Circio Holding ASA (CRNA) - tidl: Targovax (TRVX) 1

[Birgitte]

CircVec teknologien er fremtiden. Det har oppstått et gedigent potensiale i fremtidens CAR-T celleterapi, Certest har nok fått blod på tann med spleen og lever resultatene og trolig 4Basebio med 6x i syntetisk DNA. 30 juni skal de ut med info. Entos sprudlet etter avtalen 3 april og gjorde Circo til partner på hjemmesiden. Og det er flere som holder på som vi ikke vet hvem er. Og mcap ligger fortsatt rundt ca 60 mill. Hvem liker ikke underprisede aksjer???

[Bompiole]

Atlas vart kvitt en haug med aksjer på Tirsdag

[bowie]

… fint det, jeg fikk flere ti-tusen til inn på ASK konto

[Bob_le_Plast]

Ytterst positivt at Atlas-potten tas såpass godt i mot av markedet. Har man troen på caset så er dette vinn-vinn for alle parter.

Traff perfekt på bunnfisket tidligere i uka, så har måttet kjøpe inn roser og rødvin for å redde helgestemninga i heimen😄

[aol]

TG01/QS-21 K-RAS-vaksinen viser god sikkerhet og immunaktivering hos 50 % av pasientene. Stabil sykdom observert hos halvparten; videre studier pågår for å evaluere effekt og immunrespons.

[TekBot]

TG01 mutant RAS cancer vaccine data showing clinical benefit in multiple myeloma presented at EHA 2025

· 12 of 20 patients have already been enrolled in the study; excellent safety
profile of TG01 vaccination confirmed
· TG01 vaccination led to an increase in mutant RAS T-cells in 6 patients; 5
…

Vis børsmeldingen

of these patients remain on study with stable disease
· Genetic characteristics of patients mechanistically support the observed
immune responses and clinical benefit, and propose novel biomarkers for patient
selection in future trials
· Circio’s strategy to develop TG01 through external collaborations continues
to demonstrate success alongside its core circular RNA program

Oslo, Norway, 16 June 2025 - Circio Holding ASA (OSE: CRNA), a biotechnology
company developing circular RNA technology for gene and cell therapy and mutant
RAS-targeting cancer vaccines, today announces that interim data from the TG01
phase 1/2 clinical trial in multiple myeloma at Oslo University Hospital (OUS)
has been presented at the European Hematology Association 2025 annual meeting in
Milan, Italy.

The results show preliminary signals of clinical efficacy for TG01 vaccination
and confirm an excellent safety profile, thus providing justification for
continued clinical development for a major unmet medical need. The trial is a
collaboration between OUS and Circio to test TG01/QS-21 vaccination as a
monotherapy in 20 KRAS or NRAS mutated multiple myeloma patients with remaining
measurable disease after completion of standard of care treatment. The aim is to
assess whether T-cell responses to mutant RAS induced by TG01 can enhance and
prolong the clinical benefit. OUS is the study sponsor, with Dr. Hanne Norseth
as the primary investigator.

“RAS-mutant multiple myeloma has poor prognosis and there are currently no
available targeted treatment options for this patient population,” said Dr.
Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University
Hospital, and President of the Nordic Myeloma Study Group “Interim data from the
first twelve patients demonstrate the capability of TG01 to induce RAS-specific
T-cell responses in a subset of patients, and suggest that these responses are
associated with disease stabilization. This is an important early indication of
clinical benefit. We look forward to completing the study, including a broad set
of genetic and immunological analyses, which will help us build the
understanding of how TG01 vaccination can fit as a future treatment option to
deepen and prolong responses in this underserved patient population.”

Oncogenic RAS mutations drive up to 30% of all cancers and an estimated 15-20%
of multiple myelomas, and remain a major unmet medical need with few effective
treatment alternatives. Circio has previously been awarded two prestigious
research grants from Innovation Norway and the Norwegian Research Council to
advance the TG mutant RAS cancer vaccine program. These grants have provided
funding towards two active clinical studies, including the present multiple
myeloma study at OUS, Norway, and a phase 2 trial at Georgetown University,
Washington D.C. USA, where TG01 is tested in pancreatic and lung cancer.

“Consistent with our prior observations in pancreatic cancer, it is very
reassuring that this early-stage multiple myeloma trial has generated results
showing immunological activity of the TG01 vaccine associated with clinical
benefit,” said Dr. Victor Levitsky, Chief Scientific Officer of Circio Holding
ASA. “The biomarker findings are consistent with the current understanding of
tumor immune control requiring a proper match between the characteristics of the
tumor and the of patient´s genetic buildup. This important connection provides a
mechanistic validation of clinical benefit and suggests specific biomarkers to
select patients who can benefit most from TG01 treatment in follow-up clinical
studies. We will continue to pursue our strategy to develop TG01 through
external partnerships in parallel with our core in house circular RNA program.”

Poster title:
The phase I/II TG01-study: Vaccinating against RAS-mutated Multiple Myeloma

Presentation date and location:
14 June 2025, EHA 2025 Annual Meeting, Milan - Italy

The main conclusions from the poster presentation were as follows:

· Available data demonstrate excellent tolerability and safety of TG01/QS-21
vaccination
· 50% (6/12) of vaccinated patients show vaccine-induced specific T-cell
responses against mutant K/N-RAS-peptides
· 50% (6/12) of patients remain on study with stable disease (SD), no
objective responses have so far been observed
· 67% (4/6) of patients with SD had a K/N-RAS-peptide specific immune response
by ELISPOT (1/2 negative patients fell very narrowly below positivity threshold)
· Enrollment and analysis of the TG01 vaccine-specific responses are ongoing

The poster is attached hereto and is available on the Circio
webpage (http://www.circio.com/)

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: erik.wiklund@circio.com

Neil Hunter - Hunter PR
Phone:+44 7821 255568 (http://tel:+447821255568)
Email: neiljameshunter@gmail.com

About Circio

Building circular RNA expression systems for enhanced gene and cell therapies

Circio Holding ASA is a biotechnology company developing powerful circular RNA
vector expression technology for next generation nucleic acid medicine.

Circio has established a unique circular RNA (circRNA) vector expression
platform for novel DNA, RNA and viral therapeutics. The proprietary circVec
technology is based on a modular genetic cassette design for efficient
biogenesis of multifunctional circRNA inside cells, which can be deployed in
multiple therapeutic settings, including genetic medicine, cell therapy and
chronic disease. The circVec platform has demonstrated up to 15-fold enhanced
and more significantly more durable protein expression vs. classic mRNA vector
systems and has the potential to become a new gold-standard platform technology
for nucleic acid and viral therapeutics in the future. The circRNA R&D
activities are being conducted by the wholly owned subsidiary Circio AB based at
the Karolinska Institute in Stockholm, Sweden.

In parallel, Circio is continuing to develop its legacy immuno-oncology program,
TG01, through external collaborations. TG01 targets RAS-mutated cancers and is
being tested in two clinical trials in Norway and the USA run through academic
networks and industry partnerships. TG01 is a therapeutic peptide vaccine
adjuvanted by STIMULON QS-21 licensed from Antigenics Inc, a wholly owned
subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary
of Agenus

Kilde

[Tippe]

CIRCIO: DATA FRA TG01-VAKSINE VISER KLINISK FORDEL OG GOD SIKKERHETSPROFIL | Finansavisen

[Bob_le_Plast]

Selv steinøks kan felle trær brukes de rett😄

Veldig gøy!

[Birgitte]

Alt klaffer for den “Svarte andungen” for tiden, først enormt sterke spleen / lever data m/ Certest, så 6x syntetisk DNA m/ 4Basebio???; i dag TG01 med OUS.

Og alt dette får du for 60 mill i mcap.

Hvor skal dette ende? Fra 0.60 til 600?

Markedet tar alltid feil det er derfor det er penger å tjene på børs.

[urban66]

Dette er vel også en melding som for første gang viser at TG01vaksine har effekt hos mennesker?

[Birgitte]

Vi får håpe Polygon tar en liten tur innom og hjelper deg med ditt spørsmål eller en annen?

[Bob_le_Plast]

Jeg har generelt vært skeptisk til effekt av peptide-baserte vaksiner, siden peptider alene ikke er spesielt effektiv å skape en immunrespons.

Det som er interessant for denne studien er bruken av immunstimmulanten/adjuvansen QS-21, denne er mest sannsynlig den beste adjuvansen tilgjengelig i markedet i dag til dette.

Kanskje det som må til å tippe effekt av peptid-vaksinen over slik at det kan gi en statistisk signifikans.

[urban66]

Så neste skritt blir samarbeidsavtale/partnering up med Agenus for QS-21-tilgang, hvis Tg01 kombo med QS-21 skal bli en realitet. Eller er jeg helt på viddene her? https://agenusbio.com/pipeline/

[Bob_le_Plast]

Fritt fra hukommelsen, men tror C har avtale med Agenus allerede.

[Bompiole]

litt for lite volum

[Birgitte]

BIO 2025 USA, Boston gigantisk konferansen, starter i ettermiddag 16 - 19 juni.
Certest og 4Bsebio er på deltakerlisten men jeg har ikke sett noe spesielt opplegg med dem.

About BIO 2025

Entos er mer synlig. Entos/ Lilly har en partnerstatus vedrørende blant annet tema øyesykdommer - de har et program Stardgardt - øyesykdom som mulig kan inngå i testingen av circVec.

ENTSTAR001 - Stargardt Disease
Stargardt disease is a rare genetic eye disease that causes blindness with vision loss starting in childhood with no treatment options. Stargardt disease occurs due to a mutation in the ABCA4 gene that leads to fatty build-up. Treatments for Stargardt disease have remained elusive because the gene that encodes for ABCA4 is large and the currently available genetic cargo delivery platforms are unable to deliver the gene effectively.

Leveraging the optimized Fusogenix PLV ocular formulation, Entos has demonstrated effective delivery of large genetic cargoes including ABCA4 to the relevant cells that impact Stargardt disease in non-human primates.

Entos is developing ENTSTAR001 for the treatment of Stargardt disease. ENTSTAR001 is a gene therapy that utilizes the Fusogenix PLV platform to deliver a functional full length copy of ABCA4 to the retina.

[aol]

[Birgitte]

4basebio4basebio10,579 followers10,579 followers1w • 1 week ago • Visible to anyone on or off LinkedIn

Follow

Our CEO, Heikki Lanckriet and COO, Amy Walker will be attending the upcoming BIO International Convention, June 16-19!

We’re excited to share how our synthetic DNA is driving innovation in cell and gene therapies and next-gen vaccines.

Attending hashtag#BIO2025? Reach out or book a meeting through the BIO partnering platform.

hashtag#CellTherapy hashtag#GeneTherapy hashtag#Vaccines hashtag#SyntheticDNA hashtag#BIOInternationalConvention

[aol]

[Bompiole]

REF EW
Kommentar til dagens resultat fra OUS?
EW-2) Overraskende gode data fra OUS, særlig tatt i betraktning at dette er monoterapi med TG01. Legger man på aPD1 kombo kan det potensielt betydelig øke effekten av vaksinering

Tipper vi kommer til å sjå en økende interesse for selskapet framover,nå er mcap knappe 66 mill,hvor lenge??