The United States Patent & Trademark Office (USPTO) has allowed the NewLink Genetics Corporation's broad claims to oral pharmaceutical compositions comprising 1-methyl-D-tryptophan (D-1MT) (US Serial No. 12/175,538) and also to oral pharmaceutical compositions comprising 1-methyl-DL-tryptophan (US Serial No. 11/603,291). The company holds exclusive rights to the allowed applications.

“These patents will strengthen our D-1MT franchise in the United States,” commented Dr Charles Link, NewLink's chairman and CEO, “and should facilitate our ongoing discussions with potential development and marketing partners for this product candidate.”

"We have studied D-1MT in multiple single-agent phase 1 studies as well as in separate phase I studies evaluating D-1MT in combination with either docetaxel or an autologous dendritic cell vaccine," noted Dr Nicholas Vahanian, NewLink's president and chief medical officer. “Data from several of these studies will be presented at the ASCO annual meeting in June."

IDO pathway inhibitors, including D-1MT, represent a potential breakthrough approach to cancer therapy using small-molecule, anti-toleragenic product candidates intended to counteract a key mechanism by which tumours evade immune-mediated destruction. IDO is an enzyme that regulates immune response by suppressing T-cell function and enabling local tumour immune escape. Recent studies have demonstrated that IDO is overexpressed in many cancers, within both tumour cells as a direct defense against T-cell attack, and also within antigen presenting cells in tumour draining lymph nodes whereby IDO promotes peripheral tolerance to tumour associated antigens (TAAs). When hijacked by developing cancers in this manner, IDO may facilitate the survival, growth, invasion, and metastasis of malignant cells expressing TAAs that might otherwise be recognized and attacked by the immune system as foreign. D-1MT is currently in multiple Phase 1B/2 studies evaluating the addition of D-1MT to Taxotere in the treatment of breast cancer and the addition of D-1MT to an autologous P-53 dendritic cell vaccine also in the treatment of breast cancer patients. In addition to its clinical D-1MT product candidate, NewLink has an active program directed at discovering and developing other IDO pathway inhibitors.

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians.