20 June 2017
An overview of the results from the Immunicums the first clinical study with ilixadencel in metastatic renal cancer has been published in Journal for ImmunoTherapy of Cancer
Immunicum AB (publ; First North Premier: IMMU.ST), a biotechnology company that develops new immunostimulerande cancer treatments for a number of solid tumours, today announces that the results from the first clinical study with ilixadencel in patients with newly diagnosed metastatic renal cell carcinoma (mRCC) has been published in the Journal for ImmunoTherapy of Cancer. The results highlight the ilixadencels potential as a novel immunostimulatory adjuvant therapy for patients with solid tumors, based on its good safety profile and initial indications showing a prolonged survival. Ilixadencel,
formerly known as the INTUVAX,
is currently being evaluated in an ongoing Phase II study in renal cell carcinoma (MERECA) and in Phase I/II studies in liver cancer and gastrointestinal stromacancer.
“The article describes the overall evaluation of the data from THE Phase I/II study and we are excited about the publication of all parts of the study in a well-regarded, international medical journal. These data constitute rationalen for the ongoing Phase-II MERECA study,” says Immunicums’s cso Alex Karlsson-Parra. “Although the study formally ended in 2014 follows we are still patients and are pleased to report that five of the eleven evaluerbara patients were still alive at the end of may 2017 and that the median survival time is clearly advantageous ämfört with the historical data at the standard treatments. One of the five patients is still alive and showed a complete regression of all of the brain – and liver metastases,as noted in the publication, also has shown an almost total regression of lung metastases and remained after the surgical removal of a small residual lungmetastas at the end of 2016 metastasfri. Even though this is only a case study, it is a promising first results based on the expected poor prognosis for these patients.”
This “first-in-human” Phase I/II study of twelve newly diagnosed mRCC patients with poor or medelrisk forecast, assessed safety as the primary endpoint and also reported early signs of clinical efficacy. The treatment consisted of two subsequent intratumorala injections of ilixadencel with 2-week intervals followed by nefrektomi (surgical removal of the tumördrabbade the kidney) and then the established standard of care. The study was initiated in January 2012 and was formally terminated in march 2014. Surviving patients are followed in order to collect data on the tumöreffekt and survival. The results published in the Journal for ImmunoTherapy of Cancer is a summary of the survey and a follow-up on survival data by december 2016.
Ilixadencel showed a very good safety profile with no serious treatment-related side effects. Tumor-specific immunaktivering indikerades of an intratumoral infiltration of CD8+ T cells, as well as an increase of tumor-specific and interferon-gamma producing lymphocytes In peripheral blood. Medianöverlevanden for the eleven evaluerbara mRCC-patients was in december 2016 45,2+ months, which is clearly advantageous compared with available historical data. At the end of may 2017 were still five of the patients from the study at the life, in which case a final median survival of 48,0 months was achieved.
“At the side of a good safety profile provides data obtained early indications that treatment with ilixadencel, followed by sunitinib, may have a potential synergistic anti-tumöreffekt, a hypothesis that we actively continued to evaluate, in the ongoing MERECA study”, commented Immunicums’s cso Alex Karlsson-Parra. “We believe that cancerbehandlingens future can be found in the fast-growing landscape that consists of the combination therapies and to ilixadencel is uniquely positioned to become an integral part of modern combination therapies”.
Carlos de Sousa, CEO of Immunicum added: “the Publication represents our commitment to communicate the data through reputable förhandsgranskande journals and thus show the validated data for ilixadencel within the global scientific and medical corps. We strongly believe in the potential for ilixadencel as a storable immunaktiverare in the treatment of solid tumors, and focuses on bringing its clinical development forward so that patients to get access to this treatment”.
Throughout the publication with the title “Intratumorally injected pro-inflammatory allogeneic dendritic cells as immune enhancers: A first-in-human study in unfavourable risk patients with metastatic renal cell carcinoma” is available via the current online version of the Journal for ImmunoTherapy of Cancer via the following link http://dx.doi.org/10.1186/s40425-017-0255-0.
About kidney cancer / carcinoma
About 273 000 patients are diagnosed globally each year, making kidney cancer, constitutes approximately two percent of all cancers. The effect of existing treatments – so-called targeted therapies – are often short-lived, with a limited prolonged survival. In the absence of alternatives to these treatments is a great need for new effective therapies that are more cost-effective and have fewer negative side effects.
If ilixadencel
Ilixadencel, cell therapy medicinal products (previously known as INTUVAX) is a cancerimmunaktiverare developed for the treatment of solid tumors. Its active ingredient, pro-inflammatory allogeneic dendritic cells, is formulated from healthy blood donors. Intratumoral injection of these cells is expected to lead to an inflammatory reaction, which in turn leads to tumor-specific activation of the patient’s cytotoxic T-lymphocytes.
FOR FURTHER 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
Media contact
MacDougall Biomedical Communications
Gretchen Schweitzer or Stephane 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
“This information is such information that Immunicum AB (publ) is obliged to publish under the EU marknadsmissbruksförordning. The information was submitted, by the above contact person in the government, forpublication at 02.01 June 20, 2017.”
