Targovax announces that the ONCOS-102 and durvalumab trial succe
Targovax announces that the ONCOS-102 and durvalumab trial successfully completes part 1 in colorectal cancer
· The pre-defined disease control efficacy threshold in part 1 in the colorectal
cancer cohort has been met
· The colorectal expansion cohort has been opened for recruitment of 14
additional patients
· The pre-defined disease control efficacy threshold in ovarian cancer was not
met and this cohort will be closed for enrollment
Oslo, Norway, 13 October 2020 - Targovax ASA (OSE: TRVX), a clinical stage
immuno-oncology company developing oncolytic viruses to target hard-to-treat
solid tumors, today announced that the colorectal cancer cohort in part 1 of the
ONCOS-102 and durvalumab trial in colorectal and platinum-resistant ovarian
cancer that has spread to the peritoneum has met the pre-defined efficacy
threshold of patients without progression at the end of week 24. The second part
of the colorectal expansion cohort is now open for recruitment.
The study is an open label, exploratory phase I/II trial assessing the
combination of intra-peritoneally delivered ONCOS-102 in combination with
systemically administered durvalumab, an anti-PD-L1 checkpoint inhibitor, in
patients with colorectal (CRC) or platinum-resistant ovarian (OC) cancers that
have metastasized to the peritoneal cavity. The trial is designed with a dose
-escalation phase assessing three different dosing levels, followed by an
expansion phase split into separate CRC and OC cohorts. The expansion phase is
divided into two parts, where the second part is opened only if a pre-defined
efficacy threshold is met in the first part. The efficacy threshold in the CRC
cohort is 1 out of 13 patients and 5 out of 18 patients in the OC cohort without
progression at week 24.
Ludwig Cancer Research, the trial sponsor, and the investigators have reviewed
the available data in part 1 of the expansion phase and concluded that the
threshold has been met in the CRC cohort. The second part of the CRC cohort has
therefore been opened for recruitment with the aim of enrolling 14 additional
patients. For OC, threshold was not met, and this cohort has been closed for
further recruitment.
Dr. Dmitriy Zamarin, Medical Oncologist at Memorial Sloan Kettering Cancer
Center (MSK), Investigator at the Ludwig Center at MSK and Principal
Investigator of the study, said: "Chemotherapy-resistant microsatellite-stable
colorectal cancer is a challenging disease to treat, with a response rate to
immune checkpoint inhibitor monotherapy of less than 5%. We are hopeful that the
immune activation by ONCOS-102 in peritoneal cavity may sensitize these tumors
to immune checkpoint inhibition and improve this response rate."
Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "The first part
of the trial has allowed us to determine which primary cancer holds most promise
for future development of ONCOS-102 in the intra-peritoneal setting. We are very
pleased to see that the efficacy threshold has been met for the CRC cohort, and
will now focus exclusively on this patient population of primary, platinum
-resistant CRC with peritoneal metastases for the second part of the trial. This
is a large patient group with no effective available treatment alternatives
today, and we are hopeful that this novel combination of immunotherapies can
deliver benefit in this disease with very high unmet medical need."
The trial is a collaboration between Targovax, AstraZeneca (LSE/STO/Nasdaq:
AZN), Cancer Research Institute (CRI) and Ludwig Cancer Research.
· The pre-defined disease control efficacy threshold in part 1 in the colorectal
cancer cohort has been met
· The colorectal expansion cohort has been opened for recruitment of 14
additional patients
· The pre-defined disease control efficacy threshold in ovarian cancer was not
met and this cohort will be closed for enrollment
Oslo, Norway, 13 October 2020 - Targovax ASA (OSE: TRVX), a clinical stage
immuno-oncology company developing oncolytic viruses to target hard-to-treat
solid tumors, today announced that the colorectal cancer cohort in part 1 of the
ONCOS-102 and durvalumab trial in colorectal and platinum-resistant ovarian
cancer that has spread to the peritoneum has met the pre-defined efficacy
threshold of patients without progression at the end of week 24. The second part
of the colorectal expansion cohort is now open for recruitment.
The study is an open label, exploratory phase I/II trial assessing the
combination of intra-peritoneally delivered ONCOS-102 in combination with
systemically administered durvalumab, an anti-PD-L1 checkpoint inhibitor, in
patients with colorectal (CRC) or platinum-resistant ovarian (OC) cancers that
have metastasized to the peritoneal cavity. The trial is designed with a dose
-escalation phase assessing three different dosing levels, followed by an
expansion phase split into separate CRC and OC cohorts. The expansion phase is
divided into two parts, where the second part is opened only if a pre-defined
efficacy threshold is met in the first part. The efficacy threshold in the CRC
cohort is 1 out of 13 patients and 5 out of 18 patients in the OC cohort without
progression at week 24.
Ludwig Cancer Research, the trial sponsor, and the investigators have reviewed
the available data in part 1 of the expansion phase and concluded that the
threshold has been met in the CRC cohort. The second part of the CRC cohort has
therefore been opened for recruitment with the aim of enrolling 14 additional
patients. For OC, threshold was not met, and this cohort has been closed for
further recruitment.
Dr. Dmitriy Zamarin, Medical Oncologist at Memorial Sloan Kettering Cancer
Center (MSK), Investigator at the Ludwig Center at MSK and Principal
Investigator of the study, said: "Chemotherapy-resistant microsatellite-stable
colorectal cancer is a challenging disease to treat, with a response rate to
immune checkpoint inhibitor monotherapy of less than 5%. We are hopeful that the
immune activation by ONCOS-102 in peritoneal cavity may sensitize these tumors
to immune checkpoint inhibition and improve this response rate."
Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "The first part
of the trial has allowed us to determine which primary cancer holds most promise
for future development of ONCOS-102 in the intra-peritoneal setting. We are very
pleased to see that the efficacy threshold has been met for the CRC cohort, and
will now focus exclusively on this patient population of primary, platinum
-resistant CRC with peritoneal metastases for the second part of the trial. This
is a large patient group with no effective available treatment alternatives
today, and we are hopeful that this novel combination of immunotherapies can
deliver benefit in this disease with very high unmet medical need."
The trial is a collaboration between Targovax, AstraZeneca (LSE/STO/Nasdaq:
AZN), Cancer Research Institute (CRI) and Ludwig Cancer Research.
Redigert 20.01.2021 kl 21:14
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Knfo
13.10.2020 kl 08:03
2014
Jeg traff veldig bra med tidspunktet jeg antydet for ONCOS-102 oppdateringen, men hadde håpet på en melding med enda bedre innhold. Blir spennende å se hvordan markedet reagerer på dagens børsmelding.
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SomSa
13.10.2020 kl 09:17
1749
Durvalumab er PD-L1 og konkurrenten med 35% ORR ble kjøpt opp for ca. USD 400 mil. AstraZeneca har ikke sin egen virus men de har inngått lisensavtale. Studien sponses av ancer Research Institute (CRI) and Ludwig Cancer Research og AstraZeneca med minimal utgifter for Targovax.
Oncos-102 testes også med Pembrolizumab (Keytruda) fra MSD som er PD-1 og har den beste resultatet blant sine konkurrenter.
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Oslo (TDN Direkt): Targovax annonserer en utvidelse av studien med ONCOS-102 i kombinasjon med durvalumab i pasienter med tykk- og endetarmkreft med spredning til bukhinnen.
Det fremgår av en melding tirsdag.
Studien utvides siden den første gruppen av tykk- og endetarmkreftpasienter har oppnådd det forhåndsdefinerte kriteriet for klinisk effekt. Studien utvides dermed for rekruttering av ytterligere 14 pasienter. For pasienter med eggstokkreft ble ikke det definerte kriteriet for effekt nådd, og denne delen av studien avsluttes, fremgår det.
Studien er et samarbeid mellom Targovax, AstraZeneca, Cancer Research Institute (CRI) og Ludwig Cancer Research.
Redigert 20.01.2021 kl 21:14
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Knfo
13.10.2020 kl 09:31
1649
Dette var jo en melding med mer luft enn substans. Er redd aksjekursen raser nedover på dette.
Redigert 20.01.2021 kl 21:14
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Selv om kursen ikke kommer til å skyte i været grunnet denne meldingen, så er det da ingen grunn til at den skal rase nedover heller.
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illuminati
13.10.2020 kl 11:21
1439
Selvfølgelig kunne vi håpe at begge indikasjonene ville oppnådd kriteriet for videre rekruttering, men vi skal også være klar over at ingen av de 2 indikasjonene har noen alternativ behandling. 5% reagerer på behandling med CPI, det forteller litt om hvor vanskelig denne kreftformen er å behandle. At vi nå ser gode nok resultater i colorectal cancer til å fortsette studien og det er lovende. Targovax har gått løs på det umulige for å bevis at Oncos kan utgjøre en forskjell, det er nå “bevist” i tre av fire indikasjoner, colorectal, melanoma og mesothelioma, vi kan vel ikke definere det som skuffende selv om vi gjerne skulle ønske å hjelpe de med eggstokk kreft med spredning til bukhinna/bukhulen.
Redigert 20.01.2021 kl 21:14
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SomSa
13.10.2020 kl 11:32
1406
Hvis Oncos-102 kan behandle kun 20000 pasienter innen disse 4 krefttypene og en behandling koster i snitt USD 45000 blir den årlige omsettingen USD 900mil eller over 8 mrd kroner. Magnus spår at Oncos-102 + CPI kombinasjonen kan gi en kraftig forbedring av mesothelioma behandlingen. Han sier dette basert på hva Oncos-102 og PD-1 CPI alene har oppnådd i mesothelioma og Oncos-102 + PD-1 CPI i hudkreft. Jeg antar at de får fast track for dette.
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focuss
13.10.2020 kl 11:50
1359
At de oppnår det de er ute etter i Colorectal ser jeg som en ren bonus og AZ &Co vil gå videre med det. Det vi venter på er jo melonoma og meotheliom data. Det er her vi kan få en trigger av betydning.
Redigert 20.01.2021 kl 21:14
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Enig, blir meget spennende og få disse dataene, gode data der så vil virkelig aksjen skyte fart!
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illuminati
13.10.2020 kl 12:25
1268
Targovax med sin Oncos har ikke siktet seg inn på indikasjoner med størst utbredelse, men indikasjoner som kan gi dem rask tilgang til markedet, lykkes det kan de gå løs på de med størst utbredelse i første linje. Colorectal cancer ligger som nummer 2 på skalaen etter pancreas over kreftformer med høyest innslag av Ras mutert kreft. Spredningen til bukhinne/bukhule går over tid, behandle colorectal på et tidligere stadium med både Oncos, TG og CPI kunne mulig stoppet colorectal kreften til å spre seg til nettopp bukhinne/bukhule.
Redigert 20.01.2021 kl 21:14
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