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For Immunicum, 2019 was a year of important clinical advancements with their lead candidate, ilixadencel. It demonstrated promising potential in both the MERECA and the GIST studies from which topline results were announced. These advancements were the main focus of the year-end report released last week. BioStock caught up with the company’s interim CEO, Alex Karlsson-Parra, to get a more in-depth perspective on the report and the year ahead.

The year-end report release by Immunicum summarizes what has been an exciting but also challenging year for the Swedish immuno-oncology biotech. One of the main highlights of the report is the ongoing clinical progress of the company’s lead candidate, ilixadencel.

Ilixadencel: the immune primer

Immune primer, ilixadencel, is being tested in combination with standard cancer therapies such as tyrosine kinase inhibitors (TKIs) and checkpoint inhibitors (CPIs). The company’s vision is to develop an off-the-shelf cell-based product able to work together with existing cancer therapies in order to improve the outlook for cancer patients.

Despite being an off-the-shelf treatment, Ilixadencel is considered an individualized treatment, meaning that it has a unique mode of action that takes advantage of each patient’s unique tumour-specific profile, without the need to characterize, select and produce each patient ́s tumour-specific antigens before treatment. By activating a tumour-specific immune response, it further optimizes the effect of TKIs and CPIs.

Positive clinical study results

The report specifically singles out the GIST and MERECA studies, which test ilixadencel together with TKIs in metastatic renal cell cancer and gastrointestinal stromal cancer patients, respectively. During 2019, the company was able to announce topline data from a Phase II MERECA clinical trial. This data was supplemented at the beginning of this year with a 6-month follow-up, which confirmed and strengthened the positive trends announced in September.

The results were selected for an oral presentation at the ASCO-SITC Immuno-Oncology Symposium in Orlando, US, in February 2020, further validating the interest of the medical community.

Meanwhile, for the GIST study, Immunicum announced in June the positive topline results from its completed Phase I/II clinical trial examining the safety and tolerability of ilixadencel in combination with TKIs in six patients. These results were also communicated in a poster presentation at ASCO-SITC in February 2020.

»The exciting momentum from 2019, and in particular, the positive clinical data, has guaranteed that there will be a lot in store for ilixadencel in 2020« — Alex Karlsson-Parra, interim CEO at Immunicum

Ilixadencel advances in preclinical study

Regarding ilixadencel in combination with CPIs, the company was able to present the results of a preclinical study where ilixadencel was combined with the anti-CTLA-4 CPI. The aim was to identify the candidate’s potential to function in combination with other immunotherapies.

The results showed that animals treated with the combination demonstrated a stronger anti-tumor response compared to animals treated with the well-established combination of two prominent CPIs: anti-PD-1 and anti-CTLA-4.

See more details about this study here.

Sufficient cash position through 2021

While the fourth quarter profit results show a burn rate of 42 MSEK and 134 MSEK for the full year, Immunicum’s cash position at year’s end was reported to be 297 MSEK – enough to sustain operations towards the end of 2021.

The increased net loss for 2019 compared to 2018 is according to plan and reflects the increase in Immunicum’s clinical activity, including process development costs for improving the manufacturing of ilixadencel.

An exciting but challenging year

The year-end report boasted the significant clinical advancements and stable cash position mentioned above and more, however, Immunicum’s interim CEO, Alex Karlsson-Parra, also points out the personal challenge of suddenly assuming the role of acting CEO of the company late last year.

BioStock was able to get in touch with Immunicum’s interim CEO, Alex Karlsson-Parra, to get a better understanding of the report’s significance and what it means for the company in 2020.

Alex Karlsson-Parra, what does it mean for you and the company to have had the positive clinical results that are mentioned in the report?

Overall, we are encouraged by these results as they indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile when combined with different TKIs. Overall the data supports the continued clinical development of ilixadencel as an immune primer in combination with TKIs in renal cell cancer and other solid tumours.

Do you expect any major announcements for those two studies in 2020?

For the MERECA study, we will continue to follow-up with patients every six months, therefore we will announce the next set of information on patient survival mid-2020.

Alex Karlsson-Parra, forskningschef Immunicum

Alex Karlsson-Parra, interim CEO at Immunicum.

You announced positive preclinical results from a study combining ilixadencel with the CPI anti-CTLA-4. Could you comment on the importance of these results?

As combination therapy approaches for the treatment of cancer continue to grow in frequency, it is beneficial to proactively identify the most effective and well-tolerated combinations for our lead candidate, ilixadencel. As such, the preclinical findings from last year indicate that the combination of ilixadencel with anti-CTLA-4 induces deeper and more durable responses than the well-known combination of anti-PD-1 and anti-CTLA-4 in that preclinical model. This data remains important as we continue to define and design the most synergistic treatment regimens that could be tested in clinical trials.

The report also mentions the Phase Ib ILIAD study testing ilixadencel in combination with CPI Keytruda (pembrolizumab). What are the implications of this study?

 During the Phase Ib part of the ILIAD study, patients will be treated with ilixadencel in combination with Keytruda (pembrolizumab). The purpose of this multi-indication study is to demonstrate:

  • The clinical safety of the combination by showing that ilixadencel can be safely combined with a checkpoint inhibitor;
  • Proof of mechanism by showing that the combination generates a systemic tumour-specific immune response;
  • Improved clinical efficacy by showing improved benefit of the combination in terms of clinical activity compared to checkpoint inhibitors alone in solid tumour patients.

As you look into the future, what most are you looking forward to in 2020 when it comes to ilixadencel?

The exciting momentum from 2019, and in particular, the positive clinical data, has guaranteed that there will be a lot in store for ilixadencel in 2020. We are now treating patients in the last cohort for the staggering phase of the ILIAD trial and expect to move to the “non-staggered” phase in the end of the second quarter, which allows for a faster inclusion of patients. In addition, we also look forward to the next follow-up for patients in the MERECA trial and to several upcoming productive discussions with regulatory authorities and experts to identify the most strategic next steps for ilixadencel. As always, we will continue to present our approach on a global scientific and industry stage.

Taking a step back and looking at ilixadencel’s trajectory for the year, our overarching goal is to find the best way forward with the shortest possible lead-time to registration. Ultimately, our long-term focus is set on benefiting patients through the introduction of a safe and novel approach to cancer therapy.

The report shows that Immunicum has 297 MSEK of cash on hand. How far would you expect this to take you?

With the next 18 months in purview, we remain well-positioned to achieve the next set of data-driven milestones and we remain with our guidance that we have cash towards the end of 2021.

Are any partnerships in sight for this year as MERECA heads into the latter stages of clinical development?

One of our corporate goals is to continue to share Immunicum’s story, scientific approach and progress with the international pharmaceutical industry. We continue our discussions with potential partners to give them a deeper understanding of the results from our clinical trials and interesting pre-clinical data.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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