FOSTER CITY, Calif. - Terns Pharmaceuticals, Inc. (NASDAQ:TERN), a biopharmaceutical company with a market capitalization of $522 million and strong financial health indicated by its current ratio of 32.99, announced promising early results from its Phase 1 CARDINAL study of TERN-701, a drug candidate for chronic myeloid leukemia (CML). According to InvestingPro data, the company maintains more cash than debt on its balance sheet, providing solid financial backing for its clinical programs. The study, which is still ongoing, has shown encouraging safety and efficacy outcomes in heavily pretreated patients with relapsed or refractory CML.
As of October 28, 2024, 15 patients across three different dosages (160mg, 320mg, and 400mg) were enrolled in the trial, with a median treatment duration of three months. The patients had been heavily pretreated with a median of four prior tyrosine kinase inhibitors (TKIs). Notably, 73% of these patients did not have a major molecular response (MMR) at the study's start, and 60% had high baseline BCR-ABL transcript levels.
The interim data revealed a cumulative MMR rate of 50% among patients who had been treated for three months or more and did not have the T315i mutation. Furthermore, 88% of patients with a baseline BCR-ABL transcript level greater than 1% experienced decreases in BCR-ABL levels during treatment.
The safety profile of TERN-701 has also been favorable, with no dose-limiting toxicities or adverse event-related treatment discontinuations or dose reductions reported across the completed dose levels. Additionally, there were no Grade 3 or higher treatment-related adverse events or serious adverse events.
The pharmacokinetic data suggested that once-daily dosing of TERN-701 achieved high levels of target coverage, with plasma protein binding-corrected average concentrations exceeding the in vitro IC90 for various BCR-ABL variants.
The CARDINAL study is set to initiate dose expansion in the first half of 2025, and additional efficacy data, including longer-term MMR rates, are expected in the fourth quarter of 2025.
Terns Pharmaceuticals, focused on developing treatments for serious diseases such as oncology and obesity, is optimistic about the potential of TERN-701 as an allosteric BCR-ABL inhibitor for CML treatment. These early findings, based on a press release statement, suggest that TERN-701 could offer a new treatment option for patients with CML, particularly those who have not responded well to previous therapies.
In other recent news, Terns Pharmaceuticals announced the appointment of Heather Turner, former CEO of Carmot Therapeutics, to its Board of Directors. The company is also advancing its clinical program, with a Phase 2 study of TERN-601, an oral treatment for obesity, underway and initial data expected in the latter half of 2025. Terns Pharmaceuticals also launched a $125 million stock offering led by Jefferies and TD Cowen to fund the development of key product candidates like TERN-701 and TERN-601. Analysts from H.C. Wainwright, Oppenheimer, Mizuho (NYSE:MFG), and Jefferies have adjusted their price targets and ratings for Terns Pharmaceuticals based on these developments and promising Phase 1 trial results for TERN-601. Additionally, Terns Pharmaceuticals has appointed Elona Kogan as its new chief legal officer and extended its office lease in Foster City, California, through 2027. These are some of the recent developments at Terns Pharmaceuticals.
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