Company also gains access to scientific and clinical resources.
The Cancer Vaccine Acceleration Fund (CVAF) has earmarked $1.5 million in research funding to support the early clinical development of Tolerx’ anticancer mAbTRX518. CVAF is a nonprofit program established by the Cancer Research Institute in partnership with the Ludwig Institute for Cancer Research.
Under terms of the collaboration between CVAF and Tolerx, the cancer fund will be eligible to receive milestone payments if TRX518 achieves future FDA approval. CVAF will, in turn, provide Tolerx with access to scientific and clinical resources, including the Ludwig Institute’s clinical trials management team and Cancer Vaccine Collaborative, a global network of 19 medical research institutions with expertise in designing and conducting immunotherapy cancer trials.
“This partnership between CVAF and Tolerx is an innovative model for how academic investigators, nonprofit medical research organizations, and biopharma companies can leverage each of their unique strengths to expedite the development of important new medicines for patients,” comments Adam Kolom, CVAF director. “Our scientific leadership selected Tolerx’ TRX518 antibody as a priority for support because it represents a powerful mechanism for enhancing and sustaining the immune system’s attack against cancer cells.”
Tolerx is focused on developing drugs that modulate T-cell activity for the treatment of autoimmune diseases, diabetes, and cancer. TRX518 is a targeted T-cell immunomodulator designed to activate the glucocorticoid-induced tumor necrosis factor receptor (GITR) found on multiple types of T cells. Activating GITR on T-effector cells with a T-cell modulating agent plays a role in enhancing the immune system’s ability to attack tumors by activating T-effector cells and rendering them resistant to suppression by T regulatory cells, Tolerx claims. TRX518 is currently in Phase I evaluation for the treatment of melanoma.
Tolerx’ lead late-stage candidate, otelixizumab (TRX4), is a CD3-targetng monoclonal antibody designed to induce immunologic remission in patients with T-cell mediated autoimmune diseases using a single short course of therapy. The drug is being developed in collaboration with GlaxoSmithKline and is currently in Phase III trials as a treatment for new-onset type 1 diabetes. Phase II trials in rheumatoid arthritis are also ongoing, and Phase Ib studies evaluating otelixizumab in psoriasis patients have been completed. Tolerx suggests potential applications for otelixizumab could include Graves disease, myasthenia gravis, celiac disease, systemic lupus, and multiple sclerosis.
Tolerx has an additional candidate in Phase I clinical trials. TRX1 is an anti-CD4 humanized monoclonal antibody in clinical development initially for the treatment of cutaneous lupus erythematosus and rheumatoid arthritis.