USPTO awards patent for key therapeutic ingredient in CNVN202 targeted molecular cancer therapy

Convergen LifeSciences, Inc. announced today that a United States Patent has been awarded by the U.S. Patent and Trademark Office jointly to The University of Texas System Board of Regents and The Secretary, U.S. Department of Health and Human Services.  U.S. Patent No. 7,902,441 is one of 23 patents, pending or issued worldwide, that Convergen LifeSciences, Inc. licenses exclusively from the Board of Regents of The University of Texas System. Among other claims, the patent covers the key therapeutic ingredient in CNVN202, a targeted molecular cancer therapy undergoing clinical testing in lung cancer patients.

The patent is based upon important discoveries made by a team of researchers from The University of Texas MD Anderson Cancer Center, The University of Texas Southwestern Medical Center and the National Cancer Institute.  Various aspects of the related research have been the subject of more than twenty peer-reviewed scientific and medical publications.  The research, development and subsequent technology application spans more than a decade of work supported by more than $35 million in peer-reviewed grant research awarded to the investigators and corporate funding, including a $4.5 million award to Convergen LifeSciences by the Texas Emerging Technology Fund.

"The patent validates our first-in-class technology platform," stated Greg Heinlein, Chief Operating and Financial Officer, Convergen LifeSciences. "By taking the novel tumor suppressors and assembling technologies from the fields of genomics, nanotechnology, molecular medicine and advanced materials sciences, we have built the foundation for a number of potential new therapies which may provide new options for cancer patients."

The patent pertains to the discovery that chromosome 3p21.3 genes act as cancer suppressors.  Loss of tumor suppression function in this chromosomal hotspot is known to be associated with the early onset of cancers.  Genes within this region induce apoptosis or programmed cancer cell death of cancer cells, and act to control cell signaling and inflammation.  The most potent apoptotic tumor suppressor within the 3p21.3 family was determined to be TUSC2, also known as FUS1.  TUSC2 aberrations are found in breast, ovarian, liver and other cancers and are associated with more than 80% of lung cancers.  TUSC2 works to kill cancer cells without harming normal cells. In CNVN202, TUSC2 is incorporated into lipid nanoparticles, which when administered intravenously, target cancer cells throughout the body. Promising results from a phase I dose escalation clinical trial testing CNVN202 (DOTAP:chol-TUSC2) monotherapy in recurrent and metastatic lung cancer patients were reported at the 2011 Annual Meeting of the American Association for Cancer Research.  

The trial showed for the first time that a tumor suppressor gene can be delivered intravenously and selectively to human cancer cells using a nanoparticle vector, express high levels of mRNA and protein in cancer cells in the primary tumor and distant metastatic sites, alter relevant pathways in the cancer cell and mediate clinically beneficial anti-cancer activity.

A phase II clinical trial is planned to evaluate CNVN202 in combination with Tarceva® (erlotinib) in lung cancer patients, who would not be expected to benefit from erlotinib alone.   CNVN202 has shown synergy when combined with erlotinib in both EGFR mutation positive and negative cancers. Tarceva® is a registered trademark of the Roche Group and Astellas Pharma.  Tarceva® is marketed by The Roche Group, including its members Genentech in the U.S. and Chugai in Japan and by Astellas Oncology in the U.S.