PH001 / Suzhou Puhe Pharma - LARVOL DELTA

High efficiency of CAR-transduction utilizing Hillgene's innovative lentivirus vector platform (ESGCT 2024) - "Optimization of lentiviral processes and key process parameters, technical challenges such as low yield, low purification process yield, and difficulty in removing impurities have been greatly improved, achieving the premium quality of lentivirus products with high yield and titer, high recovery rate, and low impurity level. Conclusion The off-shelf lentivirus for CD19 CAR-T, EGFR TIL, CD19CAR-NK, and BCMA & IL15 based CAR-NK products produced by Hillgene are now available on the market, providing global cell therapy customers with a full range of off-shelf and customized lentiviral vector services."

IO biomarker • Infectious Disease • EGFR • IL15

Safety and efficacy of YK-029A in previously treated EGFR T790M-Mutant NSCLC: A multi-center phase I trial. (PubMed, Lung Cancer) - "The results show that YK-029A in pretreated NSCLC patients with EGFR T790M mutations revealed a satisfactory safety profile and generally good tolerability. Additionally, this agent exhibited encouraging anti-tumor efficacy in patients with advanced NSCLC harboring EGFR T790M mutations previously treated with first-/ second-generation EGFR-TKIs."

Journal • P1 data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and safety outcomes of emerging EGFR‑TKIs for patients with non‑small cell lung cancer with EGFR exon 20 insertion mutations: A systematic review and meta‑analysis. (PubMed, Oncol Lett) - "Subgroup analysis revealed the following ORRs: 0.731 (95% CI, 0.560-0.901; I2=0%) for YK-029A; 0.608 (95% CI, 0.511-0.705; I2=0%) for sunvozertinib; 0.602 (95% CI, 0.440-0.764; I2=80.2%) for furmonertinib; 0.602 (95% CI, 0.486-0.718; I2=84.5%) for befotertinib; 0.566 (95% CI, 0.236-0.896; I2=96.3%) for amivantamab; 0.444 (95% CI, 0.215-0.674; I2=0%) for BEBT-109; and 0.256 (95% CI, 0.178-0.334; I2=75.0%) for poziotinib. In conclusion, the emerging EGFR-TKIs for NSCLC with EGFR exon 20 insertion have a promising treatment outcome with a manageable safety profile. However, further analysis is needed when more clinical data are released."

Journal • Retrospective data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Efficacy of YK-029A, a novel EGFR TKI, in advanced NSCLC patients with acquired T790M mutation (AACR 2024) - P1/2 | "YK-029A has promising activity in previously treated NSCLC patients harboring EGFR T790M mutation."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial. (PubMed, J Thorac Oncol) - "YK-029A showed manageable safety and was tolerable in patients with NSCLC harboring EGFR mutations and showed promising antitumor activity in untreated patients with EGFR ex20ins mutations."

EGFR exon 20 • Journal • Metastases • P1 data • PK/PD data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Discovery of YK-029A, a novel mutant EGFR inhibitor targeting both T790 M and exon 20 insertion mutations, as a treatment for NSCLC. (PubMed, Eur J Med Chem) - "Furthermore, YK-029A exhibited significant antitumor activity in EGFRex20ins-driven patients-derived xenograft (PDX) models, preventing tumor progression or causing tumor regression at well-tolerated dosages. Based on the outcomes of preclinical efficacy and safety studies, YK-029A will enter phase Ⅲ clinical trials for the treatment of EGFRex20ins NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety and preliminary efficacy of YK-029A, a novel EGFR TKI, in patients with advanced NSCLC harboring ex20ins, T790M or rare mutations. (ASCO 2023) - "YK-029A was well tolerated and showed preliminary efficacy in treatment-naïve EGFR ex20ins mutant patients with locally advanced or metastatic NSCLC. >"

Clinical • Metastases • Anemia • Hematological Disorders • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Suzhou Puhe Pharmaceutical Technology Co., LTD

Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations (clinicaltrials.gov) - P3 | N=350 | Not yet recruiting | Sponsor: Suzhou Puhe Pharmaceutical Technology Co., LTD

EGFR exon 20 • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2