Targovax - Småprat 2 (TRVX) 1

[Fornybar]

Gratulerer med fast track!

https://newsweb.oslobors.no/message/524800

[TekBot]

Targovax receives Fast-Track designation for ONCOS-102

· The US FDA grants ONCOS-102 Fast-Track designation for malignant pleural
mesothelioma
· Fast-Track opens the potential for expedited development and review with the
…

Vis børsmeldingen

US FDA

Oslo, Norway 15 February 2021 - Targovax ASA (OSE: TRVX), a clinical stage
immune-oncology company developing immune activators to target hard-to-treat
solid tumors, today announces that its lead clinical candidate ONCOS-102 has
received Fast-Track designation in malignant pleural mesothelioma from the US
FDA.

The US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre
-clinical and clinical efficacy associated with broad immune activation observed
to date. Receiving this designation is an endorsement by the US FDA of the
strength of the ONCOS-102 data package.

The FDA Fast Track-designation is awarded to therapies with potential to address
unmet medical needs in serious medical conditions and allows for more frequent
interactions with the FDA to expedite clinical development, as well as the
regulatory review processes. Fast-Track products have improved likelihood of
receiving Priority Review for a future Biologics License Application (BLA) and
may be allowed to submit parts of the application early to shorten review time.

The Fast-Track approval comes in addition to ONCOS-102´s existing Orphan Drug
Designation (ODD) with both the US FDA and European EMA in the mesothelioma
indication, which provides ONCOS-102 market exclusivity for 7 and 10 years in
the USA and EU, respectively, from the date of BLA grant.

Dr. Ingunn Munch Lindvig, VP Regulatory Affairs, said: “Securing this Fast-Track
designation is a very important milestone for the ONCOS-102 program. Most
importantly Fast-Track validates the strong potential of ONCOS-102 as a future
treatment option for solid tumors with high unmet medical need”.

---

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
Media enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no

IR enquires:
Kim Sutton Golodetz - LHA Investor Relations (US)
Email: kgolodetz@lhai.com
Phone: +1 212-838-3777

About Targovax

Activating the patient’s immune system to fight cancer

Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing
immune activators to target hard-to-treat solid tumors. Targovax aims to unlock
greater clinical benefits in cancer patients by deploying multifunctional
platforms to target key immune regulators and oncogenic drivers. Targovax’s
focus is to “activate the patient’s immune system to fight cancer”, thus
extending and transforming the lives of cancer patients with targeted
therapeutic cancer immunotherapies. The Group’s pipeline aims at different
cancer indications, including melanoma, mesothelioma and colorectal cancer. The
products are designed to harness the patient’s own immune system to fight the
cancer, whilst also delivering a favorable safety and tolerability profile.
Further, the products are well positioned for combinations with other treatment
approaches, including other immunotherapies, surgery, radiation and
chemotherapy.

Targovax’s lead product candidate, ONCOS-102, is a genetically modified
oncolytic adenovirus, which has been engineered to selectively infect cancer
cells and activate the immune system to fight the cancer. ONCOS-102 is currently
being tested in mesothelioma, melanoma and colorectal cancer and has already
shown promising clinical results both as monotherapy and in combination with
chemotherapy, and a checkpoint inhibitor.

Kilde

[TheObserver]

Helt nydelig, rett og slett

Og det til tross for at Oncos 102 egentlig ikke fungerer som det ble påstått senest i helga

For en flott uke dette kommer til å bli. Signering med Iovaxis i morgen eller onsdag vil jeg tro, og man må bare applaudere hvor proffe disse gutta har blitt de siste to åra

[Helme5]

Selv om denne Fast-Track designation til Targovax er noget fra en sikker og endelig godkendelse - så er denne FDT et godt og tydeligt tegn på, at ONCOS 102 er på rette vej - så nu er Targovax nået et meget vigtigt step videre, og mon ikke vi aktionærer kan sidde lidt mere roligt…

[Longtrader]

Sitte rolig er trixet nå.

Hold hardt på aksjene , så får vi fortere opptur , la robotene sloss om den lille free flooten.

[Bilballs]

Spennende, gjetter sluttkurs på 9,5 idag.

[TheObserver]

11,2

[Guny]

Litt om hva det betyr👍

Fast Track

[BioMed]

HealthCap (HealthCapVC)

[Guny]

Fast-track for Targovax

[Xon]

Targovax får «fast-track»-vurdering av kreftvaksine - E24 Aksjelive

[hgsd300]

Gratulerer Targovax, håper vi i Nano leiren også kan få en god nyhet snart

[Domboshawa]

Dette vil vel fort være en liten trigger for et BP samarbeid etc.!

[danron10]

Fordi en milliard?

[TheObserver]

Burde vært forbi 2 - 3 mrd for 3 måneder siden, men vi kommer dit med tiden.

Ref om dette er bra for BP-samarbeid; Merck skjønte dette for lenge siden og signet opp Targovax før resten av markedet ønsket det samme

[Helme5]

Enig ezPappi - selv om der er opnået fast track, så er der stadig en del arbejde, og vejen har stadig en del at gå, førend ONCOS bliver (måske bliver) godkendt - det tror jeg dog de flest herinde er fuldt ud klar over.

Men trods dette, så skal man også lægge mærke til det som der står i børsmeldingen - "“Most importantly Fast-Track validates the strong potential of ONCOS-102 as a future treatment option for solid tumors with high unmet medical need.””

Og det kan vel næppe siges at være en ulempe på vejen til en (evt.) godkendelse

Man skal også huske, at selv om vejen stadig er lang, så kortes den jo formodentlig lidt fordi - ““Targovax may be allowed to submit parts of the application early, to shorten review time.””

Så alt i alt - en særdeles positiv melding

[Whatsthat]

Det høres ut som conditional approval delen, som for min del nå ble mer troverdig. Vil tro tilsvarede FTD for melanoma ikke er så langt unna.

Checkmate som har dårligere resultater i refr.melanoma har FDA Fast track, så her bør det komme flere nyheter.

[Buffet]

Fantastisk! Skal vi over 12 kroner i dag? Noe vi egentlig burde vært for lenge siden!

[drdr]

Går opptil 10-11, ender 9 (kanskje under)!
Ikke glem at NANO og BGBIO har hatt FT siste 2 år uten å ha skjedd noe dritt! 🥸😬

[Savepig]

@TekBot

Targovax receives Fast-Track designation for ONCOS-102

· The US FDA grants ONCOS-102 Fast-Track designation for malignant pleural
mesothelioma
· Fast-Track opens the potential for expedited development and review with the
…

Vis børsmeldingen

US FDA

Oslo, Norway 15 February 2021 - Targovax ASA (OSE: TRVX), a clinical stage
immune-oncology company developing immune activators to target hard-to-treat
solid tumors, today announces that its lead clinical candidate ONCOS-102 has
received Fast-Track designation in malignant pleural mesothelioma from the US
FDA.

The US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre
-clinical and clinical efficacy associated with broad immune activation observed
to date. Receiving this designation is an endorsement by the US FDA of the
strength of the ONCOS-102 data package.

The FDA Fast Track-designation is awarded to therapies with potential to address
unmet medical needs in serious medical conditions and allows for more frequent
interactions with the FDA to expedite clinical development, as well as the
regulatory review processes. Fast-Track products have improved likelihood of
receiving Priority Review for a future Biologics License Application (BLA) and
may be allowed to submit parts of the application early to shorten review time.

The Fast-Track approval comes in addition to ONCOS-102´s existing Orphan Drug
Designation (ODD) with both the US FDA and European EMA in the mesothelioma
indication, which provides ONCOS-102 market exclusivity for 7 and 10 years in
the USA and EU, respectively, from the date of BLA grant.

Dr. Ingunn Munch Lindvig, VP Regulatory Affairs, said: “Securing this Fast-Track
designation is a very important milestone for the ONCOS-102 program. Most
importantly Fast-Track validates the strong potential of ONCOS-102 as a future
treatment option for solid tumors with high unmet medical need”.

---

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
Media enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no

IR enquires:
Kim Sutton Golodetz - LHA Investor Relations (US)
Email: kgolodetz@lhai.com
Phone: +1 212-838-3777

About Targovax

Activating the patient’s immune system to fight cancer

Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing
immune activators to target hard-to-treat solid tumors. Targovax aims to unlock
greater clinical benefits in cancer patients by deploying multifunctional
platforms to target key immune regulators and oncogenic drivers. Targovax’s
focus is to “activate the patient’s immune system to fight cancer”, thus
extending and transforming the lives of cancer patients with targeted
therapeutic cancer immunotherapies. The Group’s pipeline aims at different
cancer indications, including melanoma, mesothelioma and colorectal cancer. The
products are designed to harness the patient’s own immune system to fight the
cancer, whilst also delivering a favorable safety and tolerability profile.
Further, the products are well positioned for combinations with other treatment
approaches, including other immunotherapies, surgery, radiation and
chemotherapy.

Targovax’s lead product candidate, ONCOS-102, is a genetically modified
oncolytic adenovirus, which has been engineered to selectively infect cancer
cells and activate the immune system to fight the cancer. ONCOS-102 is currently
being tested in mesothelioma, melanoma and colorectal cancer and has already
shown promising clinical results both as monotherapy and in combination with
chemotherapy, and a checkpoint inhibitor.

Kilde

Sublim timing i forkant av CMD!