Immunwork, founded by renowned immunologist Tse Wen Chang, announced on July 1 that its independently developed long-acting octreotide candidate TE-8214 has successfully completed its Phase 1 clinical trial in Australia. The results demonstrated good safety and tolerability, with the drug achieving its intended pharmacological mechanism. Additionally, subcutaneous injection was well tolerated and did not cause any injection-site reactions.

Dr. Chang noted that TE-8214 has high water solubility and can be administered using a 30G fine needle, significantly reducing injection pain and patient anxiety. Immunwork is now actively preparing for a Phase 2 clinical trial, expected to launch in Taiwan in the third quarter of 2025.

TE-8214 is a long-acting octreotide analog developed using Immunwork’s proprietary platform technology. By attaching a fatty acid bundle with two fatty acid chains to the octreotide molecule, the drug’s half-life is significantly extended, making it suitable for treating acromegaly and various neuroendocrine tumor-related symptoms.

These conditions are often associated with severe endocrine dysfunction, leading to complications such as peptic ulcers, chronic diarrhea, asthma, tissue overgrowth, joint pain, and hypertension. Without appropriate treatment, they can severely impact both the quality of life and life expectancy of patients.

Driven by growing global demand for octreotide-based therapies, the market for such drugs has been expanding rapidly and is projected to reach USD 1 billion by 2030. Current commercial and developmental products are mostly formulated as high-viscosity microparticles or gel-based depot formulations, requiring large-bore 19G or 20G needles for intramuscular injections (e.g., Octreotide LAR) or deep subcutaneous injections (e.g., Lanreotide Autogel). These injections are often painful and difficult to administer, increasing the risk of injection-site pain and nodules, and consequently reducing patient compliance and treatment acceptance.

The Phase 1 trial of TE-8214 was designed as a randomized, double-blind, single ascending dose study with four dose groups: 0.6 mg, 1.2 mg, 2 mg, and 4 mg. Each group included eight healthy volunteers, six of whom received TE-8214 and two received a placebo (normal saline). The overall findings showed excellent tolerability, with only mild adverse events reported and no serious adverse events observed.

Resource: 免疫功坊長效型奧曲肽新藥TE-8214 一期臨床試驗成果佳