Gothenburg, December 7, 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 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. Additional data from Elicera's studies with the company's oncolytic viruses, ELC-100 and ELC-201, will be presented by company co-founder Dr. Di Yu later today at the Oncolytic Virotherapy Summit in Boston, USA.
The study, which is carried out in collaboration with Uppsala University as sponsor, has previously been able to report signals of clinical activity in a patient in the ELC-100 study's first patient cohort where patients were treated with the lowest of four dose levels. Now it can be reported that one more patient in the study's third patient cohort showed signs of clinical activity. All patients evaluated to date show disease progression and the clinical activity demonstrated in the two patients is based on a reduction in some, but not all, metastases.
- It is of course too early to draw any conclusions regarding efficacy, but we see it as very encouraging that there are now clear signals of clinical activity in two out of eight patients evaluated so far already in the dose escalation phase of the study, says Jamal El-Mosleh, CEO of Elicera .
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 tolerated 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. Currently, eight patients, out of a total of twelve planned, have undergone full treatment, while the ninth patient will soon have finished treatment.
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. In April 2022, Elicera successfully completed proof-of-concept studies that confirmed the mechanism of action of ELC-201. More information about the results can be found on Elicera's website: (https://www.elicera.com/press-releases-sv/elicera-therapeutics-completes-successful-preclinical-proof-of-concept-studier-som-bekraftar-verkningsmekansen- for-the-oncolytic-virus-elc-201).
This constitutes information that Elicera Therapeutics AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the below contact person on December 7, 2022, 15:30 CET.
For further information please contact:
Jamal El-Mosleh, CEO, Elicera Therapeutics AB
Phone: +46 (0) 703 31 90 51
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.
ELC-201 is a next-generation oncolytic virus with a combined three mode-of-actions in the treatment of cancer. The drug candidate has been genetically modified with the company’s proprietary immune enhancing platform technology, iTANK, in addition to 4-1BBL, both of which lead to strong activation of the patient’s endogenous killer T-cells, leading to a broad parallel attack on cancer cells. ELC-201 is applicable for treatment of most cancers.
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. G&W Fondkommission has been appointed the Company's Certified Adviser. E-mail: firstname.lastname@example.org, tel: +468-503 000 50.
For more information, please visit www.elicera.com