TENDU studien oversikt over utviklingen og meldinger:
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17/2 -21 (Q4/20):
The TENDU Phase I trial
• This trial will investigate a prostate cancer specific vaccine based on the TET technology
• The TENDU trial will be conducted at Oslo University Hospital
• 9-12 patients will be enrolled
• This Phase I trial will provide valuable information on safety and immune activation toward the
further development of new vaccine solutions based on the TET technology
• First patient is expected in Q1 2021
Som man ser opererte U da med 9-12 pasienter og 3 ulike doser. I utgangspunktet 3 pasienter på hver dose men man holdt åpent utvidelse til 12 - flere med høyeste dose.
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18/2-21 melding - Dose µ40 :
Oslo, 18 February 2021: Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today
announced the treatment of the first patient in the Phase I TENDU trial,
representing the start of clinical evaluation for the Company’s Tetanus-Epitope
Targeting (TET)-platform.
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Melding 01/10-21 - Dose µ400
Oslo, 1 October 2021: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced it has started dosing of the second cohort in the Phase I TENDU trial, evaluating the Company’s Tetanus-Epitope Targeting (TET)-platform.
“We are pleased to continue to advance this Phase 1 trial evaluating Ultimovacs’ TET platform in prostate cancer. The 400 μg dose, which we are now investigating, is in a clinically relevant range predicted by preclinical studies,”
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Melding 3/2-22 -Dose µg 960
Dose 40 og 400 ferdig innrullert med 6 pasienter.
Oslo, 3 February 202 2 : Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced it has completed treatment of the second dose cohort in the Phase I TENDU trial. The study is designed to evaluate the Company’s Tetanus-Epitope Targeting (TET)-platform in patients with prostate cancer.
The Drug Safety Monitoring Board (DSMB), a group of experts set up to monitor patient safety during a clinical trial, found no safety concerns related to the first two dose cohorts. A total of six patients have been treated; three in each dose level (40 and 400 μg). The conclusion from the DSMB enables the dose escalation study to proceed with enrollment of patients in the third and last dose cohort (960 μg).
“The continued progress of the Phase 1 safety evaluation of the TET platform is very encouraging.” said Jens Bjørheim, Chief Medical Officer of Ultimovacs . “Our main focus at this stage in the TENDU study is the safety and tolerability of our new therapeutic vaccine candidate for prostate cancer, a cancer type where the unmet medical need is high. This result also feeds into Ultimovacs’ plans for the development of the TET platform more broadly as an extension of the company’s pipeline.”
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Melding 19/8-22 Q2/22
3 pasienter µg960 ferdig innrullert. De varsler at de vil innrullere inntil 3 til på mcg960.
• TENDU trial: 9 patients have been enrolled to date, up from 8 as of the previous
quarterly report. The three main dosing cohorts are fully enrolled, and no safety
concerns or dose-limiting toxicities have been observed. Up to three additional
patients will be added at the highest dose level of 960 mcg.
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Melding 9/11-22 Q3 rapport:
• TENDU trial (prostate cancer): 10 out of 12 patients have been enrolled to date, up
from 9 as of the previous quarterly report. The three main dosing cohorts are fully
enrolled, and no safety concerns or dose-limiting toxicities have been observed.
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Melding 14/12- 2022 - Completed
Oslo, 14 December 2022: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announced that last patient enrollment has been completed in the Phase I TENDU trial in prostate cancer. Patients with relapse after primary radical prostatectomy received four doses of the TENDU vaccine during a 6-week treatment period. Three different dose levels have been explored (40, 400, 960 mcg) and half of the patients were treated at the highest dose level.
“We are pleased to have completed the enrollment of patients in the first clinical trial based on the TET platform technology”, said Carlos de Sousa, Chief Executive Officer at Ultimovacs . “The TET platform represents an innovative approach that can provide the flexibility to incorporate different antigens in vaccines relevant in different tumor types and stages.”
Som dette viser var hodedelen av studien med 3 pasienter på hvert dosenivå ferdig innrullert ved Q3 presentasjonen den 19. august 2022.
Høsten 2022 ble så de 3 tilleggspasientene som fikk høyeste dose 960mcg innrullert og ferdig 14. desember.
Det har nå gått snart et år siden de første 9 pasientene var ferdig innrullert og 6 måneders oppfølgningen av disse må ha vært ferdig slik at resultatene nå skal suppleres med de 3 siste i fjor høst innrullerte.
Vil tro at en melding om TENDU studien / TET ikke bør være langt unna.
Det er 0,2% grense for å melde inn til Finanstilsynet, men systemet deres offentliggjør utad fortsatt bare ved 0,5%.