Immuno-oncology therapies are focused on harnessing the body’s own immune system to identify and attack cancer cells. They work either by activating the immune system to work harder or arming the immune system with additional mechanisms to strengthen its ability to fight diseased cells. Immunicum’s lead drug candidate is ilixadencel, an immune system ”primer” based on allogeneic (donor derived) dendritic cells. It is designed to help the body’s immune system to recognize and target patient-specific tumor antigens, to treat solid tumors. BioStock had the chance to speak with Immunicum’s CEO Carlos de Sousa after his presentation of the company at BioStock Life Science Summit in Lund on Thursday.

Carlos de Sousa, CEO Immunicum

Firstly, could you briefly tell us about your background and the reasons why you have chosen to work with Immunicum?

– In a way, Immunicum is the culmination of my training as a medical doctor and the majority of my nearly 30-year career in pharmaceutical companies and biotechs. I have always been driven by a desire to help patients and improve clinical outcomes. After completing my M.D., I joined Pfizer as a Medical Director in clinical development and held several positions at Pfizer in medical and regulatory affairs before moving into business and corporate development, and to another large pharma, Novartis. Later on I moved to Nycomed/Takeda, and then senior leadership roles at smaller and more focused biotech companies before joining Immunicum as CEO in late 2016.

– Immunicum was a very interesting opportunity with an exciting product already in Phase 2 development, yet relatively unknown in the pharma community. It has been my focus to bring my experience and network to Immunicum to make the clinical and corporate development process for the company successful.

»Our approach, to use healthy donors, makes ilixadencel an “off the shelf”-product which means that it can be produced beforehand and stored until it needs to be administered to patients, which is a huge advantage« — Carlos de Sousa, CEO Immunicum

It is a well-established fact that immuno-oncology (I/O) is revolutionizing the field of cancer treatment. What makes Immunicum’s approach to I/O unique?

– Ilixadencel offers a personalized treatment without the need to have individual patient’s cells extracted, altered and then re-introduced. Our product is based on cells from healthy donors that are modified to become a specific immune primer product. Cells from one single donor are enough to treat about 50 patients. When administred into the patients tumour, ilixadencel is designed to activate the immune system and helps the patient’s own immune system to fight the tumour. Our approach, to use healthy donors, makes ilixadencel an “off the shelf”-product which means that it can be produced beforehand and stored until it needs to be administered to patients, which is a huge advantage.

– It is becoming more and more obvious that the I/O-field will revolutionize oncology treatments, but it will not be enough to use just one single approach. The whole field is therefore in a state where everyone is looking for the best combinations to create efficient treatments. Since ilixadencel can be produced and stored for extended periods, and our data indicates that it might enhance the effect of different classes of I/O-drugs, like checkpoint inhibitors, immune enhancers and other targeted therapies, we see a potential for ilixadencel to become a backbone therapy in several future immunotherapies. Another very important factor is, so far, ilixadencel’s excellent safety. The main side effect is fever.

Immunicum was recently invited to present at the 2018 ESMO congress. What can you tell us about the findings you presented?

– We presented preclinical results that showed anti-tumor synergy between ilixadencel and a checkpoint inhibitor or an immune enhancer. The results of the study highlight the ability of intratumoral ilixadencel to enhance anti-tumor response and enable better efficacy of systemic checkpoint inhibitors or immune enhancers. This emphasizes the potential for ilixadencel in multiple future immuno-oncology combination strategies. We plan to conduct additional preclinical studies and continue strengthening the data supporting ilixadencel’s profile.

Also quite recently, you announced plans to raise a significant amount of capital – 351 MSEK, which will finance Immunicum’s operations until at least 2021. Roughly half the sum will be raised from institutional investors like Fjärde AP-fonden (38 MSEK), Max Mittereggers fund, Gladiator (32 MSEK), Andra AP-fonden (21 MSEK), Alfred Berg (20 MSEK), Nordic Cross (17 MSEK) and Adrigo (10 MSEK). What does it mean for the company to bring in investors of this caliber?

This is of course a clear acknowledgement of Immunicum’s attractiveness as an investment. It is not a coincidence that these investors will participate now. Immunicum has made substantial achievements over the last year and with the solid financial situation created by the current issues, there are ample opportunities for reaching important data points and corporate development goals in the not too distant future. In our negotiations with future commercial partners it is of great importance to have solid finances and to have well-known investors help showcase the quality of Immunicum’s work so far.

»Big Pharma is looking for the best combinations right now and our off the shelf-product is a unique and promising candidate« — Carlos de Sousa

The other half, or 173 MSEK to be precise, will be raised in a share issue with preferential rights for current shareholders. What are the main arguments, in your opinion, for investors to participate in the share issue?

We are now in a stage where we need to accelerate the development of ilixadencel. We have been very successful in early development – the next steps in clinical development require substantially more capital. With additional capital we can continue conducting the needed studies and invest in the development of a commercial manufacturing process in order to increase the overall value of ilixadencel. The capital allows us to accelerate the commercial manufacturing process development as well as the clinical development which then reduces risk, increases ilixadencel’s potential and creates higher value of ilixadencel as a product.

– As the value of ilixadencel increases we will start looking for the best commercial partner to take the development of ilixadencel all the way to the market. In negotiating with pharmaceutical companies, it is important to have both strong science and solid finances. In these negotiations it is of great value that we are well-funded all through 2021 and can make all investments needed to produce quality data. The commercial manufacturing process will further increase potential deal value as it may additionally reduce time to market for the commercial partner. A normal negotiation process takes between nine and twelve months, so it is important to have a long-term perspective on the finances.

– With the support from the strong group of investors assembled for the directed issue, we are confident that the conditions, size and timing of the proposed issue are in the best interest of our current shareholders to capture future value.

How will the capital that is raised be allocated in your operations?

We will optimize and expand the Phase Ib/II study ILIAD which will start in the US before the end of 2018.

– In addition, we need to secure full scale production of ilixadencel so that we are ready to produce the required amounts of ilixadencel for large pivotal studies and demonstrate that we can produce ilixadencel in quantities for commercial launch. This demands large investments in the manufacturing process development. If we don’t do this now, it will delay us later and every month saved in development is important for the commercial value of ilixadencel.

– We will also conduct supportive preclinical trials to see what combinations for specific indications are most promising.

The treatment concept of ilixadencel. Click on the image to view full size.

The clinical development plan for ilixadencel covers six different cancer types in which your drug is combined with kinase inhibitors in three indications and with checkpoint inhibitors in three other indications. Can you tell us about the strategy behind this?

Cancer is a complex disease with many different components. Liver cancer has a different profile than kidney cancer. A large part of developing the best treatment is to test which combinations provide the best response in each cancer and to demonstrate that we can apply for regulatory approval in the most favorable indications. In addition, it spreads the risk, increases the probability of success and increases the potential deal value with the number of indications pursued.

With three projects then currently in phase I/II and another three soon expected to go from preclinical phase into clinical phase, you should have quite a few value inflection points on the horizon?

– Yes, in 2019 we have several potential significant value inflection points and we are looking forward to delivering top line results from a Phase II study in patients with kidney cancer and a Phase I / II study in patients with GIST, as well as safety data and potentially early efficacy data from the Phase Ib part of the ILIAD study in a number of other forms of cancers (lung, head and neck and gastric cancers).

Obviously presenting the topline results for the phase II and phase I/II are going to be important milestones. Depending on the final data readout, what is the next step in the plan?

Our main focus will be to define the most advantageous indications and treatment regimens for ilixadencel using the supporting data and continue our discussions with potential partners, which are also looking forward to this data. We also need to be able to produce enough ilixadencel for the next stage of clinical development which would be a pivotal regulatory study.

As of now there are literally thousands of preclinical and clinical I/O projects in development around the world. With a pipeline and a drug concept like yours, what is Immunicum’s position in the global competitive landscape?

– If we make the right investments now and continue to deliver data that shows how ilixadencel can be used to enhance the effect of other immunotherapies, we have a strong position. Big Pharma is looking for the best combinations right now and our off the shelf-product is a unique and promising candidate.

Immuno-oncology is arguably the hottest medical area on the planet right now. How do you plan to attract Big Pharma – or would you rather choose to partner with a niche player?

We are keeping our options open and will continue discussions with many kinds of companies which provides flexibility and improves our negotiation position.

»In all our clinical trials to date, ilixadencel has shown a good safety and a potential to make I/O combinations more effective. That potential makes ilixadencel a highly attractive addition to these combinations and therefore an interesting opportunity both for partners and investors« — Carlos de Sousa

Tell us more about your business strategy. Are you looking to strike a deal – and if yes, when? Will it be after the phase II readout, or could it happen even sooner?

– We believe that it is in the interest of our shareholders to further advance the development of ilixadencel before entering a commercial partnership. Business development is a continuous effort to explore and pursue such partnerships, which timing and value is not only dependent on your own data, but also market circumstances. We will therefore keep interacting with potential partners throughout our journey and be ready to present all offers that would capture significant value for our shareholders to the Board of Directors .

The ILIAD trial will enroll the first patient during the second half of 2018 and you got your updated protocol approved by FDA earlier this summer. What are the main advantages of running this trial as three smaller studies, versus one larger study in a single indication?

We gain a great deal of information for three very important indications faster and in parallel. Rapidly moving forward with the right indications is extremely important. It also reduces the risk as we have three shots at a goal and increases recruitment speed as you are less dependent on patient availability and treatment changes in one indication. The medical and regulatory communities are more and more supportive of flexible clinical trials designs which increase efficiencies and patient management.

Would you say that there is an industry trend in developing immune primers plus kinase inhibitors and checkpoint inhibitor combinations that is working in Immunicum’s favor when it comes to attracting interest from international investors and potential partners?

The stunning results that the industry has seen in I/O in specific cancers, which up until now have been a small number of indications and only a limited number of patients, drives the interest in expanding the success of I/O to more cancers and more patients. In all our clinical trials to date, ilixadencel has shown a good safety and a potential to make I/O combinations more effective. That potential makes ilixadencel a highly attractive addition to these combinations and therefore an interesting opportunity both for partners and investors. We have already seen this interest confirmed in a number of I/O combination deals from big pharma in 2018, and expect this to further increase moving forward.

Looking at the valuation of Immunicum, a market cap of 400 MSEK for a clinical phase II company in the I/O field would seem rather modest in a benchmark with international peers. Are biotechs in the Nordic region generally under-valued?

– I would not want to make that kind of statement. The science and technology in the Nordic region are recognized as competitive with the rest of the world. You could say that the biotech industry in the Nordic region is a younger industry and therefore may be perceived as riskier. As the risk level goes down with products moving closer to regulatory approval and more collaborations are signed and validation from the industry is acknowledged, the global market will recognize that progress in the Nordic region as well.

»We are building momentum and the support from the new investors is an indication of that. It is an exciting time for the company« — Carlos de Sousa

Immunicum recently added two high profile names within immuno-oncology to your Scientific Advisory Board. Do you plan for Dr. Pawel Kalinski or Prof. Inge Marie Svane to also take an active operative role going forward?

We are very fortunate to have both Pawel and Inge Marie as resources as we continue to move ilixadencel through clinical development. They advise us and provide the benefit of their experience and network; they are not operational in the day-to-day business.

To conclude – which upcoming milestones for Immunicum are you personally anticipating the most, and what are the main catalysts that investors should be watching going forward?

We are very excited to start the ILIAD trial and to move closer to receiving the data from the MERECA trial. There are also a lot of very interesting corporate opportunities on which we are working actively, too early to mention here. We are building momentum and the support from the new investors is an indication of that. It is an exciting time for the company.

Watch Carlos de Sousa present Immunicum at 2018 BioStock Life Science Summit:

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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