NLG8189 development status and plan
We are developing NLG8189 (d-1-methyltryptophan, or D-1MT), a small-molecule, orally bioavailable product candidate based on our proprietary indoleamine-(2,3)-dioxygenase, or IDO, pathway inhibitor technology. Preclinical experiments have demonstrated a strong, synergistic anti-tumor effect without increased toxicity when NLG8189 was administered in combination with a number of currently available chemotherapeutic agents.
We currently have two Phase 1B/2 clinical trials enrolling patients to evaluate NLG8189 in combination with other approved therapies. The first clinical trial has primary endpoints that assess safety and efficacy of NLG8189 in combination with an Ad-p53 autologous dendritic cell vaccine for solid malignancies with p53 mutations, such as lung, breast and colon cancers. The second clinical trial has primary endpoints that assess safety and efficacy of NLG8189 in combination with Taxotere for patients with advanced stage solid tumors for which Taxotere is the standard-of-care, such as metastatic breast, prostate, ovarian and lung cancers. The Phase 2 clinical trial portion of the NLG8189/Taxotere study will expand primarily to enroll patients with metastatic breast cancer. We believe NLG8189 has the potential to have a synergistic therapeutic effect in combination with Ad-p53 or Taxotere without adding systemic safety complications. These clinical trials are being co-sponsored by the NCI’s Division of Cancer Treatment and Diagnosis under a Cooperative Research and Development Agreement and letter of intent and are taking place at the Moffitt Cancer and Research Institute in Tampa, Florida.