cCam Starts Phase I Cancer

cCAM Biotherapeutics 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.

Tehila Ben-Moshe, Ph.D., VP R&D, cCAM Biotherapeutics, noted, “Preclinical data demonstrate synergistic activity of various immune checkpoint blockers, findings which encourage us to study the potential synergy of CM-24 with other existing immune checkpoint blockers. We thus have high hopes that patients that do not respond to current immune checkpoint blockers could be treated with CM-24, as a standalone or combination therapy.”

About CEACAM1 and CM-24 CEACAM1 is a novel immune checkpoint protein that belongs to the Human CEA (Carcino-Embryonic Antigen) protein family and is a target for cancer immunotherapy. CEACAM1 is widely expressed on lymphocytes within the tumor, and is also up-regulated on various cancer types including melanoma, bladder, pancreas, colon, gastric and non-small cell lung cancers. Furthermore, its expression correlates with poor prognosis, suggesting that tumor cells utilize CEACAM1 to evade the immune system. Research shows that CEACAM1-CEACAM1 interactions have an inhibitory effect on activated lymphocytes, and that prevention of these CEACAM1-CEACAM1 interactions enables enhanced killing of tumor cells by T and NK immune cells. CM-24 is a first-in-class humanized anti-CEACAM1 antibody that inhibits the immunosuppressive effect of CEACAM1,

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