ONCOS-102, Positive data :)
Responses observed in three out of six patients
Recruitment into the randomized part of the trial underway
Oslo, Norway, 2 May 2018 - Targovax ASA (OSE: TRVX), a clinical stage company
focused on developing immuno-oncology therapies to target solid tumors, today
announces encouraging results from its phase I/II trial of ONCOS-102 in
mesothelioma, in combination with standard of care chemotherapy, in which
clinical responses were observed in three out of the first six patients.
The trial is a randomized phase I/II open label trial, with a six-patient safety
lead-in cohort, of ONCOS-102 and pemetrexed/cisplatin, the current standard of
care chemotherapy, in patients with unresectable malignant pleural mesothelioma.
The aim of the trial is to assess safety and tolerability, immunological
activation and overall response rate of the combination of ONCOS-102 and
chemotherapy compared to chemotherapy alone. In February, Targovax reported that
the independent Data and Safety Monitoring Board (DSMB) had assessed the safety
data from the lead-in cohort, and recommended the trial continue into the
randomized phase without modifications. In addition, innate and adaptive immune
activation was observed in the first patients analyzed.
Now, overall response rate has been evaluated for all six patients in the safety
cohort after six months. Three out of the six patients (50%) responded, with one
patient showing a partial response and two patients showing stable disease,
according to the Response Evaluation Criteria In Solid Tumors guidelines, RECIST
1.1.
All patients in the safety cohort received ONCOS-102 and chemotherapy
combination treatment either as 1(st) line (three patients), or after previous
treatment (three patients, 2(nd)/3(rd) line). Two out of three patients in
1(st) line responded, and one of three patients that had received previous
treatment responded.
Based on this early signal of efficacy, and the previous DSMB recommendation,
recruitment into the randomized part of the trial is now underway. The trial
will include 30 patients when fully recruited, with 20 patients in the
experimental group (including the safety cohort) and 10 patients in the control
group.
Dr. Luis Paz-Ares, Chair of the Medical Oncology Department at the University
Hospital 12 de Octubre, Madrid and Principal Investigator of the trial said:
"Mesothelioma is a challenging disease to treat, with few patients surviving
beyond 12 months from diagnosis. The three clinical responses observed in the
safety lead-in cohort of the ONCOS-102 trial are encouraging. We look forward to
entering the randomized part of the trial which will further evaluate the
potential of this novel, innovative treatment to benefit more patients in the
future."
Magnus Jäderberg, CMO of Targovax, added: " We are very pleased to have
completed the safety part of the study, with the DSMB giving us approval to open
up the randomized part and start recruiting patients. This is the first time
clinical response has been observed for ONCOS-102 in combination with
chemotherapy, which is an important milestone for Targovax and the ONCOS
program. It will now be interesting to see if this early signal of efficacy is
confirmed in the randomized part of the study."
More information about the mesothelioma trial and results will be provided at
the Targovax Q1 presentation and webcast on 3 May at 10am CET.
Recruitment into the randomized part of the trial underway
Oslo, Norway, 2 May 2018 - Targovax ASA (OSE: TRVX), a clinical stage company
focused on developing immuno-oncology therapies to target solid tumors, today
announces encouraging results from its phase I/II trial of ONCOS-102 in
mesothelioma, in combination with standard of care chemotherapy, in which
clinical responses were observed in three out of the first six patients.
The trial is a randomized phase I/II open label trial, with a six-patient safety
lead-in cohort, of ONCOS-102 and pemetrexed/cisplatin, the current standard of
care chemotherapy, in patients with unresectable malignant pleural mesothelioma.
The aim of the trial is to assess safety and tolerability, immunological
activation and overall response rate of the combination of ONCOS-102 and
chemotherapy compared to chemotherapy alone. In February, Targovax reported that
the independent Data and Safety Monitoring Board (DSMB) had assessed the safety
data from the lead-in cohort, and recommended the trial continue into the
randomized phase without modifications. In addition, innate and adaptive immune
activation was observed in the first patients analyzed.
Now, overall response rate has been evaluated for all six patients in the safety
cohort after six months. Three out of the six patients (50%) responded, with one
patient showing a partial response and two patients showing stable disease,
according to the Response Evaluation Criteria In Solid Tumors guidelines, RECIST
1.1.
All patients in the safety cohort received ONCOS-102 and chemotherapy
combination treatment either as 1(st) line (three patients), or after previous
treatment (three patients, 2(nd)/3(rd) line). Two out of three patients in
1(st) line responded, and one of three patients that had received previous
treatment responded.
Based on this early signal of efficacy, and the previous DSMB recommendation,
recruitment into the randomized part of the trial is now underway. The trial
will include 30 patients when fully recruited, with 20 patients in the
experimental group (including the safety cohort) and 10 patients in the control
group.
Dr. Luis Paz-Ares, Chair of the Medical Oncology Department at the University
Hospital 12 de Octubre, Madrid and Principal Investigator of the trial said:
"Mesothelioma is a challenging disease to treat, with few patients surviving
beyond 12 months from diagnosis. The three clinical responses observed in the
safety lead-in cohort of the ONCOS-102 trial are encouraging. We look forward to
entering the randomized part of the trial which will further evaluate the
potential of this novel, innovative treatment to benefit more patients in the
future."
Magnus Jäderberg, CMO of Targovax, added: " We are very pleased to have
completed the safety part of the study, with the DSMB giving us approval to open
up the randomized part and start recruiting patients. This is the first time
clinical response has been observed for ONCOS-102 in combination with
chemotherapy, which is an important milestone for Targovax and the ONCOS
program. It will now be interesting to see if this early signal of efficacy is
confirmed in the randomized part of the study."
More information about the mesothelioma trial and results will be provided at
the Targovax Q1 presentation and webcast on 3 May at 10am CET.
Redigert 20.01.2021 kl 19:55
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Spekulatorspurv
02.05.2018 kl 07:42
3515
Håper du har rett. Blir spennende å høre mer om dataene på presentasjonen imorgen, dette er jo en helt unik mulighet til å komme seg inn på en bra kurs. Tipper vi ser 18 idag i allefall, kanskje kan vi klare 20 iløpet av uken om vi er heldige. Denne suser lett over 30 alt i år. Skal ikke utelukke at vi tar en PCIB og toucher 40 også for så å falle ned igjen. Merkelig att ikke flere viser interesse for denne aksjen. Biotec blir man ikke klok på, hehe.
Redigert 20.01.2021 kl 19:55
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Spekulatorspurv
02.05.2018 kl 07:47
3500
Targovax ASA melder at fase I/II-studien med ONCOS-102 i mesotheliom i kombinasjon med kjemoterapi viser oppløftende resultater.
Klinisk respons ble observert hos tre av de seks første pasientene, i en sjelden form av lungekreft som er svært vanskelig å behandle.
- Vi er veldig fornøyd med å ha fullført safety-delen, og at vi har fått godkjenning til å fortsette med den randomiserte delen av studien. Dette er første gang vi ser klinisk respons for ONCOS-102 i kombinasjon med kjemoterapi, så dette er en viktig milepæl for Targovax og ONCOS-programmet. Det blir spennende å se om denne tidlige indikasjonen på effekt blir bekreftet i den randomiserte delen av studien, sier Magnus Jäderberg, medisinsk direktør i Targovax, i en melding.
Forsøket er et randomisert fase I/II studie, med seks pasienter som får ONCOS-102 og pemtetrexed/cisplatin som er nåværende standardbehandling for pasientgruppen med inoperabel malignant pleuralt mesotheliom. Dette er kreft i lungesekken, som ofte er forårsaket av asbesteksponering, og pasientene har få behandlingsmuligheter og svært dårlige prognoser.
Målet med studien er å vurdere toleranse, immunaktivering og klinisk respons med kombinasjonen av ONCOS-102 og kjemoterapi, sammenlignet med kjemoterapi alene.
I februar rapporterte Targovax at det uavhengige organet «Data and Safety Monitoring Board» (DSMB) hadde vurdert toleranse-data fra den første safety-kohorten, og anbefalt at studien fortsatte inn i den randomiserte fasen uten endringer. I tillegg ble aktivering av både det medfødte og adaptive immunsystemet observert i de første pasientene som ble analysert. Nå har responsraten blitt analysert for alle seks pasienter i safety-kohorten etter seks måneders behandling. Tre av seks pasienter (50 prosent) responderte, med én pasient som viste delvis respons og to pasienter som viste stabil sykdom, i henhold til responsevalueringskriteriene som benyttes i slike studier (RECIST 1.1).
Alle pasienter i kohorten fikk ONCOS-102 og kjemoterapi som kombinasjonbehandling. Behandlingen ble gitt som førstelinje i tre pasienter, mens de tre andre hadde fått tidligere behandling med kjemoterapi (andrelinje). To av tre pasienter i førstelinje responderte, mot en av de tre som hadde fått tidligere behandling. Basert på denne tidlige indikasjonen på effekt, og den forutgående anbefalingen fra DSMB, er det nå igangsatt rekruttering til den randomiserte delen av studien. Totalt vil 30 pasienter delta, 20 pasienter i forsøksgruppen og 10 i kontrollgruppen.
Dr. Luis Paz-Ares, Leder for kreftavdelingen ved Universitetssykehuset Hospital 12 de Octubre i Madrid, og ansvarlig lege for studien sier:
- Mesotheliom er en krevende sykdom å behandle, og svært få pasienter overlever mer enn 12 måneder fra diagnose. Den kliniske responsen vi observerte hos tre deltakere i sikkerhetskohorten av ONCOS-102-studien er derfor lovende. Vi ser fram til å jobbe videre med den randomiserte delen av studien, og håper denne nye og innovative behandlingen kan komme til nytte for flere pasienter i fremtiden.
Klinisk respons ble observert hos tre av de seks første pasientene, i en sjelden form av lungekreft som er svært vanskelig å behandle.
- Vi er veldig fornøyd med å ha fullført safety-delen, og at vi har fått godkjenning til å fortsette med den randomiserte delen av studien. Dette er første gang vi ser klinisk respons for ONCOS-102 i kombinasjon med kjemoterapi, så dette er en viktig milepæl for Targovax og ONCOS-programmet. Det blir spennende å se om denne tidlige indikasjonen på effekt blir bekreftet i den randomiserte delen av studien, sier Magnus Jäderberg, medisinsk direktør i Targovax, i en melding.
Forsøket er et randomisert fase I/II studie, med seks pasienter som får ONCOS-102 og pemtetrexed/cisplatin som er nåværende standardbehandling for pasientgruppen med inoperabel malignant pleuralt mesotheliom. Dette er kreft i lungesekken, som ofte er forårsaket av asbesteksponering, og pasientene har få behandlingsmuligheter og svært dårlige prognoser.
Målet med studien er å vurdere toleranse, immunaktivering og klinisk respons med kombinasjonen av ONCOS-102 og kjemoterapi, sammenlignet med kjemoterapi alene.
I februar rapporterte Targovax at det uavhengige organet «Data and Safety Monitoring Board» (DSMB) hadde vurdert toleranse-data fra den første safety-kohorten, og anbefalt at studien fortsatte inn i den randomiserte fasen uten endringer. I tillegg ble aktivering av både det medfødte og adaptive immunsystemet observert i de første pasientene som ble analysert. Nå har responsraten blitt analysert for alle seks pasienter i safety-kohorten etter seks måneders behandling. Tre av seks pasienter (50 prosent) responderte, med én pasient som viste delvis respons og to pasienter som viste stabil sykdom, i henhold til responsevalueringskriteriene som benyttes i slike studier (RECIST 1.1).
Alle pasienter i kohorten fikk ONCOS-102 og kjemoterapi som kombinasjonbehandling. Behandlingen ble gitt som førstelinje i tre pasienter, mens de tre andre hadde fått tidligere behandling med kjemoterapi (andrelinje). To av tre pasienter i førstelinje responderte, mot en av de tre som hadde fått tidligere behandling. Basert på denne tidlige indikasjonen på effekt, og den forutgående anbefalingen fra DSMB, er det nå igangsatt rekruttering til den randomiserte delen av studien. Totalt vil 30 pasienter delta, 20 pasienter i forsøksgruppen og 10 i kontrollgruppen.
Dr. Luis Paz-Ares, Leder for kreftavdelingen ved Universitetssykehuset Hospital 12 de Octubre i Madrid, og ansvarlig lege for studien sier:
- Mesotheliom er en krevende sykdom å behandle, og svært få pasienter overlever mer enn 12 måneder fra diagnose. Den kliniske responsen vi observerte hos tre deltakere i sikkerhetskohorten av ONCOS-102-studien er derfor lovende. Vi ser fram til å jobbe videre med den randomiserte delen av studien, og håper denne nye og innovative behandlingen kan komme til nytte for flere pasienter i fremtiden.
Redigert 20.01.2021 kl 19:55
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Differenza
02.05.2018 kl 15:50
3150
Senaste dealen inom onkolytiska virus värd 1 miljard dollar!!!
Indikerar ett framtida värde på Targovax:)
https://endpts.com/playing-the-long-game-in-i-o-jj-inks-1-04b-deal-to-buy-oncolytic-virus-platform-biotech-benevir/
Indikerar ett framtida värde på Targovax:)
https://endpts.com/playing-the-long-game-in-i-o-jj-inks-1-04b-deal-to-buy-oncolytic-virus-platform-biotech-benevir/
Redigert 20.01.2021 kl 19:55
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Spekulatorspurv
16.05.2018 kl 09:47
2774
Så bra, det kan bli en fin investering, det kommer data om få dager, 3 forskjellige konferanser :)
Satser på et etterlengtet byks nå!
Targovax to present at upcoming investor and industry conferences
Oslo, Norway, 16 May 2018 - Targovax ASA (OSE: TRVX), a clinical stage company
focused on developing immuno-oncology therapies to target solid tumors,
announces that members of its senior management will present at the following
life sciences and investor conferences:
Date: 17 May 2018
Poster presentation:
The Combinatory Treatment of the Oncolytic Adenovirus ONCOS-102 with Anti PD-1
(Keytruda(®)) Show Synergistic Anti-Tumor Effect in Humanized A2058 Melanoma
huNOG Mouse Model
Venue: 21st Annual Meeting of the American Society of Gene & Cell Therapy,
Chicago, USA
Presentation time: 5:15 PM - 7:15 PM CDT
Presenter: Anne-Sophie Møller (Head of Clinical Science) and Lukasz Kuryk
(Director, Clinical Science)
Date: 23 May 2018
Venue: ABGSC Cancer Seminar, Stockholm, Sweden
Presentation time: 09:00 CET
Presenter: Magnus Jäderberg (CMO)
Date: 28 May 2018
Venue: Redeye Pre-ASCO Seminar, Stockholm, Sweden
Presentation time: 11:05 CET
Presenter: Erik Digman Wiklund (CFO)
The presentations will be available to download at www.targovax.com following
these events.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no
Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: Targovax@fticonsulting.com
About Targovax
Arming the patient's immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage company focused on developing and
commercializing novel immuno-oncology therapies to target, primarily, treatment-
resistant solid tumors. Immuno-oncology is currently one of the fastest growing
therapeutic fields in medicine.
The Company's development pipeline is based on two novel proprietary platforms:
The first platform, ONCOS, uses oncolytic viruses as potential multi-target,
neo-antigen therapeutic cancer vaccines. ONCOS uses an adenovirus that has been
engineered to be an immune activator that selectively targets cancer cells. In
phase I trials it has demonstrated immune activation at lesional level which was
associated with clinical benefit. In an ongoing phase I trial in advanced
melanoma we expect important proof of concept data for checkpoint inhibitor
refractory patients.
The second platform, TG, are neo-antigen cancer vaccines designed to
specifically treat tumors that express mutated forms of RAS. Mutations to the
RAS protein are common in many cancers and are known to drive aggressive disease
progression and treatment resistance. There is a high unmet medical need for
therapies that are effective against tumors that express these mutations. The TG
platform's therapeutic potential stems from its ability to enable the patient's
immune system to identify and destroy tumors bearing any RAS mutations. In early
2017, key proof of concept data for the TG platform from a clinical trial of
TG01 in resected pancreatic cancer patients showed encouraging overall survival
and will give guidance for the future clinical development of this platform.
Targovax's development pipeline has three novel therapeutic candidates in
clinical development covering six indications.
Both platforms are protected by an extensive portfolio of IP and know-how and
have the potential to yield multiple product candidates in a cost-effective
manner. Additionally, Targovax has other products in early stages of
development.
This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Satser på et etterlengtet byks nå!
Targovax to present at upcoming investor and industry conferences
Oslo, Norway, 16 May 2018 - Targovax ASA (OSE: TRVX), a clinical stage company
focused on developing immuno-oncology therapies to target solid tumors,
announces that members of its senior management will present at the following
life sciences and investor conferences:
Date: 17 May 2018
Poster presentation:
The Combinatory Treatment of the Oncolytic Adenovirus ONCOS-102 with Anti PD-1
(Keytruda(®)) Show Synergistic Anti-Tumor Effect in Humanized A2058 Melanoma
huNOG Mouse Model
Venue: 21st Annual Meeting of the American Society of Gene & Cell Therapy,
Chicago, USA
Presentation time: 5:15 PM - 7:15 PM CDT
Presenter: Anne-Sophie Møller (Head of Clinical Science) and Lukasz Kuryk
(Director, Clinical Science)
Date: 23 May 2018
Venue: ABGSC Cancer Seminar, Stockholm, Sweden
Presentation time: 09:00 CET
Presenter: Magnus Jäderberg (CMO)
Date: 28 May 2018
Venue: Redeye Pre-ASCO Seminar, Stockholm, Sweden
Presentation time: 11:05 CET
Presenter: Erik Digman Wiklund (CFO)
The presentations will be available to download at www.targovax.com following
these events.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no
Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: Targovax@fticonsulting.com
About Targovax
Arming the patient's immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage company focused on developing and
commercializing novel immuno-oncology therapies to target, primarily, treatment-
resistant solid tumors. Immuno-oncology is currently one of the fastest growing
therapeutic fields in medicine.
The Company's development pipeline is based on two novel proprietary platforms:
The first platform, ONCOS, uses oncolytic viruses as potential multi-target,
neo-antigen therapeutic cancer vaccines. ONCOS uses an adenovirus that has been
engineered to be an immune activator that selectively targets cancer cells. In
phase I trials it has demonstrated immune activation at lesional level which was
associated with clinical benefit. In an ongoing phase I trial in advanced
melanoma we expect important proof of concept data for checkpoint inhibitor
refractory patients.
The second platform, TG, are neo-antigen cancer vaccines designed to
specifically treat tumors that express mutated forms of RAS. Mutations to the
RAS protein are common in many cancers and are known to drive aggressive disease
progression and treatment resistance. There is a high unmet medical need for
therapies that are effective against tumors that express these mutations. The TG
platform's therapeutic potential stems from its ability to enable the patient's
immune system to identify and destroy tumors bearing any RAS mutations. In early
2017, key proof of concept data for the TG platform from a clinical trial of
TG01 in resected pancreatic cancer patients showed encouraging overall survival
and will give guidance for the future clinical development of this platform.
Targovax's development pipeline has three novel therapeutic candidates in
clinical development covering six indications.
Both platforms are protected by an extensive portfolio of IP and know-how and
have the potential to yield multiple product candidates in a cost-effective
manner. Additionally, Targovax has other products in early stages of
development.
This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Redigert 20.01.2021 kl 19:55
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