Tempest Receives FDA Study May Proceed for Pivotal Phase 3 Trial of Amezalpat Combination Therapy for the Treatment of First-Line Hepatocellular Carcinoma
Tempest Therapeutics (Nasdaq: TPST) announced receiving a 'Study May Proceed' letter from the FDA for a pivotal Phase 3 trial of amezalpat (TPST-1120) combined with atezolizumab and bevacizumab. This trial will compare this combination against the current standard of care alone in treating first-line unresectable or metastatic hepatocellular carcinoma (HCC). Chief Medical Officer Sam Whiting highlighted the potential of amezalpat to improve patient survival, citing positive Phase 2 data. The company aims to advance this program to benefit patients with this life-threatening disease.
Tempest Therapeutics (Nasdaq: TPST) ha annunciato di aver ricevuto una lettera 'Study May Proceed' dalla FDA per un trial clinico pivotale di Fase 3 di amezalpat (TPST-1120) in combinazione con atezolizumab e bevacizumab. Questo trial confronterà questa combinazione con l'attuale standard di cura per il trattamento del carcinoma epatocellulare (HCC) non resecabile o metastatico in prima linea. Il Direttore Medico Sam Whiting ha sottolineato il potenziale di amezalpat di migliorare la sopravvivenza dei pazienti, citando dati positivi della Fase 2. L'azienda mira a portare avanti questo programma a beneficio dei pazienti affetti da questa malattia potenzialmente letale.
Tempest Therapeutics (Nasdaq: TPST) anunció que ha recibido una carta 'Study May Proceed' de la FDA para un ensayo clínico pivotal de Fase 3 de amezalpat (TPST-1120) combinado con atezolizumab y bevacizumab. Este ensayo comparará esta combinación contra el estándar de atención actual solo en el tratamiento del carcinoma hepatocelular (HCC) irresecable o metastásico en primera línea. El Director Médico Sam Whiting destacó el potencial de amezalpat para mejorar la supervivencia de los pacientes, citando datos positivos de la Fase 2. La compañía tiene como objetivo avanzar este programa para beneficiar a los pacientes con esta enfermedad potencialmente mortal.
템페스트 테라퓨틱스(나스닥: TPST)는 아메잘파트 (TPST-1120)와 아테졸리주맙, 베바시주맙의 조합에 대한 3상 임상시험의 'Study May Proceed' 서한을 FDA로부터 받았다고 발표했습니다. 이번 임상시험은 이 조합을 기존의 표준 치료법과 비교하여 첫 번째 치료가 불가능한 간세포암(HCC) 또는 전이성 간세포암 치료에 사용될 것입니다. 최고 의학 책임자인 샘 와이팅은 아메잘파트가 환자의 생존율을 개선할 수 있는 잠재력을 강조하며, 2상에서 긍정적인 데이터를 인용했습니다. 이 회사는 이 생명을 위협하는 질병으로 고통받는 환자들에게 혜택을 주기 위해 이 프로그램을 발전시키는 것을 목표로 하고 있습니다.
Tempest Therapeutics (Nasdaq: TPST) a annoncé avoir reçu une lettre 'Study May Proceed' de la FDA pour un essai clinique pivot de Phase 3 sur amezalpat (TPST-1120) combiné avec atezolizumab et bevacizumab. Cet essai comparera cette combinaison au traitement standard actuel dans la prise en charge du carcinome hépatocellulaire (HCC) non résécable ou métastatique en première ligne. Le directeur médical Sam Whiting a souligné le potentiel d'amezalpat pour améliorer la survie des patients, citant des données positives de la Phase 2. L'entreprise vise à faire avancer ce programme pour bénéficier aux patients atteints de cette maladie mortelle.
Tempest Therapeutics (Nasdaq: TPST) gab bekannt, dass sie von der FDA einen 'Study May Proceed'-Brief für eine entscheidende Phase-3-Studie zu amezalpat (TPST-1120) in Kombination mit Atezolizumab und Bevacizumab erhalten hat. Diese Studie wird diese Kombination mit der aktuellen Standardversorgung allein bei der Behandlung von nicht resezierbarem oder metastasierendem hepatozellulärem Karzinom (HCC) in der Erstlinientherapie vergleichen. Der Chief Medical Officer Sam Whiting hob das Potenzial von amezalpat zur Verbesserung der Überlebensrate der Patienten hervor und verwies auf positive Daten aus Phase 2. Das Unternehmen strebt an, dieses Programm voranzutreiben, um Patienten mit dieser lebensbedrohlichen Erkrankung zu helfen.
- FDA approval to proceed with pivotal Phase 3 trial.
- Potential of amezalpat to improve survival in HCC patients, as indicated by positive Phase 2 data.
- None.
Insights
This FDA clearance for a pivotal Phase 3 trial marks a significant milestone for Tempest Therapeutics' amezalpat program in liver cancer. The trial design, combining amezalpat with atezolizumab and bevacizumab, builds upon positive Phase 2 results and targets the lucrative first-line HCC market. For context, HCC is the most common type of primary liver cancer with a substantial market opportunity, currently dominated by combination therapies.
The regulatory pathway appears well-defined, with the Phase 3 trial positioned as a registration-enabling study. The combination approach with standard-of-care treatment could potentially lower regulatory hurdles and increase the probability of clinical success. However, investors should note that Phase 3 trials typically require significant capital investment and take several years to complete, which may impact the company's cash runway.
BRISBANE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in a pivotal randomized Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
“The clinical and regulatory team at Tempest are thrilled to receive this notice from FDA with respect to the planned pivotal Phase 3 trial to evaluate amezalpat as a potential treatment for first-line liver cancer,” said Sam Whiting M.D., Ph.D., chief medical officer and head of R&D of Tempest. “Previously reported positive Phase 2 data underscore amezalpat’s potential to improve the survival of patients facing this life-threatening disease, and our team is dedicated to advancing the program and bringing amezalpat to patients.”
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. In August 2024, the company received agreement from the FDA 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. The company is working to enable a Phase 3 study to start in the first quarter of 2025.
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 on August 8, 2024 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
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