Everolimus Injection (Sapu003) / GMP Biotech - LARVOL DELTA

Oncotelic Therapeutics Joint Venture Identifies Biomarker Signature Predicting Tumor Sensitivity to IV Sapu003 (City Buzz) - "Data show that mTORC2-dominant tumors exhibit heightened mTOR dependency and predicted sensitivity to Sapu003. These tumors include HR+/HER2- breast cancer, lung adenocarcinoma, gastric cancer, renal cancer, ovarian cancer, acute myeloid leukemia (AML), and T-cell malignancies."

Biomarker • Clinical data • Acute Myelogenous Leukemia • Gastric Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Adenocarcinoma • Ovarian Cancer • Renal Cell Carcinoma

Oncotelic and Sapu Nano Announces New PK Data Demonstrating IV Sapu003 Reduces GI Accumulation of Everolimus up to 67-Fold Compared With Oral Dosing (GlobeNewswire) - "New tissue-distribution data show that Sapu003, delivered intravenously, eliminates the extreme gastrointestinal accumulation characteristic of oral everolimus. After oral dosing, everolimus reaches 2,448× plasma levels in the stomach, 750× plasma in the small intestine, and 323× plasma in the large intestine, confirming that the gut is the dominant exposure site for the oral formulation...In contrast, IV Sapu003 demonstrates only 36–48× plasma levels across the same GI tissues, representing a 67-fold reduction in stomach exposure, a 15.7-fold reduction in small-intestinal exposure, and a 7.4-fold reduction in large-intestinal exposure....These findings provide a clear mechanistic explanation for the well-documented GI toxicity of oral everolimus—including stomatitis, mucositis, abdominal discomfort, and diarrhea."

PK/PD data • Preclinical • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Sapu Nano to present at the 2025 San Antonio Breast Cancer Symposium (SABCS) Highlighting Sapu003 (Deciparticle Everolimus) (GlobeNewswire) - "Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor–positive (HR⁺)/HER2⁻ metastatic breast cancer and RCC and NET."

Biomarker • P1 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Neuroendocrine Tumor • Renal Cell Carcinoma

Oncotelic to present at the 2025 San Antonio Breast Cancer Symposium (SABCS) Highlighting Sapu003 (Deciparticle Everolimus) (GlobeNewswire) - "Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor–positive (HR⁺)/HER2⁻ metastatic breast cancer."

Biomarker • Clinical data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Sapu Nano Unveils First-in-Human Clinical Trial of Sapu-003 at 8th Australian Translational Breast Cancer Research Symposium (GlobeNewswire) - "The trial (ACTRN12625001083482) is now open for enrollment at leading oncology centers across Australia. Eligible participants include adults with advanced HR+/HER2– breast cancer or other mTOR-sensitive tumors who have exhausted standard therapies. Physicians are encouraged to refer patients who may benefit from participation."

Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Sapu Nano has received approval from Australia’s Human Research Ethics Committee to begin enrolling patients in clinical trials for Sapu003, an injectable form of Afinitor (Everolimus) for breast cancer treatment (City Buzz)

New trial • Breast Cancer