The US biotech firm Tempest Therapeutics is actively seeking strategic partnerships to advance its liver cancer drug amezalpat (TPST-1120) into Phase III clinical trials, following promising Phase II results but facing significant funding challenges in the current investment climate.
"The capital markets have been unavailable to support the next stage of development," Tempest's CEO Stephen Brady stated on April 9, as the company announced it was exploring "strategic alternatives" including potential mergers, acquisitions, or partnerships to move forward.
Promising Clinical Results in Liver Cancer
Amezalpat has already received FDA clearance for a pivotal Phase III trial (NCT06680258) where it will be evaluated in combination with Roche's Tecentriq (atezolizumab) and Genentech's Avastin (bevacizumab) for patients with unresectable or metastatic hepatocellular carcinoma (HCC).
The drug showed significant promise in earlier studies, demonstrating a six-month improvement in median overall survival for patients receiving the combination therapy compared to the control arm of Tecentriq and Avastin alone in a Phase I/II umbrella study.
As a peroxisome proliferator-activated receptor alpha (PPARα) antagonist, amezalpat represents a novel approach to liver cancer treatment. PPARα is primarily known for its role in lipid metabolism, but growing evidence suggests it also plays a significant role in carcinogenesis. If successful, amezalpat would be the first FDA-approved PPARα antagonist.
Regulatory Support and Market Potential
The FDA has recognized the drug's potential by granting it both fast track designation and orphan drug designation for HCC treatment, highlighting its promise in addressing unmet needs in liver cancer therapy.
Tempest believes amezalpat has blockbuster potential in first-line HCC treatment. For context, Tecentriq, one of the current standard treatments, generated $2.14 billion in sales for Roche in 2024, indicating the substantial market opportunity for effective liver cancer therapies.
Financial Challenges Amid Biotech Investment Downturn
Tempest's funding challenges reflect broader trends in the biotech sector, where investment has remained at historically low levels since the 2021 boom. The company ended fiscal year 2024 with $30.3 million in cash, down from $39.2 million at the end of 2023, while annual losses increased from $29.5 million to $41.8 million.
The company's market capitalization stands at approximately $25.1 million, highlighting the significant gap between its current resources and the substantial funding typically required for Phase III clinical trials.
Existing Partnerships and Pipeline
Tempest has already secured a partnership with Roche to supply Tecentriq for the planned Phase III trial, building on their existing collaboration in earlier studies. This relationship could potentially form the foundation for expanded partnerships to fund the next development phase.
Beyond amezalpat, Tempest is also seeking strategic partnerships for TPST-1495, a dual EP2/4 prostaglandin receptor antagonist with FDA orphan drug designation for treating familial adenomatous polyposis (FAP). This asset is poised for Phase II studies, further stretching the company's limited financial resources.
Strategic Options Under Consideration
Brady emphasized that the company's strategic alternatives "include finding a strategic partner with the resources to develop what we believe are potentially life-saving therapies for patients in need."
In addition to partnerships focused specifically on drug development, Tempest is considering a range of transaction types including mergers, acquisitions, joint ventures, and licensing arrangements to secure the necessary resources to advance its promising pipeline.
The announcement comes at a critical juncture for both Tempest and patients with liver cancer, as the company navigates the challenging path from promising mid-stage results to the large-scale trials needed for potential regulatory approval.
