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EspenB
TRVX 04.01.2018 kl 08:11 4215

Targovax announces that ONCOS-102 generates immune activation in checkpoint inhibitor refractory melanoma patients
Thursday, January 04, 2018
Oslo, Norway, 4 January 2018 - Targovax ASA (OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces immune activation data in the first four 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.

This is the first time ONCOS-102 has been used therapeutically in melanoma patients, and also the first time the virus has been administered to CPI refractory patients. In this Phase I open label study, patients are scheduled to receive three intra-tumoral ONCOS-102 injections during the first week, and thereafter subsequently re-challenged with the programmed cell death protein 1 (PD-1) blocking CPI KEYTRUDA®. As reported in December, the first planned safety review passed without any issues, and the trial was recommended to continue (December press release).

To date, four patients have been treated with ONCOS-102, and immune activation has been assessed at week 3. Early systemic immune activation in all four patients was indicated by:

Increase of several pro-inflammatory cytokines
Increase of the relative level of cytotoxic CD8+ T-cells
Increase of PD-1 expression on CD8+ T-cells
These data indicate that ONCOS-102 may induce both an innate and adaptive immune activation in CPI refractory patients. In addition, increased PD-1 expression on the surface of CD8+ T-cells after ONCOS-102 treatment suggests that the tumors may be susceptible to re-challenge with KEYTRUDA®.

Magnus Jäderberg, CMO of Targovax, said: "After the positive safety review reported in late 2017, we are very pleased to now also be able to confirm immune activation in checkpoint inhibitor refractory melanoma patients. These results are in line with data reported in our completed all-comers phase I trial, but this is the first time we have treated melanoma patients. It will be interesting to see if the immune activation and increased PD-1 expression on CD8+ T-cells will have an impact on clinical outcome after re-challenge with KEYTRUDA®."

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

Julia Phillips/Simon Conway - 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.
Source: Targovax ASA
Redigert 19.01.2021 kl 11:44 Du må logge inn for å svare
Gryntgrynt
04.01.2018 kl 08:36 4079

Fantastisk melding på morgenen med 100% respons. Oncos gjør non responders til responders!
Mdg1
04.01.2018 kl 08:42 4065

Da blir det vel mange som selger idag. Bare fire pasienter, men trenden er veldig positiv. For hver positive melding øker sannsynligheten for at medisinen virker. Det blir spennende å se resultatet av studiene fremover.
EspenB
04.01.2018 kl 08:45 4038

Det er vel 4/4 som responderer positivt?
nw2011
04.01.2018 kl 09:19 3937

Hva tror dere ift kursutvikling fremover.
Burde vi ikke snart etablert oss over emi kurs ?
InVes1
04.01.2018 kl 09:42 3852

Ser det ikke ud til at den var nede at lukke et gap og nu fortsætter op ad?

Slettet bruker
04.01.2018 kl 12:30 3639

Mye tyder på at TRVX vil levere positivt en tid framover nå, bl.a. med støtte i dagens melding. Det må større datamengder til for å levere et kvantesprang men dagens melding er PRINSIPPIELT viktig: Medisinen virker som forutsatt.
Underbygges dette med større datamengder, blir det moro. Vi sitter derfor forventningsfullt i TRVX :-)

Generelt:
Bra start på året for flere farmaaksjer:
- PCIB har levert så det holder
- BGBIO har fått FDA i fjor og rigger seg for kommende meldinger
- TRVX kan være på vei mot en liten "PCIB" nå
- NANO må vi nok vente lenger på

stockwalker
05.01.2018 kl 20:21 3257

Redeye vurdering...

Targovax: Lovande start i melanom-studie

2018-01-05 09:34
Patientdata som presenterades under gårdagen, från pågående studie inom melanom med Oncos-102, ser lovande ut. I hittills fyra av fyra behandlade patienter har det noterats en systemisk immunaktivering. Att det handlar om patienter som är refraktära till checkpointhämmare gör detta än mer intressant. Vi anser att melanom-studien är en av de mest betydelsefulla pågående studierna för Targovax, vilket förklarar den positiva marknadsreaktionen.
I pågående melanom-studie utvärderas Oncos-102 i patienter som inte längre svarar på behandling med checkpointhämmare. Extra intressant med denna studie är att studera om behandling med Oncos-102 kan återaktivera immunrespons i dessa patienter. Totalt ska studien inkludera tolv patienter, där Oncos-102 ges tre gånger under en vecka, följt av behandling med checkpointhämmaren Keytruda (pembrolizumab) från Merck.
Gårdagens interimsdata bygger på analys av fyra patienter efter tre veckor. Det är visserligen en mycket begränsad skara patienter och en relativt kort uppföljningsperiod, men att det noterats en systemisk immunaktivering i samtliga av dessa fyra patienter är mycket lovande. Att det noterats ökning av cytotoxiska CD8+ T-celler och ökat uttryck av PD-1 på CD8+ T-celler är riktigt intressanta resultat.
Aktien gjorde ett glädjeskutt under gårdagen efter offentliggörandet av resultaten, vilket vi anser var motiverat. Under 2018 förväntar vi oss ökat kliniskt nyhetsflöde från bolaget, något som talar för ett stärkt intresse för aktien.
Vi ser en betydande uppsida från nuvarande nivåer, med ett motiverat värde i basscenariot på 32 NOK.
Slettet bruker
06.01.2018 kl 15:43 3061

Det vet vi ikke før høst 2018. Det eneste meldingen sier er at 4 av 4 har fått en positivt immunrespons på oncos/keytruda. Selskapet har ikke og kan ikke melde at non responders blir responders, av den enkle grunn at de ikke vet det.