July 23, 2018
Immunicum AB (publ) announces that the FDA approved protocol that enables the start of an expanded Phase Ib/II multi-indikationsstudie with combination therapy
Immunicum AB (publ; IMMU.ST) today announced that the us regulator, FDA, has approved the studieprotokollet for the company’s planned Phase Ib/II study to evaluate the safety and efficacy of intratumoralt administered ilixadencel in combination with checkpointhämmare. This regulatory approval enables the company to commence patient recruitment. As previously communicated, the plan Immunicum to include the first patient in the study during the second half of 2018.
The study, abbreviated in the ILIAD, is a randomized, open, Phase Ib/II study conducted by Immunicum on a number of centers to evaluate the safety and efficacy of intratumoralt administered ilixadencel in combination with checkpointhämmare. The combination will be tested in three indications: head and neck cancer, non-small cell lung cancer and stomach cancer. The study will be divided into two parts: Phase Ib and Phase II. The purpose of the Phase Ib part of the study is to assess the safety and determine the optimal dose and dosing schedule for ilixadencel in combination with standarddoser of pembrolizumab (Keytruda®) in patients with any of these three types of cancer.
An important change in the study is that the Phase Ib part will now cover the 21 patients, compared with 9 in the original protocol that was developed during the third quarter of 2017. This modification of the study design based on the views of clinical experts and EU authorities as well as advice from the FDA. The expansion of the Phase Ib study means that it will generate more data on the dose levels and treatment schedule for phase II and will have the potential to show initial signs of effect. The length of the Phase Ib will be affected, but it will also be dependent on when patient recruitment started, and how quickly it is implemented.
The phase II part of the study involve up to 150 patients randomly according to the 2:1 method may ilixadencel in combination with checkpointhämmare versus only checkpointhämmare. In this phase grouped the patients according to the respective diagnosis in the three different studies that run in parallel. The purpose of the Phase II study is to demonstrate a beneficial effect of ilixadencel in combination with checkpointhämmare. Each diagnostic group will include a sufficient number of patients to show a statistically significant difference in clinical activity between the different treatment groups.
— It is a great achievement for Immunicum to have had the protocol approved which allows us to start the study as planned. The increased number of patients in the Phase Ib study will contribute with more valuable data and increase the possibility of being able to see signs of clinical activity earlier in the study, said Carlos de Sousa, CEO of Immunicum. The company has, as previously announced, the funding until the end of 2019 and will provide updates of the development in a Phase Ib study in the current year and in 2019, » continues de Sousa.
— We put great value on the contributions we have received regarding the design of the study from the clinical experts and researchers, and appreciate the positive contacts with the supervisory authorities. Now we are looking forward to start recruiting patients in the second half of 2018, » adds Peter Suenaert, MD, PhD, CMO at Immunicum.
If the ILIAD
Immunicum has given its planned Phase Ib/II multi-indikationsstudie for combination therapies with checkpointhämmare the name in the ILIAD. It stands for ILIxadencel in combination with checkpointhämmare in patients with AD —vanced (advanced) cancer. For the study, the company will recruit patients with head and neck cancer, non-small cell lung cancer and gastric cancer and GEJ cancer (gastroesophageal junction adenocarcinoma) clinical center in the united states and Europe.
Cellterapiprodukten ilixadencel is a cancerimmunaktiverare that can be stored «on the shelf» («off-the-shelf») and has been developed for the treatment of solid tumors. The active ingredient is activated allogeneic dendritic cells taken from healthy donors. Intratumoral injection of these cells gives rise to an inflammatory response, which in turn leads to a tumor-specific activation of the patient’s cytotoxic T-cells.
The information is such that Immunicum is obliged to publish in accordance with the EU regulation on market abuse. The information was submitted for publication, through the above contact person in the government, 23 July 2018, there is a 08.00 CET.
For further information, please contact:
Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
Michaela Gertz, Cfo, Immunicum
Telephone: +46 (0) 70 926 17 75
Gretchen Schweitzer, and Joanne Tudorica
Telephone: +49 172 861 8540
About Immunicum AB (publ)
Immunicum is establishing a unique approach within the immunonkologi through the development of the storable allogeneic cell-based therapies. Our goal is to fight cancer by activating and strengthening the patient’s own immune system, and thus improve the survival and quality of life. The company’s leading product, ilixadencel, consisting of the pro-inflammatory allogeneic dendritic cells, have the potential to become a backbone of modern combination therapy of several solid tumors. Immunicum is founded and based in Sweden, and is listed on Nasdaq Stockholm. www.immunicum.com
20180723_Immunicum_Combination Trial Start_SWE_Final
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Source: Immunicum AB via Globenewswire