Clinical Trials

Date: 2018-09-28

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the 4th CRI-CIMT-EATI-AACR International Cancer lmmunotherapy Conference

Company: Alligator Bioscience (Sweden)

Product: ATOR-1017

Action mechanism:

• monoclonal antibody/immune checkpoint modulator. ATOR-1017 is an agonistic antibody that activates the co-stimulatory receptor 4-1BB (also known as CD137) expressed on T cells in the tumor area. Activation of tumor-specific T cells leads to an anti-tumor immune attack and has the potential to give rise to a long-term protection from tumor growth. ATOR-1017 is being developed for treatment of metastasizing cancer. The properties of the antibody may direct the immune activation to the tumor area, which is believed to improve the risk-benefit profile.

Disease:

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• • On September 28, 2018, Alligator Bioscience announced at the presentation of preclinical safety data for ATOR-1017 at the 4th CRI-CIMT-EATI-AACR International Cancer lmmunotherapy Conference in New York, USA. ATOR-1017 is a monoclonal antibody in development for the treatment of metastasizing cancer. It activates the costimulatory receptor 4-1BB and its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells.
• The new data include preclinical safety studies supporting a good tolerability profile of ATOR-1017. The inclination for inducing cytokine release, a common adverse effect of immunotherapy, was assessed in standardized assays and was found to be low. In accord, ATOR-1017 was found to be well tolerated in a repeated dose toxicology study with no signs of adverse events. Furthermore, the expression of 4-1BB in circulating immune cells of cancer patients was found to be low. Also, co-expression of the two targets needed for effect, 4-1BB and Fc-gamma receptors, was seen in tumors but lacking in healthy liver tissue. Taken together, these data support the potential of ATOR-1017 to induce stronger immune activation in the tumor area compared to other parts of the body, which is believed to minimize the risk of systemic immune-related adverse events.
• • On June 21, 2018, Alligator Bioscience  will present additional preclinical data for ATOR-1017 at the 3rd Annual World Preclinical Congress in Boston, US. These new data show that ATOR-1017 activates NK cells as well as T cells, both contributing to an effective immune-mediated killing of tumor cells. NK cells are immune cells that directly target tumor cells which attempt to evade the immune system. NK cells also enhance the cytotoxic response induced by tumor specific T cells. Agonistic antibodies recognizing 4-1BB will therefore strengthen the tumor killing capacity of both NK cells and cytotoxic T cells. The data further support a best-in-class profile for ATOR-1017, with demonstrated high efficacy and potential for tumor-directed immune activation.
• • On May 3, 2018, Alligator Bioscience  present pre-clinical data for the drug candidate ATOR-1017 at the Protein Engineering Summit (PEGS) 14th Annual Meeting in Boston, US. The data support a best-in-class profile for ATOR-1017, with a strong potential for high efficacy and tumor-directed immune activation. ATOR-1017 is dependent on cross-linking with Fc-gamma receptors. This means that it has to bind both 4-1BB and Fc receptors for full activity. Both 4-1BB and Fc-gamma receptors are highly expressed in certain tumors and these receptors could be used as predictive efficacy biomarkers. Patients that overexpress these receptors should demonstrate a higher efficacy response to ATOR-1017, resulting in an increased immune activation in the tumors compared to the rest of the body. This supports that ATOR-1017 has the potential for a superior benefit/risk profile.
• • On June 12, 2017, Alligator Bioscience announced that it has advanced another wholly-owned checkpoint modulator program, ATOR-1017, into pre-clinical development.
• Sartorius Stedim Cellca and Glycotope Biotechnology have been contracted to manufacture clinical material. Cellca will apply their CHO cell expression platform technology in order to develop a high-producing, high-quality production cell line and upstream process. and Glycotope will undertake further development and cGMP manufacturing. The agreement will provide Alligator with supplies of ATOR-1017 drug product for early stage clinical trials in cancer patients. ATOR-1017 is Alligator Bioscience's third immuno-oncology asset to start manufacturing and enter pre-clinical development,

Is general: Yes