Following the merger with DCprime in late 2020, Swedish cancer immunotherapy company Immunicum has built an advanced clinical pipeline addressing two major challenges in oncology: hard-to-treat solid tumours and tumour recurrence. BioStock reached out to Immunicum’s CEO Erik Manting to get his thoughts on the company’s achievements during 2021 and what to expect from Immunicum in 2022.
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 early part of 2021 gave the company the opportunity to expand and strengthen its team and clinical development portfolio, as well as solidify its vision.
Immunicum uses an off-the-shelf cell-based approach to address two major challenges in cancer treatment: hard-to-treat solid tumours and tumour recurrence, or cancer relapse. For this goal, the company has two main products in development: intratumoural immune primer ilixadencel and cancer relapse vaccine DCP-001.
To learn more about Immunicum’s vision as a company and how it plans to impact the cancer therapy landscape, read here.
Both ilixadencel and DCP-001 benefit from excellent safety profiles, making them potential candidates for combination therapies with checkpoint inhibitors (CPIs), tyrosine kinase inhibitors (TKIs) or other classes of immunotherapies. The two candidates have both reached phase II of clinical development.
Immune primer ilixadencel has demonstrated promising signs of clinical efficacy in a range of hard-to-treat solid tumours including renal cell carcinoma and gastro-intestinal stromal tumours (GIST). Towards the end of 2021, Immunicum successfully completed a phase Ib trial studying the safety profile of ilixadencel in combination with pembrolizumab, a standard-of-care CPI for the treatment of multiple solid tumours.
Read more about the phase I ILIAD trial here, including an in-depth Q&A with Immunicum’s CEO Erik Manting who discusses the implications of the trial results and what they mean for the future of ilixadencel.
»In all aspects 2021 was a transformative year for the company. As we broadened the technology base and product pipeline thanks to the merger with DCprime, we were able to position the company as the leading player in the field of allogeneic dendritic cell biology that it is now. And at the same time, we set up our in-house process development, necessary to optimize production processes for the leading programs.« — Erik Manting, CEO Immunicum
Cancer relapse vaccine DCP-001, is currently being investigated in a phase II trial, ADVANCE II. The study includes patients with acute myeloid leukaemia (AML) who are in complete remission but have persistent measurable residual disease (MRD), thus being at high risk for tumour recurrence.
In December last year, Immunicum presented data from the ADVANCE II trial at the 63rd ASH conference. The phase II data showed that DCP-001 has the ability to convert or significantly reduce detectable MRD in those patients, with fully converted patients demonstrating greater overall survival.
The primary endpoint of the study is MRD response, and the projected secondary endpoints of relapse free survival (RFS) and overall survival (OS) are still to be evaluated. The trial is continuing follow-up on patients to assess MRD responses over time and to assess RFS and OS.
Additional work with DCP-001
Meanwhile, in November 2021, Immunicum published in vitro DCP-001 mechanism of action data in the peer-reviewed journal Cells. The paper explains how DCP-001 interacts with the patient’s immune system, particularly the patient’s own dendritic cells, which play an essential role in presenting tumour antigens to the killer T-cells. Read more about the significance of this data here.
Additionally, Immunicum is taking the opportunity to investigate DCP-001’s potential in the treatment of a solid tumour, ovarian cancer, through the phase I/II ALISON trial. The study is being carried out by Professor Hans Nijman and his research group in Groningen, the Netherlands, and the first patient was recruited for the trial in June 2021.
Q&A with Immunicum’s CEO
Last year was, in many ways, an eventful year for Immunicum. Not only did the merger with DCprime help strengthen the company in terms of its clinical pipeline. It also added structure to the organisation by bringing in Erik Manting as CEO and making other critical changes to its executive leadership.
Moreover, the company reached several regulatory milestones during 2021. Ilixadencel was awarded Orphan Drug Designation (ODD) by the EMA in February as a treatment for gastrointestinal tumours, and DCP-001 received ATMP classification from EMA in June.
BioStock got in touch with Manting to get his take on Immunicum’s accomplishments during 2021 and what he is most excited about in the year to come.
Erik Manting, why was 2021 an important year for Immunicum?
– In all aspects 2021 was a transformative year for the company. As we broadened the technology base and product pipeline thanks to the merger with DCprime, we were able to position the company as the leading player in the field of allogeneic dendritic cell biology that it is now. And at the same time, we set up our in-house process development, necessary to optimize production processes for the leading programs.
What has been the main challenge for the company since the merger?
– Ilixadencel has been studied in many different indications, with promising signs of efficacy in several tumour types. It is however part of a vast expanding cancer therapy landscape, in which many alternative approaches have been developed since the foundation of the company, for example changing the standard of care in renal cell carcinoma. To define a competitive positioning for ilixadencel, with GIST as a prioritized indication for the product, has turned out to be a main challenge, which we addressed diligently and with help from experts in the field.
Immunicum’s market cap saw a 50 per cent drop in 2021. What is your plan for reversing the trend?
– The narrowing down of ilixadencel’s path forward was a logical and necessary process, but was met with apparent investor disappointment. At the same time, we have provided the company with a much stronger basis moving forward, including the promising DCP-001 data published at ASH 2021, which continue to mature and could provide for a new impulse to the share price.
Finally, what are the milestones we can expect from the company in 2022?
– Next to progressing the clinical pipeline with additional data from the ongoing studies, we will build out the company’s infrastructure including our new facilities in Leiden, leading to the further strengthening of our in-house know-how and expertise. This will be essential to continue to develop the company into a fully integrated player and stronger potential partner for big pharma, thus allowing us to capture more shareholder value in the longer-term.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.