Immunicum is developing cancer-treating therapeutic candidates using a unique immuno-oncology approach. Their cell-based therapy is aimed at priming the patient’s immune system to attack and kill cancer cells. Immunicum’s lead candidate, ilixadencel, is currently in a Phase II clinical program where results are expected this year. BioStock has reached out to the company’s CEO, Carlos de Sousa, to get a summary of the main events in 2018, and what to expect from Immunicum in the year to come.
Carlos de Sousa, CEO of Immunicum, what events would you like to highlight as the most important for the company when looking back through 2018?
– 2018 was a pivotal year for Immunicum as the company made important advancements both from a corporate and clinical perspective. More specifically, we delivered on several important value inflection points including uplisting onto the main market of Nasdaq Stockholm, completing patient recruitment in the ongoing, global Phase II MERECA (Metastatic Renal Cell Carcinoma) clinical trial, securing a capital raise of SEK 351M backed by strong institutional investors and receiving protocol approval from the FDA enabling the initiation of the expanded multi-indication Phase Ib/II combination trial.
»The agreement with Merck KGaA and Pfizer is the first corporate agreement Immunicum has signed with a large pharmaceutical company, which is a demonstration of their interest in our approach and our ability to negotiate this type of contract« — Carlos de Sousa, CEO Immunicum
– As a part of the preparation for that trial, we signed an agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to evaluate ilixadencel in combination with avelumab, an anti-PD-L1 monoclonal antibody, also known as a checkpoint inhibitor. We have brought on new key members to our management team, Board of Directors and Scientific Advisory Board as well as further validated our approach through presentations at global scientific conferences and publications in peer-reviewed scientific journals.
What do the milestones achieved during 2018 mean for the company going forward?
– The agreement with Merck KGaA and Pfizer is the first corporate agreement Immunicum has signed with a large pharmaceutical company, which is a demonstration of their interest in our approach and our ability to negotiate this type of contract. The achievement of these corporate and clinical milestones has set Immunicum on a solid foundation moving into 2019 that will allow us to maintain focus on the advancement of our clinical development programs, further develop and streamline the commercial manufacturing process and continue to explore and validate ilixadencel through preclinical studies and peer-reviewed scientific publications. Every month in which we can maintain our focus and implement goals in development, we decrease risk and increase the future potential which creates higher value for ilixadencel.
– Our ultimate goal is to explore the potential of ilixadencel in a range of indications and accelerate its development towards regulatory approval to help patients with solid tumors as quickly as possible.
You describe Immunicum’s immuno-oncology approach as unique. What makes it so unique compared to other approaches? And do you think this kind of approach has the potential to become a standard for treating other diseases?
»Our data indicate that ilixadencel has the ability to enhance the efficacy of other immuno-oncology treatments, such as checkpoint inhibitors«
– Our approach is based on the fundamental concept of strengthening the ability of a patient’s immune system to recognize and kill tumor cells. Our data indicate that ilixadencel has the ability to enhance the efficacy of other immuno-oncology treatments, such as checkpoint inhibitors. In particular, our approach is advantageous in comparison to other cell-based therapies as our lead candidate, ilixadencel, can be produced in advance and stored for a period of over 3 years. It does not require any costly adaption to the individual patient, but instead is ready to be used for different patients directly off-the-shelf, while the treatment induces an individualized effect for the specific patient and tumor when injected. This is a unique approach with strong advantages. This is also why we believe that ilixadencel has the potential to be a key component in future combination treatments for solid tumors. Furthermore, it has proven to be safe in over 90 patients and has indicated efficacy in clinical and preclinical studies.
Looking to 2019, what milestones can we expect from Immunicum?
– In 2019, we expect topline results from the Phase II MERECA renal cancer trial, which is a very important clinical milestone for ilixadencel and the company. In addition, we will have Phase I/II results in gastrointestinal stromal tumors (GIST) as well as initial safety and potential early efficacy data from the multi-indication Phase Ib/II ILIAD study. We will also continue to validate ilixadencel through preclinical studies, expand activities for our commercial development process, as well as attend and present at global industry and scientific conferences to increase the awareness about Immunicum and the potential of our lead drug candidate.
»The immuno-oncology research field holds great potential in breaking down and addressing the multiple ways in which cancer can manifest and spread in humans.«
Immunicum has received substantial financial backing from investors in a recent rights issue worth 351 MSEK. This is, of course, good news for the company, but how will it translate to action in the years to come? Basically, what is your long-term strategy in terms of your drug development program?
– Our long-term strategy is to make an impact for patients with solid tumors by developing an easy-to-produce and effective cell-based therapy while continuing to bring value to our dedicated shareholders. As we continue to grow, we envision making significant progress in manufacturing and clinical development and expect pivotal studies to be initiated on our path to the market, potentially in collaboration with a leading pharmaceutical partner.
You obviously have high hopes for your candidates and immuno-oncology in general. In broader terms, do you envision immuno-oncology as the research field that will eventually find a cure for cancer? Or will collaborations with companies in other fields, e.g. gene therapy, become necessary?
– We unfortunately cannot predict the extent to which we will be able to treat cancer in the distant future. Despite this, the immuno-oncology research field holds great potential in breaking down and addressing the multiple ways in which cancer can manifest and spread in humans.
– Our hope is that moving forward, there will be a range of therapeutic options available to patients that will tackle this notoriously stealthy and difficult-to-treat disease.
On a more personal note; do you have any New Year’s resolutions?
– 2018 has been a very exciting year and I am looking forward to working with all of the Immunicum team to achieve our goals for the company and to bring ilixadencel to the patients who would benefit from additional treatment options. Nevertheless, I resolve also to spend more quality time with my family.
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