In 2020, the Department of Health and Aged Care revealed that approximately 2,000 Australians were diagnosed with brain cancer. New cases of brain cancer are increasing every year and Glioblastoma, the most common, complex, treatment-resistant, and deadliest type of brain cancer, accounts for 45% of all malignant brain tumours. On a global scale, it is estimated that there are 300,000 people that were diagnosed with a primary brain tumour in 2020.

While Glioblastoma currently has no cure, the latest breakthrough by ASX’s only cell therapy company Chimeric Therapeutics (ASX: CHM) has recently achieved a groundbreaking milestone in the fight against Glioblastoma, giving a glimmer of hope for Glioblastoma survivors approaching the forthcoming Glioblastoma Awareness Day that this year will be commemorated on 19 July. Chimeric’s first class CLTX CAR T cell therapy CHM 1101 has moved to a Phase 1B clinical trial in patients with recurrent and/ or progressive glioblastoma. The trial, testing safety and efficacy of the cell therapy, is now open for enrollment at the Sarah Cannon Transplant & Cellular Therapy Program at St. David’s South Austin Medical Center in Austin, Texas.

Jennifer Chow, CEO and Managing Director of Chimeric Therapeutics commented, “We are very excited to be activating the first site in our CHM 1101 Phase 1B clinical trial as it marks a new chapter in the development of CHM 1101”.

“This multi-center trial will enable us to more rapidly advance the development of CHM 1101 with recruitment across multiple clinical trial sites and also prepare us to accelerate the next phase of development if supported by the clinical results.”

Glioblastoma (GBM), also referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. Characterized by its rapid growth and infiltrative nature, glioblastoma invades the nearby brain tissue, but generally does not spread to distant organs. GBMs can infect patients of all ages and backgrounds. 

Chimeric is aiming to address high unmet medical needs in curing recurrent or progressive Glioblastoma through utilising chlorotoxin (CLTX), a peptide component of scorpion venom, as the tumour-targeting component in CHM 1101. 

The CHM 1101 Phase 1B trial, being conducted under a US IND, is a two-part clinical trial designed to determine a recommended Phase 2 dose and administration schedule. Part A of the trial will enroll 3-6 patients at the highest dose tested in the ongoing clinical trial at City of Hope Cancer Centre. The trial result will be assessed in late 2023. If the trial results in a favourable outcome, Part B of the trial, which is a dose expansion cohort, will be opened to enroll 12 to 26 additional patients. 

Previously, the CHM 1101 demonstrated safety with approximately 70% disease stability in the initial two dose cohorts during the Phase 1A investigator-initiated clinical trial.

Other than developing trials for CHM 1101, Chimeric is also expanding its portfolio across multiple different disease areas in oncology with other clinical programs in gastrointestinal and neuroendocrine tumours as well as blood cancers and solid tumours.

In the quarter ending 31 March 2023, Chimeric recorded a $687k cash outflow primarily due to staff costs and Research and Development (R&D) costs. This includes receiving a $3m Government R&D tax incentive rebate relating to the fiscal year ending 30 June 2022 during the March 2023 quarter. The Company currently has $2.8m cash at bank with no additional loan facilities.

Chimeric will continue to employ cash management strategies such as delaying operating activities, and is currently assessing alternative capital sources.