SPEDOX-6 / Sunstate Biosciences - LARVOL DELTA

Efficacy and toxicity of the antitumor agent SPESN38-8. (ASCO 2026) - "Only prodrug approach on SN38 has resulted in 2 types of drugs, irinotecan and sacituzumab govitecan... 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 SPEDOX-6 into human phase IB/IIA clinical trial (NCT0764018)... SPESN38 complexes provide a novel water soluble SN38 formulation. SPESN38‑5 & SPESN38‑8 demonstrate better PK values, lower toxicity and superior antitumor efficacy in mouse models, compared with irinotecan, DOX & doxorubicin. FDA has green-lighted SPESN38-8 (IND #: 164346) for clinical development."

Clinical • Colorectal Cancer • Oncology • Solid Tumor • TOP1

Cardiotoxicity and efficacy outcomes of SPEDOX-6 for targeted treatment of soft tissue sarcomas. (ASCO 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 level) tumor growth, but SPEDOX-6 has less efficacy against SK-ES-1, relative to HT-1080. Combined with above 3 mouse model studies, SPEDOX-6's antitumor efficacy displays an inverse relationship with FcRn levels, thereby providing a potential mechanism for SPEDOX-6's targeted STS treatment. With "Orphan Drug Designation" status, SPEDOX-6's current human phase Ib/IIa clinical trials for treating STS underway (NCT07064018) will provide more information on establishing the correlation between antitumor efficacy of SPEDOX-6 and FcRn levels of cancer tissues. SPEDOX-6 may become the first targeted cancer therapy based on the FcRn level, revolutionizing STS's treatments."

Clinical • Cardiovascular • Ewing Sarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer

Antibody-encapsulated actinomycin D for targeted cancer treatments. (ASCO 2026) - "Recently, Tr-based antibody drug conjugates (ADCs), trastuzumab emtansine and trastuzumab deruxtecan, have emerged as a new class of anti-HER2 therapies by combining targeted antibodies with cytotoxic agents via linkers... 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 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, like actinomycin D (ACT), forming antibody encapsulated drugs (AEDs)...In vivo anticancer efficacy of Tr-ACT2 at 1 mg/kg vs irinotecan at 50 mg/kg using A549 mouse model has been evaluated, showing that Tr-ACT2 was significantly more effective in suppressing..."

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

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