Technology

Non small cell lung cancer, Head and neck squamous cell carcinoma, Esophageal squamous-cell carcinomas

AP203 employs a dual-targeting mechanism that combines PD-L1 blocking with T-cube-enabled CD137 activation to enhance T cell activity while avoiding the risk of a cytokine storm. By blocking the interaction between tumor PD-L1 and T cell PD-1, AP203 prevents T cell suppression, allowing the immune system to better detect and attack cancer cells. At the same time, activating the CD137 signaling pathway promotes T cell proliferation and survival, leading to a more robust and sustained anti-tumor response. This mechanism re-directs activated T cells into the tumor microenvironment, enhancing the effectiveness of existing immunotherapies and offering a safer, comprehensive approach to cancer treatment.

1. Approval for Phase I clinical trials granted by the U.S. FDA in September 2022.
2. Approval for Phase I clinical trials granted by the Taiwan TFDA in November 2022.
3. In the process of international patent examination, U.S. patents have already been granted.
4. Part of preclinical study was presented as posters at the Immuno-Oncology Summit Europe 2022 conference in July 2022.
5. Part of preclinical studies were published in 2023 in the journal 'Journal of Translational Medicine,' titled 'A bispecific antibody AP203 targeting PD-L1 and CD137 exerts potent antitumor activity without toxicity' [PubMed].

1. A true target-dependent T cell activation of the bispecific antibody, it activates cytotoxic T cells expressing CD137 only upon binding with both CD137 and PD-L1 on cancer cells. This design minimizes the risk of cytokine release syndrome typically associated with CD3-based bispecific antibodies, ensuring higher safety levels.
2. The bivalent binding activity of AP203 to both PD-L1 and CD137 is superior to monovalent binding of other bispecific antibodies. AP203 can efficiently trigger CD137 activation in T cells through PD-L1 clustering.
3. The oppositely binding regions of PD-L1 and CD137 facilitate the bridging between PD-L1-expressing cancer cells and CD137-expressing T cells without spatial hindrance. 
4. The symmetrical structure expressing only heavy and light chains is advantageous for antibody expression and formation. It can be adapted the downstream purification processes established for monoclonal antibodies, eliminating the need to develop new processes for asymmetric bispecific antibodies.

From 2015 to 2019, the global oncology drug market expanded from $83.2 billion to $143.5 billion, accounting for 7.5% and 11.0% of the global pharmaceutical market, respectively, with a Compound Annual Growth Rate (CAGR) of 14.6% during this period. The continuous expansion of the market can be attributed to the rising patient population, enhanced accessibility to healthcare services, and the introduction of cutting-edge and advanced treatment options.

The global oncology market is expected to reach $244.4 billion by 2024, representing 14.9% of the global pharmaceutical market. During the forecast period from 2019 to 2024, the anticipated compound annual growth rate is 11.2%. Immuno-oncology and biologics are potential therapeutic approaches for various cancer types and offer the prospect of long-term remission or cure.