FOSTER CITY, Calif. - Terns Pharmaceuticals, Inc. (NASDAQ:TERN), a biopharmaceutical company focusing on the development of small-molecule drugs for serious diseases, including oncology, has announced recent findings from a Phase 1 study of TERN-701. The study, which is currently in progress, examines the pharmacokinetics, safety, and tolerability of TERN-701 in healthy volunteers.
TERN-701 is an oral, potent, allosteric BCR-ABL inhibitor, a new class of therapy for chronic myeloid leukemia (CML) that aims to offer superior efficacy and safety over traditional active-site tyrosine kinase inhibitors (TKIs). The interim findings suggest that TERN-701 can be administered once daily with or without food, which could provide a significant advantage over the current allosteric BCR-ABL inhibitor, asciminib, that requires fasting and twice-daily dosing.
The Phase 1 trial has enrolled 32 healthy volunteers across four dose cohorts ranging from 20 mg to 160 mg. Results indicated no clinically significant changes in clinical laboratory data, vital signs, or electrocardiogram parameters, with a pharmacokinetic profile consistent with that observed in a similar study conducted in China by Terns' partner, Hansoh Pharmaceuticals.
A key finding from the study was that at 80 mg doses, TERN-701 showed no significant differences in plasma exposure whether taken with a high-fat meal or on an empty stomach. This supports the potential for flexible dosing schedules for patients.
The CARDINAL trial, a global Phase 1 clinical trial evaluating the safety, pharmacokinetics, and efficacy of TERN-701 in patients with previously treated CML, is ongoing. Interim data from the initial cohorts is anticipated in the second half of 2024.
CML is a type of cancer where the bone marrow produces an excess of white blood cells. In the United States, it is considered an orphan disease with an estimated 9,280 new cases expected in 2024. Despite the availability of TKI therapy, resistance or intolerance can lead to suboptimal long-term disease control, creating a need for new treatments.
The development of TERN-701 is part of Terns Pharmaceuticals' broader mission to address serious diseases with their portfolio of small-molecule product candidates. The company plans to present data from the healthy volunteer study at an upcoming scientific conference.
InvestingPro Insights
As Terns Pharmaceuticals, Inc. (NASDAQ:TERN) makes strides in the development of TERN-701 for chronic myeloid leukemia, it's important for investors to consider the financial health and market performance of the company. According to real-time data from InvestingPro, Terns Pharmaceuticals holds a market capitalization of $329.84 million USD, which provides a sense of the company's size and scope in the biopharmaceutical industry.
Despite the potential of TERN-701, InvestingPro Tips indicate that the company is not expected to be profitable this year, with analysts noting the absence of dividends for shareholders and a tendency for the stock to move inversely to market trends. The company's quick cash burn and weak gross profit margins are areas of concern for investors. On the bright side, Terns Pharmaceuticals does have more cash than debt on its balance sheet, and its liquid assets exceed its short-term obligations, providing some financial stability as it continues to invest in research and development.
Key InvestingPro Data metrics reveal a P/E Ratio (adjusted for the last twelve months as of Q4 2023) of -3.64, and a Price / Book value of 1.29. The company's stock has experienced a 25.15% drop in the last month, reflecting the challenges it faces in the market. However, these numbers provide a nuanced picture of Terns Pharmaceuticals' financial outlook as it progresses through clinical trials.
For investors looking to delve deeper into Terns Pharmaceuticals' financials and forecasts, there are additional InvestingPro Tips available at https://www.investing.com/pro/TERN. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, which includes access to a comprehensive set of metrics and expert analyses to inform investment decisions.
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