Elpiscience Biopharmaceuticals is all set to commence the Phase I clinical trial of the anti-CD39xTGF-β bispecific antibody, ES014, to treat patients with advanced solid tumours.
The latest move comes after the US Food and Drug Administration (FDA) granted clearance for the company’s Investigational New Drug (IND) application to launch the trial of ES014.
ES014 can target the CD39-adenosine and TGF-β pathways at the same time.
These pathways are the two key immunosuppressive mechanisms in the tumour microenvironment (TME).
Solid tumours commonly express TGF-β, which hinders T cell activation and elicits CD39 expression, the rate-limiting enzyme in the ATP-adenosine pathway.
The anti-CD39 target is intended to guide ES014 to the TME where the anti-TGF-β activity boosts effector T cell function and immune activation while preventing or lowering systemic immunotoxicity.
In addition, the anti-CD39 activity of the antibody is meant to reverse TME immunosuppression by lowering suppressive adenosine while upholding increased immune-stimulatory extracellular ATP levels.
Elpiscience Biopharmaceuticals chief medical officer Steve Chin said: “We are delighted that our IND for ES014 was cleared by FDA.”
“In preclinical studies, ES014 demonstrated significant anti-tumour activity in a PD-1 resistant in vivo efficacy model.”
Earlier, the company and its partner Compass Therapeutics reported positive interim findings from the Phase II trial of ES104 (also called CTX-009) along with paclitaxel in people with biliary tract cancers (BTC).
The trial data showed that ES104 offered an overall response rate (ORR) of 42% based on ten subject patients with partial responses (PRs), including nine PRs validated by RECIST 1.1.