MISGAV, Israel--cCAM Biotherapeutics, a biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies, announced today that the first patient was 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, multicenter, 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, characterization of the pharmacokinetic profile and immunogenicity of CM-24, and evaluation of preliminary efficacy of the drug. The trial is 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 tumor types that responded to treatment in the first stage of the study.
Prof. Mario Sznol, Yale Cancer Center 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."
About CEACAM1 and CM-24
CM-24 is directed against CEACAM1, a novel immune checkpoint protein that belongs to the Human CEA (Carcino-Embryonic Antigen) protein family and is the only member that is expressed on lymphocyte upon activation. CEACAM1 is found to be widely expressed on lymphocytes within the tumor, and is also up-regulated on various cancer types. Furthermore, its expression correlates with poor prognosis, suggesting that tumor cells utilize CEACAM1 to evade the immune system. Research shows that CEACAM1 interactions have an inhibitory effect on activated lymphocytes, and prevention of these interactions enables enhanced killing of tumor cells by T and NK cells.
CM-24 is a first-in-class humanized anti-CEACAM1 antibody that inhibits the immunosuppressive effect of CEACAM1, leading to an enhanced immune response of T and NK cells against cancer cells. Preclinical trials show that CM-24 enhances the cytotoxic activity of tumor-infiltrating lymphocytes (TILs) against various CEACAM1-positive tumor cell lines. CM-24 is being developed for multiple oncological indications according to the expression pattern of its target protein, and also has the potential to synergize with other immune checkpoint blockers.
About cCAM Biotherapeutics
Founded in 2010, cCAM is a biopharmaceutical company focused on the discovery and development of novel immunotherapies to treat cancer. Its lead product, CM-24, is a first-in-class humanized anti CEACAM1 monoclonal antibody undergoing Phase 1 clinical trials. CM-24 is based on the research done by Dr. Gal Markel, Head of Research, Ella Institute of Melanoma, at Sheba Academic Medical Center Hospital, Israel. Investors in the Company include Arkin Holdings, Orbimed and Pontifax. For more information, please visit http://ccam-bio.com/.