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Technology & Products

AP203

Indication

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

Mechanism of Action

1. Blocking the interaction between tumor PD-L1 and T cell PD-1 to prevent the suppression of T cell activation.

2. Activating the CD137 signaling pathway on T cells to enhance T cell activity.

3. Re-directing activated T cells into the tumor microenvironment to kill cancer cells.

Status

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.

Strength

  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.
  1. 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.
  1. 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. 
  2. 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.

Market

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.

Development Stage

AP203 was granted clinical phase I approval in the United States and Taiwan in Q4 2022

  • Candidate
  • Target/Mechanism
  • Indication
  • Discovery
    Pre-Clinical
    Phase I
    Phase II
    Phase III
  • Partner
AP203
T-cube BsAb
Non-small cell lung cancer, head and neck cancer, and esophageal cancer
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