Matinas BioPharma Holdings, Inc. announced positive results from an in vivo animal study of an oral LNC formulation of docetaxel, a well-known chemotherapeutic agent used in the management of multiple metastatic and unresectable tumors. Currently, docetaxel is administered intravenously and can be associated with significant side effects and toxicities. Study Design: Purpose: Document the efficacy of an oral LNC docetaxel formulation to target and treat tumors, with both negative (untreated) and positive (IV docetaxel) controls.

Syngeneic tumor model (C57BL/6 mice injected with B16F10 murine melanoma cells) Four treatment groups Untreated controls Low-dose oral LNC docetaxel High-dose oral LNC docetaxel IV docetaxel Dosing of oral LNCs and IV docetaxel initiated at Day 5 following tumor cell injection Low-dose and high-dose oral LNC arms dosed daily through Day 14 IV docetaxel administered on Day 5 and Day 10 Tumor volume (caliper measurements) measured throughout the course of treatment Toxicity monitored throughout treatment and assessment of hematologic parameters at Day 14 Animal sacrifice at Day 14 Tumor volume measured at Day 14 Key Findings: Efficacy: Anti-tumor effect of daily oral LNC docetaxel in both the high-dose and low-dose arms were comparable to IV docetaxel with statistically significant reductions in tumor volume compared with untreated controls at Day 14 (high dose oral LNC -63%; low dose oral LNC -57%; IV docetaxel -68%), and similar reductions in tumor weight at Day 14. Safety: No systemic toxicities were noted. Body weight was stable over treatment duration and hematologic parameters were similar to untreated controls.

Potential next steps for Matinas include evaluating the efficacy of the current LNC docetaxel formulation in other tumor models and evaluating longer-term treatment regimens to confirm lack of toxicity. Additionally, Matinas plans to evaluate the potential anti-tumor activity of LNC formulations of small oligonucleotides.