding environment.
• Tempest Therapeutics is exploring strategic partnerships to advance its promising liver cancer drug amezalpat to Phase III trials after positive Phase II results showed a six-month improvement in overall survival. • The company cites challenging capital markets as the primary obstacle, with CEO Stephen Brady actively seeking partners with resources to develop what they believe are "potentially life-saving therapies." • Amezalpat, a novel PPAR-alpha antagonist with FDA fast track and orphan drug designations, will be evaluated in combination with Roche's Tecentriq and Genentech's Avastin for unresectable or metastatic hepatocellular carcinoma.
- Tempest Therapeutics is actively seeking strategic partnerships to advance its liver cancer drug amezalpat to Phase III trials after positive Phase II results showed a six-month improvement in overall survival. - The FDA has recognized amezalpat's potential by granting it fast track and orphan drug designations for hepatocellular carcinoma, positioning it as the first PPAR-alpha antagonist that could reach market approval. - Despite having FDA clearance for a pivotal Phase III trial in combination with Roche's Tecentriq and Genentech's Avastin, Tempest faces significant funding challenges with a market cap of just $25.1 million and increasing annual losses.
- Tempest Therapeutics received FDA clearance to proceed with a Phase 2 clinical trial of TPST-1495, a novel dual receptor inhibitor of prostaglandin signaling, for treating Familial Adenomatous Polyposis (FAP). - The study will evaluate TPST-1495's efficacy in reducing duodenal polyp burden in FAP patients who have undergone colectomy, with data expected in 2026. - The trial will be conducted by the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute's Division of Cancer Prevention, highlighting the need for innovative cancer prevention approaches.
- Amezalpat, a PPARα antagonist, receives Fast Track Designation from the FDA, following its prior Orphan Drug Designation for hepatocellular carcinoma (HCC). - Phase 1b/2 trial data showed a 6-month improvement in median overall survival when amezalpat was added to atezolizumab and bevacizumab for advanced HCC. - The combination therapy also demonstrated a 30% objective response rate, compared to 13.3% with atezolizumab and bevacizumab alone. - Tempest Therapeutics is preparing for a pivotal Phase 3 study of amezalpat in first-line HCC, supported by agreements with the FDA and EMA.
• Tempest Therapeutics has secured a drug supply agreement with Roche for its Phase 3 study in first-line Hepatocellular Carcinoma (1L HCC). • The FDA has agreed to Tempest's Phase 3 study plan, including dosing and overall survival (OS) as the primary endpoint, potentially shortening the timeline with an early efficacy analysis. • Tempest Therapeutics estimates the Phase 3 study will cost around $100 million, but the Roche agreement is expected to reduce expenses by $30-50 million. • Despite positive clinical advancements, Tempest Therapeutics acknowledges the need for significant funding to support the Phase 3 study.
