Tack vare sammanslagningen med DCprime har det svenska immunterapibolaget Immunicum byggt en solid grund för att bli en integrerad, internationell organisation med en avancerad klinisk pipeline. Efter publiceringen av bolagets Q2-rapport, kontaktade BioStock Immunicums vd Erik Manting för att få hans syn på bolagets mål och vad man kan förvänta sig av Immunicum under resten av 2021.

I slutet av 2020 slutförde Stockholmsbaserade Immunicum en sammanslagning med det nederländska syskonbolaget DCprime, vilket gav Immunicum en mer balanserad profil inom området för immunterapier mot cancer,  baserade på en allogen dendritcellsbiologi. Sammanslagningen gav bolaget, som nu leds av vd Erik Manting, möjlighet att expandera och stärka sin portfölj för klinisk utveckling. Bolaget fokuserar nu på två produkter, den intratumorala immunaktiveraren ilixadencel och canceråterfallsvaccinet DCP-001.

Hantering av två stora onkologiutmaningar

Båda produkterna har en liknande underliggande biologi baserad på allogena dendritiska celler med förmågan att aktivera immunsystemet för att hantera svårbehandlade solida tumörer samt tumöråterfall – två stora utmaningar inom cancerbehandling. Deras kompletterande tillvägagångssätt inkluderar både solida tumörer och tumörer i blodet. Dessutom har både ilixadencel och DCP-001 fördelar av att ha utmärkta säkerhetsprofiler, vilket gör dem till potentiella kandidater för kombinationsbehandlingar och underhållsbehandlingar.

Ilixadencel, som har visat proof-of-concept (PoC) i bolagets ledande studie, MERECA, utvärderas i tre andra kliniska studier, inklusive fas Ib/II ILIAD-studien, där kandidaten testas i kombination med pembrolizumab, en standard för checkpointhämmare för behandling av flera solida tumörer.

Samtidigt går canceråterfallsvaccinet DCP-001 in i en utvecklingsfas som är viktig för dess positionering i det konkurrensutsatta landskapet för tumörer i blod, särskilt akut myeloid leukemi (AML), som har stor sannolikhet för återfall efter initial behandling. En betydande grupp AML-patienter kan inte genomgå en potentiell livräddande hematopoetisk stamcellstransplantation, vilket ger upphov till stort omättat medicinskt behov av nya underhållsbehandlingar.

»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, vd Immunicum

Interimsresultat från den pågående fas II ADVANCE-II-studien med DCP-001, som presenterades vid ASH 2020-konferensen i december förra året, gav en tidig indikation på kandidatens potential som monobehandling. Under andra kvartalet i år presenterade Immunicum immunmonitoreringsdata från ADVANCE II-studien vid konferensen European Hematology Association, vilka uppvisade inducerade systemiska immunsvar mot flera tumörassocierade antigener efter DCP-001-vaccination.

Ny potential för DCP-001

Även under andra kvartalet 2021 började Immunicum undersöka DCP-001:s potential i solida tumörer. Bolaget inledde en feasibility-studie med DCP-001-vaccination mot äggstockscancer, som på grund av hög återfallsfrekvens är en av de mest dödliga gynekologiska cancerformerna. Studien utförs i samarbete med professor dr Hans Nijman och hans välrenommerade forskningsteam vid University Medical Hospital i Groningen. Dessutom underlättades den regulatoriska situationen för DCP-001 när den blev klassificerad som avancerad terapimedicin (ATMP) av den Europeiska läkemedelsmyndigheten (EMA) i juni.

Immunicums vd ser fram emot ett aktivt 2021

Under andra kvartalet genomförde Immunicum en framgångsrik kapitalanskaffning på cirka 141,2 Mkr genom en riktad emission. Kapitaltillskottet är avsett att användas för att slutföra de pågående kliniska prövningarna, förbereda för expansion av den kliniska pipelinen, utvidga processutvecklingen och den prekliniska forskningsverksamheten samt för allmän bolagsutveckling.

BioStock kontaktade Immunicums nya vd Erik Manting för att få höra hans tankar om de pågående aktiviteterna och om de kommande kliniska milstolparna för bolaget.

»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.

Innehållet i BioStocks nyheter och analyser är oberoende men BioStocks verksamhet är i viss mån finansierad av bolag i branschen. Detta inlägg avser ett bolag som BioStock erhållit finansiering från. 

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