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Schjesvold, an international leader in the field and founder of the Oslo Myeloma
Center, the largest Myeloma center in the Nordics
Oslo, Norway, 22 June 2023 - Circio Holding ASA (OSE: CRNA), today announces
that the first multiple myeloma (MM) patient has been dosed with mutant RAS
cancer vaccine TG01 at Oslo University Hospital (OUS). The study is led by
multiple myeloma expert Dr. Fredrik Schjesvold in a clinical collaboration
between OUS and Circio. OUS is the study sponsor, with Dr. Schjesvold as the
principal investigator, in collaboration with project lead Dr Hanne Norseth and
Research medical student Hedda Monsen. Circio will provide TG01 drug supply,
scientific support and a financial contribution.
Mutations in the RAS genes are commonly found in pancreatic cancer, colon cancer
myeloma and lung cancer but outside of lung cancer there are no RAS-targeted
therapies available for these patients. TG01 is a mutant RAS therapeutic cancer
vaccine adjuvanted by QS-21 STIMULON, which targets the seven most commonly
found RAS mutations. TG01 has previously demonstrated robust immune responses
and survival benefit in resected pancreatic cancer combined with standard of
care chemotherapy.
In this study, TG01 vaccination will be tested as a monotherapy in 20 KRAS or
NRAS mutated myeloma patients who have either high risk smoldering myeloma or
have evidence of disease after completion of standard of care (SoC) therapy. The
treatment period is 12 months. In the first 3 months TG01 is given every other
week, and thereafter it is given once every second month for 9 months. The aim
is to assess whether anti-RAS T-cell priming induced by TG01 can delay the
disease progression and enhance the clinical response.
Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo
University Hospital, and President of the Nordic Myeloma Study Group, said:
“There are no targeted therapy options available for RAS-mutated multiple
myeloma patients which continue to have a clear need for better and more
tolerable treatments. I believe the TG01 vaccine has the potential to eliminate
residual disease and delay recurrence following standard of care treatment, and
we look forward to work with Circio to test this therapeutic concept at our
center.”
Margrethe Sørgaard, VP and Head of Clinical Development of Circio Holding ASA,
added: “Having the first patient dosed in Dr. Schjesvold´s study in multiple
myeloma is an important milestone for the TG program. It is the first time the
TG01 cancer vaccine will be tested in this indication, and the first time the
new and enhanced vaccine format of sub-cutaneous single-injection TG01
adjuvanted by QS-21 STIMULON has been administered to a patient in Europe. We
firmly believe that TG01 can bring targeted clinical benefit, with a favorable
safety profile, to this underserved area of RAS-mutated multiple myeloma.”
About TG01 mutant RAS vaccine
Oncogenic mutations in the RAS family of genes drive up to 30% of all cancers
and remain a major unmet medical need with few good treatment alternatives.
Circio was recently awarded two prestigious research grants from Innovation
Norway and the Norwegian Research Council, totaling NOK 18m, to advance its TG
mutant RAS cancer vaccine program.
About Agenus, QS-21 STIMULON
Agenus is a clinical-stage immuno-oncology company focused on the discovery and
development of therapies that engage the body’s immune system to fight cancer
and infections. In March 2022, Circio announced a collaboration with Agenus to
utilize the proprietary adjuvant QS-21 STIMULON as an immune-stimulatory
component of the TG vaccines for future development and commercialization. QS-21
STIMULON has consistently demonstrated powerful antibody and cell-mediated
immune responses both in cancer trials and as a component of the commercial
Shingrix*, Mosquirix* and Arexvy* vaccines. QS-21 STIMULON is expected to
further potentiate the TG vaccines by driving stronger anti-RAS T-cell
responses.
*Trademarks owned by GSK.
For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: erik.wiklund@circio.com (erik.wiklund@targovax.com)
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@circio.com (renate.birkeli@targovax.com)
Media enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no
About Circio
Building next generation RNA therapeutics
Circio Holding ASA is a biotechnology company developing novel circular RNA and
immunotherapy medicines.
Building on deep experience in RNA biology, immunotherapy and viral vector
engineering, Circio has established a unique circular RNA (circRNA) platform to
develop novel circRNA medicines for cancer, vaccines, protein replacement for
genetic disorders and cell therapy. The proprietary circVec technology is based
on a modular genetic cassette design for efficient biogenesis of multifunctional
circRNA from DNA-based vectors that can be deployed for multiple purposes. The
most advanced therapeutic concept, circAde, builds on the company´s experience
in oncolytic viruses to use engineered adenoviruses for delivery of circRNA to
cancer cells. This unique approach is the only currently known circRNA program
targeting solid tumors. Circio´s strategy is to develop novel circAde cancer
medicines in-house and seek partnerships in other therapeutic areas to
demonstrate the broad potential of the circVec platform and accelerate our
circRNA pipeline development. The circRNA R&D activities are being conducted by
the wholly owned subsidiary Circio AB based at the Karolinska Institute in
Stockholm, Sweden.
Circio´s clinical immunotherapy programs are designed to activate the patient´s
own immune system to fight cancer cells and provide benefit to patients with no
or few treatment alternatives. Lead candidate ONCOS-102 is an oncolytic
adenovirus (AdV5) carrying a genetic cassette for mRNA-based expression of the
cytokine GM-CSF, designed to selectively target cancer cells and drive an anti
-tumor immune response. ONCOS-102 has demonstrated an excellent safety profile,
strong immune responses and clinical efficacy in several cancer types in Phase
1/2 studies, both as monotherapy and in combinations with checkpoint inhibitors
or standard-of-care chemotherapy. Circio is aiming to progress ONCOS-102 into a
phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor
treatment, subject to additional external financing and/or partnerships to
support the program.
Circio’s second clinical stage program is an immunotherapy targeting KRAS driver
mutations. Lead candidate TG01 has previously shown robust immune responses and
encouraging clinical benefit in surgically resected pancreatic cancer, and is
currently being tested in two clinical trials in RAS-mutated pancreatic cancer
and multiple myeloma in the USA and Norway. These studies are being run through
industry and academic collaborative networks, supported by prestigious research
grants from Innovation Norway and the Norwegian Research Council, creating broad
future optionality for the TG01 program at low cost to Circio.
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