Yingli Pharma Doses First US Patient in Phase 1 Study of YL-13027 for Patients With Advanced Solid Tumors

Yingli Pharma US, Inc. recently announced the first patient has been dosed in its Phase 1 clinical study evaluating YL-13027, a potent and selective TGFβ receptor 1 (TGFβR1) inhibitor. The dose-finding exploratory trial in patients with advanced solid tumors is being conducted in collaboration with The University of Texas MD Anderson Cancer Center and 4 clinical centers in the US.

YL-13027 is an oral inhibitor designed to neutralize TGFβ signaling and enhance immunomodulation in the tumor microenvironment by selectively targeting TGFbR1. The Phase 1 study is evaluating the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YL-13027. The dose escalation portion of the study will include up to four cohorts of 3-6 patients who will be treated in 28-day cycles with YL-13027, and it will evaluate the safety and tolerability of the drug to determine the recommended Phase 2 dose. A dose expansion phase is planned to further evaluate the safety, tolerability and anti-tumor activity of the TGFβR1 inhibitor at the recommended Phase 2 dose. The study has an estimated enrollment of 54 participants.

“The TGFβ pathway represents a promising target for cancer therapeutics. As yet, no therapies have been approved that inhibit TGFβR1 signaling,” said Michael Hui, MBA, Chief Executive Officer of Yingli. “We are delighted to be opening the clinical study in the US and hope to build on the positive preliminary results seen in the ongoing YL-13027 Phase 1 trial in China with promising pharmacokinetics, safety and preliminary evidence of durable antitumor activity. We believe that our drug has potential as a monotherapy or in combination with immunotherapies, and we’re excited to advance this therapy and provide patients with advanced solid tumors a convenient oral treatment option.”

The Phase 1 study is part of an ongoing collaborative agreement between Yingli and MD Anderson.

 YL-13027 is a potent and selective oral TGFβR1 inhibitor that is rationally designed to neutralize the TGFβ pathway and enhance immunomodulation in the tumor microenvironment. In IND-enabling studies, YL-13027 showed reliable dose-proportionality and pharmacokinetic properties and was safe and tolerable in toxicity studies. Preliminary results of a Phase 1 dose escalation clinical trial demonstrated that YL-13027 is safe, effective and well-tolerated. Yingli Pharma is also launching a Phase 1b/2 study in China exploring the benefits of YL-13027 in combination with a checkpoint inhibitor.

Yingli Pharma US, Inc. is developing oral small molecule drugs with first-in-class or best-in-class potential for cancers and other diseases with high unmet need. Its lead clinical candidate, linperlisib, is a next-generation PI3 kinase delta (PI3kδ) inhibitor under review in China for marketing approval in follicular lymphoma. Linperlisib is also under evaluation in a U.S. Phase 2 study in relapsed and refractory peripheral T cell lymphoma. Yingli’s clinical stage portfolio also includes YL-15293, a KRAS G12C inhibitor that is a part of its precision medicine program targeting oncogene drivers in cancer, under development in US and China. In addition, Yingli is advancing several early-stage precision therapy programs leading to IND-enabling studies this year. For more information, visit http://www.yl-pharma.com.