Earlier this month, Tempest Therapeutics announced that it would explore strategic alternatives for its oncology pipeline of assets. Specifically, it has a phase 3-ready drug in its pipeline known as Amezalpat (TPST-1120), which had already been evaluated in a phase 2 study for the treatment of patients with first-line hepatocellular carcinoma (liver cancer).
The biotech has been struggling to find a suitor who would be willing to put up the cash to fund its endeavor of running a phase 3 study to get Amezalpat to the finish line. The hope is that a strategic alternative will be established to boost shareholder value, as no trial has yet been initiated to move this program forward.
Things looked very good back in October of 2023, when the stock price soared as much as a historic 1,500% in one day after the Amezalpat combination was shown to be superior to that of Roche’s current standard of care (SOC), atezolizumab (TECENTRIQ) plus bevacizumab (AVASTIN), in targeting such 1st-line liver cancer patients. In essence, it was shown in a phase 1b/2 study that Amezalpat (TPST-1120) in combination with atezolizumab plus bevacizumab achieved a confirmed objective response rate (ORR) of 30%. Compared to that of current SOC, allowing patients to typically achieve a cORR of only 13.3%.
With the company now looking towards some type of strategic transaction to take place, it went one step further last Friday. In an 8-K SEC filing, which was filed on April 18, 2025, it was revealed that it would remove about 21 of 26 of its full-time employees in an effort to conserve cash. Whether such a move is a smart one highly depends on if Tempest can garner some type of merger or transaction or be bought out before it runs out of cash.
In a press release today, the company noted that it had received Orphan Drug Designation for its other oncology candidate from its pipeline, known as TPST-1495. This particular novel dual receptor inhibitor of prostaglandin (PGE2) signaling is being developed for the treatment of patients with Familial Adenomatous Polyposis (FAP). FAP is a rare, inherited disorder that occurs because of a mutation of the APC gene. A major issue of this disorder is that it brings about the growth of hundreds of polyps in the colon and rectum. What’s worse is that if it is not quickly taken care of, then it could increase the risk of a person getting cancer.
As a matter of fact, surgical removal of the colon might be a necessary option in order for a person to avoid the ability to get cancer. The main way a patient gets this is because of the APC gene, but there is an instance where approximately 25% to 30% of people might have the genetic mutation occur spontaneously. TPST-1495 is developed to take care of immunosuppression that tumors and cancers deploy. It inhibits cancer cell proliferation in this manner by blocking the EP2 and EP4 receptors, which are overactivated by prostaglandin E2 (PGE2). Having the formation of T-cells and natural killer (NK) cells might be enough to avoid the development of polyp burden, but this remains to be seen.
A phase 2 trial for this program is set to kick off in 2025, and clinical data from it is expected to be released at some point in 2026. Of course, while not guaranteed, it is possible that the company could have achieved its strategic alternative by then. However, there is no assurance of this, as thus far, it has not fared well in capturing a suitor who is willing to fund its phase 3 study of Amezalpat in targeting patients with 1st-line hepatocellular carcinoma.