Hansoh Pharmaceutical Group Company Limited announced that its self-developed B7-H3-targeted antibody-drug conjugate (ADC), HS-20093 for injection, has been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) of China on November 1, 2024. This designation is for the proposed indication of extensive stage small cell lung cancer (ES-SCLC) that has progressed after standard first-line treatment consisting of platinum doublet chemotherapy combined with immunotherapy.
Significance of Breakthrough Therapy Designation
The Breakthrough Therapy Designation is designed to expedite the development and review of drugs intended to treat serious or life-threatening conditions. For HS-20093, this designation underscores the potential of the ADC to address a critical unmet need in ES-SCLC, a disease with limited treatment options after first-line therapy.
HS-20093: A Novel ADC Targeting B7-H3
HS-20093 is an antibody-drug conjugate that targets B7-H3, an immune checkpoint protein highly expressed in various cancers, including small cell lung cancer. By targeting B7-H3, HS-20093 aims to deliver a cytotoxic payload directly to cancer cells, potentially enhancing efficacy while minimizing systemic toxicity. The ADC approach combines the specificity of antibody targeting with the potent cell-killing activity of a chemotherapy drug.
Clinical Context and Unmet Need in ES-SCLC
Small cell lung cancer (SCLC) is an aggressive malignancy characterized by rapid growth and early metastasis. While first-line treatment with platinum-based chemotherapy and immunotherapy can provide initial responses, most patients eventually experience disease progression. The prognosis for ES-SCLC remains poor, with limited effective treatment options available after first-line failure. HS-20093 offers a potential new therapeutic avenue for these patients, leveraging the B7-H3 target to deliver targeted therapy.
Development and Future Plans
Hansoh Pharmaceutical is advancing the clinical development of HS-20093, with plans to initiate further clinical trials to evaluate its safety and efficacy in ES-SCLC and potentially other B7-H3-expressing cancers. The Breakthrough Therapy Designation is expected to facilitate the drug's development and accelerate its potential availability to patients in need.
