Tempest Receives Clearance to Proceed with Pivotal Trial of Amezalpat Combination Therapy for First-Line HCC in China
Tempest Therapeutics (NASDAQ: TPST) has received approval from China's National Medical Products Administration (NMPA) to proceed with a pivotal trial for its drug candidate amezalpat (TPST-1120). The trial will evaluate amezalpat in combination with atezolizumab and bevacizumab, compared to the standard of care alone, for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
The regulatory clearance follows previous approvals from the FDA and EMA, marking a significant expansion into China, which has the world's largest population of HCC patients. According to Dr. Sam Whiting, Chief Medical Officer and Head of R&D at Tempest, this approval represents a crucial milestone for reaching global markets with high HCC prevalence.
Tempest Therapeutics (NASDAQ: TPST) ha ottenuto l'approvazione dalla National Medical Products Administration (NMPA) cinese per avviare uno studio pivotale sul suo candidato farmaco amezalpat (TPST-1120). Lo studio valuterà l'efficacia di amezalpat in combinazione con atezolizumab e bevacizumab, rispetto al trattamento standard, come terapia di prima linea per il carcinoma epatocellulare (HCC) non resecabile o metastatico.
Il via libera regolatorio segue le precedenti approvazioni da parte di FDA ed EMA, segnando un'importante espansione in Cina, che ospita la più grande popolazione mondiale di pazienti con HCC. Secondo Dr. Sam Whiting, Chief Medical Officer e Responsabile R&D di Tempest, questa approvazione rappresenta una tappa fondamentale per l'accesso ai mercati globali con alta prevalenza di HCC.
Tempest Therapeutics (NASDAQ: TPST) ha recibido la aprobación de la Administración Nacional de Productos Médicos de China (NMPA) para avanzar con un ensayo pivotal de su candidato a medicamento amezalpat (TPST-1120). El ensayo evaluará amezalpat en combinación con atezolizumab y bevacizumab, en comparación con el tratamiento estándar, para el tratamiento de primera línea del carcinoma hepatocelular (HCC) irresecable o metastásico.
La autorización regulatoria sigue a aprobaciones previas de la FDA y EMA, marcando una expansión significativa en China, que tiene la mayor población mundial de pacientes con HCC. Según Dr. Sam Whiting, Director Médico y Jefe de I+D de Tempest, esta aprobación representa un hito clave para acceder a mercados globales con alta prevalencia de HCC.
템페스트 테라퓨틱스(NASDAQ: TPST)가 중국 국가약품감독관리국(NMPA)으로부터 후보 약물 아메잘파트(TPST-1120)의 중대한 임상시험 진행 승인을 받았습니다. 이번 임상시험은 아메잘파트를 아테졸리주맙 및 베바시주맙과 병용하여, 표준 치료 단독과 비교해 절제가 불가능하거나 전이된 간세포암(HCC)의 1차 치료제로 평가할 예정입니다.
이번 규제 승인으로 FDA와 EMA의 이전 승인에 이어 중국 시장으로의 중요한 확장이 이루어졌으며, 중국은 전 세계에서 가장 많은 HCC 환자 인구를 보유하고 있습니다. 템페스트의 최고 의료 책임자이자 연구개발 책임자인 샘 휘팅 박사에 따르면, 이번 승인은 HCC 유병률이 높은 글로벌 시장 진출에 중요한 이정표라고 합니다.
Tempest Therapeutics (NASDAQ : TPST) a obtenu l'approbation de l'Administration nationale des produits médicaux de Chine (NMPA) pour lancer un essai pivot de son candidat médicament amezalpat (TPST-1120). L'essai évaluera amezalpat en combinaison avec l'atezolizumab et le bevacizumab, comparé au traitement standard seul, pour le traitement de première ligne du carcinome hépatocellulaire (CHC) non résécable ou métastatique.
Cette autorisation réglementaire fait suite aux approbations précédentes de la FDA et de l'EMA, marquant une expansion significative en Chine, qui compte la plus grande population mondiale de patients atteints de CHC. Selon Dr Sam Whiting, directeur médical et responsable R&D chez Tempest, cette approbation représente une étape cruciale pour accéder aux marchés mondiaux à forte prévalence de CHC.
Tempest Therapeutics (NASDAQ: TPST) hat von der chinesischen National Medical Products Administration (NMPA) die Zulassung erhalten, eine entscheidende Studie für seinen Wirkstoffkandidaten Amezalpat (TPST-1120) durchzuführen. Die Studie wird Amezalpat in Kombination mit Atezolizumab und Bevacizumab im Vergleich zur Standardtherapie als Erstlinienbehandlung von nicht resezierbarem oder metastasiertem hepatozellulärem Karzinom (HCC) evaluieren.
Die behördliche Freigabe folgt auf vorherige Zulassungen durch die FDA und EMA und markiert eine bedeutende Expansion nach China, das die weltweit größte HCC-Patientenpopulation beherbergt. Laut Dr. Sam Whiting, Chief Medical Officer und Leiter der F&E bei Tempest, stellt diese Zulassung einen wichtigen Meilenstein für den Zugang zu globalen Märkten mit hoher HCC-Prävalenz dar.
- Received NMPA approval for pivotal trial in China, following FDA and EMA clearances
- Targeting China's market, which has the world's largest HCC patient population
- Trial aims for registration-directed (pivotal) status, potentially accelerating path to commercialization
- None.
- Builds on clearances already received by FDA and EMA
- China has the largest population of patients with hepatocellular carcinoma in the world
BRISBANE, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received approval from the National Medical Products Administration (NMPA) in China to proceed with a pivotal trial to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC).
“This regulatory clearance to proceed with a pivotal trial in China is a significant milestone towards reaching global markets where HCC has high prevalence,” said Sam Whiting M.D., Ph.D., chief medical officer and head of R&D of Tempest. “It is rewarding that the regulatory officials in China see the promise and potential of amezalpat and have provided the green light to begin a registration-directed trial. We strongly believe amezalpat is a drug that can make a difference in the lives of patients with HCC and believe it should be advanced to pivotal testing.”
About the TPST-1120-301 Study (NCT06680258)
The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab versus placebo plus atezolizumab and bevacizumab, the standard of care, for the first-line treatment of patients with unresectable or metastatic HCC. The company has also received agreement from the FDA and EMA on its Phase 3 study design, dose of amezalpat, and the statistical plan, including a pre-specified efficacy analysis that could shorten the time to primary analysis.
About Hepatocellular Carcinoma
HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030.1 Every year, more than 900,000 people worldwide are diagnosed with HCC.2 Incidence and mortality are highest in East Asia and are increasing in parts of Europe and the US.3 In the US, HCC represents the fastest-rising cause of cancer-related death.3
Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.4
Even if diagnosed in the early stage, an estimated 70
About Amezalpat
Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by additional positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors, including renal cell carcinoma and cholangiocarcinoma.
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated Phase 3 study for amezalpat; anticipated therapeutic benefit and regulatory development of the Company’s product candidates the Company’s ability to advance into a late-stage clinical company; and the Company’s ability to achieve its operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q filed for the quarter ended March 31, 2025 and other documents filed by the Company from time to time with the Securities and Exchange Commission. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.
Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
| i If approved by the FDA |
1 Rahib, L. et al. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 74, 2913-2921 (2014).
2 World Health Organization. Liver Cancer Factsheet. Globocan. 2020. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf. Last accessed: April 2023.
3 Llovet, J. M., Kelley, R. K., Villanueva, A., et al. Hepatocellular carcinoma. Nature Reviews Disease Primers. 2021, 7(1), 6.
4 Office for Health Improvement & Disparities. Liver disease profiles: November 2021 update. Available at: https://www.gov.uk/government/statistics/liver-disease-profiles-november-2021-update/liver-disease-profiles-november-2021-update. Last accessed: April 2023.
5 Hack SP, Spahn J, Chen M et al. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncology. 2020 May;16(15):975-989.
6 Saito A, Toyoda H, Kobayashi M et al. Prediction of early recurrence of hepatocellular carcinoma after resection using digital pathology images assessed by machine learning. Modern Pathology. 2021. 34, 417-425.
FAQ
What approval did Tempest Therapeutics (TPST) receive from China's NMPA?
What is the significance of TPST's trial approval in China for HCC treatment?
How will TPST's amezalpat be tested in the Chinese pivotal trial?
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