TaiRx, Inc. has seen promising results from the Phase II preliminary trials of its CVM-1118 new drug for treating neuroendocrine tumors and liver cancer, exceeding expectations. Chairman Lin Chun announced on the 26th that the company is currently advancing in three main directions: international collaboration, frontline drug usage, and the initiation of an Antibody-Drug Conjugate (ADC) drug program, aiming to compete on the global stage.
Given the ongoing positive progress in clinical trials, TaiRx plans to submit an application for approval of its technology venture within the year, initiating plans for market listing.
General Manager Jian Du-Hsien stated that CVM-1118, the fastest-developing new drug under the company, is being tested in Phase 2a clinical trials for the treatment of neuroendocrine tumors. It is primarily used for patients in the second or third line of treatment for whom standard therapy is ineffective and the condition worsens. With a single drug administration, the trial has already enrolled 33 participants. The primary clinical observation indicator is progression-free survival (PFS), which, compared to the current PFS of patients ranging from approximately 3.6 to 5.6 months, has already exceeded the target of eight months set by CVM-1118. It outperforms the control group and several clinically-tested drugs already on the market. It is expected to obtain more accurate efficacy data results by June this year.
Moreover, CVM-1118 is also being used in combination with immunotherapy "Nivolumab" to treat unresectable liver cancer patients. The first phase of the Phase II trial is expected to enroll 29 participants and is in its final stages. The results will compare whether combination therapy shows better treatment outcomes than immunotherapy alone. Currently, 30 participants have been effectively enrolled, with seven showing positive tumor responses, all of whom are still undergoing treatment. TaiRx has submitted a paper to the American Society of Clinical Oncology (ASCO) and plans to present it in early June, hoping to attract the attention of international pharmaceutical companies.
Jian Du-Xian stated that due to the excellent clinical data, TaiRx is also upgrading the most effective component of CVM-1118 to produce CVM-1125 with a longer half-life, combining it with HER 2 antibodies to create an ADC drug. Animal experiments have shown complete disappearance of breast cancer tumors. Future plans also include targeting indications for lung cancer. Targeting ADCs has become a trend, and TaiRx does not rule out deepening its layout through mergers and acquisitions.
Lin Chun mentioned that in addition to CVM-1118, another product in clinical trials is TRX-920, an oral anticancer drug, with the main component being SN38, the active ingredient of the commonly used chemotherapy drug Irinotecan. Its activity is over 1,000 times higher than the original drug. The first-phase dose escalation clinical trial of this new drug has been initiated at two major medical centers in Taiwan, with results expected to be completed next year.
As for the oral new drug/new indication TRX-105, used to treat and relieve various types of colitis, animal toxicology tests are expected to be completed this year, with plans to apply for Investigational New Drug (IND) status by the end of the year and initiate the first-phase clinical trial.
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