ROCKVILLE, Md.—In early February, Rexahn Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing targeted therapeutics for the treatment of cancer, announced that it had entered into a collaboration and license agreement with Zhejiang Haichang Biotechnology Co. Ltd. (Haichang) to develop RX-0201 (Archexin) for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.
Under the terms of the agreement, Haichang will develop a nano-liposomal formulation of RX-0201 using its proprietary QTsome technology and conduct certain preclinical and clinical activities through completion of a Phase 2a proof-of-concept clinical trial for the treatment of HCC. Any clinical trials conducted by Haichang will be designed to meet both U.S. and Chinese regulatory requirements. Haichang will fund all research and development activities through completion of the Phase 2a clinical trial.
The parties will share an agreed ratio of downstream licensing fees and royalties paid by third parties in connection with the further development and commercialization of the nano-liposomal formulation of RX-0201 for the treatment of HCC.
“We are delighted to enter into this collaboration to take RX-0201 forward in hepatocellular carcinoma,” said Dr. Peter D. Suzdak, CEO of Rexahn. “We are impressed with Haichang’s QTsome technology. It has the potential to target RX-0201 to the liver and to promote uptake into cancer cells to enhance efficacy.”
“The incidence of liver cancer is growing worldwide, and especially in Asia,” said Dr. Ben Zhao, CEO of Haichang. “There are very few treatment options for patients and unfortunately, the prognosis for patients with advanced disease is very poor. Akt-1 is an important signaling protein in liver cancer and we are excited about the potential for RX-0201. It is an ideal candidate for our liposomal technology, and we look forward to advancing the development of RX-0201 in collaboration with Rexahn.”
In connection with the agreement with Haichang, Rexahn plans to discontinue the internally funded programs of Archexin and will cease enrollment in the current Phase 2a clinical study of Archexin in metastatic renal cell carcinoma. Patients currently enrolled in the trial will continue to be followed.
RX-0201 is an antisense oligonucleotide compound that is complementary to Akt-1 mRNA and highly selective for inhibiting its mRNA expression, which leads to reduced production of Akt-1. Akt-1 is a protein that is associated with cancer cell growth and proliferation and the development of resistance to certain anticancer agents. Akt-1 is over-expressed in multiple forms of cancer including hepatic, renal, breast, colorectal, gastric, pancreatic, prostate and melanoma.
In a Phase 1 clinical trial in patients with advanced cancers, RX-0201 appeared to be safe and well tolerated, with minimal side effects.