Rexahn Pharma announces collaboration with Zhejiang Haichang Biotechnology

Rexahn Pharmaceuticals announced that it has 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 pre-clinical and clinical activities through completion of a Phase IIa 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 IIa clinical trial.

The parties will share in an agreed ratio 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 Peter D. Suzdak, Ph.D., Chief Executive Officer 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. We are also very pleased to have non-dilutive funding to take the program through Phase IIa proof-of-concept studies.”

“The incidence of liver cancer is growing worldwide, and especially in Asia,” said Dr. Ben Zhao, Chief Executive Officer 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.”

”While we continue to be encouraged by the safety and efficacy of RX-0201, the treatment landscape for metastatic renal cell carcinoma (mRCC) has significantly changed over the past two years with the approval of three new therapies by the FDA. This will limit the commercial viability of RX-0201 in mRCC. For this reason, Rexahn has decided to stop the development of RX-0201 for mRCC,” said Lisa Nolan, Ph.D., Chief Business Officer for Rexahn. “The Haichang collaboration allows Rexahn to capitalize on the clinical data already generated in Phase I and Phase II clinical studies and change the focus of the RX-0201 program to hepatocellular carcinoma using non-dilutive funding to take the program through Phase IIa proof-of-concept studies while retaining the potential for future milestones/royalties for the product. This will also allow Rexahn to focus its own resources on progressing RX-3117 and Supinoxin™ (RX-5902) through Phase II clinical development.”

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 IIa clinical study of Archexin in metastatic renal cell carcinoma (mRCC). Patients currently enrolled in the trial will continue to be followed.