Regulatory News:
Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63;
Mnemonic: ALOPM), a biopharmaceutical company specializing in
precision medicine for the treatment of resistant and metastatic
cancers, and Navigo Proteins GmbH (Halle, Germany), a
biopharmaceutical company specializing in the discovery and
development of Precision Medicine applications based on the
Affilin® technology platform, announce the signature of a strategic
collaboration agreement for the discovery and development of new
systemic radiotheranostic agents.
OPM operates three technological platforms dedicated to
precision medicine. OncoSNIPER is a technology using AI to select
and validate new therapeutic targets involved in resistant and
metastatic cancers, in particular kinases and targets expressed
specifically on the tumor cell surface. The aim is to discover and
develop new kinase inhibitors based on the Nanocyclix® technology
platform and new radioligand therapy agents from its 3rd technology
platform, Promethe®.
The construction of radiotheranostics is based on the
identification of a specific target on the cancer cells' surface
(surface antigen), and on small molecule, peptide, antibody or
small protein (like Affilin®) targeting molecules that are highly
specific for the identified target, enabling radioactivity
(emitters a, β+- or γ) to be delivered to the tumor cell and thus
triggering its detection and destruction. This therapeutic approach
has already been clinically proven in the treatment of metastatic
prostate cancer (Pluvicto®; Novartis) and inoperable or metastatic
gastroenteropancreatic neuroendocrine tumors (Lutathera®;
Novartis).
OPM has chosen Affilins®, a proprietary technology from Navigo
Proteins GmbH, as biological targeting molecules to support its
Promethe® platform.
Affilins® are small proteins derived from human ubiquitin, a
protein naturally present in all cells. A huge number of ubiquitin
variants are available in large libraries where each variant is
modified in a slightly different way on its surface and has lost
its natural biological functions but potentially binds to a given
target structure. Phage display selection and screening is applied
to identify Affilins® that bind selectively and with high affinity
to the targeted surface antigen, like antibodies. The molecular
weight of Affilins® is 1/15th of an antibody improving the
pharmacokinetics, particularly the distribution and route of
elimination which is predominantly through the kidney. Unlike
antibodies, Affilins® are resistant to proteases, acids and bases
and are highly thermostable facilitating their radiolabeling.
Because they are human derived, Affilins® have a low immunogenicity
risk (unwanted immune reaction after injection). The molecules have
no post-translational modification like antibodies which allows
their production in simple bacterial systems. Affilins® are highly
engineerable and can be combined with other functional elements,
enabling a modular design of molecules, adapted to clinical needs.
For all these reasons, Affilin® molecules are ideal for use as
radiotheranostic targeting molecules.
Navigo Proteins GmbH, a protein engineering company based in
Halle, Germany, is headed by a strong and experienced team
committed to leveraging Affilin® technology in multiple areas. This
collaboration will enable OPM and Navigo to build a first-class
entity in the field of radioligand therapy based on the
complementary strengths of the two companies. Navigo's Board is
composed of leading professors and scientists in the field of
radioligand therapy, such as Oliver Buck (co-founder of ITM and
member of the board of directors of Telix Pharmaceuticals).
Under the terms of the agreement, research will initially focus
on two different targets in the field of oncology, particularly in
resistant and metastatic digestive tract tumors, and molecules will
be developed to the stage of drug candidates. Oncodesign Precision
Medicine will fund this program over the next 3 years. This
agreement is a first step towards a strong strategic alliance
between OPM and Navigo Proteins GmbH with the vision to expand the
partnership to additional targets.
Philippe GENNE, Co-founder, Chairman and CEO of Oncodesign
Precision Medicine, said: " This strategic alliance will
provide OPM with the opportunity to rapidly develop its portfolio
of radiotheranostics and leverage its extensive knowledge and
expertise in the discovery of next generation radioligand
therapies. This is a promising therapeutic area that will
revolutionize the treatment of inoperable and metastatic tumors. We
are proud and delighted to benefit from the technology developed by
Navigo, our partner in this collaboration, which in addition to its
expertise in terms of Affilin® engineering, is also a
bio-industrial company with the ability to support innovative
bioprocessing of Biologics, often a delicate stage in the
development of such molecules. Our objective is to build a
world-class player in the field of radioligand therapies in the
near future."
Jan HOFLACK, Co-Founder and Chief Medical Officer of
Oncodesign Precision Medicine added: " Our Promethe® technology
represents the 3rd key element in our fight against cancers without
therapeutic solution. It is highly complementary to our other
technologies, Oncosniper and Nanocyclix®. These 3 approaches enable
us to position ourselves on metastatic and resistant cancers, using
immuno-oncology and radiotheranostics. These methods could be used
in synergy in the future. Navigo's Affilins® give us access to a
cutting-edge platform in terms of targeting vectors. The strengths
and expertise of OPM and Navigo are highly complementary, which is
the main reason for our alliance. Despite the logistical challenges
associated with these radioligand therapy molecules, their
potential to act both as imaging diagnostics at low doses and with
an appropriate radioisotope, and as therapeutics at higher doses
and with an isotope able to annihilate cancer cells, make them
tremendous tools to fight cancers without a solution for the
benefit of patients."
Henning Afflerbach, CEO of Navigo Proteins GmbH,
concludes: “Our collaboration with Oncodesign Precision Medicine
provides us with the ideal opportunity to advance our platform in
radiotheranostics towards clinical application. Our proprietary
Affilin® technology offers unparalleled modularity combined with
exceptional biodistribution properties making Affilins® invaluable
tools in our quest to revolutionize cancer treatment. By leveraging
OPM’s expertise in preclinical development, targeted oncology and
bio-industrial capabilities, we are keen to tackle together key
challenges in targeted therapeutics development. Our alliance with
OPM underscores the synergy between our strengths and expertise,
aiming to deliver innovative solutions that benefit patients
worldwide.”
About radiotheranostics
This is a radiotherapy technique used in nuclear medicine in the
field of oncology. Unlike external radiotherapy, irradiation is
targeted by molecules able to bind to tumors. These are
radiolabeled and administered intravenously, in the same way as
chemotherapy or other targeted therapy. External radiotherapy is
currently used in more than 50% of clinical protocols in oncology,
but it is only feasible in the case of a single tumor or a limited
number of tumors (oligometastases). Radioligand therapies, on the
other hand, are well suited for the treatment of disseminated
metastases.
Technologically, radioligand therapies are based on the
administration of a targeting molecule containing a radioactive
isotope (= radiopharmaceutical) aimed at specifically destroying
tumors. Its effectiveness comes from the highly localized energy
released in radioactive decay, which results in cell death
preferentially of tumor cells, while not damaging adjacent healthy
tissue. These particle-emitting radioisotopes are directed at
targets over-expressed by tumor cells, using highly specific
targeting molecules capable of recognizing and attaching to them.
The specificity of the targeting molecule for a tumor marker
enables healthy tissue to be spared and guarantees greater efficacy
while limiting side effects, a strategy that is particularly well
suited to disseminated diseases.
One of the advantages of radioligand therapies is the potential
to create a theranostic agent, i.e. a radiopharmaceutical which,
depending on the nature of the radiation from the chosen isotope,
enables diagnostic imaging (prediction/therapeutic monitoring, β+
or γ emitters) or patient therapy (β-, α, auger emitters).
About Oncodesign Precision Medicine (OPM)
Oncodesign Precision Medicine (OPM), founded in 2022, is a
biopharmaceutical company specializing in precision medicine,
dedicated to the discovery of treatments for resistant and
metastatic cancers.
OPM currently has two kinase inhibitors in clinical trials:
OPM-101, for the treatment of chronic immuno-inflammatory digestive
diseases, which demonstrated a significant therapeutic margin and
lack of toxicity in phase I trials with healthy volunteers, with a
phase II trials in cancer patients with severe colitis induced by
treatment with immuno checkpoint inhibitors (CUII) scheduled to
start at the end of 2024. OPM-201, licensed to Servier for the
treatment of Parkinson's disease, completed its phase I trial in
healthy volunteers this year, with phase II scheduled to start in
2025.
Finally, a third kinase inhibitor, OPM-102, targeting oncology,
is in preclinical development.
These three molecules come from the Nanocyclix® technology
platform, which enables the design and selection of small
macrocyclic kinase inhibitors that are highly effective and
selective. We now have 12,000 such molecules in our library and
will be using AI to accelerate the discovery of drug candidates
while reducing the cost of this phase.
OPM's two other technology platforms are:
(i) OncoSNIPER, for the selection of
therapeutic targets using artificial intelligence, in partnership
with Servier for the search of targets in pancreatic cancer, (ii)
PROMETHE® for the design and selection of radiolabeled biological
molecules for systemic radioligand therapies, for which we are
currently discussing partnerships with vectorization companies. The
current agreement is a result of these discussions.
OPM, co-founded by Philippe Genne, Jan Hoflack and Karine
Lignel, is based in Dijon, in the heart of the university and
hospital cluster, and has 22 employees.
Further information: oncodesign.com
About Navigo Proteins GmbH
Navigo Proteins is a fast-growing biopharmaceutical company
focused on Precision Medicine and particularly next generation
radiotheranostics based on its proprietary Affilin® platform.
Affilins® are novel target-binding proteins, combining the
advantages of antibodies and peptides. Easily customizable as
mono-, bi-, or multi-specific ligands, Affilins® can be coupled to
radioactive isotopes and cytotoxic payloads for potent anti-cancer
therapeutics against Tumor Associated Antigens (TAAs) and
immuno-oncology (I/O) targets. The high modularity of the Navigo
platform allows faster innovation cycles building on proven and
tested components.
Our growing Affilin® portfolio, backed by unique pre-clinical
data, tackles key challenges in targeted therapeutics, achieving
exceptional tumor-specific accumulation and favorable
biodistribution. Collaborations in the Radiopharmaceutical industry
with strong partners like ITM as well as in-house programs drive
the development of Affilins® for targeted radioligand therapy and
imaging. Our ultimate aim at Navigo Proteins is to deliver
best-in-class therapies and life saving products to patients
faster.
Further information: https://www.navigo-proteins.com/
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version on businesswire.com: https://www.businesswire.com/news/home/20240515866105/en/
Oncodesign Precision
Medicine
OPM Karine Lignel Deputy General Manager Tel: +33 (0)3 80
78 41 93 investisseurs@oncodesign.com
NewCap Investor Relations Mathilde Bohin / Alban Dufumier
Tel: +33 (0)1 44 71 94 95 oncodesign@newcap.eu
NewCap Media Relations Arthur Rouillé Tel: +33 (0)1 44 71
00 15 oncodesign@newcap.eu
Navigo Proteins
Dr. Michael Hamm Head of Business Development Tel: +49
(0)1755006944 michael.hamm@navigo-proteins.com
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