Novel Oncolytic Virus Shows Efficacy Signals in Neuroendocrine Tumors

Treatment with ELC-100, an investigational oncolytic virus, demonstrated promising efficacy signals among a small cohort of patients with advanced end-stage neuroendocrine tumors (NETs), according to a press release on data from a phase 1/2a study (NCT02749331).¹

Among 8 evaluable patients, 2 achieved partial responses after receiving ELC-100. Additionally, 75% of evaluable patients were progression free at 12 weeks following the fourth treatment cycle.

Investigators noted that ELC-100 was typically well-tolerated, as they observed no dose-limiting toxicities among 12 patients who received treatment. The agent’s safety profile was consistent with prior reports of oncolytic virus-based therapies. Investigators identified 1 x 10¹² viral particles as the maximum tolerated dose.

“These are encouraging results from our phase 1/2a safety trial with ELC-100. In this study of 12 patients with advanced metastatic [NETs], we observed a favorable safety profile with no dose-limiting toxicities and manageable adverse events [AEs] consistent with the mechanism of an oncolytic virus. Importantly, we saw partial responses in 2 of 8 patients evaluable for efficacy, which represents meaningful early evidence of anti-tumor activity in a disease setting where new treatment options are needed,” Jamal El-Mosleh, chief executive officer at Elicera Therapeutics, the developer of ELC-100, stated in the press release.¹ “Given these positive signals, we will now carefully evaluate our strategic options for the continued development of the ELC-100 program.”

Investigators of the phase 1/2a study assessed 4 escalating doses of ELC-100 among 12 patients with advanced NETs. Across the dosing groups, patients received a maximum of 8 repeating doses of the oncolytic virus via hepatic artery infusion or intra-tumoral injection.

The trial’s primary end point was the number of AEs based on CTCAE v4.03 criteria.² Secondary end points included changes in tumor size, changes in tumor metabolic activity, progression-free survival, changes in the agent’s replication profile, changes in the humoral immune response, and changes in the cytokine-mediated immune response.

Patients 18 years and older with histologically and radiologically confirmed progressive neuroendocrine carcinoma of gastrointestinal, pancreatic, or bronchial origin with multiple liver metastases and disease that was not considered resectable for potential cure or tumor resection were eligible for enrollment on the trial. Other eligibility criteria included having a Karnofsky performance status of at least 70%, a life expectancy of at least 6 months, and adequate liver perfusion.

Those with chronic liver dysfunction prior to the development of metastatic cancer, active infection, or any viral syndrome diagnosed within 2 weeks prior to study entry were ineligible for enrollment. Patients were also unable to enroll on the trial if they had chemotherapy within 4 weeks of initiating study treatment, radiotherapy to the target tumor size within the last 24 weeks from a baseline CT scan, a concomitant malignancy, or any prior participation in research involving administration of adenovirus vectors.

In January 2025, the FDA granted orphan drug designation to ELC-100 as a treatment for patients with pancreatic NETs.³

“[NETs] represent a highly heterogeneous indication and in our ongoing clinical study with [patients who are] severely ill [who] can be divided into several subgroups, including based on treatment history. This diversity highlights the need for new therapeutic solutions to be developed with a broad understanding of the specific needs of different patient groups. We are very pleased that ELC-100 has been granted orphan drug designation in the US,” El-Mosleh stated in a press release at the time of the agency’s decision.³

References

1. Elicera Therapeutics announces final data from its phase I/IIa trial demonstrating a favorable safety profile and promising efficacy signals of oncolytic virus ELC-100 in neuroendocrine tumors. News release. Elicera Therapeutics. January 9, 2026. Accessed January 9, 2026. https://tinyurl.com/2btpd7bm
2. Study of recombinant adenovirus AdVince in patients with neuroendocrine tumors; safety and efficacy (RADNET). ClinicalTrials.gov. Updated December 3, 2024. Accessed January 9, 2026. https://tinyurl.com/3dkemufc
3. Elicera Therapeutics' drug candidate ELC-100 receives orphan drug designation in the U.S. for the treatment of pancreatic neuroendocrine tumors. News release. Elicera Therapeutics. January 13, 2025. Accessed January 9, 2026. https://tinyurl.com/yhbztjh2