MONTREAL - Theratechnologies (NASDAQ:THTX) Inc. (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company, has announced progression to a higher dose level in Part 3 of its Phase 1 clinical trial for sudocetaxel zendusortide, targeting advanced ovarian cancer.
The Medical Review Committee (MRC) has confirmed the safety of the prior dose and approved recruitment for the next patient cohort. Centers are actively enrolling patients, with one already receiving the increased dose of 2.50 mg/kg.
The study aims to determine the optimal dose and schedule of the drug, which is administered over three consecutive weeks with one week of rest. The initial six patients received a dose of 1.75 mg/kg, and the MRC's approval for the next cohort came after observing one or fewer dose-limiting toxicities in the first group.
Dr. Ira Winer, a trial investigator, expressed optimism about the drug's safety profile in the initial cohort and emphasized the importance of this research for patients with platinum-resistant ovarian cancer, a group with limited treatment options.
Sudocetaxel zendusortide is a novel peptide-drug conjugate that targets the sortilin receptor (SORT1), expressed in a variety of tumor types. This receptor is linked to aggressive disease and poor prognosis. The FDA has granted Fast Track designation for the drug as a single agent for sortilin-positive recurrent advanced solid tumors refractory to standard therapy.
Theratechnologies completed enrollment for the first cohort in February 2024, with the first patient dosed in October 2023. The FDA approved the amended trial protocol in June 2023.
The company's SORT1+ Technology™ platform is the basis for developing peptide-drug conjugates (PDCs) that target SORT1, which is prevalent in several cancers, including endometrial, ovarian, colorectal, triple-negative breast, and pancreatic cancers.
Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies, remarked on the importance of reaching the next dose level for further characterizing the therapy's potential for advanced ovarian cancer patients.
The information for this article is based on a press release statement from Theratechnologies.
InvestingPro Insights
As Theratechnologies Inc. advances its clinical trials for sudocetaxel zendusortide, the company's financial health and market performance are also of interest to investors. According to InvestingPro, Theratechnologies is currently experiencing significant volatility in its stock price, with a 1-month price total return of -27.65% and a 6-month price total return of -43.06%. This aligns with one of the InvestingPro Tips noting that the stock price movements are quite volatile.
The company's market capitalization stands at 58.39 million USD, reflecting its size within the biopharmaceutical industry. Despite the challenging stock performance, the company has maintained a high gross profit margin over the last twelve months as of Q4 2023, at 75.99%. However, it is important to note that Theratechnologies has not been profitable during this period, with an operating income margin of -10.6%. This is consistent with another InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.
For investors seeking a deeper analysis, there are additional InvestingPro Tips available on the platform, including insights such as the Relative Strength Index (RSI) suggesting the stock is in oversold territory, and the lack of dividend payments to shareholders. In total, there are 7 more tips that can provide a comprehensive view of Theratechnologies' financial and market performance.
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