Fikk du noe svar på mailen @Cinvest?
Har sjekket opp i dette “surret”, da jeg tror folk tar dette litt feil.
- Studien har stått som ferdig i Juli 2018 siden januar 2016 og frem til april 2018. Så jeg ser det som stor tilfeldighet at de nå har oppdatert dette til nå H1 2020 for Melanoma studien. De skriver dette i kriteriene, noe som jeg mener er høyst sansynelig grunnen til at de må ut i 2020.
- All patients must agree to use barrier contraception (i.e. condom) during study treatment and for 2 months after the last virus treatment and 4 months after the last dose of chemotherapy and pembrolizumab.
Videre, så tenker jeg også at selskapet sa i Q1 at det er H12019 som gjelder for fult datasett i Melanoma Studien, og det er enda ikke endret på dette offisielt. Så la oss heller ikke skape mer ut av det enn det er.
Det kommer data på 4 nå rett rundt hjørnet da de 4 var ferdig dosert i Januar, og 6 med etter er i nå i september siktet. Det er nok innen for å få inn 8 pasienter til på 3 ulike rekrutteringssentre. så jeg sitter rolig og nyter at Soug og co jobber for meg!
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Jeg håper du har rett, men har sendt mail til Renate Birkeli (IR) for å avkrefte/bekrefte utsettelsen. Deler så snart (hvis) jeg får svar.
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To ting her, at det står at studiet er ferdig i 2020 kan ha med avlesing av PFS og OS å gjøre, så ingen grunn til panikk.
Men dere som tror at en utsettelse av guidingen blir børsmeldt har ikke fulgt med i timen. Det er helt vanlig innenfor denne bransjen. Endinger blir bare oppdatert under kvartalspresentasjoner o.l-
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TRVX har ikke gitt opp enda med TG-platformen 
Conference Day Two | Friday November 16 2018
10.30 TG01 - A Neo-antigen Specific Peptide Vaccine
Targeting RAS Mutations in Solid Tumors
• RAS mutations, a well characterised neo-antigen and
therefore a most attractive target
• TG01, a 7 peptide vaccine able to cover 98% of RAS
mutations in pancreas cancer
• Encouraging phase II clinical data using
• TG01 in combination with adjuvant chemotherapy in
resected pancreas cancer
Magnus Jaderberg, Chief Medical Officer, Targovax
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December 4-6th, 2018 Boston, MA
This year we will be incorporating commercial insights from companies such as Amgen, Pfizer, Merck, Replimune, Targovax, DNAtrix, Vyriad, Virogin and many more, which will allow you to learn from their case studies and improve your development strategies. Participate in the interactive roundtable and workshops to build strategies that maximise success in the clinic and commercially. Want to know more?
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Hvor kan man finne mer informasjon om Oncos 103-104-105? Lite info på hjemmesiden.
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Burde vel stå en del i kvartallspresentasjonene tenker jeg. Ellers publiserte Savepig tror jeg d var, en god oppsummeringspresentasjon gjort til ABG Collier her for noen uker siden.
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Dags för lite nyheter från Targovax. Vem vet, det kanske kommer något nästa vecka.
Trevlig helg!
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Targovax har sagt at de planlegger CMD i oktober. Dato er såvidt jeg vet ikke fastsatt. Flere enn meg som tenker at selskapet går og venter på data fra en av stuidene før dato for CMD blir offentlig gjort? 
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I påvente av nyheter, er det spennende å grave litt fra tiden oncos-102 ble utviklet av Oncos-Therapeutics. Denne er fra 2012. Det beviser jo at Targovax sitt virus virkelig har blitt utviklet over lang tid, og at man har mye god dokumentasjon, spesielt mtp safety.
The patient data cumulated over the past 5 years have contributed significantly to the design of the entire clinical development program of the company. “In addition to existing clinical safety data, which is unique to this stage of development, we also have a wealth of supportive data to guide the selection of target tumor types, optimal treatment administration, and other essential elements including clues regarding mechanism of action and possible biomarkers. We are very excited about the design of our entire development program driven by clinical data,” summarizes Chief Medical Officer and Head of Research of Oncos Therapeutics, Mikael von Euler.
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Targovax ASA: Issuance of options to primary insider
Oslo, 25 September 2018: Reference is made to the announcement made by Targovax
ASA (“Targovax” or the “Company”) on 13 September 2018 regarding the appointment
of Torbjørn Furuseth as the new CFO of the Company.The Board of Directors has resolved to grant 200,000 share options in the
Company under the Company’s long term incentive program, each with a strike
price of NOK 10.26, to Torbjørn Furuseth.Following the grant Torbjørn Furuseth holds nil shares and 200,000 options in
the Company.The options are granted without consideration. Pursuant to the vesting schedule,
25% of the options will vest 12 months after the day of grant (as long as the
option holder is still employed). Thereafter, 1/36 of the remaining options will
vest each month as long as the option holder is employed, with the first 1/36
vesting 13 months after the day of grant. The strike price is equal to the
volume weighted average trading price of the shares of the Company on Oslo Børs
on the date of the grant. Options that have not been exercised will lapse 7
years after the date of grant.For further information, please contact:
Øystein Soug, CEO
Phone: +47 90 6565 25
Email: [email protected]Ekstern link: http://www.newsweb.no/index.jsp?messageId=460088
Nyheten er levert av OBI.
http://www.netfonds.no/quotes/release.php?id=20180925.OBI.20180925S15
Er det noe de er gode på i disse biotek selskapene, så er det å dele ut opsjoner til seg selv. Oss andre må bare leve i infotørke…
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Jeg synes jeg så en udtalelse fra TRVX om at der kommer information i oktober om det produkt der er sat på hold. Er der andre der ved lidt mere om det?
Det du referer til er TG-01 vaksinen, som kjørte en fase 1/2 studie i Bukspyttkjertelkreft. Målgruppen var da pasienter som hadde fjernet tumoren. Oppløftende overlevelses resultater på de 32 pasientene, sett i forhold til SoC, spesielt i cohort 2. De var i grunn klare for det som kunne utvikle seg til å bli en registrerings studie, men så kom en konkurrent på sidelinjen, ut av det blå nærmest, og viste slam dunk resultater. I utgangspunktet kunne Targovax kjørt TG01 i kombinasjon med Folfirinox ( som viste slam dunk resultater), men det ville tatt minimum 5-7 år og få data. Noe som sier seg selv ikke er veldig økonomisk fornuftig for et lite biotek selskap. Kjipt for Targovax, men utrolig bra for pasientene. Uansett er de resultatene de nå oppnår, viktig dokumentasjon i samtaler med myndighetene og andre ift andre eventuelle indikasjoner.
Som de har påpekt en rekke ganger, det er ikke noe galt med vaksinen, og de ønsker å se på indikasjoner hvor veien er kortere til mål, for å bevise effekten. Det kjøres en PoC studie i Australia på pasienter som allerede har tumor, hvor man vil få bekreftende svar i h1 2019. I utgangspunktet skulle en tro at de ønsket å vente på de resultatene, men de har jo lovet en oppdatering om veien videre på Capital markets day.
“spydspiss” strategien de nå ser ut til å ha med sitt onkolytiske virus liker jeg godt. Både sett fra et kostnadsperspektiv, men også der interessen virkelig er stor.
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Targovax to Host Key Opinion Leader Symposium on Oncolytic Viruses in New York City, 11 October 2018
Symposium faculty to include Dmitriy Zamarin, MD, PhD, and Alexander N.
Shoushtari, MD, medical oncologists from Memorial Sloan Kettering Cancer CenterOslo, Norway, 27 September 2018 - Targovax ASA (OSE: TRVX), a clinical stage
biotechnology company developing immune activators to target hard to treat solid
tumors, is hosting a Key Opinion Leader (KOL) symposium in New York City on
Thursday 11 October 2018, featuring two renowned immunotherapy experts from the
Memorial Sloan Kettering Cancer Center.
The meeting will consist of presentations from world leading experts on
oncolytic viruses, as well as presentations from the Targovax senior management
team. Presentations and discussion will include an overview of oncolytic viruses
in general and the potential of this emerging technology in the treatment of
cancer, including how the engineered ONCOS adenovirus fits into the broader
landscape.The CMO of Targovax, Dr. Magnus Jäderberg, will also discuss the status of the
ongoing ONCOS-102 clinical program, and Dr. Shoushtari will present interim data
from the Phase I trial in checkpoint inhibitor (CPI) refractory advanced
melanoma. Please see press
release (http://www.targovax.com/Investors/News/default.aspx) issued today for
top-line results.Symposium Faculty participants:
Dmitriy Zamarin, MD, PhD, Medical Oncologist, Memorial Sloan Kettering
Dr. Zamarin’s research is focused on the development of novel ways to use the
immune system to treat cancer, including evaluation of novel immunotherapy
drugs. He has published several landmark papers on oncolytic viruses and is the
Study Chair on the ONCOS-102 trial in peritoneal cancer, in collaboration with
Cancer Research Institute (CRI), Ludwig Cancer Research and
MedImmune/AstraZeneca.Alexander N. Shoushtari, MD, Medical Oncologist, Memorial Sloan Kettering
Dr. Shoushtari is a renowned expert in melanoma, with a research focus on uveal
and mucosal melanomas. He has been part of several immunotherapy trials at MSKCC
and is the Principal Investigator on the ONCOS-102 phase I trial in CPI
refractory advanced melanoma.Drs. Zamarin and Shoushtari are both members of the research team of Dr. Jedd
Wolchok, MD, PhD, Chief, Melanoma and Immunotherapeutics Service at the Memorial
Sloan Kettering Cancer Center.The event starts at 12:00 EST / 18:00 CET. A complete program agenda will be
available shortly. A live webcast of the symposium will be available in the
Events and Presentations section of the Targovax website.To register for the event, please contact [email protected] or visit
www.troutaccess.com.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: [email protected]
Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: [email protected]
Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: [email protected]
About TargovaxActivating the patient’s immune system to fight cance
Targovax (OSE:TRVX) is a clinical stage biotechnology company developing immune
activators to target hard to treat solid tumors. Immuno-oncology is currently
one of the fastest growing therapeutic fields in medicine.Targovax’s lead product candidate, ONCOS-102, is a genetically modified
oncolytic adenovirus, which has been engineered to selectively infect and
replicate in cancer cells. It is used as a therapeutic cancer vaccine and has
been shown to activate the immune system to generate tumor-specific immune
responses. In phase I trials, ONCOS-102 induced both local and systemic innate
and adaptive immune activation, which has been associated with clinical benefit.
ONCOS-102’s lead indication is mesothelioma, where the virus is currently being
tested in a randomized phase II trial, with a phase Ib safety lead-in cohort.
Another trial, in advanced melanoma, is expected to produce important proof of
concept data for checkpoint inhibitor refractory patients within the next 6-12
months.Targovax is also developing a neo-antigen cancer vaccine targeting tumors that
express mutated forms of RAS - mutations known to drive cancer. The TG vaccine
program has shown a signal of efficacy in a 32-patient trial with TG01 in
resected pancreatic cancer. A next generation product candidate, TG02 is
currently tested as monotherapy and will also be tested in combination with
Keytruda® (an anti-PD1 Check point inhibitor, CPI)Ekstern link: http://www.newsweb.no/index.jsp?messageId=460272
Nyheten er levert av OBI.
http://www.netfonds.no/quotes/release.php?id=20180927.OBI.20180927S5
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Og denne som jeg fikk på mail:
# Targovax announces interim results from Phase I trial of ONCOS-102 in checkpoint inhibitor refractory melanoma
One of the first six patients showed a complete response to the treatment
Oslo, Norway, 27 September 2018 - Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors, today announces interim tumor response data from the first six patients treated with ONCOS-102 followed by the checkpoint inhibitor (CPI) pembrolizumab (KEYTRUDA®) in patients with advanced melanoma whose disease has progressed after prior CPI treatment. Results show that one of the six patients had a complete response to the treatment.
One of the main aims of the trial has been achieved, which is to demonstrate that ONCOS-102 has the potential to immune activate CPI refractory patients to respond to PD-1 blockade. Complete responses are rarely seen in this patient population. The patients received three ONCOS-102 injections prior to KEYTRUDA® treatment, which may be insufficient in highly advanced disease. As such, Targovax and the investigators now intend to optimize the dosing schedule by increasing the number of ONCOS-102 injections and expand the trial with additional patients.
Dr. Magnus Jäderberg, CMO of Targovax, said : “Given the limited number of patients who have completed the study to date, it is encouraging to already see a complete response to ONCOS-102 primed KEYTRUDA ® treatment in this CPI refractory patient population. This case is particularly interesting, as the patient became refractory to KEYTRUDA ® before entering our trial. At the same time, five patients progressed, which we believe may be partly due to an insufficient number of ONCOS-102 injections. Consequently, we have agreed with the investigators to expand the trial with additional patients, who will receive an increased number of ONCOS-102 injections. The complete response, combined with the optimized dosing regimen, makes us optimistic that we may demonstrate the full potential of ONCOS-102 in the checkpoint inhibitor refractory setting.”
The results will be presented at a KOL event hosted by Targovax in New York City on 11 October 2018, which will also be available by webcast. Invitation and full event details has been issued separately and is posted on www.targovax.com.
Conference call
At 14:00 CET (08:00 EST) today, Targovax will host a conference call to answer questions about the results. Call-in details can be found below.Call-in numbers:
Norway Toll-Free Number: 80062196
Norway Toll Number: +47 23500243
UK Toll-Free Number: 08003589473
UK Toll Number: +44 3333000804
US Toll-Free Number: +1 855 85 70686
US Toll Number: +1 6319131422
Access code: 60258218#
Please make sure to dial in at least 5-10 minutes ahead to complete your registration.
See attached list for more dial-in numbers:
About the trial
In this open label trial running in three centers in the USA, patients that have progressed on CPI treatment receive three intra-tumoral ONCOS-102 injections during the first week, followed by eight infusions of the programmed cell death protein 1 (PD-1) blocking CPI pembrolizumab (KEYTRUDA®). As reported in December 2017 and January 2018, the first planned safety review passed without any issues. Both local and systemic immune activation, which includes T-cell tumor infiltration and increased PD-1 expression on CD8+ T-cells, has been confirmed in all evaluated patients.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: [email protected]
Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: [email protected]
Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: [email protected]
About Targovax
Activating the patient’s immune system to fight cance
Targovax (OSE:TRVX) is a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.
Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It is used as a therapeutic cancer vaccine and has been shown to activate the immune system to generate tumor-specific immune responses. In phase I trials, ONCOS-102 induced both local and systemic innate and adaptive immune activation, which has been associated with clinical benefit. ONCOS-102’s lead indication is mesothelioma, where the virus is currently being tested in a randomized phase II trial, with a phase Ib safety lead-in cohort. Another trial, in advanced melanoma, is expected to produce important proof of concept data for checkpoint inhibitor refractory patients within the next 6-12 months.
Targovax is also developing a neo-antigen cancer vaccine targeting tumors that express mutated forms of RAS - mutations known to drive cancer. The TG vaccine program has shown a signal of efficacy in a 32-patient trial with TG01 in resected pancreatic cancer. A next generation product candidate, TG02 is currently tested as monotherapy and will also be tested in combination with Keytruda® (an anti-PD1 Check point inhibitor, CPI).
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