20.06.2017 02:01

Immunicum Announces Publication in Journal for ImmunoTherapy of Cancer of Results Overview from Ilixadencel's First Clinical Study in Metastatic Renal Cell Carcinoma



Press Release

20 June 2017

Immunicum Announces Publication in Journal for ImmunoTherapy of Cancer of Results Overview from Ilixadencel's First Clinical Study in Metastatic Renal Cell Carcinoma

Immunicum AB (publ; First North Premier: IMMU.ST), a biopharmaceutical company advancing a novel immuno-oncology treatment against a range of solid tumors, today announced that the results from the first clinical study of ilixadencel in patients with newly diagnosed metastatic renal cell carcinoma (mRCC) have been published in the Journal for ImmunoTherapy of Cancer. The results highlight ilixadencel's potential as a novel add-on, immune priming treatment for patients suffering from solid tumors based on its good safety profile and initial indications of prolonged survival. Ilixadencel, formerly known as INTUVAX, is currently in an ongoing Phase 2 trial in renal cell carcinoma (MERECA) as well as Phase 1/2 studies in hepatocellular cell carcinoma and gastrointestinal stromal tumors.

"This publication represents the complete analysis of data from the Phase 1/2 trial and we are pleased to have achieved peer reviewed publication in a well reputed international journal on all the elements of the trial. These data provided the rationale for the ongoing Phase 2 MERECA study," said Alex Karlsson-Parra, Chief Scientific Officer of Immunicum. "Even though the study has been formally completed in 2014, we are still following the patients and are pleased to report that as of May 2017, five out of 11 evaluable patients were still alive and the mean overall survival is clearly favourable compared to available historical data for the standard of care. One of the five patients still alive, experienced a complete regression of all brain and liver metastases, as noted in the publication. The patient has also demonstrated a nearly total regression of lung metastases and was metastasis-free following surgical removal of a small remaining lung metastasis at the end of 2016. Although this is only one case study, it is a promising initial result considering the expected poor prognosis for these patients."

The Phase 1/2, first-in-human study in twelve intermediate- and poor-risk patients with newly diagnosed mRCC investigated safety as a primary endpoint and reported on early signs of efficacy. The treatment regimen included two consecutive intratumoral injections of ilixadencel within 2 weeks followed by nephrectomy and subsequent standard of care. The study was initiated in January 2012 and formally completed in March 2014. Living patients are still followed to capture tumor response and survival data. The results published in the current issue of the Journal for ImmunoTherapy of Cancer represent a summary of the trial and the survival follow-up as of December 2016.

Ilixadencel showed a very good safety profile with no severe adverse events related to the treatment. Tumor-specific immune activation was indicated by intratumoral infiltration of CD8+ T cells and an increase in tumor-specific and interferon-gamma producing lymphocytes in peripheral blood. Median overall survival for the 11 evaluable mRCC patients was 42.5 months as of December 2016, which compares favourably with existing historical data. As of late May 2017, five of the patients that were enrolled in the study were still alive and a final median overall survival of 48.0 months was reached.

"Apart from the good safety profile, the data provided early indications that ilixadencel given in conjunction with sunitinib could have a potential synergistic antitumor effect, which we will be further investigating in the ongoing MERECA trial," commented Alex Karlsson-Parra, Chief Scientific Officer of Immunicum. "We believe that the future of cancer treatment lies in the rapidly evolving landscape of combination therapies and ilixadencel is uniquely positioned to become an integral part of modern combination regimens."

Carlos de Sousa, Chief Executive Officer of Immunicum added: "The publication represents the committment to our strategy to communicate data through peer review and therefore build validation for ilixadencel within the global scientific and medical community. We strongly believe in the potential of ilixadencel as an off-the-shelf immune primer in the treatment of solid tumors and are focused on advancing its clinical development to bring this therapy to patients."

The full publication titled "Intratumorally injected pro-inflammatory allogeneic dendritic cells as immune enhancers: A first-in-human study in unfavourable risk patients with metastatic renal cell carcinoma" can be accessed through the current online version of the Journal for ImmunoTherapy of Cancer and the following link http://dx.doi.org/10.1186/s40425-017-0255-0.

About renal cell cancer / carcinoma
There are approximately 273,000 new cases of Renal Cell Cancer (RCC) diagnosed worldwide each year, representing approximately two percent of all cancers. The therapeutic effect of existing treatments, called directed therapies, is often of short duration, with limited survival rate gain. With no alternatives to these therapies, there exists a relatively large unsatisfied medical need for new treatments that are effective, more cost-efficient and have less unwanted side effects.

About ilixadencel

Ilixadencel cell therapy product (formerly known as INTUVAX®) is a 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

The information is such information that Immunicum is obliged to make public pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the company's contact person on June 20, 2017 at 02.01 CET.

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



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Immunicum AB via Globenewswire

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