Tempest Therapeutics, Inc. develops clinical-stage cell therapy and small-molecule product candidates for cancer and related disease areas. News about TPST centers on its dual-targeting CAR-T platform, including TPST-2003, a CD19/BCMA CAR-T therapy under development for relapsed or refractory multiple myeloma, and clinical updates from programs such as REDEEM-1 and POEMS-1.
Company updates also cover CAR-T manufacturing and technology-transfer work, partner-supported development activities, business development and licensing priorities, and the amezalpat small-molecule program. Recurring corporate news includes financial results, pipeline portfolio changes following acquired CAR-T assets, leadership appointments, and governance or capital-structure matters tied to the company’s Nasdaq-listed common stock.
Tempest Therapeutics (TPST) has received Orphan Drug Designation (ODD) from the FDA for TPST-1495, its dual receptor inhibitor of prostaglandin signaling, for treating Familial Adenomatous Polyposis (FAP). The designation marks a significant milestone for the company's second clinical program.
A Phase 2 study of TPST-1495 in FAP patients is scheduled to commence in 2025, led by the Cancer Prevention Clinical Trials Network with National Cancer Institute Division of Cancer Prevention funding. Study results are anticipated in 2026.
Tempest Therapeutics (NASDAQ: TPST) has announced plans to explore strategic alternatives to advance its clinical-stage oncology programs and maximize stockholder value. The company has retained MTS Health Partners as financial advisor for this process.
Key highlights include:
- Their lead drug amezalpat (TPST-1120) is Phase 3-ready for first-line hepatocellular carcinoma (HCC) treatment, having received both Orphan Drug and Fast Track designations
- Phase 1b/2 clinical study showed amezalpat improved median overall survival by six months when combined with atezolizumab and bevacizumab
- FDA has issued "Study May Proceed" letter for TPST-1495 in Phase 2 trial for familial adenomatous polyposis (FAP) treatment, with data expected in 2026
- The company has established an agreement with Roche for evaluating amezalpat in combination therapy
Tempest Therapeutics (NASDAQ: TPST) reported significant progress in 2024, highlighted by key developments for their cancer therapeutics. Their lead drug Amezalpat received both Orphan Drug and Fast Track designations from the FDA for Hepatocellular Carcinoma (HCC) treatment. The company secured an agreement with Roche to advance Amezalpat into a Phase 3 trial.
Clinical results showed Amezalpat delivered a six-month improvement in median overall survival when combined with standard treatments for HCC. For TPST-1495, the company received FDA clearance for a Phase 2 trial in Familial Adenomatous Polyposis.
Financial results showed cash position of $30.3 million at year-end, down from $39.2 million in 2023. Net loss increased to $41.8 million ($1.50 per share) compared to $29.5 million ($1.91 per share) in 2023. R&D expenses rose to $28.5 million from $17.5 million, while G&A expenses increased to $13.6 million from $11.7 million.
Tempest Therapeutics (NASDAQ: TPST) has announced that data supporting the immune component of amezalpat's mechanism of action will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The presentation, which will be in poster format, is scheduled to take place during the conference running from April 25-30, 2025 in Chicago, IL. The abstract highlights clinical data that reinforces amezalpat's potential as a novel cancer treatment.
Tempest Therapeutics (TPST) has received FDA clearance to proceed with a Phase 2 clinical trial for TPST-1495, their novel dual receptor inhibitor of prostaglandin signaling, to treat Familial Adenomatous Polyposis (FAP). This marks the company's second clinical program entering Phase 2, with data expected in 2026.
The study will be conducted by the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute's Division of Cancer Prevention. The trial aims to develop new treatment options for FAP, a high-risk condition that significantly increases the risk of multiple GI cancers. The Phase 2 study is scheduled to begin in 2025.
Tempest Therapeutics (NASDAQ: TPST) has received Fast Track Designation (FTD) from the FDA for amezalpat, their oral PPAR⍺ antagonist drug for treating hepatocellular carcinoma (HCC). This follows the Orphan Drug Designation (ODD) granted in January after positive Phase 1b/2 clinical trial results.
The global randomized study evaluated amezalpat combined with standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in first-line treatment of unresectable or metastatic HCC. Key results showed a six-month improvement in median overall survival with a hazard ratio of 0.65 for patients receiving the combination therapy. The survival benefit was maintained in key sub-populations, including PD-L1 negative disease patients, supporting amezalpat's proposed mechanism targeting both tumor cells and the patient's immune system.
Tempest Therapeutics (TPST), a clinical-stage biotech company focused on developing targeted cancer therapeutics, has announced a new employee compensation grant. The company's Compensation Committee approved nonqualified stock options for one employee to purchase 45,000 shares of common stock under its 2023 Inducement Plan. The options will vest over four years, with 25% vesting after the first year and the remaining portion vesting at 1/48th monthly thereafter, contingent on continued employment.
Tempest Therapeutics announced that the FDA has granted Orphan Drug Designation to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist, for the treatment of patients with hepatocellular carcinoma (HCC).
According to Sam Whiting, M.D., Ph.D., this designation highlights the critical need for new treatments for this challenging disease. Tempest plans to proceed with a pivotal phase 3 study for amezalpat in first-line HCC patients.
The designation follows positive data from a global randomized Phase 1b/2 clinical study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in treating unresectable or metastatic HCC. Key results include:
- A six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 for the amezalpat combination therapy.
- An objective response rate (ORR) of 30% compared to 13% for the control arm.
- Preserved survival benefit in key sub-populations, including PD-L1 negative disease and b-catenin mutated disease.
These outcomes are consistent with amezalpat’s mechanism of action, targeting both tumor cells and the patient’s immune system.
Tempest Therapeutics (Nasdaq: TPST) announced that its Compensation Committee has granted stock options to one employee under the company's 2023 Inducement Plan. The grant consists of nonqualified stock options to purchase 9,450 shares of common stock. The options will vest over a four-year period, with 25% vesting on the first employment anniversary and the remaining 1/48th vesting monthly thereafter, contingent on continued employment.
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotech company focused on developing first-in-class targeted and immune-mediated cancer therapeutics, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's senior management will engage in a fireside chat on Tuesday, December 3, 2024 at 9:00 a.m. ET. Interested parties can access both live and archived recordings of the discussion through the investor section of Tempest's website at ir.tempesttx.com.