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AcadeMab Biomedical Enters Critical Phase for AM-928; Plans Phase II Combination Therapy
2026-05-21

At the Healthcare Conference Taipei 2026, AcadeMab Biomedical revealed the latest progress for its core pipeline candidate, AM-928. General Manager Dr. Lee Tsung-chou stated that the company has initiated the Clinical Study Report (CSR) following Phase I data and is planning Phase II trials using a combination therapy strategy.

  • Core Asset (AM-928): A first-in-class monoclonal antibody targeting cancer stem cells. Phase I (NCT05687682) results demonstrated favorable safety and preliminary efficacy signals, including tumor shrinkage in colorectal cancer patients. The Phase II trial will primarily target KRAS-mutant colorectal cancer.
  • mRNA-LNP Platform: The company’s mRNA-LNP technology has successfully bypassed the Antibody-Dependent Enhancement (ADE) safety bottleneck in Dengue fever vaccine development. Their tetravalent vaccine induced high titers of neutralizing antibodies in animal trials with a low side-effect profile.
  • LNP API Manufacturing: AcadeMab Biomedical has developed GMP-grade cationic lipids (LNP API) that outperform benchmark commercial lipids. The company has secured patents in Taiwan and is filing PCT applications for the US, EU, Japan, and Korea, aiming to enter the global supply chain for mRNA and nucleic acid drugs.
  • International Collaboration: AcadeMab Biomedical has signed an agreement with MD Anderson Cancer Center to co-develop AM-928 for Anaplastic Thyroid Cancer, further enhancing its international strategic value and paving the way for future out-licensing.

Resource: 研生生醫新藥開發進入關鍵催化期 AM-928擬以合併療法推進二期臨床

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