On September 3, 2022 Yingli Pharma (the "Company" or "Yingli"), a clinical stage biotechnology company developing oral small molecule drugs for cancers with high unmet need, reported that the first patient has been dosed in a Phase 2 trial evaluating linperlisib, a potent inhibitor of the delta isoform of PI3 kinase (PI3Kδ) in patients with relapsed/refractory peripheral T/NK cell lymphoma (r/r PTCL) (Press release, Yingli Pharmaceutical, SEP 3, 2022, View Source [SID1234618977]).
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This single arm study will evaluate the safety, efficacy and pharmacokinetics of orally administered linperlisib under a strategic collaboration with The University of Texas MD Anderson Cancer Center. Additional trial sites will include medical centers in the United States and Italy.
"We are pleased to commence this study of linperlisib in the United States in patients suffering from advanced PTCL," said Michael Hui, MBA, chief executive officer of Yingli. "Linperlisib is a next generation inhibitor of PI3Kδ with enhanced selectivity and potency to offer strong anti-tumor effect while minimizing potential adverse reactions. We are encouraged by the safety and preliminary efficacy data obtained in Phase 1 dose-finding studies in China and look forward to further evaluating linperlisib’s potential in this Phase 2 study."
"Patients living with advanced PTCL, an aggressive type of lymphoma, face limited treatment options and most do not respond or stop responding to available therapies. Linperlisib may provide a solution for these patients who need an expanded treatment armamentarium, and we’re excited to continue studying the drug’s potential as we start the Phase 2 study."
Linperlisib, a convenient once daily oral drug, is a small molecule inhibitor of PI3Kδ, a validated target in lymphomas due to its critical role in cell proliferation and survival. This Phase 2 (NCT05274997), single arm, open-label trial will evaluate the safety, efficacy and pharmacokinetic properties of linperlisib monotherapy in adult patients with r/r PTCL who have failed at least one prior line of systemic therapy. Enrolled participants will receive linperlisib 80mg once daily orally in a 28-day cycle. The primary outcome is overall response rate to treatment. Secondary outcomes include duration of response, overall survival, progression-free survival, adverse effects and pharmacokinetics parameters. An estimated 97 patients will be enrolled in the study.
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 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. Preliminary results of single agent linperlisib from a relapsed or recurrent PTCL Phase1b study were reported at ASCO (Free ASCO Whitepaper) 2021, indicating an overall response rate of 70% with 33% CRs for this difficult to treat and aggressive form of lymphoma.