Unable to secure additional financing amid a stormy market, Tempest Therapeutics has put a call out for partners as it seeks to take its liver cancer drug into phase 3.
The Brisbane, California-based biotech’s lead candidate is amezalpat, a PPARα antagonist Tempest has touted as having blockbuster potential in hepatocellular carcinoma (HCC). The company has already completed the necessary interactions with U.S. and EU regulators to initiate a phase 3 trial of amezalpat in combination with Tecentriq and Avastin, but it has struggled to find the cash needed to get the drug back into the clinic.
Tempest also has a dual EP2/4 antagonist called TPST-1495, for which the company has secured the go-ahead from the FDA to begin a phase 2 study in a genetic colon disorder called familial adenomatous polyposis (FAP).
A phase 1/2 study back in 2023 of the amezalpat/Tecentriq/Avastin combo treatment demonstrated a 30% objective response rate compared to 13.3% ORR among a control arm.
“Notwithstanding the positive randomized data set from the amezalpat phase 2 and its blockbuster potential in first-line HCC, as well as the potential of TPST-1495 as it moves towards a phase 2 in FAP, the capital markets have been unavailable to support the next stage of advancement,” Tempest CEO Stephen Brady said in an April 9 release.
“We are initiating a process to explore alternatives available to the company to maximize stockholder value, which include finding a strategic partner with the resources to develop what we believe are potentially life-saving therapies for patients in need,” Brady explained.
“Given the positive data and commercial potential with this pipeline, as well as the clearance from FDA on the lead program’s pivotal study, we believe this is a rare opportunity for a partner,” the CEO added.
Tempest, which went public via a reverse merger with Millendo Therapeutics in 2021, entered this year with $30.3 million in the bank.