SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its antibody drug conjugate (ADC), GQ1005, targeting HER2 in patients with non-surgical/metastatic breast cancer.
Preclinical studies have shown that GQ1005 exhibits anti-tumor effects that are on par with those of Enhertu across various xenograft tumor models, with a notable absence of significant toxicity and an enhanced therapeutic index. The Phase I clinical data has demonstrated that GQ1005 is well-tolerated and safe within the dose range of 2.0mg/kg to 8.4mg/kg, and it has shown promising therapeutic effects in patients with breast cancer, gastric cancer, lung cancer, and other solid tumors.
This advancement to Phase III trials signifies a significant milestone for GeneQuantum Healthcare, reflecting the potential of GQ1005 as a treatment for HER2 positive breast cancer and its position as a contender in the ADC space. The company’s commitment to advancing innovative oncology therapies is evident in its progress with GQ1005, which could offer a new option for patients in need. – Flcube.com
