Technology

Solid tumor, including Hepatocellular carcinoma, Renal cell carcinoma, Non small cell lung cancer

AP505’s is designed for dual targeting of PD-L1, along with angiogenic factors VEGF. This bispecific antibody can thus simultaneously inhibit T cell suppression and tumor angiogenesis and growth, enhancing the immune response and tumor suppression. By targeting both pathways, AP505 aims to provide a more comprehensive treatment approach that improves efficacy and minimizes side effects compared to traditional therapies.

1. Licensing out of AP505/B1962 to Tasly Biopharmaceutical for development, production, and marketing rights in China (Now Tasly Pharmaceutical Group Co., Ltd).
2. Received China NMPA Phase I clinical trial approval in August 2022 and successfully recruited the first participant in March 2023
3. Obtained U.S. FDA Phase I clinical trial approval in January 2023.
4. In the process of multi-country patent reviews, we have obtained patent approvals in Taiwan, Russia, Australia, and South Korea.

By binding to PD-L1 on tumor cells, this therapy effectively inhibits angiogenesis within the tumor microenvironment, leading to enhanced tumor suppression with a lower required dosage. This approach also minimizes the bleeding side effects commonly associated with traditional angiogenesis inhibitors like Avastin.

Furthermore, its symmetric structure, expressing only heavy and light chains, offers significant advantages in antibody expression and assembly. This design enables the use of established downstream purification processes for conventional monoclonal antibodies, eliminating the need for new methods typically required for asymmetric bispecific antibodies.

According to the latest statistics from the World Health Organization (WHO), in 2020, Hepatocellular Carcinoma ranked as the sixth most common cancer globally, with 906,000 new cases. It was also the third leading cause of cancer-related deaths, accounting for approximately 830,000 deaths, or 8.3% of all cancer-related deaths. Liver cancer has long been one of the top two causes of cancer-related deaths in Taiwan.

According to GlobalData-Pharma IC data, the United States had the highest healthcare expenditure on liver cancer globally, reaching $526 million in 2020, followed by China at $299 million. Furthermore, the global liver cancer treatment market is projected to grow at a compound annual growth rate of 10.2% during the forecast period (2022 to 2028).

Currently, the clinical landscape for late-stage liver cancer treatment is being reshaped with the use of immune therapies in combination with targeted therapies. The combination of Tecentriq (PD-L1) and Avastin (VEGF) has gained prominence in first-line treatment following its inclusion in the new NCCN treatment guidelines. AP505, being a bispecific antibody targeting PD-L1 and VEGF, is poised to potentially become a first-line treatment for liver cancer in the future, competing in the global market.