Elicera Therapeutics continues phase I/IIa study with oncolytic virus as planned, following safety review in cohort 3

January 23, 2023

Gothenburg, January 23, 2022 - Elicera Therapeutics AB (publ) (“Elicera”), a clinical stage cell and gene therapy company developing next-generation therapies based on oncolytic viruses and CAR T-cells armed with the company’s proprietary and commercially available platform iTANK, today 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.

About the ELC-100 clinical phase I/IIa dose escalation study

The ELC-100 study is conducted in two phases. Phase I, which is now underway, has the primary goal of investigating the safety of the treatment and determining the maximum tolerable dose. The first phase of the study has four dose levels with three patients at each level. In addition to determining the maximum tolerable dose, efficacy is also evaluated for example in the form of tumor response.

So far, no dose-limiting adverse events have been reported. Full efficacy reporting from the ELC-100 study is expected when the study is fully completed.

About ELC-100

ELC-100 is an oncolytic virus based on a genetically modified adenovirus that has been optimized for its ability to selectively enter and replicate in neuroendocrine cancer cells but not healthy cells. Tumor cell death is achieved via so-called oncolysis when the virus particles have replicated to a sufficient extent in the tumor cell that it explodes and dies. ELC-100 is currently being used in an ongoing phase I/IIa clinical trial in the treatment of neuroendocrine tumors.

For further information please contact:

Jamal El-Mosleh, CEO, Elicera Therapeutics AB

Phone: +46 (0) 703 31 90 51

About Elicera Therapeutics AB

Elicera Therapeutics AB is a clinical stage cell and gene therapy company that develops next-generation therapies based on oncolytic viruses and CAR T-cells, armed with the company’s proprietary and commercially available platform, iTANK. The work is based on high-profile long-standing research conducted by Professor Magnus Essand's research group at Uppsala University and has resulted in the development of four drug candidates, including two CAR T-cells and two oncolytic viruses. The iTANK-platform is used to arm the company's own CAR T-cells, in addition to the oncolytic virus ELC-201, but can also be universally applied to other CAR T-cell therapies under development. The company’s share (ELIC) is traded on Nasdaq First North Growth Market. Erik Penser Bank has been appointed the Company's Certified Adviser.

For more information, please visit www.elicera.com

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