Cue Biopharma has developed its first immunotherapy against cervical and other cancers driven by the human papillomavirus (HPV).
It is already preparing an application for investigational new drug status for Cue-101, requesting that the U.S. Food and Drug Administration approve its testing in clinical trials. It expects to begin the trials of the therapy in the first half of 2018.
“We consider Cue-101 to be exemplary of our approach and represents the first of our growing pipeline of targeted immunomodulatory biologics that tailor immune responses from disease-relevant T cells by emulating the signals delivered by the body’s antigen presenting cells,” Daniel Passeri, MSc, JD, president and chief executive officer of Cue Biopharma, said in a press release. “We are excited about the data we have seen so far, and look forward to moving this promising program forward.”
T-cells, which are key immune system players, require multiple distinct signals to become fully activated. Usually these signals are found on dendritic, or antigen-presenting, cells. Cue is working on delivering activating signals directly to disease-relevant T-cells.
Cue’s products consist on an antibody scaffold embedded with an anti-cancer protein that the company has engineered so that T-cells recognize it. Another component embedded in the scaffold is an activating molecule with a specific focus: it activates only T-cell populations of interest.
By coupling an interleukin-2 (IL-2) protein with an HPV-derived protein, Cue-101 can activate a particular T-cell subset against HPV-associated cancers. Because it activates only the relevant T-cells, Cue hopes Cue-101 can maximize effectiveness while avoiding the severe toxicity associated with IL-2 administration.
Cue’s selective approach could also be used in combination therapies, with low toxicity. The idea would be to pair Cue-101 with currently approved therapies — including immune checkpoint inhibitors.
“In the preclinical setting, Cue-101 monotherapy demonstrates potent anti-tumor activity in HPV-driven cancer models, and shows durable tumor clearance when combined with checkpoint inhibitors,” Passeri said.
Cue’s treatment platform could also be used to deplete particular T-cell populations. That approach could help reduce immune activity in autoimmune diseases. It could also be used in cancer therapies to eliminate immunosuppressive regulatory T-cells.
An advantage of Cue’s approach is that T-cells can be activated in living organisms, which avoids complex cell isolation procedures, according to the company’s website. Another advantage is that T-cell activity will occur in the tumor periphery, which means the cells avoid the tumor immunosuppressive environment.