The study demonstrates that ELC-100, was generally well-tolerated with no dose-limiting toxicities observed. Importantly, the trial also revealed promising efficacy signals, including partial tumor responses in two out of eight patients evaluable for efficacy, providing early evidence of anti-tumor activity in this highly treatment-resistant population.

Safety results

ELC-100 (formerly referred to as AdVince) was generally well-tolerated, with no dose-limiting toxicities (DLTs) observed in any of the 12 treated patients. The safety profile was consistent with the expected mechanism of action of an oncolytic virus, characterized by a manageable inflammatory response. Maximum tolerated dose was established at 1 x 1012 virus particles as the highest tested dose.

Encouraging Efficacy signals

Notably, in this highly challenging patient population, consisting of individuals with advanced, end-stage neuroendocrine tumors who had exhausted all currently available treatment options, promising preliminary signals of clinical efficacy were observed. Specifically, partial responses in 2 of 8 efficacy-evaluable patients. Twelve weeks after the 4thtreatment cycle, 75% of efficacy-evaluable patients (n=8) remained progression free.

Jamal El-Mosleh, CEO of Elicera Therapeutics, commented:

“These are encouraging results from our Phase I/IIa safety trial with ELC-100. In this study of 12 patients with advanced metastatic neuroendocrine tumors, we observed a favorable safety profile with no dose-limiting toxicities and manageable adverse events consistent with the mechanism of an oncolytic virus. Importantly, we saw partial responses in two out of eight patients evaluable for efficacy, which represents meaningful early evidence of anti-tumor activity in a disease setting where new treatment options are needed. We are deeply grateful to the Victory NET Foundation for their generous financial support, which has made it possible to complete this important trial and advance the research and development of innovative therapies for this difficult-to-treat patient population. Given these positive signals, we will now carefully evaluate our strategic options for the continued development of the ELC-100 program.”