Pipeline detail

FM401
Classification Description
FM 401
  • Immuno-oncology (IO)
  • Preclinical R&D in progress
Indication
  • Solid Tumor / Immune-checkpoint inhibitor
Unmet Needs
  • Cancer has the different microenvironment from the normal cells due to its genetic or metabolic peculiarities.
  • Understanding and controlling these microenvironments are one of the challenges in tumor resistant or unresponsive to the IO therapy.
  • When extracellular adenosine level is high in tumor microenvironment, Immune cell’s ability to kill tumor is severely compromised. Therefore, many are conducting research to modulate these microenvironment.
Mechanism of Action
  • A2A adenosine receptor antagonist
  • Inhibition of A2AAR activation to prevent immune evasion mechanism
Efficacy
  • In Vitro: cAMP inhibition assay
  • In Vivo: anti cancer effects in various tumor xenograft: confirmed Anti PD-1 synergistic effect
Indication Solid Tumor and IO therapy

Solid tumor starts in a specific organ, grow, and then metastasize. Most cancers, such as stomach, lung, colorectal, and breast cancer, fall into this category. In the case of solid cancer, surgery is performed when possible, and if not, chemotherapy (treatment using chemicals with anticancer effects) is prescribed for the palliative purpose of prolonging survival because it is difficult to have a complete cure.

Currently, research on immunotherapy is actively underway, is effective in various cancers. Since many IO therapy such as Keytruda have been developed in the recent 2-3 years, IO research has been getting considerable attention as a treatment option.

Unmet Needs

Cancers have an environment different from the surrounding tissue that of normal cells due to their genetic or metabolic peculiarities. This environment is called the tumor microenvironment, and this tumor-specific environment is one of the factors that drive resistance or refractory to chemical, radioactive, or immune anti-cancer therapies. When the concentration of adenosine is high in the tumor microenvironment, the cancer-killing ability of immune cells is severely compromised. Controlling this tumor-specific microenvironment, the effect of immune checkpoint inhibitors could be enhanced, providing a solution to unmet needs of refractory and resistance of immunotherapeutic agents.

Mechanism of Action

A2AAR Mechanism of Action

  • Increased extracellular adenosine due to tumor-specific alteration
  • Adenosine binds to A2AAR on Immune cell and compromise immune cell’s ability to kill the tumor
  • FM401, an A2AAR inhibitor, prevents adenosine-A2AAR binding and reserve immune cell’s anti-cancer ability
Efficacy

Excellent Target Selectivity (A2AAR)

cAMP inhibition assay

Ability to retain immune function in both rodent and human

Strong synergistic effect with anti PD-1