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

Phase 1 study evaluates safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YL-13027, an inhibitor of TGFβ signaling

Excerpt from the Press Release:

SAN FRANCISCO, May 26, 2022 (GLOBE NEWSWIRE) — Yingli Pharma US, Inc, (the “Company” or “Yingli”), a clinical stage biotechnology company developing oral small molecule drugs for cancers and other diseases with high unmet need, today announced that 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 U.S.

YL-13027 is an oral inhibitor designed to neutralize TGFβ signaling and enhance immunomodulation in the tumor microenvironment by selectively targeting TGFβR1. 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 U.S. 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.

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