Tarrex Biopharma has announced that the US Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for TX803, a novel treatment for colorectal cancer. "This marks the first significant milestone for Tarrex in our efforts to develop innovative cancer therapeutics to address unmet medical needs and we are very excited that we will be able to start testing TX803 in advanced colorectal cancer patients," said Kanyin E. Zhang, Ph.D. chief executive officer of Tarrex.

TX803 is a first-in-class small molecule therapeutic that inhibits the PI3K/AKT pathway through a novel mechanism – by targeting, not the kinase itself, but a PI3K activating onco-protein, the truncated retinoid X receptor alfa (tRXRa). Moreover, tRXRa is found in high levels in tumor tissues obtained from a significant portion of colorectal, gastric and breast cancer patients. Preclinical studies have demonstrated that TX803 is orally bioavailable, well tolerated, and efficacious in several animal tumor models including KRAS mutated colorectal cancer. Tarrex has licensed the worldwide rights of TX803 and related intellectual properties from the Sanford Burnham Prebys Medical Discovery Institute in San Diego, California.

"Approximately 50% of colorectal cancer patients have tumors with a KRAS or NRAS mutation, which renders them resistant to anti-EGFR therapies, such as cetuximab and panitumumab. If clinically proven, TX803 has the potential to address a significant unmet need in treating RAS mutated colorectal and possibly other type of cancers," said Dr. Kimmie Ng, MD, MPH, Director of Clinical Research, Center for Gastrointestinal Oncology at Dana Farber Cancer Institute, Harvard Medical School, and Principal Investigator for TX803 clinical trials.

Tarrex Biopharma is a privately-owned drug development company with an office in San Diego, California and a research facility in Xiamen, China. Tarrex is committed to developing novel cancer therapeutics that seek to address significant unmet medical needs in major commercial markets worldwide. In addition to the lead candidate TX803 for colorectal cancer, the company is partnered with Aranda Pharma, a Finnish drug discovery company, to develop a new generation of small molecule androgen receptor (AR) antagonist for the treatment of castration resistant prostate cancer (CRPC), targeting specifically enzalutamide resistant CRPC.