KX2-361

Hand showing money in network. The concept of electronic money. Natali_Mis/Getty Images/iStockphoto Athenex is kicking off the second half of 2018 with a bang. The company secured $100 million in investments from Perceptive Advisors, is making major inroads in China with a joint venture with Chinese biotech Xiangxue Life Sciences and an in-licensing agreement from Avalon PolyTom Limited. Buffalo-based Athenex is kicking off the second half of 2018 with a bang. The company secured $100 million in investments from Perceptive Advisors, is making major inroads in China with a joint venture with Chinese biotech Xiangxue Life Sciences and an in-licensing agreement from Avalon PolyTom Limited. Athenex and Xiangxue Life Sciences, a subsidiary of Guangzhou Xiangxue Pharmaceutical Co. Ltd. , initiated a joint venture to develop T-cell receptor-engineered T cells (TCR-T). The new company will be called Axis Therapeutics Limited. Athenex will have a 55 percent ownership in the company and Xiangxue will own 45 percent, the two companies said. Axis has in-licensed Xiangxue’s TCR-T immunotherapy technology. Xiangxue has developed a new generation of TCR-T called HATac, which consists of the expression of high binding affinity soluble T-cell receptors on the engineered T-cells to target HLA-antigenic peptide complex on certain types of cancer cells. Early clinical studies in China demonstrated a good safety pro patients. Athenex and Xiangxue have collaborated before on the development of KX-02 for glioblastoma multiforme in China. To fund the new Axis, Athenex will provide the company with $30 million in cash. Additionally, Athenex will provide $55 million of Athenex common stock to Xiangxue Life Sciences as an upfront payment. Axis Therapeutics will also pay various clinical and regulatory milestones of up to $110 million to Xiangxue Life Sciences. Xiangxue Life Sciences will retain the mainland China rights to the technology and there will be royalties on net income payable to Axis Therapeutics upon successful commercialization in mainland China. Additional new TCR-T technologies developed by Axis will also be partnered with Xiangxue Pharmaceutical in the future for the mainland China rights. In addition to the joint venture with Xiangxue, Athenex also entered into a licensing agreement for a pegylated genetically modified human arginase (Pegtomarginase) from Hong Kong-based PolyTom. Preclinical work demonstrated that the Pegtomarginase was a potentially strong candidate in anti-cancer research. Athenex said the anti-cancer mechanism of the Pegtomarginase lies in the fact that some cancers don’t express either ornithine transcarbamylase (OTC) and/or argininosuccinate synthetase (ASS). Both of the enzymes are critical for the synthesis of arginine in the urea cycle pathway. This treatment approach shows specificity as the depletion of circulating arginine will starve such OTC-/ASS- deficient cancer cells, while normal cells can synthesize arginine intracellularly through urea cycle for their survival, Athenex said. As Athenex dives into the second half of the year, the company secured $100 million from Perceptive Advisors to help expand its pipeline. The $100 million includes $50 million in equity and $50 million in debt. Athenex Chief Executive Officer Johnson Lau said the company is excited about the expansion of its product pipeline with the additions of the TCR-T based cancer immunotherapy. “Given our confidence in our two Phase III programs in Oraxol for metastatic breast cancer and KX-01 ointment for actinic keratosis, we are delighted to have this opportunity to further expand our product pipeline,” Lau said in a statement. Oraxol is a novel oral formulation of chemotherapy drug paclitaxel combined with HM30181A, a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor. In April the U.S. Food and Drug Administration granted Oraxol Orphan Drug Designation for the treatment of angiosarcoma. An interim analysis of the Phase III trial of Oraxol in metastatic breast cancer is expected to be released in the third quarter of this year. In February Athenex completed enrollment in its two Phase III actinic keratosis trials. KX-01, is a dual Src kinase and tubulin polymerization inhibitor and a first-in-class topical treatment of actinic keratosis.