On April 16, 2023 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), the only ASX-listed clinical
stage cell therapy company, reported that it has received ethics approval for the initiation of a multi-site Phase 1B clinical trial of CHM 1101 in patients with recurrent and/ or progressive glioblastoma multiforme (GBM) (Press release, Chimeric Therapeutics, APR 26, 2023, View Source [SID1234630478]). This new chapter in the development of CHM 1101 will see Chimeric leading a two-part Phase 1B clinical study enrolling patients with recurrent and/ or progressive GBM at multiple clinical trial sites.
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Part A of the trial will treat 3-6 patients, completing the Phase 1 CHM 1101 dose escalation/confirmation study that was initiated at City of Hope Cancer Centre. At the end of 2023, an assessment of clinical safety and efficacy data from the Phase 1 dose escalation/ confirmation cohort will be undertaken. Should the results of that assessment
support further development, Part B of the trial design would be initiated.
Part B of the trial is a dose expansion cohort designed to enroll 12-26 patients with recurrent and/ or progressive GBM using the recommended Phase 2 dosing plan and assessing for efficacy and safety.
Upon successful completion of the Part B dose expansion cohort, a registration trial will be initiated in alignment with regulatory feedback.
"Expanding our clinical program to additional sites is critical to our mission to deliver our medicines to the patients who need them," said Dr Jason Litten, Chief Medical Officer of Chimeric Therapeutics. "The two-part trial design also ensures that we are positioned to move rapidly into the dose expansion cohort upon a positive clinical assessment of the Phase 1 data at the end of 2023."
Additional details on the CHM Phase 1B trial design and objectives are being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting as part of the Central Nervous System Tumors section on June 3, 2023.
About CHM 1101:
CHM 1101 (CLTX CAR T) is a first in class CAR T therapy that has the potential to address the high unmet medical need of patients with recurrent or progressive glioblastoma, patients who have a poor prognosis, with limited treatment options and a median survival of less than 1 year (Gallego. Curr Oncol, 2015).
CHM 1101 cells uniquely utilize chlorotoxin (CLTX), a 36-amino acid peptide derived from deathstalker scorpion venom, as the tumour-targeting component of the chimeric antigen For personal use only receptor (CAR).
In preclinical models, CHM 1101 CAR T cells have been shown to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13. CHM 1101 cells also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.
CHM 1101 is currently being studied in an ongoing phase 1A clinical trial in recurrent / progressive glioblastoma at City of Hope Cancer Centre in California. Outcomes from the initial two dose levels of the Phase 1A trial have been previously presented and demonstrated patient safety with a disease stability rate of approximately 70%.