Targovax - Småprat 2 (TRVX) 1

[Xon]

IOVaxis har enerett i deler av Asia.

Dersom TG lykkes der vil dette bli lagt merke til i andre deler av verden også. Dette må da være fordelaktig for Targovax.

Hva tror dere ?

[anon79663630]

IOVaxis

Mulig jeg tar feil, men jeg kan ikke huske at “being reviewed by NMPA” har vært brukt tidligere. Tidligere har det vært “pending IND applications”. Eller tar jeg feil ?

Vet dessverre ikke om det er noen direkte sammenheng mellom IOV03 og IOV04 og TG, men det må det jo være grunn til å anta ?

[solvoll]

Mener at det sto “pending IND applications” tidligere jeg også😊

[Whatsthat]

@anon79663630

being reviewed by NMPA” ha

Til info:

To encourage innovation and investment into the creation of new drugs, the Chinese National Medicinal Products Administration (NMPA) implemented its new 60-working day IND review system in July 2018. Under its new process, the Chinese Center for Drug Evaluation (CDE) has 60 days to review a clinical trial application from the date of acceptance and payment. If the CDE does not issue a rejection or seek additional information within that 60 days, then the application is considered approved and the clinical trial may proceed according to the submitted plan.

[anon79663630]

Ja, dette stemmer bra med det jeg fikk bekreftet tidligere i år fra en CRO representant i Kina (ref pkt 7). “This should give a clearer picture of the timeline”:

1. Pre-submission/dossier preparation: This really depends on the capability of the medical team of each company. Usually takes several months .

a. Animal trial results
b. Clinical trial plan and protocol. If it’s phase 1 and 2, it should be in details. If it’s phase 3, a high-level one should work

2. Fill-in the form at CDE and request for CDE expert discussion

3. CDE feedback about the request : takes 10 days .

4. Meeting with CDE experts: usually 3 months after CDE feedback

5. If the CDE experts are okay with the protocol and the plan, the applicant can submit paper dossier.

6. CDE will send acceptant letter to the applicant in 5 days .

7. The applicant will need to pay the fee. If no deny or questions received after that, 60 days after submission, the applicant can start its trial as designed right away and register at the trial in the database.

8. However, trials usually start 6 months later because a lot of preparations (people, sites, communications, etc.) need to be done.

[anon79663630]

Du må gjerne utdype hva du mener med dette ? Hvorfor er ikke en avtale med IOVaxis kompatibel med annen/andre partnere for TG i Europa+US ? Det kan jo tenkes at deal/no deal med IOVaxis er mer beroende på finansiering enn det regulatoriske, og at IOVaxis må ha en partner med på laget for å gjennomføre. Hvem eller hvor denne kommer fra spiller kanskje ikke så stor rolle ?

[Whatsthat]

@Xon

IOVaxis har enerett i deler av Asia.

Dersom TG lykkes der vil dette bli lagt merke til i andre deler av verden også. Dette må da være fordelaktig for Targovax.

@anon79663630

IOVaxis må ha en partner med på laget for å gjennomføre.

Ser positivt på det, gitt at TG først gjør suksess i Asia.

“Problemet” er dersom de kommende TG fase II–> studiene gjør det bra i andre deler av verden, for da sitter lille IOvaxis på TG retrighetene i Asia som kun koster 30mnok idag.

[TheObserver]

De rettighetene mister de pr 8.januar dersom de ikke legger 30 MNOK på bordet.

Da er posisjonen up for grabs, og RAS er hottere nå enn for 12 mnd siden, så hadde vært helt OK om en større og mer rutinert aktør tok over TG-utrullingen i Asia.

[Xon]

Et de så små da …

IOVaxis is the leading Chinese domestic company that works at cancer therapeutic vaccines, including personal therapeutic cancer and vaccines …

Ikke vet jeg.

[anon79663630]

Ikke sikkert at vi leser alt ved IOVaxis på riktig måte når der gjelder posisjon og/eller tilgang til kapital. Selskapet er f.eks eid med 43% av et selskap registrert på BVI. CEO var i mange år en expatriate i det akademiske miljøet i USA, og har også registrert et selskap med samme navn i USA. Vi kjenner ikke detaljene i avtalen, og hans og selskapets rolle kan jo ha noen overraskende nyanser.

[Teddy1]

Det er vel bare Kina og Singapore de har rettigheter?

[TheObserver]

Greater China; 4 stk land

[anon79663630]

IOVaxis buys an exclusive option to license the TG01/02 cancer vaccines for China, Hong Kong, Macau and Singapore, for a fee of USD 250.000

[aborum]

… der er sgu’ dømt aflåst sideleje i den aktie for nærværende; forventer en slags tiltagende intereresse fra primo december.

[Peterplys]

Den er da op 42% på et år?

[TekBot]

Targovax demonstrates encouraging survival data for ONCOS-102 in mesothelioma

· An 18-month analysis shows that median Overall Survival (mOS) will be at least
18.2 months for first-line patients receiving ONCOS-102 plus chemotherapy,
compared to mOS of 14.2 months or less in the chemotherapy-only control group
…

Vis børsmeldingen

· ONCOS-102-treated patients show broad and powerful immune activation,
associated with better survival outcome

Oslo, Norway, 24 November 2020 - Targovax ASA (OSE: TRVX), a clinical stage
immuno-oncology company developing oncolytic viruses to target hard-to-treat
solid tumors, today releases 18-month follow-up data from the randomized phase
I/II trial of ONCOS-102 in combination with standard-of-care (SoC) chemotherapy
in patients with malignant pleural mesothelioma (MPM).

The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC
chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line
treatment of MPM to assess safety, immune activation and efficacy versus SoC
only. In total, 31 patients have been included in the trial, with 20 patients in
the experimental group receiving the ONCOS-102 and SoC combination (8 randomized
in first-line), and 11 patients in the control group receiving SoC only (6 in
first-line).

At the 18-month follow-up, more than half of the patients in the first-line
ONCOS-102-treated group were still alive, and the mOS was not yet reached. Based
on current survival data the mOS will be 18.2 months or longer. For the first
-line SoC-only control group, less than half of the patients were alive, and mOS
will be 14.2 months or less, which is similar to outcomes from previously
reported trials where patients received the same chemotherapy treatment[1]. An
analysis of all the first-line patients, including 3 experimental safety lead-in
patients, shows similar results as the randomized first-line patients. The next
survival analysis is planned in first half of 2021.

In June, it was reported that ONCOS-102 treatment induces broad and powerful
immune activation in MPM, far beyond what is achieved with SoC alone.
Importantly, this immune activation is associated with better survival outcomes
at the 18-month analysis, indicating that the immunological activity of ONCOS
-102 drives the observed clinical benefit.

The powerful immune activation generated by ONCOS-102 builds a strong rationale
for combining ONCOS-102 with a checkpoint inhibitor in MPM. This combination
could provide further clinical benefits in this indication. Targovax and Merck
(known as MSD outside of the USA) are currently reviewing next steps for
combining ONCOS-102 and pembrolizumab (Keytruda) in MPM. Recently, the U.S. Food
and Drug Administration (FDA) approved the combination of ipilimumab and
nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS
of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for
further approvals.

Magnus Jäderberg, Chief Medical Officer of Targovax, said: “We are very pleased
that overall survival in first-line patients, is tracking well in the ONCOS-102
treated group. We have already established in the current study that ONCOS-102
drives favorable remodeling of the tumor microenvironment, and we are now
starting to see this immune activation translating into the encouraging improved
survival outcomes in these 18-month results. This is exactly what we had hoped
to see and prepares the way for combining ONCOS-102 with checkpoint inhibition.
The immune data suggest to us that survival outcomes in combination with
Keytruda may be further improved from the results reported today.”

The first results from the trial were announced in January 2020 (see press
release here (https://www.targovax.com/en/targovax-announces-encouraging-data-in
-mesothelioma-study-combining-oncos-102-and-standard-of-care-chemotherapy/)),
while immunological data and 12-month survival rate were reported in June 2020
(see press release here (https://www.targovax.com/en/targovaxs-oncos-102
-mesothelioma-12-month-data-powerfully-demonstrate-broad-immune-activation
-linked-to-clinical-benefit/)) and presented at the SITC annual meeting in
November 2020 (see poster here (https://www.targovax.com/en/oncos-oncolytic
-virus-publications-posters-and-oral-presentations/)).

References

1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas
2020 SITC 2020 poster

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

[Hirsh]

Spøsmål. Skal man selge i deg? Og kjøpe noen dager senere?

[Savepig]

Må si dette ser slett ikke verst ut! Viktig at det er randomisert studie.

[Teddy1]

Sterke data dette ja, men på få pasienter. Med slike tall i en registreringsstudie ville man nok fått godkjenning alene, blir spennede å se hva de får til med cpi.

[NickIsMyNick]

At the 18-month follow-up, more than half of the patients in the first-line ONCOS-102-treated group were still alive, and the mOS was not yet reached. Based on current survival data the mOS will be 18.2 months or longer. For the first-line SoC-only control group, less than half of the patients were alive, and mOS will be 14.2 months or less, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment1.