Chimeric Therapeutics (ASX: CHM) reports busy Dec quarter, with progress across clinical programs

Highlights

• IND application for CHM 2101 was cleared by the US FDA.
• Phase 1A CHM 1101 trial demonstrates Disease Control Rate of 55% in recurrent Glioblastoma (GBM), surpasses historical averages.
• In Phase 1B trial of CHM 1101 for recurrent GBM, first patient has been dosed.
• GMP manufacturing has been completed in Phase 1B ADVENT-AML trial for CHM 0201 NK cells.
• CHM 1301 showed up to 300% increase in cell killing capability in human ovarian and pancreatic cancer models.

ASX-listed biotechnology company, Chimeric Therapeutics Limited (ASX: CHM) has a diversified portfolio that comprises two autologous CAR T cell therapies and an allogeneic NK cell therapies.

Through its quarterly report, the company has shared highlights of the activities conducted during the three months, ended 31 December 2023.

During the latest quarter, the company raised nearly AU$4.5 million via entitlement offer to fund the continued clinical development of the company.

US FDA cleared IND application for CHM 2101

CHM 2101 has received the US Food and Drug Administration (FDA) IND (Investigational New Drug) clearance. CHM 2101 represents CDH17 CAR T cell therapy that targets gastrointestinal cancers. This therapy is expected to be the first CDH17 CAR T cell therapy to reach clinical trials.

CHM 2101 clinical trial is based on preclinical studies that projects its ability to eradicate established tumours in seven cancer models without affecting normal tissues. The Phase 1A trial would enrol patients with Gastric Cancer, Colorectal Cancer and Neuroendocrine Tumours. The enrolment is expected to begin in 2024.

Positive results from Phase 1A trial of CHM 1101

Phase 1A clinical trial of CHM 1101 is ongoing. CHM 1101 is a CAR T therapy which targets solid tumours. In October 2023, the company shared promising results from the trial.

In the trial, the patients were pre-treated heavily, and more than 50% of the patients received CHM 1101 as fourth or fifth therapy. The trail data demonstrated a Disease Control Rate (DCR) of 55% among the treated participants. It is a significant improvement when compared to historical DCRs. The data also showed around 10-month survival benefit for those participants that achieved disease control.

Worth mentioning here is that two patients achieved over 14 months survival and one in ongoing follow up. The patients treated in 4^th and 5^th line demonstrated the 10-month survival benefit. This result is encouraging when compared to anticipated median survival of nearly 7 months for participants treated in 2^nd line.

Treatment’s safety profile was considered acceptable with controllable adverse impacts. This finding is significant considering the limited treatment options and the typically poor prognosis for recurrent GBM.

Phase 1B trial advances for recurrent GBM

The Phase 1B clinical trial with CHM 1101 has also progressed as the first patient got dosed in November 2023. The trial is being conducted at St. David’s South Austin Medical Center in Texas. The patient received the drug as a 2^nd line therapy.

The trial includes two parts, which includes dose confirmation and dose expansion.

Phase 1B ADVENT-AML trial for CHM 0201 NK cells

During the quarter, the company shared that the GMP manufacturing of CHM 0201 NK cells has been completed that would support the ADVENT-AML Phase 1B trial. In the trial, the company will evaluate NK cell therapy in combination with standard of care therapy. The trial includes patients with newly diagnosed AML.

In November, the company shared that this trial was selected for presentation at the annual meeting of American Society of Hematology (ASH), which took place in December 2023.

Encouraging in vitro data reported for CHM 1301

The company released in vitro data for CHM 1301, a CLTX CAR NK cell therapy in pancreatic and ovarian cancer in November 2023.

The studies showed up to a 300% surge in cell killing capability, compared to 1^st gen NK cells in models of pancreatic cancers and human ovarian cancers. The findings project the capability of CHM 1301 to expand the application of CLTX CAR therapies to solid tumours with high unmet medical needs and not limited to Glioblastoma.

The CHM 1301 program has advanced to next stage of preclinical development. Newly developed armoured NK cell platform is being utilised to enhance cell potency further and overcome the immunosuppressive environment of solid tumours.

CHM shares traded at AU$0.026 apiece at the time of writing on 12 February 2024.