Gothenburg-based Elicera Therapeutics develops next-generation cell and gene therapies based on CAR T cells and oncolytic viruses. The company currently has four drug candidates in the pipeline – two in the field of CAR T cells (ELC-301 and ELC-401) and two based on oncolytic viruses (ELC-201 and ELC-100).
The company also has a proprietary and commercially available platform technology, iTANK, which aims to optimize the immune system in cancer treatment by activating patients' own killer T cells. iTANK is applied to the company's two CAR T-cell-based candidates as well as to ELC-201, which is a next-generation oncolytic virus, enabling a broad parallel attack on cancer cells.
Positive data presented at Oncolytic Virotherapy Summit
The company participated last week at Oncolytic Virotherapy Summit in Boston, one of the leading forums for oncolytic virus therapies. Here, both smaller biotech companies and large global pharmaceutical giants meet to, among other things, explore the latest research in the field. At the event, Elicera presented data on its most advanced candidate, ELC-100, which is in a Phase I/IIa study with the indication neuroendocrine tumors (NETs).
The data demonstrates that a second patient responded to the treatment with an observed reduction in tumors, this time in the third cohort of the study. The first patient with clinical signals of tumor reduction was observed in the first cohort of the study with the lowest dose level. In total, this means that clinical signals have been observed in a total of two out of eight patients evaluated so far. Since this has already occurred in the Phase I part of the study, where the dose escalation phase takes place with the primary goal of finding out the safety of the treatment and the maximum tolerable dose, the company sees the new observations as very encouraging. CEO Jamal El-Mosleh commented on the new data in a press release:
"It is of course too early to draw any conclusions about efficacy, but we see it as very encouraging that there are now clear signals of clinical activity in two of eight patients evaluated so far, already in the dose escalation phase of the study."
The Phase I part consists of four dose levels with three patients included in each level, and thus a total of twelve patients are expected to be included in the study. The company also presented in connection with the positive clinical signals that no dose-limiting serious adverse events were seen in the second cohort. For the third cohort, it is estimated Elicera that safety data will occur in Q1 2023 while full efficacy reporting from ELC-100 may not come until 2023 at the earliest.
Co-founder comments
BioStock contacted Elicera Therapeutics' co-founder and chief development officer Say Yu to learn more about the presented results.
Why did you choose to communicate these results and can you comment any more on them?
– Elicera's oncolytic virus candidate, ELC-100, which is in an ongoing phase I/IIa study, is in the most advanced development stage in our pipeline. We therefore wanted to provide the scientific and investor community in attendance at the 7th Oncolytic Virotherapy Summit with the most up to date information about our assets. Since we were presenting new clinical data, we were required to disclose this information to the capital market as well. With regards to further comment, it is too early to tell but we are encouraged by these signals and look forward to additional analysis of all the patient cohorts during the coming months.
Tell us more about ELC-100 and the medical need it seeks to address.
– Elicera's oncolytic virus ELC-100 is a genetically modified adenovirus, optimized to selectively kill NET cells and leave healthy cells alone. It has also been designed to specifically not replicate in liver cells as the treatment is administered in the liver artery to better target liver metastases. ELC-100 is thus expected to achieve a tumor-killing effect in NET cells and at the same time set in motion a long-term, systematic immune response to attack cancer cells in other parts of the body.
With regards to the medical need, NETs can be found basically anywhere in the body, but occur primarily in the gastrointestinal tract, lungs and pancreas. Approximately 450,000 people were living with NETs in 2017 in the US, Japan, France, Germany, England, Italy and Spain, and the number of patients diagnosed with this type of tumor is expected to increase. So we see a substantial medical need for new types of treatment.
What is the therapeutic potential of oncolytic viruses?
– Oncolytic viruses have significant potential to contribute to new therapies within the field of immuno-oncology. By genetically modifying oncolytic viruses they can selectively infect and kill tumor cells while leaving normal cells intact. At the same time they induce a potent anti-tumoral T-cell response that proactively infiltrates tumors and attacks cancer cells in other parts of the body. OV's therefore have the potential to convert an immunologically "cold" tumor with few tumor-reactive T-cells into a "hot" tumor with increased T-cell infiltration. Oncolytic viruses can also be genetically modified, or armed, with different transgenes that for example can code for additional immune stimulating substances. In ELC-201, we arm the drug candidate both with the iTANK platform and with another transgene that codes for 4-1BBL to further stimulate T-cells against cancer.