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2021-03-05| R&DTrials & Approvals

Tempest Lands Big Pharma Partnership to Trial Combo Therapy Against “Hard-To-Treat” Liver Cancer

by Tulip Chakraborty
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California-based Tempest Therapeutics announced on March 3rd that it had entered into a collaboration with biopharma giant Roche to advance its candidate, TPST-1120, to treat advanced hepatocellular carcinoma (HCC). This strategic collaboration will look at assessing the impact of TPST-1120 with two of Roche’s cancer therapies, atezolizumab (Tecentriq) and bevacizumab (Avastin).

“We are thrilled to work with Roche to accelerate the TPST-1120 program by evaluating this molecule in a targeted front-line clinical setting,” said Stephen Brady, President and Chief Operating Officer of Tempest.

HCC is an aggressive form of cancer affecting well over 815,000 people globally with little to no treatments available on the market. The cancer creeps up on people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption. As HCC is generally caught by the doctors in advanced stages, the patient has a less than 1-year survival rate after diagnosis.

Tempest Therapeutics looks to change that with Roche’s help and is designing a global, randomized Phase 1b/2 clinical trial. The study will evaluate TPST-1120 in combination with Roche’s Tecentriq and Avastin in patients with no previous systemic therapy. The primary objective will be to evaluate the anti-tumor activity and safety of TPST-1120 versus the standard-of-care first-line Tecentriq and Avastin regimens in a total of 60 patients with advanced or metastatic HCC.

 

TPST-1120

TPST-1120 is an antagonist of peroxisome proliferator‐activated receptor alpha (PPARα) and E‐prostanoid (EP) receptor. It first targets the transcription factor PPARα, which is responsible for moderating fatty acid oxidation, a process that produces energy for tumor cells. Restricting this process will force cancer cells to use glycolysis to produce energy, thus promoting an anti-tumor effect.

In an ongoing study, TPST-1120 has shown to be well-tolerated by patients with advanced cancers as monotherapy and in combination with the PD-1 inhibitor nivolumab. Preliminary data reveals that the drug has demonstrated early signs of a reduction in tumor size, among other indications.

“TPST-1120’s mechanism of action makes it specifically well-suited to combine with both PD-1/PD-L1 checkpoint inhibitors and anti-angiogenesis agents. This strong scientific rationale, coupled with the observed clinical safety profile and early signals of clinical benefit in treated patients, makes us hopeful that this triplet approach will offer HCC patients meaningful benefit,” added Stephen Brady.

 

Tempest’s Road Ahead

The clinical collaboration with Roche should forge a clear path forward for Tempest Therapeutics based on their sales, among other factors. In the year 2019 alone, Tecentriq managed to bag $1.9 billion in revenue while Avastin claimed $7.2 billion. Tempest Therapeutics has the potential to strike gold if TPST-1120 manages to perform well in clinical trials leading to FDA approval.

A major thorn in their path could be the availability of biosimilars. For example, Roche’s HER2 cohort, which comprises Herceptin, Perjeta, and Kadcyla, raked in approximately $11 billion. However, that now faces a threat from AstraZeneca’s and Daiichi’s Enhertu, which, like Kadcyla, is also an antibody-drug conjugate. Recently, China-based Bio-Thera solutions announced that the FDA had accepted its marketing application for BAT1706, a biosimilar to Avastin. Thus, to grab market shares, both Tempest Therapeutics and Roche need to play their cards well and focus on rapid commercialization in order to beat their competitors.

Related Article: CRISPR-Based Screening Implicates Mitochondrial Phosphatase Gene in Hypoxic Survival of Liver Cancer Cells

 

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