TFX06 / Shenzhen Yangli Pharma, WuXi AppTec - LARVOL DELTA

Tfx06 dose expansion study showed favorable safety and efficacy in patients with er+ /her2- breast cancer in a phase 2 study (SABCS 2025) - P1/2 | "TFX06 at 150 mg QD dose expansion trial enrolled endocrine therapy heavily treated patients, including prior treatment with combination of fulvestrant and CDK4/6 inhibitor progressed patients. TFX06 demonstrated favorable safety and clinical efficacy even in this hard-to-treat patient population."

Clinical • P2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

TFX06 demonstrated intracranial efficacy in patients with ER+/HER2- brain metastatic breast cancer in a phase 1/2 study (AACR-NCI-EORTC 2025) - P1/2 | "These findings highlight TFX06's potential therapeutic advantage over fulvestrant in managing brain metastatic disease. Given the paucity of systemic therapies effective against CNS metastases in ER+ breast cancer, these results underscore the clinical relevance of developing CNS-penetrant SERDs such as TFX06."

Clinical • Metastases • P1/2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

TFX06 shows remarkable safety and extracranial and intracranial efficacy in patients with ER+ /HER2- breast cancer in a phase 1 study (SABCS 2024) - "Median number of prior endocrine therapies were 2 (1-4) including fulvestrant (33.3%), CDK4/6i (54.1%) and combination of both (29.1%) and a median number of chemotherapies was 2 (0-3). Based on the preliminary results, 150 mg QD dose expansions are ongoing. TFX06 demonstrated rather favorable safety profile and compelling antitumor activity for those extensively treated patients. Durable intracranial antitumor activities were also observed in all 3 patients enrolled with brain metastasis."

Clinical • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

A Phase I clinical study to evaluate the safety, efficacy and pharmacokinetic characteristics of TFX06 tablets, a new generation oral SERD, in patients with ER+/HER2- advanced or metastatic breast cancer (CSCO 2024) - "Study group: [Organizing Committee]"

Clinical • Metastases • P1 data • PK/PD data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

TFX06, a next-generation oral CERAN/SERD, shows favorable safety and PK profile, extracranial and intracranial efficacy in patients with ER+/HER2- breast cancer: Preliminary results from a phase 1/2 first-in-human trial (SABCS 2023) - "Prior anticancer treatments included one or two lines of endocrine therapies, including fulvestrant, and/or one or two lines of chemotherapies. Based on the preliminary results, oral administration of TFX06 at 60 or 100 mg once daily had favorable safety and PK profiles. TRAEs, such as gastrointestinal toxicities, bradycardia, and visual disturbances were not observed. Pleasingly, TFX06 demonstrated early extracranial and intracranial antitumor activity (PR) in a patient with a brain metastasis."

Clinical • P1/2 data • Tumor mutational burden • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • TMB

Study of TFX06 in Women With Advanced Breast Cancer. (clinicaltrials.gov) - P1/2 | N=74 | Recruiting | Sponsor: Shenzhen Yangli Pharmaceutical Technology Co., Ltd

Metastases • New P1/2 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • HER-2