The gist: A new immunotherapy drug called CM-24 will soon be tested in patients with various types of advanced or recurrent cancer, including melanoma and non-small cell lung cancer (NSCLC). CM-24 is meant to boost a patient’s own immune system to fight cancer. It works by targeting an immune system protein called CEACAM1.
“cCAM Biotherapeutics, a biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies, has announced that it has received approval form the US Food and Drug Administration to commence a Phase 1 trial for CM-24, a first-in-class immunomodulatory monoclonal antibody (mAb) for the treatment of various types of cancers. The study is expected to commence during the first quarter of 2015.
“CM-24 is directed against CEACAM1, a novel immune checkpoint protein that is expressed on activated effector lymphocytes and a variety of cancer cells. CEACAM1 belongs to the Human CEA protein family, and preclinical data show that inhibition of CEACAM1-CEACAM1 homophilic interactions by CM-24 leads to enhanced activation of tumor specific immune cells.
“The Phase 1 trial is a first-in-human, open-label, multicenter, dose escalation study assessing the effect of the CM-24 mAb in cancer patients with selected advanced or recurrent malignancies, including melanoma, non-small cell lung adenocarcinoma (NSCLC) and bladder, gastric, colorectal or ovarian cancer. Primary objectives of the study are to assess the safety and tolerability of escalating multiple doses of CM-24 and to determine the recommended dose for Phase 2 trials with CM-24. Secondary objectives include characterization of the pharmacokinetic profile and immunogenicity of CM-24, and the evaluation of the preliminary efficacy of the drug on the basis of objective tumor response and duration of response in subjects treated with CM-24. The trial will be conducted at four sites including Yale and UCLA, and will be composed of a dose escalation stage and an expansion stage. The expansion stage will focus on subjects with cutaneous melanoma or additional malignancies that responded to treatment in the first stage of the study.”