Chimeric Therapeutics receives ethics approval for CHM CDH17 gastrointestinal cancer trial
Chimeric Therapeutics (ASX: CHM) has received ethics approval for the initiation of a multi-site Phase 1/2 clinical trial of CHM CDH17 in patients with advanced gastrointestinal cancers.
CHM CDH17 is a third generation novel CAR T cell therapy aimed at a cancer target associated with poor prognosis and metastasis in the most common gastrointestinal tumours including colorectal, gastric and neuroendocrine.
The trial is designed to build upon pre-clinical studies that showed the therapy was able to eradicate established tumours in seven cancer models with no toxicity to normal tissues.
Program advancing
Chief operating officer Rebecca McQualter said the approval represents a significant milestone in advancing the program toward study initiation under US Food and Drug Administration regulations.
“We are excited to achieve this milestone in anticipation of opening our clinical trial of CHM CDH17,” she said.
“It marks a great step forward for the use of cell therapies in solid tumours.”
CHM CDH17 is currently in pre-clinical development with a planned Phase 1A trial on gastrointestinal and neuroendocrine tumours planned for this year.
Range of therapies
Chimeric is advancing a range of therapies to treat various cancers.
In April, the company received confirmation from the US Patent & Trademark Office that it would allow the issuance of a patent application covering its CHM 0201 “killer cell” technology.
Considered a likely best-in-class NK cell platform, CHM 0201 has been clinically confirmed with data from a recent Phase 1A clinical trial demonstrating safety and efficacy in blood cancers and solid tumours.
Key collaboration
In September last year, Chimeric announced a collaboration with MD Anderson Cancer Centre at the University of Texas in support of its ADVENT Phase 1B clinical trial investigating CHM 0201 NK cells in combination with the current standard of care therapy for patients with newly-diagnosed acute myeloid leukaemia.
It is believed to be the first clinical trial to evaluate NK cell therapy in combination with standard-of-care drugs Azacitidine and Venetoclax.
The study will recruit up to 20 patients ineligible for intensive chemotherapy or allogeneic stem cell transplant.