OBI Pharma announced yesterday (17th) that it will concentrate on developing core products with significant growth potential, such as the ADC product line including OBI-992, which is currently in the second dose escalation phase of its Phase I clinical trial. Additionally, the company will leverage its proprietary ADC technology platforms, GlycOBI and EndoSymeOBI, to enter the development of bispecific ADCs.
Regarding the progress of OBI-992, OBI Pharma explained that it received FDA approval for clinical trials in January and initiated Phase I clinical trials in June, with six clinical centers in the U.S. and two in Taiwan currently enrolling participants. The trial is now in the second dose escalation phase.
For the breast cancer drug OBI-822, the company stated that it targets early-stage, high-risk, Global H-positive triple-negative breast cancer patients. OBI-822 has passed its first interim analysis, with expectations to reach the second interim analysis by the end of this year and to meet unblinding criteria by 2026.
On the development of the next generation of ADCs, CEO Heidi Wang noted that bispecific ADCs can overcome the limitations of traditional ADCs by targeting two different antigens. This approach addresses the heterogeneity of cancer cells, further enhancing the drug’s tumor selectivity and internalization rate, thereby achieving a therapeutic effect of 1+1>2.
Teng-Yi Huang, Director of Medicinal Chemistry, pointed out that OBI Pharma's GlycOBI ADC platform features a "plug-and-play" characteristic, allowing for combinations with various antibodies, linkers, and small molecule payloads. The bispecific ADCs generated using this platform exhibit specific linkage and high solubility characteristics, maintaining the original antibody structure while also providing enhanced stability.
Ming-Tain Lai, Head of R&D, explained that the bispecific ADC field is rapidly expanding, with market forecasts predicting a compound annual growth rate (CAGR) of over 25% for bispecific ADCs in the next five years. OBI Pharma will actively seize these business opportunities.
Resource (mandarin): 浩鼎聚焦發展價值核心產品 加入開發雙抗ADC行列
