Home / Academia / cCAM Biotherapeutics Receives FDA Approval to Initiate Phase 1 Trial for CM-24, a Novel Immune Checkpoint Inhibitor for Cancer Immunotherapy

cCAM Biotherapeutics Receives FDA Approval to Initiate Phase 1 Trial for CM-24, a Novel Immune Checkpoint Inhibitor for Cancer Immunotherapy סיקאם ביות'רפיוטיקס בע"מ קיבל את האישור ליזום ניסוי קליני לסרטן

First-in-human Phase 1 trial expected to commence in Q1 2015

MISGAV, Israel–(BUSINESS WIRE)–cCAM Biotherapeutics, a biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies, announced today 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.

Pini Orbach, Ph.D., Chairman of the Board, cCAM Biotherapeutics, stated:

“Antibodies blocking immune checkpoints are emerging as a breakthrough treatment that can, in some cases, lead to a cure even in advanced stage cancer. Unfortunately, a large proportion of patients do not respond to these drugs. Currently approved immune checkpoint inhibitors are based on protein targets from the B7-CD28 family, and therefore novel immune checkpoint targets from different protein families may increase the response rate to treatment. cCAM is developing a first-in-class cancer immunotherapy that is directed against a novel immune checkpoint from the CEA protein family using a different mechanism of action than the current immune checkpoint inhibitors on the market. We therefore hope that our drug will increase the percentage of cancer patients responding to treatment. This is a very exciting era in oncology, and we look forward to launching the first-in-human clinical trial with CM-24.”

Professor Antoni Ribas, M.D., Ph.D., Department of Medicine, Hematology/Oncology at the Jonsson Comprehensive Cancer Center, UCLA, commented,

“We are impressed by the preclinical data to date, and are excited to take part in this trial, assessing the safety and tolerability of a new, first-in-class immune checkpoint inhibitor. Unlike current immune checkpoints isolated to date, CEACAM1 acts both as the receptor and the ligand. CEACAM1 on a tumor cell binds to another CEACAM1 molecule on an immune cell in order to inhibit an immune attack on the tumor. Therefore, it is possible that the CM-24 antibodies blocking the activity of CEACAM1 will have a strong effect in inhibiting this particular immune-modulating pathway.”

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, 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 Phase 1 ready, first-in-class humanized anti CEACAM1 monoclonal antibody. CM-24 was discovered by Dr. Gal Markel, Head of Research, Ella Institute of Melanoma, at Sheba Academic Medical Center Hospital. Investors in the Company include Arkin Holdings, Orbimed and Pontifax. For more information, please visit http://ccam-bio.com/.


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