21 May 2018
Immunicum AB (publ) Announces End of Enrollment in Phase I/II GIST Clinical Trial
Immunicum AB (publ; IMMU.ST) today announced that the sixth and last patient has been enrolled in the first cohort of the Phase I/II clinical trial with ilixadencel for the treatment of patients with gastrointestinal stromal tumors (GIST). Due to the rarity of the disease, which has caused the enrollment to be slow, Immunicum has decided not to proceed with the recruitment of the remaining 6 patients in the second cohort. From the patients enrolled so far in the trial, the safety and tolerability of ilixadencel is positive and in line with results from the previous trials. The Company will announce the topline results in mid-2019.
“The GIST study, which we initiated in early 2016, has had its enrollment progress restricted by the low number of patients available. Taking this into consideration, we have made the decision to end enrollment in the GIST trial and for the near term, maintain our primary focus on the upcoming multi-indication study in combination with checkpoint inhibitors and continuing the ongoing MERECA trial,” said Carlos de Sousa, CEO of Immunicum.
“The data we will gain from this trial, in particular the primary endpoints of safety and tolerability in these advanced and very sick patients, will contribute to the overall understanding and validation of ilixadencel’s potential as a novel therapy for the treatment of solid tumors,” said Peter Suenaert, CMO of Immunicum.
The clinical trial aims to examine whether ilixadencel in combination with a tyrosine kinase inhibitor is safe and tolerable for GIST patients. Additional clinical endpoints, such as objective response and progression-free survival, will also be evaluated.
GIST is a very rare and complex disease with only 200 cases diagnosed in Sweden every year. GIST belongs to the group of sarcomas, cancers of which most originate in the soft tissues.
Ilixadencel, a cell therapy product, is an off-the-shelf 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 generates an inflammatory response which in turn leads to tumor-specific activation of the patient’s cytotoxic T-cells.
The information is such information that Immunicum is obliged to make public pursuant to EU Market Abuse Regulation. The information was released for public disclosure through the contact persons detailed below on 21 May 2018 at 8.00 am CET.
For more information, please contact:
Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
Michaela Gertz, CFO, Immunicum
Telephone: +46 70 926 17 75
Gretchen Schweitzer and Joanne Tudorica
Telephone: +49 172 861 8540
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 Stockholm. www.immunicum.com