Pipeline Chart

Clinical Development Path

Our lead drugs are ACT-1 and ACT-3.  ACT-1 is comprised of two FDA-approved drugs, imiquimod and interleukin-2 (IL-2), and ACT-3 is comprised of imiquimod.  Both ACT-1 and ACT-3 are first in class, newly patented medicines.  ACT-1 and ACT-3 are designed to activate the immune system to recognize cancer cells and kill them.

These novel immunotherapy drugs will: 

  • Activate Natural Killer (NK), T cells and M1 tumor-destroying macrophages, and induce the recruitment of antigen-presenting plasmacytoid dendritic cells – thus stimulating both arms of the immune system to generate more powerful anti-tumor efficacy. 
  • Increase the potency of imiquimod and interleukin-2 (IL-2), and thus increase their efficacies. It will also decrease their toxicities and this will make these drugs more tolerable to patients. 
  • Decrease the immunosuppressive effects of the tumor microenvironment, turning “cold” tumors (tumors with no immune cell infiltrate), “hot” (tumors with immune cells), thus making the tumor more recognizable to the immune system. 

Activate has engineered ACT-1 and ACT-3 to be more effective in many patients, including transplant patients, to provide durable anti-cancer responses and cures.

Activate intends to test these drugs in all-comers skin cancer clinical studies, including transplant patients. This will generate meaningful patient data to inform the further development of these drugs and support subsequent regulatory filings.  Activate has presented its clinical and manufacturing plans to the FDA in a pre-IND meeting, and the agency’s feedback indicates Activate has a clear path to evaluate both ACT-1 and ACT-3 in patients.