I sin senaste kvartalsrapport lyfter norska immunonkologibolaget Ultimovacs fram de fortsatta framstegen med sitt breda kliniska program som utvärderar det universella cancervaccinet UV1. Patientrekrytering är i full gång i alla fem av bolagets fas II-studier, och man meddelade nyligen uppmuntrande överlevnadsdata från fas Istudien med UV1 ochpembrolizumab i malignt melanom. Med solida finanser i ryggen har Ultimovacs goda förutsättningar att nå betydande kliniska utvecklingsmilstolpar nästa år. BioStock pratade med vd Carlos de Sousa som berättade mer.

Ultimovacs uttrycker tillförsikt i sin Q3-rapport. Immunonkologibolaget har ett brett kliniskt program som undersöker effekterna av den universella cancervaccinkandidaten UV1 i flera cancertyper och i kombination med anti-PD1-checkpointhämmare. De data som redovisas i rapporten stärker bolagets tro på att UV1 kan få en transformativ roll vid behandling av solida tumörer.

Patientrektyreringen rullar på

Ultimovacs har fem pågående fas II-studier med UV1, och patientrekryteringen i samtliga studier håller tempot. Rekryteringen till den mest längst komna studien, INITIUM, med fokus på metastaserande malignt melanom, slutfördes tidigare i år som inkluderade 156 patienter. Läs mer.

Under tredje kvartalet rapporterade bolaget att man rekryterat de tre första patienterna i LUNGVAC-studien, bolagets femte randomiserade kliniska fas II-studie med UV1 i kombination med checkpointhämmare  som är inriktad på lungcancer. Totalt planerar man att rekrytera 138 lungcancerpatienter till LUNGVAC.

Sammantaget räknar Ultimovacs med att rekrytera mer än 650 patienter vid nästan 100 kliniska centra i 15 länder. De tre andra fas II-studierna, NIPU, FOCUS och DOVACC, håller även de en stadig rekryteringstakt.

Övertygande fas I data

Under årets tredje kvartal stärkte Ultimovacs caset för UV1 som kombinationsbehandling ytterligare med treåriga överlevnadsdata från den avslutade UV1-103 fas I-studien i metastaserande malignt melanom. Denna studie utvärderar UV1 i kombination med patientgruppens standardbehandling, checkpointhämmaren pembrolizumab, som första linjens behandling under 14 veckor hos totalt 30 patienter.

Studien visade god säkerhet och tolerabilitet för UV1 och uppnådde därmed sitt huvudmål. Dessutom indikerar treårsdata en lovande total överlevnad – 71 procent – efter behandlingskombinationen.

Dessa resultat backades upp av biomarkördata från samma studie, som enligt Ultimovacs vd Carlos de Sousa indikerar att UV1 kan jämna ut oddsen för patienter med svårbehandlade tumörer. BioStock talade med bolagets Director Medical Affairs Espen Basmo Ellingsen för att få veta mer. Läs intervjun här.

Robust finansiering

Ultimovacs avslutade Q3 med 469,1 MNOK (490 Mkr SEK) i kassan och med totala rörelsekostnader pm 44,1 MNOK. Detta ger bolaget en stark finansiell position, man kan täcka driftskostnaderna fram till åtminstone början av 2024. De solida finanserna, som bör täcka topline-avläsningar för de fyra första fas II-studierna, är ett resultat av den starka relation som Ultimovacs har med sina aktieägare.

Vd kommenterar

Sammantaget visar Q3-rapporten att bolaget stadigt närmar sig sin ambition att utveckla en ny, effektiv, behandling för cancerpatienter. Kortsiktigt kommer Ultimovacs allt närmare viktiga värdehöjande händelser: avläsningar från de två första UV1 fas II-studierna i kombination med checkpointhämmare, INITIUM och NIPU, som förväntas under första halvåret 2023. För att få veta mer om betydelsen av de framsteg som gjordes under Q3 kontaktade BioStock Ultimovacs vd Carlos de Sousa.

Carlos, in your eyes, what is the most significant takeaway from Ultimovacs’ Q3 report?

– I think there are three key takeaways. One is that we continue to have good recruitment of patients with our phase II clinical studies. Secondly, we had exciting data coming this quarter with the 3-year survival from our phase I study in metastatic melanoma where we saw a 71 per cent survival rate. Additionally, the biomarker data we presented at the SMR (International Congress of the Society for Melanoma Research) conference showing that patients with low levels of PD-L1, associated with low efficacy with pembrolizumab monotherapy, respond well to UV1. This matches the good objective response and complete response rates we have seen in the phase I trial, and it raises a very exciting potential that needs to be further investigated. Last, but perhaps most important, we continue to move into a very exciting period in our clinical development where we expect two key phase II trial readouts.

Indeed, In the report you point out that Ultimovacs is nearing two inflection points – readouts from two phase II trials, INITIUM and NIPU. Why are these such key milestones for Ultimovacs?

– They are key milestones because, if these readouts are positive, they will kick-off a series of activities that will be very important for the company, including going to the authorities with applications that will allow us to move quickly to the next stage of development. For instance, within mesothelioma, we would apply for orphan drug designation.

– The other big activity that positive readouts would intensify is discussions with potential partners. The feedback we have received so far indicates that they all recognise that our studies are well designed, and they realise that not many biotechs perform these types of comparative and randomised studies. So, clearly, if we have positive readouts, this will mark a path for us to engage in deeper discussions with potential strategic partners for out-licensing of UV1 and maximising the product in multiple indications into eventual phase III studies.

– For the company, these will be revolutionary steps. But I should also mention that, in the broader perspective, these milestones will be transformational for the general cancer vaccine space and concept, triggering a positive feedback loop – finally, in a comparative way, we will have shown that cancer vaccines work, assuming our data is positive, of course.

Regarding your cash position, you claim it will sustain the company’s activities throught the first half of 2024. Considering the current market turbulance, how confident are you in your current expeted financial runway?

– We are very confident. We’ve protected ourselves quite well, especially in terms of currency – most of our payments are in Euro – so we are well protected in terms of exchange rates. Otherwise, the majority of the costs are the patient activities, and those are well-defined with the CRO, so I’d say that under the current conditions, despite the instability seen today, we are nicely capitalised, and we should be able to avoid any potential backlash from the current market turbulence.

In the report, you also talk about the recent rise in momentum for cancer vaccines thanks to developments from major pharma companies like Moderna and BioNtech. Will Ultimovacs be able to ride this wave of momentum?

– As alluded to earlier, if we have positive data following the phase II readouts, I do believe we will be able to ride that wave of momentum. We will have increased exposure for sure, and, based on the positive feedback received from the medical community at SMR conference where we spoke with leading experts in this field, I am sure that the confidence in cancer vaccines will grow even more.

– Another important wave we are following is this increased focus by big pharma in the neoadjuvant space. This is very interesting for us because it allows for treatment earlier in tumour development. So, we see it as something we can explore ourselves since it induces T-cell response before tumour removal.

Finally, you talk about these being very exciting times from Ultimovacs. What are you most looking forward to in terms of upcoming activities for the company?

– First and foremost, getting those phase II readouts. This will be not only exciting for us, but also extremely important for patients. Not only that, but this data will be fruition of work begun years ago – in particular, our Chief Scientific Officer Gustav Gaudernack is very excited about the upcoming readouts; he has been leading the research behind UV1’s development since the very beginning, and the played a key role in conceptualising this cancer vaccine. So, there are different people in the company looking at this from different perspectives. But most important for us, is of course to look at positive data hopefully that allows us to continue to develop important alternatives for cancer patients with unmet needs.

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