Tempest Therapeutics

Akeso Reports Positive Phase 3 Results for Ivonescimab in Lung Cancer, Building on Recent FDA Approval Success

a month ago

• Akeso announced positive Phase 3 results for ivonescimab, a novel PD-1/VEGF bispecific antibody, demonstrating superior tumor progression control when combined with chemotherapy compared to PD-1 inhibitor plus chemotherapy in lung cancer patients. • The company recently secured FDA approval for penpulimab, its PD-1 monoclonal antibody, for first-line treatment of nasopharyngeal carcinoma, marking significant expansion of Akeso's oncology portfolio. • Akeso and Summit Therapeutics are advancing ivonescimab in a global study against the standard Keytruda-chemotherapy regimen, with results expected in 2027, potentially challenging the current treatment paradigm in lung cancer.

Tempest Therapeutics Seeks Partner for Phase III Liver Cancer Drug Amezalpat Amid Funding Challenges

a month ago

• 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 Seeks Strategic Partner for Promising Liver Cancer Drug Amezalpat Amid Funding Challenges

a month ago

• 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.

FDA Clears Phase 2 Trial of TPST-1495 for Familial Adenomatous Polyposis Treatment

2 months ago

• 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.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Amezalpat Gains FDA Fast Track and Orphan Drug Designations for Hepatocellular Carcinoma

5 months ago

• 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.

FDA Approves Phase 3 Trial of Amezalpat in First-Line Liver Cancer

6 months ago

• The FDA has approved a "Study May Proceed" letter for a phase 3 trial evaluating amezalpat in combination with atezolizumab and bevacizumab for unresectable or metastatic hepatocellular carcinoma (HCC). • The trial will compare the amezalpat regimen to the current standard of care (atezolizumab and bevacizumab) as a first-line treatment for advanced HCC, with the study slated to begin in early 2025. • Amezalpat, an oral small-molecule antagonist targeting PPARα, has shown potential in earlier phase studies to improve survival in patients with HCC by directly targeting tumor cells and modulating the tumor microenvironment.

Tempest Therapeutics Advances Liver Cancer Program with Roche Collaboration and FDA Agreement

7 months ago

• 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.

Tempest Therapeutics Advances Liver Cancer Therapy with Roche Partnership

7 months ago

• Tempest Therapeutics partners with Roche for a Phase 3 trial of amezalpat in first-line Hepatocellular Carcinoma (1L HCC). • The FDA agreed to the Phase 3 study plan, potentially reducing the timeline to primary analysis by eight months. • Roche will supply atezolizumab for the study, significantly reducing Tempest's expenses by an estimated $30-50 million. • Tempest's amezalpat, combined with Roche's atezolizumab and bevacizumab, showed a six-month median overall survival improvement.

Tempest Therapeutics and Roche Partner to Advance Amezalpat in Phase 3 Liver Cancer Trial

7 months ago

• Tempest Therapeutics and Roche have partnered to initiate a Phase 3 trial of amezalpat in combination with atezolizumab and bevacizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). • The Phase 3 trial builds on positive Phase 2 data showing a six-month improvement in median overall survival with the combination therapy compared to standard care in HCC patients. • The FDA has agreed to the Phase 3 study design, amezalpat dosage, and primary endpoint, with a pre-specified early efficacy analysis potentially shortening the study timeline by eight months. • Tempest retains all development and commercial rights to amezalpat, while Roche will supply atezolizumab for the global trial, expected to begin in the first quarter of 2025.

Tempest Therapeutics' Amezalpat Receives Positive FDA Feedback for Phase 3 HCC Trial

9 months ago

• Tempest Therapeutics announced positive feedback from the FDA regarding the Phase 3 trial design for amezalpat (TPST-1120) in first-line hepatocellular carcinoma (HCC). • The FDA agreed on key aspects of the Phase 3 study, including the control arm, study endpoints, amezalpat dose, and statistical plan with an early efficacy analysis. • The Phase 3 trial, expected to begin in Q1 2025, will evaluate amezalpat plus atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone. • Amezalpat, a PPARα antagonist, has shown clinical superiority in combination with atezolizumab and bevacizumab in a Phase 1b/2 study for advanced HCC.