Xenetic Biosciences (XBIO) investor relations material

Technology platform and scientific rationale

• DNase I platform targets Neutrophil Extracellular Traps (NETs), which promote tumor growth, metastasis, and therapy resistance by shielding cancer cells from the immune system.

• DNase I enzymatically digests NETs, exposing tumor cells to immune attack and reducing resistance to chemotherapy, immunotherapy, and radiotherapy.

• NETs contribute to an immunosuppressive tumor microenvironment and facilitate metastatic spread.

• Systemic DNase I administration can be combined with immune checkpoint inhibitors or chemotherapy to enhance anti-tumor responses.

• DNase I monotherapy also shows anti-metastatic activity in preclinical models.

Preclinical efficacy and pipeline

• DNase I improves efficacy of PD-1 and CTLA-4 checkpoint blockade, reducing tumor growth and prolonging survival in colorectal cancer models.

• Combination with FOLFOX chemotherapy or gemcitabine reduces metastatic burden in colorectal and pancreatic cancer models.

• DNase I-armored CAR T cells maintain cytotoxic function and secrete DNase I, overcoming physical and immunosuppressive barriers in solid tumors.

• Proof-of-concept studies show systemic DNase I enhances CAR T antitumor activity in metastatic melanoma models.

• Collaboration with VolitionRX aims to develop proprietary adoptive cell therapies for multiple solid tumor types.

Clinical development and market opportunity

• Phase 1 study planned: multicenter, dose escalation/expansion in advanced solid tumors, with DNase I as monotherapy and in combination with chemotherapy or immunotherapy.

• Initial focus on pancreatic carcinoma, a high unmet need with poor survival rates and a projected $5.8B market by 2030.

• Success in pancreatic cancer could be demonstrated by achieving ORR >50% or PFS >9 months, exceeding current standards.

• Platform applicable to a broad range of solid tumors, with ~1.9 million new cases annually in the U.S.

• Intellectual property covers systemic DNase I, DNase I-armored CAR T, and orphan designation for pancreatic cancer.