Mendus brings ilixadencel back into clinical development

Mendus announced on Tuesday that the company will start a new ilixadencel trial in collaboration with the French cancer center Institut Bergonié. The trial will combine ilixadencel with the cancer drugs regorafenib and avelumab for soft-tissue sarcomas (STS). According to the announcement, first patient data should be available in H1’26. The news merit minor adjustments in our estimates which we will implement with the Q2’24 pre-comment.

Ilixadencel will be combined with two other drugs for STS

Mendus announced a collaboration with Institut Bergonié, a cancer center located in Bordeaux France. The institute has an ongoing multicenter, prospective, open-label Phase I/II clinical trial called REGOMUNE. The trial investigates a combination of two cancer drugs, the tyrosine kinase inhibitor regorafenib and the immune checkpoint inhibitor avelumab, for several different solid tumors. According to the announcement, ilixadencel will be combined with these two drugs for STS as part of the REGOMUNE trial. Mendus will supply ilixadencel as a study drug to treat up to 43 patients. To our understanding, Mendus’ capital requirements for the trial are very modest and not significant for the investment case.

Because of its mechanism of action, ilixadencel may act synergistically with the drug combination to achieve clinical efficacy. Approximately 80 % of STS are characterized by a “cold” immunological microenvironment. The intratumoral immune primer Ilixadencel could help turn the environment “hot” potentially enhancing immune response and therapeutic efficacy. We highlight that proving this possible synergism requires further research. Moreover, in our view, the benign safety profile of ilixadencel is an advantage, limiting the probability of severe side effects.

First results are expected in H1’26

According to the announcement, Mendus and Institut Bergonié expect to complete the preparations for the ilixadencel treatment arm within the REGOMUNE trial in H2’24. First patient data is expected to be available in H1’26. The announcement is largely in line with our expectations. The minor adjustments implicated to our estimates will be implemented with our H1’24 pre-comment. Mendus will release its Q2’24 report on August 23.