Circio announces circVec LNP-delivery collaboration with Certest progressing to in vivo testing

19 Nov 2024 12:00 CET

· Certest Biotec, S.L. and Circio are collaborating to create and test circVec
DNA-LNP formulations for potential therapeutic applications
· Certest´s proprietary ionizable lipids and their optimized LNP formulations
have shown impressive delivery specificity to several tissues of interest to
Circio, including lung, liver and spleen
· Technical formulation and in vitro analysis of circVec-LNP formulations by
Certest have been successful, and the collaboration will now progress to in vivo
delivery testing

Oslo, Norway 19 November 2024 - Circio Holding ASA (OSE: CRNA), a biotechnology
company developing next generation circular RNA vector technology for gene
therapy, today announces that it has entered a collaboration with Certest
Biotec, S.L. for formulation of circVec into lipid nanoparticles (LNPs) for
tissue specific delivery of DNA-vectors to address genetic disease.

"Circio´s powerful circVec-DNA technology achieves more than six months
durability in mouse models on a single intra-muscular injection, with up to 15
-fold increase in payload expression levels vs. standard mRNA-based vector
systems" said Dr. Victor Levitsky, CSO of Circio. "Based on these promising
findings in vivo, we are now looking for targeted delivery technology that can
enable therapeutic application of circVec in specific tissues and diseases of
high unmet medical need. We selected Certest as a preferred partner for circVec
-LNP formulation due to the impressive tissue specificity demonstrated for their
proprietary nanoparticles."

"The library of ionizable lipids developed by our team is engineered for a wide
range of nucleic acid payloads, exhibiting a great delivery capacity in
preclinical studies and allows the production of thermostable LNPs." explained
Dr. Juan Martínez Oliván, CSO of Certest Pharma, specialized unit in nucleic
acids delivery systems at Certest Biotec. "Our capability to passively target
different tissues unlocks the possibility to treat organ-specific diseases. We
are very enthusiastic about the joint formulation of Circio's new approach to
circular RNA vector technology with our versatile ionizable lipids, creating a
unique LNP-strategy for gene therapy treatment."

Under the collaboration, Certest has successfully performed packaging and in
vitro validation of circVec-LNP formulations targeted for delivery to lung,
liver and spleen, with positive technical results. Circio will now test these
circVec-LNP formulations in vivo during the next 3-6 months to assess delivery
efficiency, expression level and durability. If successful, these experiments
can pave the way to development of multiple circVec therapeutic candidates in
the field of genetic diseases for both in-house development and partnering.

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
Email: neiljameshunter@gmail.com

About Circio

Building next generation RNA therapeutics

Circio Holding ASA is a biotechnology company developing novel circular RNA gene
therapies and immunotherapy medicines.

Circio has established a unique circular RNA (circRNA) platform for genetic
medicine. The proprietary circVec technology is based on a modular genetic
cassette design for efficient biogenesis of multifunctional circRNA from DNA and
viral vectors, which can be deployed in multiple disease settings, including
cell and gene -therapy and chronic diseases. The circVec platform has
demonstrated enhanced and more durable protein expression vs. classic mRNA
vector systems and has the potential to become the new gold-standard for DNA and
virus-based 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 addition, Circio is developing a pan-RAS cancer vaccine, TG01, targeting KRAS
driver mutations. TG01 is currently being tested in two clinical trials: RAS
-mutated pancreatic and lung cancer in the USA and multiple myeloma in Norway.
These studies are being run through academic and industry collaborative
networks, supported by prestigious research grants from Innovation Norway and
the Norwegian Research Council, creating read-outs and future optionality for
the program at low cost to Circio.

About Certest Biotec SL

Pioneering next-generation drug delivery systems for nucleic acid therapeutics

Certest Biotec, established in Spain in 2002, is a cutting-edge, innovation
-driven company whose success is rooted in its commitment to research,
development, and exploring untapped market opportunities. The company's growth
stems from its highly specialized, customer-focused organizational approach.

Certest's latest business unit, Certest Pharma, is dedicated to advancing RNA
and oligonucleotide therapeutics by developing innovative platforms that
prioritize enhanced delivery and thermostability. A cornerstone of this
endeavour is the development of raw materials, including state-of-the-art
ionizable lipids, which represent one of the company's flagship products.

Certest Pharma offers a comprehensive solution, drawing from its expertise in
drug delivery:

· Delivery Technology: Ionizable lipids, essential components for the
production of lipid nanoparticles (LNPs), play a pivotal role in the systemic
delivery of RNA therapeutics. By screening over 1,000 ionizable lipids using a
semi-rational design process, Certest has developed proprietary, high
-performance ionizable lipids with exceptional thermostable LNP properties.
· Targeting Precision: With an extensive portfolio of ionizable lipids and a
variety of innovative approaches, Certest enables passive targeting of RNA and
oligonucleotide therapeutics, achieving unique biodistribution profiles.
Additionally, the introduction of an active targeting strategy for LNPs and
oligonucleotides allows Certest to deliver tailored solutions for diverse
therapeutic needs.
· RNA Platform: Building on more than 20 years of expertise in the field,
Certest Pharma's RNA platform covers every stage of the process-from the design,
synthesis, and development to the scale-up and evaluation of effective RNA and
oligonucleotide therapeutic molecules. Notably, all raw materials, including the
enzymes for mRNA production, are developed and produced entirely in-house,
ensuring full control over quality and innovation.

With its relentless focus on innovation, Certest Biotec aims to set a new
benchmark in drug delivery, empowering partners to unlock the full potential of
RNA-based therapies and transform patient outcomes worldwide.

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