Press Release
17 August 2017
Immunicum Completes Strategic Analysis and Defines Updated Clinical Development Plan for Ilixadencel
Immunicum AB (publ; First North Premier: IMMU.ST), a biopharmaceutical company advancing a novel immune-priming cancer treatment against a range of solid tumors, today announced the completion of an internal strategic review process to define the next phase of ilixadencel`s clinical development program. Ilixadencel, formerly known as INTUVAX®, is an off-the-shelf allogeneic cell-based therapy currently being investigated in an ongoing Phase II trial in renal cell carcinoma (MERECA) as well as Phase I/II studies in hepatocellular carcinoma and gastrointestinal stromal tumor (GIST) patients. The review process was initiated in the beginning of 2017 to evaluate the current therapeutic landscape and ensure that the company`s clinical development efforts are strategically positioned to realize ilixadencel`s full potential. Based on the updated plan, the company is considering different funding options to enable its implementation.
"An important part of effective drug development is to be aware of how the therapeutic landscape changes and adapts to incorporate new medical procedures and innovative therapies into current treatment regimens," said Carlos de Sousa, CEO of Immunicum. "We have a unique opportunity with ilixadencel because of its broad applicability as a cell-based therapy for treating many different types of cancer, therefore we have developed our plan to maximize that potential, expand our strategic options and increase the value of the program. Ilixadencel has been designed to be a safe and effective backbone that can be incorporated into current standard of care as well as novel combination approaches."
The strategic review was conducted by Immunicum`s leadership team with the Board of Directors to define the next phase of ilixadencel`s clinical trial development program. Overall, the plan seeks to increase the number of key value inflection points by expanding the indications and regulatory opportunities for the product. While the current trial programs in renal cell carcinoma, hepatocellular carcinomas and GIST will continue, the company will also, based on the present knowledge on ilixadencel`s safety profile, initiate additional clinical studies that 1) incorporate the combination with additional immuno-oncology drugs, such as checkpoint inhibitors, 2) explore indications with high unmet medical need that could enable accelerated regulatory review and 3) seek to continue to establish ilixadencel`s potential in the indications Immunicum is testing now. In addition, Immunicum will start the Chemistry, Manufacturing and Controls (CMC) commercial development activities required for initiation of a pivotal trial for ilixadencel if the MERECA study results are supportive.