ELC-100 / Elicera Therap - LARVOL DELTA

RADNET: Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: Uppsala University | Trial completion date: Dec 2019 ➔ Dec 2020 | Trial primary completion date: Aug 2019 ➔ Aug 2020

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

RADNET: Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: Uppsala University | Trial primary completion date: Aug 2018 ➔ Aug 2019

Trial primary completion date • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

RADNET: Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: Uppsala University | Trial completion date: Sep 2022 ➔ Sep 2024 | Trial primary completion date: Aug 2022 ➔ Aug 2023

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

RADNET: Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: Uppsala University | Trial completion date: Dec 2020 ➔ Sep 2022 | Trial primary completion date: Aug 2020 ➔ Aug 2022

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

RADNET: Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy (clinicaltrials.gov) - P1/2 | N=35 | Active, not recruiting | Sponsor: Uppsala University | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Dec 2025 | Trial primary completion date: Aug 2023 ➔ Aug 2025

Enrollment closed • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

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 (Elicera Press Release) - "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....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."

P1/2 data • Neuroendocrine Tumor

Elicera Therapeutics postpones final reporting of ELC-100 study due to database transition (Elicera Press Release) - "Elicera Therapeutics AB (publ)...announces today that the final reporting from the dose-escalation study with the drug candidate ELC-100 has been delayed. The plan was to report data during the summer, but based on new information from the contract research organization (CRO) responsible for the study's database and analysis, the study results are now expected to be reported before the end of 2025."

P1/2 data • Neuroendocrine Tumor

Elicera Therapeutics enters a Material Transfer Agreement with University Hospital Tübingen for testing of the company’s oncolytic virus candidates, ELC-100 and ELC-201 (Elicera Press Release) - "Elicera Therapeutics...announces that it has entered into a Material Transfer Agreement (MTA) with University Hospital Tübingen in Germany. Under the agreement, the company’s oncolytic virus candidates ELC-100 and ELC-201 will be included in tests aimed at developing a new type of companion diagnostic to predict the potential success of a novel neuroendocrine neoplasm (NEN) therapy, immuno-virotherapy....According to Elicera’s MTA with University Hospital Tübingen, the hospital, under the leadership of Professor Ulrich M. Lauer and Dr. Linus Kloker, will receive access to ELC-100 and ELC-201 to conduct testing aimed at developing a new type of companion diagnostic. The purpose of this diagnostic is to predict the potential success of immuno-virotherapy before initiating treatment with this new combination for NEN."

Licensing / partnership • Neuroendocrine Tumor

Elicera Therapeutics’ drug candidate ELC-100 receives Orphan Drug Designation in the U.S. for the treatment of pancreatic neuroendocrine tumors (Elicera Press Release) - "Elicera Therapeutics AB (publ)...announces today that the company's drug candidate ELC-100 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic neuroendocrine tumors....In the fall of 2024, the company announced that the final patient had been recruited for the first part of an ongoing Phase I/II clinical trial aimed at identifying the maximum tolerated dose (MTD) and evaluating the treatment's safety in patients. The company is expected to report the final data from the first part of the study around mid-2025."

Orphan drug • P1/2 data • Neuroendocrine Tumor • Pancreatic Cancer

Elicera Therapeutics enrolls the last patient in the clinical phase I/II-trial with oncolytic virus ELC-100 (Elicera Press Release) - "Elicera Therapeutics AB...announced today that the last patient has been enrolled in the clinical phase I/II study evaluating the company's oncolytic drug candidate ELC-100 (AdVince) against neuroendocrine tumors. The study's preliminary results are expected to be reported in the first half of 2025."

Enrollment closed • P1/2 data • Neuroendocrine Tumor

Elicera Therapeutics continues phase I/IIa study with oncolytic virus as planned, following safety review in cohort 3 (Market Screener) - "Elicera Therapeutics AB...announced that the Data Safety and Monitoring Board (DSMB) completed its third assessment of the ongoing clinical phase I/IIa study with oncolytic virus, ELC-100, in neuroendocrine tumors and recommended continuation of the trial, as planned. The dose escalation study, which is carried out in collaboration with Uppsala University as sponsor, has previously been able to report signals of clinical activity in two of eight evaluable patients in the ELC-100 study, where a total of 12 patients are planned to be treated in four dose levels/cohorts. After the DSMB's recommendation to continue the trial, recruitment of the remaining three patients in the last cohort can commence."

DSMB • Trial status • Neuroendocrine Tumor • Oncology • Solid Tumor

Elicera Therapeutics reports additional signals of clinical activity in patients treated for neuroendocrine tumors in the ELC-100 study at the Oncolytic Virotherapy Summit in Boston (Cision) - P1/2 | N=35 | RADNET (NCT02749331) | "Elicera Therapeutics AB..announced that two of a total of eight patients so far fully treated and evaluated in the ongoing phase I/IIa study, which evaluates the oncolytic virus ELC-100 for the treatment of neuroendocrine tumors, have shown signs of clinical activity by reducing the size of some metastases....Reporting of safety data for the third patient cohort is expected to occur in the first quarter of 2023. So far, no dose-limiting adverse events have been reported in the second cohort. Full efficacy reporting from the ELC-100 study is expected when the study is fully completed, which is estimated to occur in 2023 at the earliest....Besides the additional signals of clinical activity from the ELC-100 study, proof-of-concept data from the company's preclinical studies for its second oncolytic virus ELC-201, which confirms the virus' mechanism of action, will also be presented at the conference."

P1/2 data • Preclinical • Neuroendocrine Tumor • Oncology • Solid Tumor