Clinical stage cell therapy company, Chimeric (ASX:CHM), has just confirmed that all patients dosed in its Phase I of its CLTX CAR T cell clinical trial have now advanced beyond the 28-day follow-up period, without experiencing dose-limiting toxicities.

This development has achieved the targeted safety milestone, and will enable the trial to go ahead to the second dosing level.

The second dosing will administer CAR T cells at a total dose of 88 x 106 CAR T cells. Thi will be done via two routes – intratumoral (ICT ) and intracranial intraventricular (ICV).

The clinical study is taking place at the City of Hope, a world-renowned cancer research and treatment centre near Los Angeles.

Cell therapy for glioblastoma patients

The objective of the study is to evaluate the safety and maximum tolerated dose of Chimeric’s Chlorotoxin CAR T cell therapy in patients with recurrent or progressive glioblastoma (GBM).

GBM is an aggressive cancer that occurs in the brain or spinal cord. The cancer is formed around the nerve cells, and often causes headache, nausea, and blurred vision.

The CAR T cell therapy is essentially a new form of immunotherapy that uses specially altered T-cells (an important component of the immune system) to directly and precisely target cancer cells.

The therapy utilises chlorotoxin (CLTX), derived from scorpion toxin, which has demonstrated potent anti-tumour activity against glioblastoma in pre-clinical models.

In March, the company announced that it was conducting a Phase 1 study that aims to enrol 18-36 patients with recurrent or progressive GBM, across four dose levels.

The goal was to evaluate the safety and efficacy of CAR T cells, and to establish recommended dosing for a phase 2 trial.

The success of the first dosing today means that the study will now continue to the second dosing level, without the need for staggered doses as was done in the first one.

Market opportunity

Chimeric says that more than 300,000 patients globally are diagnosed each year with brain and nervous system cancer, and GBM is the most common and most lethal of these cancers. Only around 38% of patients with GBM survive more than one year.

In 2020, Chimeric licensed the exclusive global rights to the CLTX CAR T cell therapy.

The company is yet to make any revenue, and the latest half shows a $3.6 million loss.

Chimeric floated its shares on the ASX at an IPO price of 20 cents a share in January, and is now trading at 30 cents.


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