Immunicum AB (publ) is establishing a unique immuno-oncology approach for the treatment of cancer through the development of allogeneic, off-the-shelf cell-based therapies. Ilixadencel, the company’s lead product, is currently being evaluated as an immune-activating therapy in two clinical trials for the treatment of various cancers with an additional study in the final stages of preparation.
One defining characteristic of cancer cells is their ability to “hide” from the immune system and thereby avoid detection from immune cells and subsequent destruction. Recent discoveries in the oncology field have allowed researchers to create therapeutics and add-on treatments that reactivate the immune system.
Focusing on innovation to combine precision and convenience
Immunicum’s approach is to create off-the-shelf cell-based therapies that prime the patient’s own immune system to fight cancer. The company’s lead candidate, ilixadencel, is manufactured from dendritic cells from healthy donors that have been activated to produce factors that stimulate the immune system. One donation from a healthy donor produces around 100 doses, which can treat about 50 patients. The cryopreserved product already has a shelf-life of three years.
Injecting ilixadencel directly into the tumour triggers a local inflammatory reaction, similar to that seen in a viral infection. This inflammation destroys tumour cells and activates the immune system against the tumour, recruiting the patient’s dendritic cells to engulf the fragments of tumour cells and the range of neoantigens (mutated antigens that are specific to the tumour). The dendritic cells then alert other immune cells in an adaptive systemic response that is personalised to the individual patient’s tumour.
“We believe that we have created an off-the-shelf agent that has potential as a therapy against a wide range of solid tumours and that requires no genetic manipulation making it simpler to manufacture, store and administer,” said Carlos de Sousa, CEO, Immunicum.
Immunicum is assessing ilixadencel for a range of solid tumours. The lead indication is renal cell carcinoma, and other indications include hepatocellular carcinoma, gastrointestinal stromal tumour (GIST), head and neck squamous cell carcinoma, non-small cell lung cancer and gastric adenocarcinoma.
“Cancer treatments are increasingly focused on combination approaches. We believe that our approach could be used as a backbone therapy along with checkpoint inhibitors, chemotherapy and tyrosine kinase inhibitors [TKIs], such as sunitinib. One additional benefit is the excellent safety of ilixadencel,” said de Sousa.
Moving forward through the clinic
Ilixadencel first moved in to clinical trials in October 2013, with a now-completed Phase I open-label safety study in patients with newly diagnosed metastatic renal cell carcinoma from which a number of papers and posters have been published. This trial was followed by the MERECA open-label Phase II study evaluating ilixadencel and sunitinib compared with sunitinib alone in metastatic renal cell carcinoma. MERECA closed enrolment in January 2018 and results are expected in the third quarter next year.
“We now have a new key Phase Ib/II study in place, known as ILIAD, which combines ilixadencel with checkpoint inhibitors, including Keytruda [pembrolizumab], in head & neck cancer, gastric and gastroesophageal junction adenocarcinoma and non-small cell lung cancer. The FDA has approved the trial and we are in process of activating the centres in the US,” said de Sousa.
“We are now also listed on the main market of Nasdaq Stockholm, as a small cap company within the healthcare sector, and are funded through to the end of 2019,” said de Sousa.
Preclinical development programs at Immunicum include opportunities based on the IMM-2 (formerly Subcuvax-Adenovirus) and IMM-3 platforms (formerly CD70) that are currently in research and preclinical evaluation.