Continuing the discussion from Ultimovacs (ULTI) småprat 2 - #7791 av enurs.
Previous discussions:
For en trist dag for selskap og sektor. Her leverer de POC som var bedre enn det man turte å drømme om og blir belønnet slik på børs. Viser hvor sårbart det er for kursangrep som på morgenen i dag med et relativt lite antall aksjer.
Én mrd ned på PE not met i juni. Én mrd ned på statistisk signifikant POC.
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Wow, litt av en mottakelse på børsen i dag, ja.
Jeg har ikke fått fulgt med så mye i dag, men fikk se webcasten nå. Selskapet har aldri vært tydeligere på hvor fornøyd de er med resultatet, og nå får vi vite at det på Q3 kommer en avklaring om INITIUM-avlesning (som høres ut som fortsatt er planlagt i H1-24). Og de snakker åpent om BTD og AA i Mesotheliom.
Bare å logge av og tenke på noe annet i mellomtiden. Alle piler peker fortsatt i riktig retning! 
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Er det ikke mulig vi får OS data ved Q3?
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Nei, kommer nok på konferanse i november-isj
Edit: NIPU OS data altså. Initium data kommer ikke før 1H24
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Jeg vil tippe vi kan få det i løpet av november eller desember, men selskapet holder konservativt på guidingen H1-24 før de får det helt avklart om eventuelt tidligere avlesning med FDA, sikkert.
Studien går ikke på OS men progresjonsfri kreft. PE kommer 1H men OS data er noe helt annet og de kan komme tidligere
Nei, det kan de ikke
Biotek - togreisen der man stort sett ender opp med å bli med toget i det det kræsjer i veggen.
Aldri for sent å hoppe på, risikoen man behøver å ta på seg er først og fremt bare fra sjarmøretappen nærmer seg og de farligste svingene er gjort unna.
Man får ikke lengre så godt betalt for å være idioten som håpet på ved stopp 2.
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Man lærer av dette også, risikioen er ikke verdt det at all
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Dagens handel av Ultimovacs er DUMMERE enn når “markedet” (bergenseren) sendte Funcom ned på nyheten om at Tencent kjøpte 1/3 av selskapet. Oslo børs skjender et selskap som verdens første POC på universell kreftvaksine. Tenk på det.
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Haha, dette er jo faktisk verre enn som så, også. Her fikk vi en ørliten oppgang (ca. 30%) etter POC. Folk trodde man fikk være med på togreisen til en lav premium, og kjøpte på >150. Så var det slutt på moroa.
Nå hadde de problemer med nettet sitt, men det som ble med i opptaket har jeg lastet ned og fått laget undertekst til.
NIPU results at ESMO Transcript
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Good afternoon everybody.
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We are streaming directly from Madrid at ESMO conference.
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As you know, the biggest cancer conference in Europe.
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And we are very pleased to have the opportunity and the pleasure of having
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Professor Heland with us during this broadcast to really talk about the
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exciting results we were presented by her at the conference regarding our
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nipple trial in second line.
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Mesothelioma. If we can move to the third slide.
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So in terms of agenda and so that everybody is aware of how this is going to
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proceed. So what we’ll introduce more formally Professor Helen and then
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Professor Allen will talk us through really mesothelioma in giving us more
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details about the disease but also the study rationale the results and
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afterwards we will have a period of time for Q A to Professor Heland.
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We will have to respect her time.
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She is very busy during this conference.
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So we will prioritize some of the questions and then the management team at
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Ultimovax will talk a little bit more about what is that we planning in
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terms of future for UV One and mesotolioma and other news coming soon
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regarding Ultimovax and then of course we will also open and time for Q and
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A to the management team regarding specific Ultimovax.
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So if we can move to the next slide.
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Again. Big thank you to Professor Helen.
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We really very appreciative not only of you being here to really share the
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results with the audience but also a big thank you for your and your team
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and all the investigators and of course patients and the families for the
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participation in the NICU trial.
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Professor Helen is a research director at OECI that is accredited Oslo
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Comprehensive Cancer Center.
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She is an oncologist by training with expertise in thoracic oncology.
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She is also professor at the University of Oslo Institute of Clinical
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Medicine. She is director of the National Research Center for Clinical
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Cancer Research Matrix and she leads the National Center for Lung Cancer
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Research funded by the Norwegian Cancer Society.
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She leads the research group Translational Research on Solid Tumors at the
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Institute for Cancer Research at the Norwegian Radium Hospital in Oslo and
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it’s focusing on translational studies on solid tumors with a special
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interest in lung cancers and pancreatic cancers.
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She furthermore leads several clinical and translational studies in lung
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cancer, the Dart trial, the Nipple trial and the Impress Norway study.
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And all this dedication and work were rewarded as Professor Helen was
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awarded in this in 2023 with award King Olaf the Fifth Cancer Research
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Honorary prize.
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So it’s really a well deserved recognition of all her dedication to the
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cause of finding new alternative treatments for cancer patients.
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So with this I give the word to Professor Helen.
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And again, thank you so much for being here with us.
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So thank you for the opportunity to come here and talk about the
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nucleotrial. First, some few words about malignant plural mesothelioma.
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This is a disease arising from the mesothelial cells lining the lungs, as
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you see on the figure, it’s the white part which is a cancer in the cells
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lining the lungs and can spread throughout this lining.
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It has a long latency period and is associated with asbestos exposure.
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It can take up to 50 years before the symptoms appear and is a very serious
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disease with a poor prognosis.
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It is commonly diagnosed at a late stage due to diffuse symptoms.
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As said, it has a very poor prognosis and it is a disease with few treatment
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options and the five year survival ranges from seven to 24% in advanced and
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localized disease respectively.
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So the next slide please.
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Here we see that most patients are diagnosed with regional disease, very few
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patients can be treated with curative intent and very few percentage are
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operated. There’s huge over representation among men as it’s connected and
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associated with the work commonly among men as it is associated with
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asbestos and we see that the disease the incidence have started to decline
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in some countries as asbestos and the use of asbestos has been prohibited in
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several countries the past years.
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So most cases are inoperable and are then treated with chemotherapy or
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epilemumab and nivolamab.
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Some countries have implemented the use of epilemab and evolomab as it is
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approved both by FDA and Em.
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But many countries have not started using epinevo yet, and they then tend to
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first use chemotherapy still in second line, there is no approved therapies
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and sometimes new chemotherapy is tried or inclusion in clinical studies,
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and the prognosis is really poor.
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Next slide please.
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So the study rationale for nico is that in mesothelioma cells telomerase is
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commonly expressed, it is a disease with few treatment options, as I already
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said, meaning that there’s a huge clinical need for improvements.
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Although checkpoint inhibitor therapy has been approved in first line, many
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patients still do not respond and there is a need also in this case in order
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to try to have more patients benefit from the checkpoint inhibition.
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There’s a rationale for combining with other therapies, for instance a
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vaccine and phase one trials of UV one have demonstrated good safety profile
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and robust immune responses induction.
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So, next slide please.
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So the NIPA trial has been ongoing in several countries in the world, both
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in Australia, in Perth, where they have been using asbestos for a long time
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and have a high incidence of mesotheliomas.
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It has been including patients in Spain, in Barcelona, in addition to the
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Scandinavian countries, Sweden, Denmark and Norway.
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It’s for all patients with an inoperable malignant pleural mesothelioma and
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after chemotherapy first it’s for patients with reasonable performance
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status and we had to have measurable disease according to Mrs.
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In addition, the patients had to have adequate organ function and it’s a
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second line study, strictly the primary endpoint was discussed before we
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started and we decided on going for progression free survival per blinded
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independent central review.
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The target was HR of zero six with a power of 80% and a one sided alpha of
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zero one.
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It’s an event driven design and the readout was supposed to be when 69 PFS
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events occurred, which was in February.
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The secondary endpoints was overall survival and objective response rate and
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safety measurements.
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The study has been supported by both Ultimolox and BMS.
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So this is a trial design first, the patients then receive chemotherapy.
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All patients progress on chemotherapy, unfortunately, and upon progression
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the patients could be included and then randomized between either epinevo
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alone or epinevo combined with a UV one vaccine.
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At eight time points, the patients were treated up to two years if they
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tolerated the treatment and did not progress.
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The first readout was, as I said, after 69 PFS events and thereafter the
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patients will be followed for five years.
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Next slide please.
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So when looking at the two arms, they seem to be reasonably balanced with
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76% 79% male, median age of approximately the same.
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There’s 70 ish percent in eco status one and the histology is also
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reasonably balanced between the two arms with the epitaloid histology the
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majority of the cases which is representative of the disease.
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Unfortunately, we missed PDL one status on quite a lot of the patients and
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few patients were PDL one positive.
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The next slide please.
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So, when looking at the endpoint, this figure shows the progression free
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survival reported by Bicker and on the right hand side by the investigator.
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The study did not meet its primary endpoint as was predefined and the hazard
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ratio for PFS based on Bicker was 1.1 and the median PFS in patients treated
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with epinevo was 4.7 months compared to 4.2 months in patients treated with
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a UV One vaccine.
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In addition, however, supportive analysis with the investigator evaluated
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PFS revealed a significant difference in favor of the UV one treated
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patients with a hazard ratio of zero six and a median PFS of 2.9 months in
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the EP nevo arm and 4.3 months in the patients treated with UV One vaccine.
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In addition, this means that for the assessments performed at the hospital,
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the PFS survival based on investigated assessment gave a HR of 0.6 and a p
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value of zero 125.
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Next slide please.
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Here we see the objective response rates per biker.
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We see that in arm A the patients treated with a vaccine.
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In addition, we saw an objective response rate of 31%, whereas in arm B with
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epinego alone, 16% of the patients experienced objective response rate.
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Objective response.
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This gave an alterative of 2.44 with a one sided p value of 00:28.
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So it’s easy to see that by Bicker more patients responded significantly in
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the patients treated with the UV One vaccine.
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In addition, regarding the overall survival after 17 months of follow up, we
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see that there is a significant difference in the overall survival in the
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median overall survival among the two groups.
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In arm A receiving the UV One vaccine, the median survival was 15.4 months,
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whereas in the arm B the patients treated with epinevo alone, the median
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survival was 11.1 months.
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So we see that according to the planned analysis, the median survival is
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longer among the patients treated with UV One was seen.
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Of course, we will follow the patients further and this data will be updated
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later. To the next slide, please.
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So when looking at the toxicities, we saw that the addition of UV One to
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epinevo was safe, and we did not see any significant added toxicity of the
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vaccine. There was patients with serious adverse events, 61% in RM A and
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59.3% in RM B.
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So it was similar.
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Next slide, please.
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So, in conclusion, we saw a meaningful prolonged survival in the patients
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treated with UV One vaccine in addition to Epinevo, meaning that we saw
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signs that warrants further investigations of this combination in this
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patient group.
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Thank you.
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Thank you so much, Professor Helen, and for a very clear presentation.
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And we will open now the floor to Q A and Haspen, our Director of Medical
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Affairs will be leading this part.
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All right, thank you.
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Yes, we have received some questions that people want to ask Professor
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Helen. So it’s one question concerning the overall survival and that we
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observed an HRO point 73.
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And the question is, will this possibly change with longer follow up? Yes,
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that might change.
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That number might change.
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When we have longer follow up during the course of a clinical study, we
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censor patients that are not followed longer.
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So this might change both in both directions.
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So the answer is, yes, this might change.
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Thank you.
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And then there’s a question regarding different subgroup analyses.
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And I assume well, I know that you’re performing extensive translational
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research, so there’s a question here whether you will look into different
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subgroup analyses in the time to come.
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Yes, we have several ongoing studies already.
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We will look into cytokine profiles.
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We will look into microbiota.
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Actually, we are currently doing that analysis.
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Now we have studies on Pet images which are ongoing, although we don’t have
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any obvious or clear results yet, as we are still following the patients.
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And we will do multiplex immunohistochemistry sequencing.
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So we have several ongoing clinical translational projects to see if we can
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identify or understand more about why some patients respond very well,
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whereas others still would need some improvements.
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Okay, thank you.
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And the next question concerns the discrepancy in PFS observed by the
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blinded independent central review and based on the local assessment.
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So would you like to comment
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about that? Because it was kind of compelling.
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Of course, mesothelioma, as I showed on one of the very early slides, it’s a
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tumor that grows along it lines, the lungs.
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So of course it depends on where the radio
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and I think it’s a very difficult disease to do the resist evaluations on.
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So I think that might impact or might influence whether or not they find the
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same, it’s much easier to do resist evaluations on a tumor.
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Like for instance, lung metastases from a melanoma where you have these
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round lesions in the lung, you can measure the longest diameter and you can
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compare that with the last evaluation or follow the lesions continuously.
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In mesothelioma, you can have parts of the tumors lining the lung growing
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maybe, and other parts with reduced size and radiologists have to measure
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the same spot or the same area of the lining every time.
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It’s much more difficult to make a clear evaluation in this disease.
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So I think that must impact the evaluation.
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And of course, in the end, survival is what we are aiming for, right? As a
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clinician I want my patients to live as long as possible with as good as
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possible portal life.
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So of course, that’s the aim with all the new treatment to accomplish that.
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Thank you.
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I think we have time for one more question.
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So the NEPU trial was run in second line mesothelioma.
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Now that Ipinebo has been approved in first line setting, do you consider
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that to maybe be a more appropriate treatment line for future studies? Yeah,
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and the discussion Saturny was talking about adjuvant setting, but
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Nestleomas are very rarely operated on and the results of the surgery is
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quite controversial or it’s not necessarily the best for the patient.
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So I think as adjuvant to surgery, I don’t think that’s the way to go.
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But of course it would help the patients if we could have the first line
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treatment as effective as possible.
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So a first line trial with epinevo and a combination with either UV one
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vaccine would give us answer if this could improve the prognosis and the
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quality of life of these patients.
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Move on.
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I should say also that there are some questions that want to of course
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congratulate you and your team on the study completion and the results.
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So I need to mention that then I think we should move on.
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Thank you.
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Absolutely. And again, thank you Professor Allen, for your know, it’s
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pleasing to also see that a lot of your colleagues, experts in the area were
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complimenting you in these results.
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There’s really not much.
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Thank you
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and I will give the word to our chief medical Officer, Jens.
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You’re right.
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Thank you so much, Carlos.
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First of all, I would like to acknowledge Professor Oslo Helen and her team
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for the accomplishments with the Nipu trial.
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Thank you so much.
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So, as you know, the nepotrial is one of five phase two trials we are
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running.
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The Nipple trial is the first of them to present data in a randomized
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fashion. For us in ultimox, it’s very important to understand the biology,
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how the vaccine works in different biologies, both in those cancer forms
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that are more hard to treat and also in more cancer forms where we know the
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CPIs have more efficacy based on the results, the positive results on
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efficacy and safety for the nepotrial.
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We are ready to move forward with the development of U One in this
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indication. We are acting on these results by discussing them with the
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regulatory authorities.
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As you remember, we have already received orphan drug designation for the
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vaccine in Mesothelioma a couple of weeks back.
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We have also started discussions both with investigators in the trial and
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also third party investigators that were not connected to the trial to
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understand the way forward for Ubibom in this indication, both when it comes
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to the design of the trial and as you just discussed with Oslagge Helam what
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kind of line such trial should be conducted.
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This is a process that I’ve already started for this indication and we look
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forward to update you further on the Mesothelioma path.
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Thank you.
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Thank you Jens.
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And I think this is the exciting part of all of this data.
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And earlier I was mentioning that a lot of Mesoleum experts complimenting
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Professor Helen but also congratulating us on these results due to very high
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need, medical need for finding solution for these.
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I think if we talk about all the portfolio clinical trials that we have
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running, of course with Nipu, as Jens mentioned, we have the safety, we have
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the efficacy, a clear path to then talk with the authorities and also talk
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with the opinion leads to decide next steps and this is what we are going to
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do. But of course, our program is not just Nipu.
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Nipu is one of the clinical trials.
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Our main trial is initial in melanoma is our lead indication and as you all
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know, very fortunate for the patients in our study, they are not
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progressing, not dying, so very good news for them.
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And we have been moving and moving the expected timing for having these
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results. As I informed the market, this could continue.
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So we took the decision to internally look at ways of having access to the
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data earlier without impacting, of course, the statistics of the study, I’m
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pleased to inform that that was done.
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So we are already then submitted these proposals to the authorities and I
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expect to provide feedback to the market and information when we get to our
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Q Three report meeting.
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So the idea is again that we will be able to look at the data earlier and
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continue to keep with our guidance of providing data to the market and to
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the physicians during the first half of 2024.
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So this is a very exciting period for Ultimofax and for the team.
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A lot of work is going on and also let’s not forget that very soon after
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initiating we have the Focus trial in adenac cancer also coming.
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So it’s going to be a very exciting, very busy period for Ultimovax and for
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the team.
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But there’s a lot of excitement, I can tell you in terms of the team really
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by being linked to what is in reality the first results in a randomized
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trial of a universal cancer vaccine that we hope will be potentially be used
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and provide solutions for treatment cancer patients in many other again, you
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know, the field of treating oncology patients.
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We are the second company in the world with randomized data together with
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moderna, of course, different vaccines complementary but it’s great news for
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patients and for physicians results that show that there is a benefit by
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adding cancer vaccines to the current immunotherapies.
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And this is, of course, a very exciting field and for us as a team.
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And with this, I will open for the Q A session.
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All right, so a few questions have come in.
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So I’ll start with the first one here.
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The management team in Ultimovax has earlier communicated potential interest
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from institutional investors abroad when randomized data is available.
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Now there is randomized data available from the NEPA trial.
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Do you now expect to see more interest from potential institutional
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investors?
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Update on this data.
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It looks like I was lost again.
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Can you hear me? Yeah.
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Okay. All right, so apologies for that.
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Again, you know what this is there’s a lot of communications and a lot of
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meetings going on all at the same time.
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So yes, just to repeat, we are updating a series of groups, as I mentioned,
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regulatory authorities, physicians, potential partners, and of course,
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institutional investors, specialist investors that we have been in regular
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contact to.
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We will now be also in the process of updating them.
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So it’s a series of activities that we will, of course, intensify now more
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that we have the results and we all hope that this will deliver results.
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All right, so the next question concerns regulatory designations.
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And have you applied for any of those in Mesothelioma? We already applied in
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terms of the Orphan Drug designation that we received.
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And now with this data, it’s part of the plan and the team was already
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working it to really submit it.
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Yeah, I think we might have lost you again once.
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Okay, again, sorry for that.
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I can say that we have informed the regulatory authorities.
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We received orphan drug designation.
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And now that we have the full set of data, we have initiated the sharing of
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this information with the regulatory authorities to check if we can receive
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any of the designation, breakthrough designation, past track designation.
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And this is part of the process.
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In addition, of course, as Jens mentioned, that sharing the data to
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determine the next stage, the next phase in the development of UV One in
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Mesothelio. All right, then the next question concerns partnering.
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So concerning your search for a partner for the Phase Three program, will
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you do those? Will you try to find a partner for each indication
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individually or one for all indications? This is a very good question and it
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gives me again, the opportunity to clarify that
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when we select that partner, they will receive all of the
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yes, I’m back.
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Okay, sorry.
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So again, and apologies for all this.
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In these days, there is only one market authorization, so you cannot have
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license to different indications, to different partners.
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So we will be talking with different partners.
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We identify the best one that we believe will maximize the value of UV one,
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and that partner then will have the rights to all of the indications,
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current and future, due also to the extensive potential that UV One can
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deliver in terms of multiple indications.
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Okay, and then the next question.
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So you have previously mentioned that there is certain steps to be taken if
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a phase two is successful.
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So the question is, can you elaborate on those steps? This is primarily a
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medical and a clinical development question.
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So I will give the word to Jens.
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Thank you, Carlos.
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Thank you, Carlos.
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Just to put this NIPA trial into context first, so Van Oslag, Helen
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contacted us back in 20 18 19, discussing mesotelioma as a possible
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opportunity for a vaccine to be added on checkpoint inhibitors.
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There were no CPIs in that area.
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First line was chemotherapy, as it also is in some countries today.
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So we started off with that trial and you have now seen the results from the
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phase two trial.
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We are happy with the results and we plan to move on into next phases of
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development with them.
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But certainly the market has changed, the standard care has changed over the
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last years.
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So we need to discuss where to place the drug,
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as we have in the other indications.
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So one of the most important things in Ultimox when we have developed and
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assigned trials earlier, is that we have had a very close discussion with
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investigators, with experts in the field to understand really where they
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would like to put their patients.
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So the sign of the study is something that is developed in parallel with the
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information from the outside world regarding standard care, et cetera.
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Also, of course, you need the authorities agreeing to the protocol.
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In a phase three protocol, you need to answer the questions, the authorities
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need to approve the drug so that you can treat patients in different
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countries, be sure about good safety and also efficacy for patients.
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This is a process that involves several meetings with the authorities and
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also agreement on the design, the statistics, et cetera.
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In a phase three trial, there will be more patients than there is in a phase
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two trial.
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The number of patients included in a phase two trial gives you limited
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information on the results.
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In a phase three, you need to have statistics that is stronger so that you
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can be more sure about the numbers you observe in your trial.
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So all of this is a dynamic process, both internally towards the
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so again, I thank you for your patience.
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We have been hearing that everybody, because of the volume of meetings and
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conferences, the internet is really being stretched to a limit.
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But I hope you understand that.
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Do we have any more questions? Aspen
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yeah, there’s of course a few questions to Professor Helen, but of course
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she’s not with us now, so I think that was what we had for the ultimate wax
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management team.
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Good. OK.
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So I want to thank everybody for the time taking the time and also of course
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we already thank Professor Helen and this data just came out.
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I can tell you as I mentioned earlier, that there’s a lot of interest and
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excitement about data from different sectors.
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So that really provides us with this desire to then really act on the state
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and as Jens said, to move to the next step.
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Talk with the authorities, talk with so we are not going to stop.
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And that is going to be the
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we are providing treatment alternatives and potentially new solutions for
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cancer patients.
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And there are also several cancer patients in the conference.
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And that is
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so in in case you miss me again, we are very pleased and thank you for your
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time. And we are off now.
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Bye.
27 Likes
Dette er da tredje gang aksjen dykker på gode nyheter som markedet ikke plukker opp.
Noen som husker hva som hendte de forrige gangene?
Omaniacs Nescafe Gull modell sier at de hentet seg inn igjen og at dette vil gjenta seg.
Endel av grunnen til de store utslagene er jo overreaksjoner av den typen vi ser her i forumet. Når vi mister hodet, hva kan vi forvente av de som har 0 kunnskap om aksjen?
De ser sånne fine postere med en type som respektfullt er uenig med Helland, uten å vite noe om bakgrunnen.
Her inne jobber Dommedagslars hardt med å snakke ned aksjen, og i helgen har vi alle blitt overøst med modeller som 90% av oss ikke skjønner så mye av.
NIPU leverte, og det peker 90% på at INITIUM lander klokkeklart. Når nesten ingen her inne skjønner hvorfor aksjen går ned, så er det fordi den ikke skulle gjøre det. Da ligger potensialet klart.
Vi må evne å se litt fremover.
Dette er ikke en aksje for de mørkeredde. Den er for oss som ser gjennom mørket.
16 Likes
Sluttkurs dagen før NIPU “feilet” i juni: 117
Kurs etter NIPU leverte POC på ESMO: mindre?
6 Likes
Blir ikke mørkeredd her, føler at vi (altså oss her inne) samlet har såpass god kontroll på hva caset er. Blir bare sykt frustrert av en kjøperside som åpenbart ikke evner å kjenne sin besøkelsestid. Den er som amerikanerne i WW1 – lovlig seint ute.
Med forbehold om at noen herper aksjen, hvermannsen vet ikke bedre. De forventet sikkert nyheter om oppkjøp eller noe lignende.
NIPU er bare et vanskelig mellomsteg.
De fleste av oss har evnet å se fremover. Nå fikk vi bekreftet at markedet tar POC med et gjesp. Det hadde jeg ikke sett for meg. Neste mulighet er en eventuell homerun i melanom, men vi bør kanskje skru ned forventningene til hvilke kursutslag det vil gi.
Krysser fingrene for at det ikke blir 1 mrd til ned