ULTIMOVACS-Den som venter på noe godt...


Venter ikke forgjeves.
Redigert 21.01.2021 kl 09:34 Du må logge inn for å svare

Har folk glemt ULTI??

Nye lovende meldinger om TET, meget spennende pipeline og mulig kommersialisering innen 12mnd.

Tidenes mulighet til å være med på biotek fest uten sidestykke.
heilo888
11.04.2022 kl 11:08 6647

Ja veldig positivt med god sikkerhetsmelding for TET-platformen.
Dette kan bli en vinner som de fleste selskaper innen kreftvaksiner bare må ha for å henge med.
heilo888
10.05.2022 kl 09:15 5933

Resultater gull verd!

De som forstår hva dette betyr og investerer deretter vil gjøre en økonomisk kule etter hvert!
Men trolig ser de fleste ser mer til kortsiktig makro enn til disse resultatene som sier mye om hva som vil komme fra Ultimovacs i de kommende par årene.

Ultimovacs Announces Presentation of UV1 Immune Monitoring Data at Cancer Immunotherapy Annual Meeting

UV1 immune monitoring data from three Phase I/IIa clinical trials show dynamic T cell responses lasting up to 7.5 years
Measurable UV1-specific immune response in 91% of patients when combined with checkpoint inhibitor, as compared to 82% and 67% without checkpoint inhibitor
Immune responses induced more rapidly when UV1 was combined with a checkpoint inhibitor
Development of UV1-specific immune responses associated with longer survival time




Oslo, 10 May 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced the presentation of results from long-term follow-up data from three Phase I/IIa clinical. The data is substantiating the clinical relevancy of the UV1-specific immune response and the rationale for combining the Company’s lead product, the universal cancer vaccine UV1, with checkpoint inhibitors.



The data will be presented as a poster at the upcoming Cancer Immunotherapy (CIMT) annual meeting in Mainz, Germany, 10-12 May 2022. The CIMT poster can be found on the Company website.



The poster reports on a long-term follow-up study of the use of the UV1 vaccine. The researchers looked every six months for up to 7.5 years for UV1-specific immune responses in 51 patients enrolled in three early trials of UV1 in malignant melanoma, non-small cell lung cancer (NSCLC) and prostate cancer.



For patients with malignant melanoma, where UV1 was combined with the checkpoint inhibitor ipilimumab, UV1-specific immune responses occurred earlier and more frequently than in patients with NSCLC or prostate cancer where no checkpoint inhibitors were involved. 91% of patients with malignant melanoma showed a detectable immune response within three months.



The high rate and rapid induction of immune responses provide support for synergy between UV1 vaccination and checkpoint inhibition. The data further demonstrate that UV1 vaccination leads to induction of memory T cells with an inflammatory cytokine profile. These cytokines produced by the UV1-specific T cells, including IFN-gamma and TNF-alpha, are considered appropriate in terms of supporting anti-tumor activity. Immune response induction associated with longer survival time, with a median overall survival in immune responders of 54.8 months, compared to 23.4 months in non-immune responders.



“These data – from what we believe to be the longest immune monitoring study of a therapeutic cancer vaccine - are highly relevant to Ultimovacs’ ongoing Phase II programs in which UV1 is combined with various checkpoint inhibitors, as well as to potential future clinical studies. The data shows that the patients’ UV1-specific immune responses may be embedded in immune memory, providing the potential for dynamic long-term defenses against cancer” said Carlos de Sousa, Chief Executive Officer of Ultimovacs.



==ENDS==
Gullit
10.05.2022 kl 09:27 5907

Eg kjøpte meg inn igjen no. Det er for Mye bra som skjer her, klarte ikke stå på sidelinjen lenger. Så er det vel en tryggere havn i disse utrygge tider.
heilo888
10.05.2022 kl 09:39 5880

Ja mye kortsiktig irrelevant tenkning hos mange investorer.

Som polygon ironisk skriver på TI:
"Men likevel får vi enda en dag med: Vaksine som meget sannsynlig både kurerer og hindrer kreft? Nei takk - det blir jo inflasjon! :roll_eyes:"
Gullit
10.05.2022 kl 16:29 5737

Bare å la denne kose seg i skuffen no.. verdien kan bli enorm
Redigert 10.05.2022 kl 16:29 Du må logge inn for å svare
heilo888
10.05.2022 kl 16:53 5713

Ja dersom Ulti blir godkjent og anerkjent som en universell kreftvaksine i kombinasjon med sjekkpunkthemmere (immunterapi) for 80% av verdens krefttyper kan man bare fantasere om prisingen!
Redigert 11.05.2022 kl 17:49 Du må logge inn for å svare
heilo888
12.05.2022 kl 08:35 5496

Ultimovas rapporterer 41 nye innrullerte i deres fase 2 studier.
Deres første studie INITIM er nå 89% ferdig rekruttert.
Og Tendu-studien går etter planen.

Ultimovacs ASA: First quarter 2022 result presentation

Oslo, 12 May 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announces its first quarter 2022 results today.

The presentation by the company's management team can be followed as a live webcast at 13:00 CET and will be made available on the website. It will be possible to post questions during the presentation through the webcast.



Highlights for the first quarter of 2022:

On 22 April 2022, Ultimovacs received a Notice of Allowance from the United States Patent and Trademarks Office (USPTO) concerning its US patent application on the use of vaccine-checkpoint inhibitor combinations to treat cancer.
On 25 March 2022, Ultimovacs reported the complete disappearance of tumors in yet another patient in the UV1-103 study (Phase I study in malignant melanoma in combination with pembrolizumab), raising the complete response rate in the study to 33%. The objective response rate remains the same at 57%.
In March 2022, median overall survival was reached at 66.3 months for the Phase I study in malignant melanoma where UV1 is combined with ipilimumab.

Clinical trial enrollment update

INITIUM trial: 137 out of 154 patients have been enrolled to date, up from 120 as of the previous quarterly report.
NIPU trial: 78 out of 118 patients have been enrolled to date, up from 66 as of the previous quarterly report.
FOCUS trial: 18 out of 75 patients have been enrolled to date, up from 10 as of the previous quarterly report.
DOVACC trial: 4 out of 184 patients have been enrolled to date, up from 2 as of the previous quarterly report.
LUNGVAC trial: Preparations are ongoing for the initiation of the trial, with the first patient expected to be included during 1H 2022.
TENDU trial: 8 patients have been enrolled to date, up from 6 as of the previous quarterly report. On 3 February 2022, Ultimovacs reported that no safety concerns had been found related to the first two dose cohorts. Thus, the study proceeded to the third dose cohort of 960 mcg, in which two patients have been enrolled so far.
Redigert 12.05.2022 kl 08:36 Du må logge inn for å svare
Gullit
12.05.2022 kl 10:33 5410

Kjempe god utvikling.. bør bli en grønn dag…
Rassen
12.05.2022 kl 11:01 5381

Ser mørkt (rødt) ut gitt.
Gullit
12.05.2022 kl 11:05 5373

Ja det ser man, men bør bli grønn iløpet av dagen. Alt går på skinner. Kassen er full…
Merlin
12.05.2022 kl 20:40 5227

Ultimovacs (Pharm. & Biotechnology, Norway)
Recommendation: Buy
Price target: NOK 200.00
DNB Markets
Patrik Ling
Strong recruitment in Q1

Ultimovacs’ Q1 report was to a large extent a non-event, with the most important information being the recruitment rate for the different trials: once again, the recruitment was strong. We believe the INITIUM trial could be fully recruited by the time of the Q2 report, while the NIPU trial should be fully recruited in early 2023. We reiterate our BUY and NOK200 target price.

Operating loss smaller than expected. The company reported an operating loss of cNOK32m in Q1 compared to our forecast of a loss of cNOK56m. The main difference was slightly lower personnel costs, and clearly lower R&D spending than our forecast. However, we see no drama in this as we have estimated relatively equal costs between the quarters, even though the trajectory for costs should be upward-sloping with higher costs later in the year due to greater trial activity.

Recruitment, the most important factor, remained strong in Q1. The company announced that it now has 137 of 154 patients recruited to the INITIUM trial (an increase of 17 since the last report) and the NIPU trial has 78 patients recruited (out of 118 needed), 12 more than the last report. The FOCUS trial added another eight patients and the DOVACC trial added two patients.

At the current pace, INITIUM should be fully recruited by the Q2 report. If the company maintains the current pace, the INITIUM trial should be fully recruited by the Q2 report, which is in line with our view. The NIPU trial is still lagging behind a little, but Ultimovacs has already adjusted the timelines for the slightly slower recruitment rates seen earlier. We believe the company will be able to release top-line data from the INITIUM and NIPU trials in H1 2023; this timeline was re-confirmed in connection with the report.

Plans to run a supplemental 20-patient trial after INITIUM is fully recruited. The company announced that this additional cohort will be recruited after recruitment to the INITIUM trial is completed. The aim is to evaluate in more detail the immune response to the UV1 vaccine. These patients will not be part of the primary endpoints in the trial and thus this should not delay the top-line data read-out.

Strong financial position. The company had cNOK524m of cash on the balance sheet at quarter-end and it reiterated that this should last into 2024 (thus beyond the most important expected data read-outs from the INITIUM and NIPU trials).

BUY and NOK200 target price reiterated. The company is achieving its recruitment rate plans as well as the timelines for when we could expect top-line data from the first phase II trials. We have made minor adjustments to our forecasts.
Redigert 12.05.2022 kl 20:41 Du må logge inn for å svare
heilo888
13.05.2022 kl 16:41 5033

Edisons betraktninger om Q1

Edison har estimatene sine «under review».

https://www.edisongroup.com/publication/uv1-phase-ii-data-flow-creeps-closer/30893/
heilo888
18.05.2022 kl 10:03 4691

Artikkel om Ultimovacs hos BioStock:

Ultimovacs keeps delivering in Q1
17 May, 2022
Q1 saw Norwegian immuno-oncology company Ultimovacs advance on a number of fronts. The company’s clinical programmes with universal cancer vaccine UV1 and adjuvant platform TET have continued to progress steadily. Moreover, milestones were reached at the preclinical level as well as the intellectual property level.

Immuno-oncology biotech Ultimovacs develops a vaccine, UV1, that the company hopes will enhance a cancer patient’s immune system to help it fight off the cancer. UV1 is an off-the-shelf peptide-based vaccine that induces a specific T-cell response against telomerase, an antigen expressed in 85-90 per cent of all cancer types. This property makes the vaccine universal.

From the company’s latest interim report, it is quite clear that the clinical validation for UV1 is advancing on schedule, without any hiccups. One phase I trial and five phase II trials are ongoing for evaluating the candidate. Additionally, Ultimovacs has an ongoing phase I trial with its cancer vaccine adjuvant technology – TET (Tetanus-Epitope Targeting). This trial is also progressing smoothly.

Progress in the clinic
Four of the five phase II trials are currently recruiting patients. Lead trials INITIUM, in metastatic malignant melanoma, and NIPU, in mesothelioma, have recruited 137 out of 154 patients and 78 out of 118, respectively. Both trials are two proof-of-concept studies testing the triple combination of UV1 with checkpoint inhibitors (CPIs) ipilimumab (Yervoy) and nivolumab (Opdivo) .This means the company is well on the way to its recruitment goals, and topline data readouts for both trials are still expected for H1 2023.

Meanwhile, preparations are underway for the initiation of the LUNGVAC trial, where UV1 will be evaluated incombination with the CPI pembrolizumab in non-small cell lung cancer (NSCLC) patients. The first patient is expected to be included during H1 2022.

The company has also recently presented data from a 7.5-year followup study of over 50 patients from three prior phase I trials with UV1. The results presented at the Annual Meeting of Association for Cancer Immunotherapy (CIMT) from May 10-12 2022 show dynamic T-cell responses lasting throughout the evaluation period. The data clearly indicate that the patient’s immune responses are UV1-specific and may be retained in immune memory. These results are highly relevant to Ultimovacs’ ongoing phase II programmes as well as future clinical development.

Novel adjuvant technology platform shows preclinical promise
During Q1, Ultimovacs also made progress with its cancer vaccine adjuvant technology – TET, which is being evaluated in the phase I TENDU study. An adjuvant is a substance that increases or modulates the antigen-specific immune response driven by a vaccine, so TET is aimed at enhancing novel cancer vaccines in development.

Ultimovacs announced in February that treatment of the second dose cohort in TENDU had been completed, and no safety concerns were reported. Since then, the trial has continued to the third dose cohort – the first two patients out of three patients have been enrolled. Interim safety data will be published six months after the treatment of the third patient in cohort three, as previously communicated.

Ultimovacs presented a poster with positive preclinical data on TET at the annual American Association for Cancer Research (AACR) conference that took place last month. The results indicate that the adjuvant platform efficiently primes T-cells, and it does so safely, thus supporting the clinical transition to the ongoing TENDU phase I trial with TET in prostate cancer patients.

The data also suggest that TET could be used as a basis for developing multiple therapeutic vaccines targeting solid tumours. Moreover, by combining cancer antigens and the vaccine adjuvant in the same molecule, the TET platform can generate vaccine candidates with a beneficial safety and administration profile, presenting an opportunity to treat patients at an early stage of their disease.

Validation from US patent office
During the quarter, Ultimovacs also got good news from the United States Patent and Trademarks Office (USPTO) with a Notice of Allowance on a patent application for the use of vaccine-checkpoint inhibitor combinations to treat cancer at least until June 2037. As the company continues to advance in the clinic, the prospects of commercialisation increase, and this form of validation from the USPTO drives up the value of Ultimovacs’ work as it strives to deliver innovative contributions to combination immunotherapies in cancer.

Read more here.

Strong relationship with shareholders
Despite the significant volatility in biotech stocks during the last few months, Ultimovacs has shown why it continues to have a strong relationship with its shareholders. The diversified pipeline of clinical projects continues to move forward on par with expectations, and preclinical as well as phase I data continues to support the company’s ambition to help cancer patients with unmet need. With solid financing until the first part of 2024, which should cover topline readouts for the first four phase II trials, it doesn’t look like Ultimovacs’ relationship with shareholders will be shaken any time soon.

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.
heilo888
18.05.2022 kl 23:35 4424

Betraktninger fra polygon på TI i etterkant av podkasten i dag:

"Hvis noen ikke trodde helt på det jeg skrev for et par uker siden:

Konkurranse : Siden bivirkningene er små, og alle er enige om at kombinasjoner er fremtiden, så er den eneste reelle konkurransen andre kreftvaksiner som har samme target - og det er TO stykker, som begge ligger langt bak i utviklingsløpet, og langt fra har like overbevisende data som UV1. At det blir annen ny SoC mens noen av Ultimovacs sine studier rekrutterer som ødelegger for rekrutteringen, er så godt som utelukket. At det blir ny SoC i indikasjoner som Ultimovacs kjører studier som ikke kan gi grunnlag for godkjenning, kan selvfølgelig skje, men da kan man kombinere med denne i neste studie.

Carlos de Sousa i dagens Radium om konkurransen for andre “immunprimere” i samme indikasjoner som Ultimovacs sine fase II:

“these companies are different mechanisms that are not going to compete with us. And where we see some positive results like in Nivo + LAG3 in melanoma. We have had very good discussions with key opinion leaders and some of the investigators, and it’s good to see that the combination of ipilimumab and nivolumab is going to continue as a standard of care. But for us, if the new combination will be used … it is already approved … it will also be positive for us, because I think we can also be combined with them.”

Carlos de Sousa i dagens Radium om den reelle konkurransen:

“In reality there were two companies, but we haven’t seen much activity ongoing there so they are definitely behind us. We don’t see much news, so we are clearly in a leading position not only in the phase of development, but also in the number of clinical trials we are running and that will give the data.”

Og som Jens Bjørheim sier om konkurransen for den enkelte studie (i fremtiden):

“Checkpoint inhibitors are our friends […] The most important thing here is to understand how the CPI field is moving. What will happen with different indications and different subgroups of patients and different stages. So we need to be alert to have relevant clinical studies with good combinations and in the right stage of cancer.”

Dette siste her er så vanvittig viktig, og er noe Ultimovacs har hatt fullt fokus på helt fra selskapet ble startet."

"I forlengelsen av svaret på et spørsmål om hvem som betaler for CPIene i de forskjellige studiene, og hvor de Sousa forklarer hvorfor det er riktig for dem å ha full kontroll over INITIUM alene, men også verdien av å ha formelle samarbeid i NIPU og DOVACC: “but of course it has been vey good to have very close interaction with both these big pharmas [henholdsvis BMS og Astra Zeneca] that we will continue to maintain. […] It’s good to have regular contact with these companies that can be potential partners for us when we decide to partner UV1”.

Strategien har for Ultimovacs hele tiden vært å gjøre avtale etter fase II. De kunne kanskje solgt skinnet nå eller tidligere for en pris, men den blir en helt annen når bjørnen er skutt om et års tid.

(og jeg er altså ganske trygg på at det RedEye skisserer er i sjangeren skinn-pris, og at de dermed bommer)"
Redigert 18.05.2022 kl 23:36 Du må logge inn for å svare
heilo888
23.05.2022 kl 18:34 3861

Ja Sara Mangsbo og hennes gruppe i Uppsala er virkelig et verdifullt funn for Ultimovacs!
Hun har ofte vært på SvenskTV for å kommentere helserelaterte saker.
Gullit
26.05.2022 kl 07:22 3532

Ta plass folkens!!

Oslo, 25 May 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced the publication of long-term follow-up data on UV1 in the Journal for ImmunoTherapy of Cancer (JITC). The data show that dynamic UV1 specific immune responses last up to 7.5 years, are associated with longer survival and are enhanced when UV1 is used in combinations with checkpoint inhibitors.

It is important to be able to share this validating data with our research and clinical colleagues through JITC. The data demonstrate highly durable UV1-induced immune responses that are associated with substantially longer overall survival and boosted by checkpoint inhibitors. This is strong support for Ultimovacs broad Phase II program combining UV1 with checkpoint inhibitors across five different cancer indications, said Carlos de Sousa, Chief Executive Officer of Ultimovacs.

The Journal for ImmunoTherapy of Cancer is the peer-reviewed open access journal of the Society for Immunotherapy of Cancer. Ultimovacs paper in JITC reports data from three Phase I/IIa clinical trials on Ultimovacs cancer vaccine lead UV1 in three separate cancer indications malignant melanoma, non-small cell lung cancer (NSCLC) and prostate cancer.

The data demonstrate that UV1 vaccination leads to dynamic immune responses in patients, notably the induction of memory T cells with a cytokine profile involving the production of IFN-gamma and TNF-alpha. Furthermore, the paper demonstrates the development of a UV1-specific immune response associated with longer survival time across the three cancer types.

Adding checkpoint inhibitors boosts the potentially protective UV1 response. UV1-specific immune responses occurred earlier and more frequently in patients with malignant melanoma, where UV1 was combined with the checkpoint inhibitor ipilimumab, than in patients with NSCLC or prostate cancer where no checkpoint inhibitor was involved. Around 91% of patients with malignant melanoma showed a detectable immune response within three months.
Redigert 26.05.2022 kl 07:23 Du må logge inn for å svare
TRD73
26.05.2022 kl 10:42 3417

Fantastiske nyheter både for oss aksjonærer og ikke minst pasientene som har fått delta. Her ligger alt til rette for videre suksess. Når kommer de store farmasigigantene på banen for å sikre seg rettighetene til å kombinere UV-1 med sine CPI’er?
Rassen
02.06.2022 kl 16:06 2913

Det tok ikke akkurat av!

Forventninger om noen triggere her i nærmeste fremtid?
Rassen
08.06.2022 kl 16:09 2627

Folk selger jo på 74!! skjønn det den som kan!!!
Skier
08.06.2022 kl 19:04 2533

Nei, ikke Ulti. Amerikansk selskap som har utviklet kreftmedisin etter tilnærmet lik utnyttelse av t-cellene som fremmer eget immunforsvar, se link om utvikling av
Dostarlimab: What Is the Drug With Unprecedented Cancer ...https://www.nbcnewyork.com › w...
Developed by a biotech company out of Massachusetts called Tesaro before being acquired by GlaxoSmithKline in 2019.

Så GSK slukte dette selskapet.

Lurer på hvem som til slutt ender opp med å kjøpe Ulti. De skal uansett ikke få det billig!!

Rassen
09.06.2022 kl 11:10 2242

Er ikke dette negativt for Ulti? Ser sånn ut på kursen i hvert fall.

Noen med peiling som har et godt begrunnet svar på det?
heilo888
09.06.2022 kl 18:29 2070

Dette er vel relatert til en mindre undergruppe innen endetarmskreft med spesielle gener og er ikke noe nytt.
Ultimovacs har ingen studier i denne kreftindikasjonen, men jeg mener at det norske selskapet Hubro har pågående studier innen dette spesielle området. Tror enda at de er i preklinisk fase.
Rassen
14.06.2022 kl 10:06 1459

Faller og faller og faller. Noen som har peiling på årsak? De er ikke veldig «på» når det gjelder info ut i offentligheten.
heilo888
14.06.2022 kl 10:44 1424

All biotek og tek faller pga. makro og overdreven frykt ved at renten igjen skal tilbake til det normale.
På et annet diskusjonsforum spekuleres det i at stillheten er pga. at ledelsen har viktige diskusjoner på gang og derfor nå avlyser planlagte presentasjoner.
Selvsagt spekulasjoner men den som "lever får se"!?
Rassen
14.06.2022 kl 12:16 1367

Vel… det er bare Ulti som faller mye av de jeg kjenner. Flere er opp så langt i dag, mens Ulti er den store taperen.

Gode 2-årsresultater fra Ulti:
ww.dn.no/bors/ultimovacs/bjorn-rune-gjelsten/norsk-kreftvaksineutvikler-skyter-opp-pa-oslo-bors/2-1-1241624

https://finansavisen.no/nyheter/helse/2022/06/20/7884757/gladmelding-fra-gjelstens-kreftselskap?internal_source=sistenytt
Redigert 20.06.2022 kl 11:44 Du må logge inn for å svare