Thanks to the merger with DCprime, Swedish immuno-oncology company Immunicum has built a solid foundation for becoming an integrated, international organization with an advanced clinical pipeline. Following the release of the company’s Q2 report, BioStock reached out to Immunicum’s CEO Erik Manting to get his view on the company’s main goals and what to expect from Immunicum during the rest of 2021.
At the end of 2020, Stockholm-based Immunicum completed a merger with Dutch sibling company DCprime, giving Immunicum a more well-rounded profile within the immuno-oncology space. The merger gave the company, now led by CEO Erik Manting, the opportunity to expand and strengthen its clinical development portfolio, which now focuses on two products: intratumoural immune primer ilixadencel and cancer relapse vaccine DCP-001.
Tackling two major oncology challenges
Both products have a similar underlying biology based on allogeneic dendritic cells with the capacity to engage the immune system to address hard-to-treat established tumours as well as tumour recurrence – two major challenges in cancer therapy. Their complementary approaches address both solid and blood-borne tumours. Furthermore, both ilixadencel and DCP-001 benefit from excellent safety profiles, making them potential candidates for combination therapies and maintenance therapies.
Ilixadencel, which has achieved proof-of-concept (PoC) in the company’s lead study, MERECA, is being evaluated in three other clinical studies, including the phase Ib/II ILIAD trial, where the candidate is being tested in combination with pembrolizumab, a standard of care checkpoint inhibitor (CPI) for the treatment of multiple solid tumours.
Meanwhile, cancer relapse vaccine DCP-001 is entering a development phase important to its positioning within the competitive landscape of blood-borne tumours, specifically acute myeloid leukaemia (AML), which has a high probability of relapse following initial treatment. A significant group of AML patients cannot undergo a potential life-saving hematopoietic stem cell transplantation, which leaves a largely unmet medical need for novel maintenance therapies.
»Combining both companies created scientific leadership and a broader positioning in both blood borne and solid tumours. DCprime had furthermore established in-house research and process development capabilities, from which Immunicum also immediately benefitted. Today, we are one company addressing two key challenges in cancer therapy, being hard-to-treat established tumours and tumour recurrence« — Erik Manting, CEO Immunicum
Interim results from the ongoing phase II ADVANCE II trial with DCP-001 that were presented at the ASH 2020 conference provided a preview of the candidate’s potential as a monotherapy. During Q2 this year, Immunicum presented immunomonitoring data from the ADVANCE II study at the European Hematology Association conference, demonstrating induced systemic immune responses to multiple tumour-associated antigens following DCP-001 vaccination.
New potential with DCP-001
Also in the second quarter 2021, Immunicum began investing DCP-001’s potential in solid tumours. The company initiated a single-centre feasibility study for DCP-001 vaccination in ovarian cancer, which is among the deadliest gynaecological cancers due to a high recurrence rate. The study is carried out in collaboration with the renowned group of Prof Dr Hans Nijman at the University Medical Hospital in Groningen. Furthermore, the regulatory path for DCP-001 was facilitated by an Advanced Therapy Medicinal Product (ATMP) classification received from the European Medicines Agency (EMA) in June.
Immunicum’s CEO looks forward to an active 2021
During Q2, Immunicum successfully completed a capital raise of approximately 141.2 MSEK through a directed share issue. The net proceeds are intended to be used to complete the ongoing clinical trials, prepare for clinical pipeline expansion, extend process development and preclinical research activities, as well as for general corporate purposes.
BioStock reached out to Immunicum’s new CEO Erik Manting to get his thoughts on all the ongoing activities and on the upcoming clinical milestones for the company.
»The immuno-oncology space has revolutionized cancer therapy, but has also created novel challenges, particularly how to increase the number of patients responding and improve the duration of clinical responses. Immunicum is focusing on rendering tumours more susceptible to the immune system, which could lead to higher patient numbers responding in certain tumour types like renal cell carcinoma and gastro-intestinal stromal tumours, two indications in which we have already observed promising signs of efficacy.«
Erik Manting, Immunicum’s merger with DCPrime at the end of 2020 obviously required a transition phase to basically establish a new company. What has been the most challenging part of this transition, and would you say the transition is complete?
– Two cultures, two countries – it could have been a challenge, but it never was, really. Integrating respective research, process development, and quality assurance proved to be astonishingly smooth. We have realized a highly synergistic organization during the past six months, and yes, the transition phase is complete thanks to everybody involved.
Overall, how does the merger with DCprime add value to Immunicum?
– Immunicum and DCprime were developing different approaches in cancer therapy, but with a similar basis in allogeneic dendritic cell biology. Combining both companies created scientific leadership and a broader positioning in both blood borne and solid tumours. DCprime had furthermore established in-house research and process development capabilities, from which Immunicum also immediately benefitted. Today, we are one company addressing two key challenges in cancer therapy, being hard-to-treat established tumours and tumour recurrence.
Has the vision for the company changed at all after the merger? If so, how?
– Yes and no. Immunicum is still a company addressing difficult-to-treat solid tumours with our unique expertise in intratumoural immune primers. What has shifted is that today we have a broader technology and pipeline basis, combined with in-house research facilities, to fuel our ambition to become a fully integrated biopharmaceutical company. Addressing the challenge of process development and manufacturing of our products is a significant one, but we are now able to deal with that ourselves instead of being dependent on outside parties. Finally, the cancer relapse vaccination approach developed by DCprime allows us to address tumour recurrence, as another important challenge in cancer therapy. In order to become more competitive and focused, we will have to decide more critically which programs we will continue to pursue, and which ones will be given less priority or made subject to partnering. The building out of our platforms and ongoing research will at the same time allow us to establish a longer-term pipeline.
In the large scheme of things, why does your pipeline stand out when it comes to the immuno-oncology space?
– The immuno-oncology space has revolutionized cancer therapy, but has also created novel challenges, particularly how to increase the number of patients responding and improve the duration of clinical responses. Immunicum is focusing on rendering tumours more susceptible to the immune system, which could lead to higher patient numbers responding in certain tumour types like renal cell carcinoma and gastro-intestinal stromal tumours, two indications in which we have already observed promising signs of efficacy. Cancer relapse vaccination addresses residual disease, which often leads to a quick recurrence of the disease, thereby limiting the duration of clinical responses in indications like acute myeloid leukaemia and ovarian cancer. Finally, we are developing novel approaches that work synergistically with other cancer immunotherapies such as immune checkpoint inhibitors and CAR-T therapies.
Given the merger, and also given the financing round in June, how strong are Immunicum’s finances?
– Supported by new investors as well as our strong existing shareholder basis, we have secured financing for a foreseeable period ahead. The most important thing for us is that we can implement our business strategy in the near future, and we can.
What are the top milestones we can expect from Immunicum in the coming months?
– In the near term, there are two significant milestones. Firstly, ADVANCE II, the ongoing, international phase II trial investigating DCP-001 as a potential relapse vaccination in AML patients. Top line efficacy data are expected in Q421. And secondly, the completion of the phase Ib/II ILIAD study, which is the first study where we are combining ilixandencel with checkpoint inhibitors and for which safety and feasibility was positively reviewed by an independent data safety monitoring board last July. We are currently evaluating all available clinical data to assess the most relevant and competitive next clinical studies in the context of the broader cancer therapy space.
Finally, what will the company look like a year from now?
– In a year from now, we have developed a strategy that sets out the further development of our clinical pipeline. We will also continue to invest in our collaboration network with both industry and academic partners and establish the new facilities for our R&D activities in Leiden, The Netherlands, to further solidify our scientific leadership and core expertise.
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