Chimeric Therapeutics receives FDA clearance for CHM 2101 to treat gastrointestinal cancers
Cell therapy development company Chimeric Therapeutics (ASX: CHM) has received confirmation that the US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for its lead candidate CHM 2101 to treat gastrointestinal cancers.
The first-in-class CDH17 CAR T cell therapy will now be subject to a multi-centre, open label Phase 1A/B clinical trial for patients with advanced colorectal, gastric and neuroendocrine tumours.
The company plans to begin patient enrolments in the new year.
CHM 2101 is a third-generation solution developed to target the CDH17 (Cadherin-17) biomarker which is associated with poor prognosis and metastasis in the most common gastrointestinal carcinomas.
Research has shown that overall survival rates in patients with CDH17 upregulation are lower than in those without expression of the gene.
The clinical program for CHM 2101 builds on pre-clinical studies which demonstrated the eradication of established tumours in seven cancer models with no toxicity to normal tissues.
It is believed to be a critical step forward in developing a new CAR T therapy for gastric cancers and may provide new hope for patients who are refractory to existing therapies.
CHM 2101 has been labelled a “potentially transformative new investigational agent” in cancer care.
In March, Chimeric announced it had completed a pre‐Investigational New Drug (pre-IND) meeting with the FDA and received positive feedback on the development plan for CHM 2101.
The meeting included details and specific questions regarding Chimeric’s clinical development strategy and technical operations, including drug product manufacturing and quality release plans for CHM 2101.
The company received positive written responses from the FDA which provided a clear pathway to the IND submission.
Chimeric also completed a manufacturing and quality release for the CHM 2101 viral vector, which is a key milestone in advancing CHM 2101 towards clinical trials.
Viral vector is considered to be the backbone for CAR T cell therapy manufacture due to its valuable genetic engineering instructions.