Immunicum AB (publ) Completes Strategic Analysis and Defines Updated Clinical Development Plan for Ilixadencel

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.

Immunicum leadership will provide further details about the next phase of clinical development and its financing in its second quarter financial report and in additional communications over the next several weeks.

About ilixadencel
Ilixadencel cell therapy product (formerly known as INTUVAX®) is an off-the-shelf anti-cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy blood donors. Intratumoral injection of these cells is expected to lead to an inflammatory response which in turn leads to tumor-specific activation of the patient's cytotoxic T-lymphocytes.

For more information, please contact:

Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
E-mail: info@immunicum.com

Investor Relations Sweden

Helena Stångberg
Hallvarsson & Halvarsson
Telephone: + 46 709 71 12 53
E-mail: helena.stangberg@halvarsson.se

Investor and Media Relations EU/US

MacDougall Biomedical Communications
Gretchen Schweitzer or Stephanie May
Telephone: +49 89 2424 3494 or +49 175 5711562
E-mail: gschweitzer@macbiocom.com or smay@macbiocom.com

The Company's Certified Adviser is Redeye AB
Telephone: +46 (0) 8 545 013 31
www.redeye.se

 

About Immunicum AB (publ)

Immunicum is establishing a unique immuno-oncology approach through the development of allogeneic, off-the-shelf cell-based therapies. Our goal is to improve survival outcomes and quality of life by priming the patient's own immune system to fight cancer. The company's lead product ilixadencel, consisting of pro-inflammatory allogeneic dendritic cells, has the potential to become a backbone component of modern cancer combination treatments in a variety of solid tumor indications. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq First North Premier. www.immunicum.com