NewLink Genetics announces results from two clinical studies with indoximod

NewLink Genetics Corporation (NASDAQ: NLNK), an oncology-focused biopharmaceutical company specializing in immunotherapy, today announced results from two clinical studies with indoximod, an orally administered small molecule drug candidate that inhibits the IDO pathway. Indoximod was tested in a Phase 1 study in combination with docetaxel and in a Phase 1B/2 study in combination with dendritic cell cancer vaccine (AD.p53DC). In both studies, data indicated that indoximod was well tolerated when combined with these anti-cancer agents. The data also indicated promising signs of anti-tumor activity. Based on these results, NewLink has recently advanced indoximod into two separate Phase 2 cancer trials in patients with metastatic breast cancer.

The Phase 1 trial of indoximod in combination with docetaxel was conducted in patients that failed prior treatments to determine the maximum tolerated dose and evaluate the safety and activity for the combination of indoximod and docetaxel. The data showed that in 22 evaluable patients, 18 percent (4/22) exhibited a partial response and 41 percent (9/22) had stable disease. Data indicated that the combination therapy was well tolerated with no increase in expected toxicities or unexpected drug-drug interactions. Further, the pharmacokinetic profile of the combination therapy was similar to the profile of each drug as a single agent. Based on these results, a randomized Phase 2 clinical study was initiated evaluating the potential of indoximod in combination with docetaxel in patients with metastatic breast cancer using 1200 mg twice per day (BID) of indoximod and 75 mg/m² of docetaxel once every three weeks.

The Phase 1B/2 trial of indoximod in combination with a dendritic cell cancer vaccine (AD.p53DC) was conducted in 32 patients with metastatic solid tumors who failed prior treatments, 22 of whom had metastatic breast cancer. The primary objective of the study was to determine the maximum tolerated dose of the two agents when combined. Data indicated that the combination therapy was well tolerated and established the Phase 2 dose for the combination.  Stable disease was observed in three patients during the initial treatment phase of the study. Of the 22 patients in the study with metastatic breast cancer, 11 patients that showed tumor progression after treatment with indoximod plus vaccine were subsequently treated with gemcitabine-based chemotherapy. Six of these 11 patients (54 percent) achieved an objective response, including a complete response in one patient who had received four prior chemotherapies.  Based on these results, a Phase 2 clinical study was initiated evaluating the potential of indoximod in combination with the cancer vaccine in patients with metastatic breast cancer using 1600 mg BID of indoximod and the vaccine. This trial will also evaluate the impact of salvage therapy for patients using carboplatin and gemcitabine.

"Taken together, we believe the data from these trials demonstrate the significant potential of indoximod and its action as an IDO pathway inhibitor to disrupt the mechanisms by which cancer evades a patient's immune system and to boost the effect of other therapies, including cytotoxic agents and cancer vaccines for the treatment of solid tumors," commented Charles J. Link, Jr. , MD, Chairman and Chief Executive Officer of NewLink Genetics.

Both studies were discussed in poster presentations at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO) by NewLink researchers and collaborators.  The first poster presentation was entitled "A phase 1 study of indoximod in combination with docetaxel in metastatic solid tumors." The second poster presentation was entitled "A phase I study of ad.p53 DC vaccine in combination with indoximod in metastatic solid tumors."