Taipei, June 10, 2025 - MegaPro Biomedical Co., Ltd. (hereafter referred to as "MegaPro" , TWSE: 6827), a clinical-stage biopharmaceutical company, today announced strong Phase I clinical results for its next-generation anti-cancer drug, MPB-1734. Developed using MegaPro's proprietary nano-micelle platform, MPB-1734 is a novel, Tween-80-free formulation of cabazitaxel (Jevtana®), designed to reduce toxicity and enhance clinical outcomes in patients with advanced solid tumors. Key findings reveal that MPB-1734 offers a safer, more tolerable treatment profile-with fewer blood-related and gastrointestinal side effects-while maintaining potent anti-tumor activity. Based on these outcomes, the recommended Phase II dose has been set at 25 mg/m², higher than the currently approved dose for cabazitaxel (20 mg/m²), highlighting the potential for superior efficacy with fewer trade-offs. Key Highlights from the Phase I Trial:
Unlike traditional cabazitaxel, which carries a black box warning for hypersensitivity due to its use of Tween-80, MPB-1734 showed no allergic responses in any patients.
At 25 mg/m², MPB-1734 demonstrated a Grade =3 neutropenia rate of just 29%, a sharp reduction compared to >80% with cabazitaxel. No moderate or severe diarrhea was observed, compared to 6% Grade 3 incidence with the reference drug.
In evaluable patients, disease control was achieved in 76.9%, with a clinical benefit rate of 61.5%. One patient with head and neck cancer achieved a partial response lasting over 30 treatment cycles, and seven patients maintained stable disease.
Unlike conventional taxane-based drugs, which frequently cause nerve damage (7-13% incidence in CBZ), no cases of peripheral neuropathy were reported in any MPB-1734 patients. President Commentary "This data represents a breakthrough in formulation science," said Dr. Yuan-Hung Hsu, Presiden of MegaPro. "By removing Tween-80, we not only reduced adverse events but also preserved-and possibly enhanced-therapeutic impact. MPB-1734 is a strong candidate for patients needing better tolerated second-line therapies, especially in hard-to-treat tumors." Dr. Hsu added, "Our results in non-approved indications like head and neck cancer are especially exciting. MPB-1734 has the potential to expand cabazitaxel's therapeutic reach while improving patients' quality of life." What's Next MegaPro has completed its Phase I data analysis and is preparing to initiate the next stage of development after its upcoming fundraising round. The company plans to pursue accelerated regulatory approval via the 505(b)(2) pathway, enabling a faster path to market. This milestone positions MegaPro to unlock significant value in the oncology treatment landscape and drive the next phase of company growth. 10/06/2025 Dissemination of a Financial Press Release, transmitted by EQS News. |