SPEDOX-6 / Sunstate Biosciences - LARVOL DELTA

Single protein encapsulated SN38: Extremely effective anticancer drug with low toxicity (AACR 2026) - "At present, only prodrug approach on SN38 has resulted in 2 types of therapeutics approved by the FDA, irinotecan/ONIVYDE and Trodelvy...Therefore, novel approaches are urgently needed for effectively delivering SN38. Our patented single protein encapsulation (SPE) platform, allowing encapsulation of small-molecule drugs by a single protein (albumins or globulins) without artificial nanoparticles and chemical modifications to drugs and proteins, has made the first drug product, SPEDOX-6 into human phase IB/IIA clinical trial (NCT0764018)... SPESN38 complexes provide a novel water soluble SN38 formulation. SPESN38‑5 and SPESN38‑8 demonstrate better PK values, lower toxicity and superior antitumor efficacy in mouse models, compared with irinotecan, DOX and Doxil. FDA has green-lighted SPESN38-8 (IND #: 164346) for clinical development."

Colorectal Cancer • Ewing Sarcoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

SPEDOX-6: First-in-human Phase IB/IIA trial on soft tissue sarcomas (AACR 2026) - P1/2 | "SPEDOX-6 at 30 mg/kg is significantly better than Doxil at 4 mg/kg (MTD) and DOX at 3.5 mg/kg (MTD) in inhibiting SK-ES-1 (Ewing sarcoma, with the highest FcRn) tumor growth, but SPEDOX-6 has less efficacy against SK-ES-1, relative to HT-1080. With Orphan Drug Designation of SPEDOX-6, only phase 2A trial is needed for full approval, granted by FDA. Superior clinical antitumor efficacy of SPEDOX-6 on STSs is expected to be achieved because a possible high dose at 310 mg/m2 (> 4-folds DOX) can be used for treating patients without cardiotoxicity, which will save lots of lives."

First-in-human • P1/2 data • Cervical Cancer • Ewing Sarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer

Antibody encapsulated drug: Tr-ACT2 for targeted treatments of various cancers (AACR 2026) - "Trastuzumab (Tr) has demonstrated efficacy in treatment of HER2+ breast cancer and advanced gastric cancer. Recently, Tr-based antibody drug conjugates (ADCs), Kadecyla and Enhertu, have emerged as a new class of anti-HER2 therapies by combining targeted antibodies with cytotoxic agents via linkers...Therefore, smarter and more efficient designs are urgently needed. Our patented single protein encapsulation (SPE) platform, allowing encapsulation of small-molecule drugs by a single protein (albumins or globulins) without artificial nanoparticles and chemical modifications to drugs and proteins, has achieved great success in development of 2 drug products, SPEDOX-6 under human clinical trial (NCT0764018) and SPESN38-8 (IND #: 164346) under IND-enabling study based on albumin, which have prompted us to utilize antibody, such as Tr to encapsulate cytotoxic payload, actinomycin D (ACT, RNA polymerase inhibitor), forming antibody encapsulated drugs (AEDs)... We have developed..."

Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor