First patient dosed in Phase 1 trial of CM-24, a novel immune checkpoint inhibitor for cancer immunotherapy

cCAM Biotherapeutics has announced that the first patient has been dosed in a Phase 1 clinical trial of CM-24, a first-in-class immunomodulatory monoclonal antibody (mAb) for the treatment of various types of cancers.

The Phase 1 trial is a first-in-human open-label multi-centre dose escalation study assessing the effect of the CM-24 mAb on cancer patients with advanced or recurrent malignancies including melanoma, non-small-cell lung, bladder, gastric, colorectal and ovarian cancers. The main objectives of the study are to assess the safety and tolerability of CM-24 and to determine the recommended dose for Phase 2 trials, characterisation of the pharmacokinetic profile and immunogenicity of CM-24 and evaluation of preliminary efficacy of the drug. The trial is being conducted at four sites in the US and Israel and is composed of a dose escalation stage and an expansion stage. The expansion stage will focus on tumour types that responded to treatment in the first stage of the study.

Preclinical studies demonstrate the potential of CM-24 in treating melanoma and lung cancer

Prof. Mario Sznol, Yale Cancer Centre and the principal investigator in the CM-24 Phase 1 study, said, “One of the most significant advances in cancer treatment is the recent introduction of immune checkpoint inhibitor drugs which have shown promising results in treating multiple advanced cancers including melanoma and non-small-cell lung carcinoma. There is a need for novel immune modulating antibodies to address the large proportion of patients who do not respond to the current agents that are approved or in development. CM-24 is a first-in-class antibody directed against a novel immune checkpoint which enhances immune responses by a different mechanism of action than the current immune checkpoint inhibitors on the market. We are very excited to launch this first clinical trial to assess the safety and preliminary activity of CM-24.”

Dr Tehila Ben-Moshe, Chief Operation Officer cCAM Biotherapeutics, stated, “We are pleased to have our CM-24 Phase 1 clinical trial underway. Promising preclinical results including studies in mice tumour models have demonstrated the potential of CM-24 in treating melanoma as well as several other malignancies such as lung cancer. We therefore hope that CM-24 will generate positive results in this first-in-human clinical trial and will become an important and beneficial addition to the anticancer drug arsenal. This is an important milestone for our company and we look forward to the results of the CM-24 trial.”