Chimeric Therapeutics Ltd (ASX:CHM) has signed a strategic partnership deal with OncoBay Clinical to provide comprehensive research support to advance and expand the clinical development program for CHM 1101 (CLTX CAR T).
CHM 1101, a novel CAR T cell therapy that uniquely utilizes Chlorotoxin as its tumour targeting domain, has shown promising preclinical safety and efficacy and is being studied in a single site phase-I clinical trial.
OncoBay Clinical, a subsidiary of the Moffitt Cancer Center, is a boutique clinical research organization (CRO) that has extensive experience in cell therapy development.
“A natural partner”
Chimeric Therapeutics CEO Jennifer Chow said: “OncoBay is a natural partner for us, building upon the cell therapy expertise of our team.
“With its experience managing the complexity of cell therapy research programs and scientific support from the Moffitt Cancer Center, we believe that the team at OncoBay is uniquely positioned to support the expansion of the CHM 1101 (CLTX CAR T) development program.”
Preparing for phase 2 registration
CHM 1101 was developed by scientists at the City of Hope Medical Centre in California where it is currently being studied in a phase 1 clinical trial.
Chimeric believes that partnering with OncoBay Clinical will enable the expansion of the program to additional clinical trial sites and help it in collecting data from all sites to prepare for the registration of the phase 2 clinical program.
Expansion of this program will take place under Chimeric’s recent investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) for its application for CHM 1101 (CLTX CAR T) for patients with recurrent/relapsed Glioblastoma.
Managing complex cell therapy trials
OncoBay Clinical is a first-of-its-kind immuno-oncology CRO specializing in rare and complex oncology indications including cellular therapies.
Through the direct partnership, OncoBay Clinical can leverage the support of Moffitt’s top scientific advisors, embedding scientific expertise into every project team and creating ‘vein-to-vein’ control of cell therapy trials.
OncoBay Clinical president and CEO Krystyna Kowalczyk said: “We are excited to be partnering with Chimeric on the development of CHM 1101.
“We are confident that our proven ability to succeed in managing the complexities of cell therapy research will enable the accelerated development of Chimeric’s CHM 1101 program.”