Zellunas mördarceller eliminerar flaskhals vid solid cancer

För att förstå Zellunas nuvarande riktning behöver man blicka tillbaka till ett avgörande vägskäl i mars 2025. I syfte att snabba på utvecklingsarbetet gick det privata bioteknikbolaget Zelluna Immunotherapy AS samman med det börsnoterade Ultimovacs ASA i vad som kan beskrivas som en transformativ fusion.

Bakgrunden var tämligen dramatisk. Efter en rad kliniska bakslag under 2024, där de tidigare vaccinprogrammen stött på stora utmaningar, behövde Ultimovacs en ny vetenskaplig bas för att resa sig ur askan. Zelluna blev den nystart som krävdes. I och med detta blev Zelluna det första cellterapibolaget någonsin att noteras på Oslo Børs.

Detta innebar en definitiv nystart för bolaget. Genom att fasa ut den gamla vaccinverksamheten för att bli ett renodlat TCR-NK-bolag har Zelluna i praktiken bytt ut bolagets motor. Draget motiverades av ambitionen att nå de publika kapitalmarknaderna och säkra den finansiella flexibilitet som krävs för att kunna ta en potentiell ”first-in-class”-behandling för solida tumörer till patienter globalt.

Utmanar branschens begränsningar

Kärnan i det nya börsbolaget är en teknik utformad för att lösa en av de största begränsningarna inom modern immunonkologi. Zelluna banar väg med en plattform som kombinerar T-cellsreceptorers (TCR) specifika målsökningsförmåga med den naturliga mördarcellens (NK-cellens) inneboende förmåga att döda cancerceller.

Dagens autologa terapier begränsas av en logistisk flaskhals: de är långsamma, kostsamma och kräver komplex tillverkning anpassad för varje enskild patient. Dessutom har de ofta svårt att rent biologiskt tränga in i solida tumörer. Med sin allogena (”off-the-shelf”) TCR-NK-metod kringgår Zelluna båda dessa hinder, med målet att erbjuda en skalbar och kostnadseffektiv behandling som är tillgänglig direkt vid behov.

Grönt ljus för klinisk strategi i Storbritannien

Med bolagsstruktur och teknik på plats exekverar nu Zelluna på sin kliniska färdplan. En central punkt i den senaste verksamhetsuppdateringen är framstegen i dialogen med myndigheterna i Storbritannien. I oktober 2025 erhöll Zelluna positiv vetenskaplig rådgivning (scientific advice) från den brittiska läkemedelsmyndigheten MHRA.

Detta regulatoriska samförstånd täcker kritiska delar av prekliniska data, tillverkningsprocesser och studiedesign för huvudkandidaten ZI-MA4-1. Detta skapar förutsättningar för inlämnandet av en ansökan om klinisk prövning (CTA) senare i år. För att genomföra denna fas har Zelluna knutit till sig tung expertis; professor Fiona Thistlethwaite vid The Christie i Manchester har föreslagits som huvudprövare (Chief Investigator), och studiedesignen har utformats i samarbete med dr Andrew Furness vid The Royal Marsden i London.

Övergång från labb till GMP-tillverkning

Parallellt med det regulatoriska arbetet har de operativa förberedelserna skruvats upp. Under sommaren 2025 inledde Zelluna GMP-tillverkning (Good Manufacturing Practice) av den kliniska batchen för fas I-studien i samarbete med Catalent, en av de ledande globala aktörerna inom tillverkning av cellterapier..

Samarbetet är ett viktigt steg för att minska riskerna i projektet. Det bekräftar att Zelluna framgångsrikt har överfört sina forskningsprotokoll till en låst, skalbar process som kan leverera material av klinisk kvalitet – en viktig validering av ”off-the-shelf”-konceptet.

Pipeline-expansion och finansiell uthållighet

Samtidigt som det omedelbara fokuset ligger på ZI-MA4-1 breddar Zelluna sin horisont. Under tredje kvartalet förvärvade bolaget en portfölj av TCR:er riktade mot KKLC1 från den tyska TCR-specialisten Medigene. Detta kliniskt validerade cancerantigen kompletterar huvudprogrammet och minskar beroendet av ett enskilt mål.

Finansiellt står bolaget på en stadig grund. Tack vare en riktad nyemission som genomfördes den 3 november 2025 bedömer Zelluna att likviditeten räcker in i första kvartalet 2027.

Den 9 december ställde styrelsen in en planerad reparationsemission. Eftersom aktien handlades under teckningskursen bedömde bolaget att aktieägare istället med fördel kan köpa aktier direkt över öppna marknaden, vilket gör att Zelluna slipper onödiga administrativa kostnader.

Intervju med vd Namir Hassan

BioStock kontaktade vd Namir Hassan för att höra mer om bolagets planer framåt.

Investors followed the ”old” company for years. How does the investment case for the new, pure-play Zelluna fundamentally differ from the legacy operations?

– The Zelluna of today is an entirely different company from the legacy organisation. The outcome of the merger for the ”old” company resulted in a new technology, a new strategy, and a new leadership team – with deep expertise in immunotherapies – as well as a wholly differentiated therapeutic approach. Our investment thesis is built around delivering first-in-class, off-the-shelf TCR-NK cell therapies for solid tumours, an area with significant unmet need and very limited competition. Our lead programme, ZI-MA4-1, is on the cusp of clinical entry and is set to become the world’s first MAGE-A4-targeting TCR-NK therapy, applicable across multiple solid cancers. Importantly, the entire TCR-NK platform is protected by a landmark, granted patent providing dominant intellectual property coverage across the entire TCR-NK field, a major strategic advantage as the platform advances.

– Another important distinction from the legacy business is that Zelluna operates in a field – cell therapy – that is clinically validated. There are nine approved cell therapies globally, demonstrating unequivocally that cell therapies can work. These approvals are primarily in liquid cancers; we are focused on solid tumours, which account for ~90% of the global cancer burden.

– Since the merger, we have delivered substantial progress:

• Successfully completed the integration and transitioned to a publicly listed, pure-play TCR-NK company
• Expanded our pipeline with Medigene’s KKLC1-targeting TCRs
• Locked the scalable, GMP-ready manufacturing process for ZI-MA4-1, applicable across the entire TCR-NK platform
• Completed the full preclinical data package for ZI-MA4-1
• Produced the first clinical GMP batch, enabling clinical start
• Engaged leading UK investigators – Professor Fiona Thistlethwaite (The Christie) as Chief Investigator and Dr Andrew Furness (Royal Marsden) – to execute the first-in-human trial
• Received positive feedback from the UK MHRA on preclinical, CMC, clinical design and patient screening
• Strengthened our financial position with a NOK 58 million raise, extending runway into 2027 and enabling initial clinical data

– Zelluna is a focused, off-the-shelf cell therapy company with a validated strategy, a clinical-ready asset, a scalable platform, and strong IP protection. This comes at a time when major industry transactions are increasingly validating the shift toward scalable, off-the-shelf cell therapies. Over the past year, six high-profile deals have been executed by companies such as Roche, AstraZeneca, Kite, AbbVie and Bristol Myers Squibb, many based on early, limited clinical data and largely focused on liquid tumours. In contrast, Zelluna’s platform is purpose-built for solid cancers, which represent the vast majority of the global cancer burden

This represents a fundamentally stronger and more compelling investment case than anything that preceded it. Current cell therapies often struggle to treat solid tumors effectively. How does combining TCRs with NK cells specifically unlock the ability to attack these hard-to-reach cancers?

– Solid tumours are heterogenous and demand a therapy that can do two things at once: precisely target tumour cells, and kill them through multiple recognition mechanisms to reduce the chance of tumour escape. TCR-NKs are uniquely positioned to deliver both.

• The TCR provides high-precision, clinically validated tumour targeting – something antibodies and CARs often cannot achieve.
• The NK cell adds potent innate cytotoxicity and multi-signal tumour recognition. NK cells detect stress signals, missing-self, and other tumour features – giving them multiple ways to kill cancer cells even when antigen expression fluctuates. NKs also have a well-established favourable safety profile and are suitable for outpatient treatment

– By combining these strengths, ZI-MA4-1 becomes a precisely targeted yet multi-sensing cancer-killing cell, designed to overcome the biological barriers that limit many current approaches. Importantly, it avoids many of the safety challenges associated with other cell therapies.

– This is why we believe TCR-NKs could unlock solid tumours in ways other modalities have not, while offering a scalable, off-the-shelf product that can reach patients quickly and broadly.

You emphasize the ”off-the-shelf” aspect of your platform. Why do you believe the industry must shift away from patient-specific (autologous) treatments to succeed long-term?

– Autologous therapies have demonstrated what cell therapy can achieve, but they are fundamentally limited in ways that prevent broad and sustainable impact. They are:

• Slow and operationally complex, with manufacturing that takes weeks for each individual patient
• Highly variable, as product quality depends on the patient’s own immune system
• Difficult and costly to scale, restricting access to a small number of specialised centres

– For solid tumours – where patients often decline rapidly – these constraints become critical. Many patients simply cannot wait.

– Our off-the-shelf TCR-NK platform is built to overcome these barriers. It offers:

• Immediate availability, so patients can be treated when they need it
• Use of healthy donor cells ensuring consistent, reproducible quality, independent of disease stage or prior treatments
• True scalability, enabling broad global access at a cost structure autologous systems cannot match

– If cell therapies are to reach large patient populations and become a mainstream modality in oncology, the field must move beyond patient-specific manufacturing. We believe off-the-shelf products will define the next decade of immuno-oncology – and TCR-NKs have the potential to lead that transition.

Regarding your pipeline expansion and the recent KKLC1 acquisition from Medigene – what is the strategic rationale behind broadening the portfolio beyond your lead candidate?

– The KKLC1 acquisition strengthens our strategy on multiple levels:

1. Target diversification:

– It broadens our reach across a wider range of solid tumours, increasing the number of patients we can ultimately treat.

2. Highly validated tumour biology:

– KKLC1 is a well-characterised, validated cancer antigen with strong and selective expression in several difficult-to-treat solid tumours. This makes it an ideal fit for our TCR-NK approach.

3. Platform scalability and credibility:

– Adding KKLC1 demonstrates the versatility of our TCR-NK platform and supports a multi-asset development strategy, which is critical for long-term value creation and attractive to both partners and investors.

– Overall, we are building a durable off-the-shelf cell therapy company with a pipeline, not a single-asset story. Diversifying targets early ensures strategic resilience, scientific breadth, and a clear path to multiple clinical opportunities.

Despite operational delivery, the market seems to apply a confidence discount to the stock. What is your strategy to bridge this gap and prove to investors that the ’new’ Zelluna warrants a re-rating?

– We recognise that the market is still calibrating to the “new” Zelluna, and that confidence is earned, not assumed. Our strategy to close this gap is straightforward: consistent delivery, transparency, and clinical execution.

– Our priorities are to:

• Advance ZI-MA4-1 into the clinic,
• Demonstrate that our TCR-NK platform performs exactly as intended,
• Continue strengthening our pipeline and Business Development footprint, and
• Communicate clearly and consistently with the market as milestones are reached

– As we convert our preclinical success into clinical evidence, we expect the valuation to increasingly reflect the underlying fundamentals and long-term potential of the company.

What are the key milestones investors should look out for over the next 12 months?

– The next 12 months will be an exceptionally active period for Zelluna, with several key milestones that we believe will drive significant value:

• CTA submission and anticipated approval for ZI-MA4-1 in the UK
• First patient dosed in the ZIMA-101 Phase I trial
• Initial clinical data from the early dose-escalation cohorts
• Further preclinical updates across our TCR-NK pipeline, including progress with the newly acquired KKLC1 portfolio
• Potential strategic partnerships as our clinical program and platform validation advance

– Collectively, these milestones represent our transition from a preclinical innovator to a clinical-stage, platform-driven off-the-shelf cell therapy company.

– We are now entering the most important and a very exciting phase of our journey – demonstrating the clinical potential of first-in-class TCR-NK therapies in patients.