On June 7, 2018 China’s Luye Pharma Group Ltd. reported that it has partnered up with U.S. biotech firm Elpis Biopharmaceuticals Corp. to work on dual target based therapies for cancer patients who fail to respond to current treatment (Press release, Luye Pharma, JUN 7, 2018, View Source [SID1234576655]). As a continuing effort of the collaboration initiated last year, the two companies signed a license agreement recently to jointly develop chimeric antigen receptor T-cell (CAR T) therapies and biologic drug candidates in immuno-oncology. "This is a global collaboration. Luye will be in charge of the development and commercialization of the co-developed products in China and will have the exclusive rights in the Chinese market," Sammy Jiang, vice president of strategy and business development at Luye, told BioWorld.
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"Elpis will be responsible for the same in the overseas market and have the exclusive rights in those markets," Jiang added. "With that said, we are still entitled to share the profits of our co-developed products in the overseas markets."
Luye and Elpis plan to build a long-term strategic partnership, working to discover and develop drug candidates, such as antibodies and CAR T therapies through the technologies developed by Elpis.
The great potential in Elpis’ in-house technology is one of the reasons Luye decided to collaborate with the Boston-based biotech firm. "Elpis’ founder has many years of experience in developing immuno-oncology drugs and CAR T therapies," Kehao Zhao, senior director of discovery biology at Luye Boston R&D, told BioWorld.
"Elpis developed a unique discovery platform to rapidly screen and develop fully human therapeutics antibodies. Their immuno-oncology expertise, particularly in CAR T therapeutics and antibody discovery technology, led to this collaboration in developing novel immuno-oncology drug candidates," Zhao added.
Their collaboration has already generated a compound that is at the IND-enabling preclinical study stage.
"The first CAR T therapy we co-developed with Elpis is dual target, which is technically more challenging to develop and can apply to broader disease areas compared with the single target CARTs. It holds more potential than the existing single target ones," said Zhao.
To treat cancer, activation of T cells through tumor-specific targeting has proved to be a powerful therapy, but still, more than half of the cancer patients fail to react to immune checkpoint inhibitors. Although currently approved CAR T targeting to single-target tumor-specific antigen has high response rate in hematological cancer treatment, many patients do not respond well or develop acquired resistance. The two companies hope to increase the effective response rate and overcome the resistance in treating cancer patients. "Besides the dual target CAR T therapies, under this partnership, we are also co-developing innovative next generation therapeutic antibodies to treat hematopoietic malignancies and solid tumors," said Zhao. "The project is currently in proof-of-concept stage. We hope to complete the animal trials by the end of this year. Then we can move it forward next year."
Growing U.S. presence
Joining the Boston team last year, Zhao carries the mission of introducing the latest technology and breakthroughs in the Boston area to Luye for its R&D of innovative drugs.
"While forming our own local R&D team in Boston, we are also seeking partners that possess advanced technologies," said Zhao. "We hope to develop innovative drugs on our own and through partnerships and internal efforts. Therefore, we can enhance our R&D capabilities for biologics and expand our development, striving for more presence in the global markets."
Luye is quickly advancing its biologics development. The company has launched five oncology products, including Tiandida (amifostine for injection) for advanced ovarian cancer or non-small-cell lung cancer, Tiandixin (lentinan for injection) for malignant tumors, Yitaida (arsenious acid and sodium chloride injection) for acute promyelocytic leukemia and primary advanced liver cancer, CMNa (sodium glycididazole for injection) for tumor radiotherapy, and Lipusu (paclitaxel liposome for injection) for ovarian cancer and metastatic ovarian cancer.
"We set our eye on biologics three years ago. Although there are a few chemical compounds in our pipeline, we plan to develop more biologics," said Jiang. "We don’t just focus on CAR T therapies, but the whole immuno-oncology area, so we think a lot about small-molecule drugs and antibodies as well." "We are also exploring the possibility of striking similar deals with other European companies that develop CAR T therapies," she added.
But before expanding into Europe, Luye has been enhancing its presence in the U.S. "We set up an office in New Jersey five years ago, which is responsible for clinical trials and new drug registrations," said Jiang. "Currently, we have four drug candidates in the U.S. that are undergoing clinical trials."
Luye has R&D centers in China, the U.S. and the EU and has five R&D platforms for long-acting and extended-release technology, liposome and targeted drug delivery, transdermal drug delivery system, new compounds and biological antibody technology.
"We actively expand our partnerships worldwide," said Jiang. "Our products are commercialized in more than 80 countries, either promoted by Luye’s in-house team or by our partners in the local markets."