Focused on Developing Precision Therapeutics

CVM-1118 (Foslinanib) is a novel synthetic small molecule with a differentiated mechanism of action targeting cancer-associated pathways. CVM-1118 has been shown to modulate Tumor Necrosis Factor Receptor-Associated Protein 1 (TRAP1), a mitochondrial chaperone protein involved in cancer cell metabolism, survival, and treatment resistance.

CVM-1118 also inhibits vasculogenic mimicry (VM), a tumor-associated vascularization mechanism implicated in tumor progression, metastasis, and treatment resistance. This distinctive VM-inhibitory activity supports the potential of CVM-1118 as a first-in-class therapeutic. In 2016, Science highlighted CVM-1118 as “the first drug that targets vasculogenic mimicry to reach clinical trials” (Science 352: 1381-1383, 2016 “Tumor’s DIY Blood Vessels”).

As a next-generation oral anticancer drug candidate, CVM-1118 combines the convenience of oral administration with therapeutic potential across multiple tumor types, including breast, ovarian, and colorectal cancer, neuroendocrine tumors (NETs), and hepatocellular carcinoma (HCC). CVM-1118 is protected by broad worldwide patent coverage and has completed Phase I clinical studies in the United States and Taiwan. Results from these studies demonstrated that CVM-1118 was generally well tolerated and established its maximum tolerated dose (MTD).
Building on the Phase I results and its pharmacological profile, CVM-1118 has advanced into Phase II clinical development in two oncology indications. In HCC, CVM-1118 is being evaluated in combination with immunotherapy as a potential treatment option. In advanced NETs, CVM-1118 has been evaluated as monotherapy in a Phase II study, with encouraging efficacy signals observed.

Irinotecan (CPT-11) is an approved chemotherapeutic agent used in the treatment of colorectal and pancreatic cancers. Administered intravenously, irinotecan is often associated with significant treatment-related adverse effects that may negatively impact patients’ tolerability and quality of life.
SN-38 is the primary active metabolite of irinotecan, while TRX-920 is an innovative oral formulation developed to deliver SN-38 directly. Since the conversion of irinotecan to SN-38 in humans is limited (<5%), while SN-38 is substantially more potent than its parent compound, irinotecan, direct oral delivery of SN-38 through TRX-920 may enhance exposure to the active drug in tumor tissues.
TRX-920 is designed to reduce the need for high-dose irinotecan while maintaining therapeutic activity, with the potential to improve dosing convenience and reduce treatment-related adverse effects. TRX-920 has advanced into Phase I clinical development.

The TRX-ADC platform utilizes targeted antibodies to deliver CVM-1125, the active metabolite of CVM-1118, directly to tumor cells, combining the specificity of antibody-based targeting with the potent anticancer activity of a small-molecule payload. Preclinical studies in animal tumor models have demonstrated the feasibility of using CVM-1125 as an antibody-drug conjugate (ADC) payload.
Through optimization of linker design and selection of appropriate targeting antibodies, the TRX-ADC platform is designed to enhance the selective delivery of CVM-1125 to tumor cells and further expand the therapeutic potential of CVM-1125 as a novel ADC payload. Multiple combinations of antibodies, linkers, and drug-to-antibody ratios (DARs) are currently being evaluated to further optimize the performance of the platform.
TaiRx has also filed patent applications in major global markets to support the development of the TRX-ADC portfolio and to protect the TRX-ADC portfolio and support its global development and partnering opportunities.

TRX-105 is a known small molecule being developed for new therapeutic indications in the treatment of various types of colitis and inflammatory gastrointestinal disorders. In a preclinical animal model of acute colitis, TRX-105 demonstrated superior activity compared with mesalazine in reducing colonic inflammation and intestinal ulceration, while also promoting the repair of the damaged intestinal mucosal barrier. These findings suggest that TRX-105 has the potential to promote intestinal mucosal healing associated with colitis.
Based on its pharmacological properties, TRX-105 may offer therapeutic benefits across multiple inflammatory gastrointestinal conditions, including colitis, enterocolitis, immune-related colitis and chemotherapy-induced colitis, potentially providing a new treatment option for patients. TRX-105 has completed the development of a Colon-targeting formulation and the preclinical program.

Nodal, an embryonic morphogen belonging to the TGF-β superfamily, plays an important role in regulating signaling pathways during embryonic development and in maintaining the pluripotency of embryonic stem cells. While Nodal expression is normally low or absent in most adult tissues, it has been reported to be re-expressed at elevated levels in multiple malignancies, including melanoma, breast cancer, pancreatic cancer and hepatocellular carcinoma.

Preclinical research has demonstrated that Nodal signaling is involved in tumor growth and vasculogenic mimicry (VM) formation and may contribute to tumor metastasis and disease progression. In addition, Nodal has been detected in cancer stem cell (CSC) populations and has been associated with their self-renewal and invasive properties. Clinical studies have shown that elevated Nodal expression is associated with poor prognosis. These findings support Nodal as a potential therapeutic target, particularly in tumors that are resistant to currently available therapies.
TaiRx has licensed a portfolio of Nodal-related patents from Northwestern University in the USA. Building on this intellectual property portfolio, the TRX-NOC program is focused on developing Nodal-targeted antibody therapeutics as a novel biologic therapy for cancer treatment.