Yingli Pharma and MD Anderson Initiate Strategic Collaboration to Advance Development of Multiple Oncology Programs
Five-year collaboration to provide support for clinical and preclinical efforts as Yingli Pharma expands its U.S. presence with robust oncology pipeline
Yingli Pharma US, Inc. (the “Company” or “Yingli”), a biotechnology company developing innovative small molecules, and The University of Texas MD Anderson Cancer Center today announced a strategic alliance to advance several oncology programs from preclinical discovery through clinical development. The five-year collaboration brings together Yingli’s experience in medicinal chemistry with MD Anderson’s comprehensive clinical and translational resources to drive existing Yingli therapeutic candidates into four U.S.-based clinical trials and to facilitate preclinical discovery and development in additional indications.
“This tremendous opportunity will accelerate our efforts as we look to bring new pharmacological agents to cancer patients in need," said Michael Hui, MBA, chief executive officer of Yingli. “We look forward to working with the experts at MD Anderson,
complementing our own expertise as we continue to build a well-rounded oncology pipeline.”
Two of the programs supported by the collaboration will leverage favorable clinical trial findings collected from China-based studies. The first program will focus on linperlisib, a PI3Kδ inhibitor with a novel structure, which has had positive results in eight active or completed Phase 1 and Phase 2 clinical trials for patients with lymphomas and solid tumors, including peripheral T cell lymphoma (PTCL).
“We are pleased to be working with Yingli to initiate a Phase 2 clinical trial evaluating linperlisib in patients with PTCL,” said principal investigator Swaminathan Iyer, M.D., professor of Lymphoma & Myeloma at MD Anderson. “This collaboration brings a potentially effective treatment option with a favorable safety profile to the U.S. to address an unmet need for patients with this aggressive cancer. I look forward to leading this exciting study.”
The second program will develop YL-13027, a novel, oral TGFβR1 inhibitor for use in advanced solid tumors with plans to initiate a U.S.-based Phase 1 clinical trial in 2022, led by Jordi Rodon, M.D., Ph.D., associate professor of Investigational Cancer Therapeutics at MD Anderson.
“The TGFβ pathway is an important immune regulator in the tumor microenvironment, and new treatments focused on enhancing anti-tumor immunity are desperately needed,” Rodon said. “We look forward to working with Yingli to conduct the first U.S.-based clinical trial evaluating their TGFβR1 inhibitor.”
In addition to advancing existing clinical programs, the collaboration also will focus on translational studies to further Yingli’s discovery programs. The collaborative approach will provide a steady stream of new therapeutic candidates for oncology clinical development, which the MD Anderson team, including David S. Hong, M.D., deputy chair of Investigational Cancer Therapeutics, will investigate.
About Linperlisib Linperlisib (YY-20394) is a highly selective and potent PI3Kδ inhibitor that has shown a favorable safety profile, encouraging anti-tumor activities and promising PK and pharmaceutical properties as an oral once-a-day agent in late-stage clinical development. A Phase 1 clinical trial was completed in 2020 demonstrating linperlisib to be a safe and tolerable agent, and a recommended Phase 2 dose of 80 mg QD was established. Linperlisib was awarded NMPA Breakthrough Therapy status in China, leading to a Phase 2 study in follicular lymphoma (FL) that was completed and submitted in 2021 to China marketing authority for approval. In addition, linperlisib received FDA Orphan Drug Designations for FL, CLL/SLL and T cell lymphoma. Multiple linperlisib clinical trials being conducted in FL, PTCL, other lymphomas, solid tumors, combination with gemcitabine/oxaliplatin in r/r DLBC and combination with therapeutic PD1 antibody are underway in China and the U.S. Preliminary results of single agent linperlisib from a relapsed or recurrent PTCL Phase1b study were reported at ASCO 2021, indicating an overall response rate of 70% with 33% CRs for this difficult to treat and aggressive form of lymphoma.
About YL-13027 YL-13027 is a potent small molecule antagonist of TGFβR1 kinase in early-stage clinical development. The compound was optimized with selectivity against TGFβR2 and other kinases, differentiating YL-13027 from other inhibitors blocking TGFβ signaling. In preclinical studies, YL-13027 demonstrated anti-tumor efficacy, tumor immune modulation and combination benefit with immunotherapy. In IND-enabling studies, YL-13027 showed reliable dose-proportionality and pharmacokinetic properties, and the agent proved to be safe and tolerable in toxicity studies. The preliminary results of a Phase 1 dose escalation clinical trial of single agent YL-13027 were reported at ASCO 2021, including the safety and efficacy findings that the open-label study is continuing in order to establish a recommended Phase 2 dose of YL-13027.
About Yingli Yingli Pharma US, Inc. is headquartered in San Francisco, CA. Yingli is an innovative clinical stage biotechnology company that is developing best-in-class and first-in-class oral investigational agents for the treatment of cancer, metabolic and autoimmune diseases. In addition to linperlisib and YL-13027, Yingli has two other investigational agents in clinical development, including YL-15293, a novel selective inhibitor of KRAS G12C and YL-90148, an investigational oral URAT-1 inhibitor for the treatment of in hyperuricemia/gout. Several additional oncology programs are in IND-enabling or candidate development stages.
For more information about Yingli and the investigational agent portfolio, visit http://www.yl-pharma.com
About MD Anderson The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 51 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is No. 1 for cancer in U.S. News & World Report’s “Best Hospitals” rankings. It has been named one of the nation’s top two hospitals for cancer since the rankings began in 1990. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).