Chimeric Therapeutics sets new horizons in cell therapy for gastrointestinal and brain cancers

Clinical stage cell therapy company Chimeric Therapeutics (ASX: CHM) achieved significant success on a number of fronts during a highly-active quarter ending 31 December 2023.

Most notably, the company obtained US Food and Drug Administration clearance for an investigational new drug application for its CHM 2101 novel third-generation CDH17 CAR T cell therapy for gastrointestinal cancers.

The company is now preparing to commence enrolment for the phase 1A clinical trial of patients with colorectal cancer, gastric cancer and neuroendocrine tumours.

Expected to be the first CDH17 CAR T cell therapy to enter clinical trials, Chimeric’s development targets CDH17, a cancer marker linked to poor prognosis and metastasis in common gastrointestinal tumours.

The CHM 2101 clinical program has been demonstrated to have an ability to completely eradicate established tumours in seven cancer models without harming normal tissues.

Positive glioblastoma results

The December quarter also saw Chimeric obtain promising preliminary results from its ongoing phase 1A clinical trial of CHM 1101 Chlorotoxin CAR T cell therapy for patients with recurrent or progressive glioblastoma multiforme (GBM), an aggressive form of brain cancer.

The CHM 1101 data revealed a disease control rate (DCR) of 55% among the treated participants, a notable improvement compared to historical DCRs of 20% to 37% for patients treated in second line.

Chimeric also reported an approximate 10-month survival benefit for patients that achieved disease control in the trial.

Of those, two patients achieved more than 14 months with one currently in ongoing follow-up.

Chimeric was particularly encouraged by the 10-month survival benefit for patients treated in fourth and fifth line when compared to the expected median survival of about seven months for patients treated in second line.

In November, Chimeric dosed its first participant in a phase 1B clinical trial with CHM 1101 in patients with recurrent or progressive GBM.

In the trial conducted at St. David’s South Austin medical centre in Texas, the patient received CHM 1101 as a second line therapy.

The phase 1B trial is structured in two parts: dose confirmation and dose expansion.

Successful cell manufacture

Late in the quarter, Chimeric revealed it had been successful in good manufacturing practice development of CHM 0201 NK cells to support the ADVENT-AML phase 1B clinical trial.

In that trial, Chimeric’s NK cell therapy is being evaluated in combination with standard of care therapy for patients with newly-diagnosed acute myeloid leukemia (AML).

The CHM 0201 NK cells were manufactured at the Cellular Therapy Integrated Services laboratory at Case Western Reserve University, where the CHM 0201 cells were developed.

Positive phase 1A clinical data from 2022 showed safety and promising efficacy of CHM 0201 cells as a monotherapy in treating both solid tumours and blood cancers.

One AML patient notably achieved a complete response and has been in remission for over two years.