Press Release: Sanofi, RadioMedix, and Orano Med announce licensing
agreement on next-generation radioligand medicine for rare cancers
![](https://ml-eu.globenewswire.com/Resource/Download/60c20d32-408e-49af-a206-4aa639fa483e/image2.jpeg)
![](https://ml-eu.globenewswire.com/Resource/Download/4fcc4a91-e14d-4fb9-a5b4-5e0f200e72a5/image3.jpeg)
Sanofi, RadioMedix, and Orano Med announce
licensing agreement on next-generation radioligand medicine for
rare cancers
Paris, France, and Houston, Texas,
September 12, 2024. As part of its effort to develop
innovative treatments for people living with rare cancers, Sanofi
has entered into an exclusive licensing agreement with RadioMedix,
Inc., a US clinical-stage biotechnology company developing
radiopharmaceuticals for PET imaging and targeted alpha therapy
(TAT) against unmet medical needs in cancer, and Orano Med, a
French clinical-stage biotechnology company, subsidiary of the
Orano Group, developing lead-212 (212Pb) radioligand
therapies (RLTs) against cancer.
This collaboration between Sanofi, RadioMedix
and Orano Med focuses specifically on the late-stage project,
AlphaMedixTM (212Pb-DOTAMTATE), which
currently is being evaluated for the treatment of adult patients
with unresectable or metastatic, progressive somatostatin-receptor
expressing neuroendocrine tumors (NETs), a rare cancer.
AlphaMedixTM is a TAT which consists of a somatostatin
receptor-targeting peptide complex radiolabeled with lead-212
(212Pb) that serves as an in vivo generator of alpha
particles.
Dietmar Berger
Chief Medical Officer, Global Head of Development, Sanofi
“We are excited to develop a leading-edge project in
the rapidly evolving field of radioligand
therapies in rare cancers. Early results for 212Pb have
demonstrated its differentiated biophysical and clinical
profile, reinforcing its potential to be a transformative
radioligand therapeutic for patients across multiple
difficult-to-treat rare cancers. This agreement underscores
our efforts to explore innovative collaborations that
leverage novel technologies to address the needs of
people living with cancer.”
AlphaMedixTM has recently been
granted Breakthrough Therapy Designation in gastroenteropancreatic
neuroendocrine tumors (GEP-NETs) from the US Food and Drug
Administration (FDA) for patients who are naïve to peptide-receptor
radionuclide therapy. The FDA’s decision was based on findings from
phase 1i and 2 clinical studies, which found that
AlphaMedixTM was well tolerated and provided substantial
reduction in tumor burden, with a durable response rate (ORR
according to RECIST 1.1) of 62.5%.i
AlphaMedixTM is currently completing phase 2 clinical
development, and the data is being discussed with the FDA for
potential regulatory filing and approval.
Ebrahim S.
Delpassand
Chairman and CEO, RadioMedix
“The Breakthrough Therapy Designation of AlphaMedix is a
testament of its success in validating targeted alpha therapies. We
see this as a potential for the future of
nuclear oncology in general, and today it is
pioneering next-generation treatment for patients with
neuroendocrine tumors. In our research, we have seen
that significantly higher energy delivery over much shorter
path lengths in the tissue of alpha emitters can overcome the
limitations of currently available beta emitter radioligand
therapies. We believe 212Pb is an ideal alpha emitter with highly
desirable physical and supply characteristics in
comparison to other alpha emitters. RadioMedix has been one of
the pioneers in the field of radioligand therapy in the U.S and,
through this licensing agreement with Sanofi, our goal is to bring
this potentially life-saving therapy to as many patients as
possible.”
Julien Dodet
President and CEO, Orano Med
“At Orano Med, we are at the forefront of innovation in
radioligand therapy and are developing a global industrial platform
for the manufacture and distribution of our 212Pb-conjugated drugs.
This marks a pivotal moment to expedite the development of this new
therapy and in our fight against cancer. Through this agreement, we
aim to lead the charge in advancing radioligand therapies with the
ambition to revolutionize cancer therapeutics.”
Under the licensing agreement, Sanofi will be
responsible for the global commercialization of
AlphaMedixTM, while Orano Med will be responsible for
the manufacturing of AlphaMedixTM through its global
industrial platform currently under development. Under the terms of
the agreement, RadioMedix and Orano Med will receive an upfront
payment of €100 million and up to €220 million in sales milestones
and be eligible for tiered royalties. This agreement is subject to
standard regulatory approvals required for transactions of this
nature.
In striving to become the number one
immunoscience company globally, Sanofi remains committed to
advancing oncology innovation. Through focused strategic decisions
the company has reshaped and prioritized its pipeline, leveraging
its expertise in immunoscience to drive progress. Efforts are
centered on difficult-to-treat cancers such as select hematologic
malignancies, and solid tumors with critical unmet needs, including
multiple myeloma, acute myeloid leukemia, certain types of
lymphomas, as well as gastrointestinal and lung cancers.
About neuroendocrine tumors
Neuroendocrine tumors (NETs) are a heterogeneous group of rare
cancers that originate from neuroendocrine cells. These cancers
occur mostly in the gastrointestinal tract and pancreas but can
also occur in other tissues including the thymus, lung, and other
uncommon sites such as ovaries, heart, and prostate. Most NETs
strongly express somatostatin receptors. In the United States,
around 12,000 patients annually are expected to be diagnosed with
neuroendocrine tumors, with an average 5-year survival rate of 60%
at a metastatic stage. Despite the global prevalence of NETs
increasing each year, it is considered a rare cancer that is
estimated to affect approximately 35/100,000 individuals
worldwide.
About RadioMedix
RadioMedix, Inc. is a clinical-stage biotechnology company, based
in Houston and Humble, Texas. The company is focused on innovative
targeted radiopharmaceuticals for diagnosis, monitoring, and
therapy of cancer. RadioMedix is developing radiopharmaceuticals
for PET imaging and therapy (alpha- and beta-labeled agents). The
company established contract service facilities for academic and
industrial partners. including a cGMP and analytical suite for
Phase I-II-III clinical trials and commercial launch. To learn
more, visit www.radiomedix.com and LinkedIn. For more information
about this press release, please contact:
radiomedix@knbcomm.com.
About Orano Med
Orano Med, a subsidiary of the Orano Group, is a clinical-stage
biotechnology company that develops a new generation of targeted
therapies against cancer using the unique properties of lead-212
(212Pb), an alpha-emitting radioisotope and one of the
more potent therapeutic payloads against cancer cells known as
Targeted Alpha-Emitter Therapy (TAT). The company is developing
several treatments using 212Pb combined with
various targeting agents. Orano Med has 212Pb
manufacturing facilities, laboratories, and R&D centers in
France and in the US and is currently investing to further expand
its GMP-manufacturing capacities for 212Pb
radiolabeled pharmaceuticals in North America and Europe.
As a recognized international operator in the
field of nuclear materials, Orano Group delivers solutions to
address present and future global energy and health challenges. Its
expertise and mastery of cutting-edge technologies enable Orano to
offer its customers high value-added products and services
throughout the entire fuel cycle. Every day, the Orano group’s
17,500 employees draw on their skills, unwavering dedication to
safety and constant quest for innovation, with the commitment to
develop know-how in the transformation and control of nuclear
materials, for the climate and for a healthy and resource-efficient
world, now and tomorrow.
About Sanofi
We are an innovative global healthcare company, driven by one
purpose: we chase the miracles of science to improve people’s
lives. Our team, across the world, is dedicated to transforming the
practice of medicine by working to turn the impossible into the
possible. We provide potentially life-changing treatment options
and life-saving vaccine protection to millions of people globally,
while putting sustainability and social responsibility at the
center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Contacts
Sanofi Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 |
evan.berland@sanofi.com
Nicolas Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.com
Victor Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.com
Timothy Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Sanofi Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 |
thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.com
More contact information available here.
RadioMedix
radiomedix@knbcomm.com
Orano Med Media Relations
Sophie Letournel | +33
6 38 44 34 11| sophie.letournel@orano.group
Orano Press Office | +33 (0)1 34 96 12
15| press@orano.group
Orano Med Investor Relations
Marc
Quesnoy | investors@orano.group
Sanofi Forward-Looking
Statements
This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions, and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic and market conditions, cost containment
initiatives and subsequent changes thereto, and the impact that
pandemics or other global crises may have on us, our customers,
suppliers, vendors, and other business partners, and the financial
condition of any one of them, as well as on our employees and on
the global economy as a whole. The risks and uncertainties
also include the uncertainties discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2023. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
All trademarks mentioned in this press release
are the property of the Sanofi group with the exception of
AlphaMedix.
i Delpassand ES, Tworowska I, Esfandiari R, et
al. Targeted α-Emitter Therapy with 212Pb-DOTAMTATE for the
Treatment of Metastatic SSTR-Expressing Neuroendocrine Tumors:
First-in-Humans Dose-Escalation Clinical Trial. J Nucl
Med. 2022;63(9):1326-1333. doi:10.2967/jnumed.121.263230.
Sanofi (EU:SAN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Sanofi (EU:SAN)
Historical Stock Chart
From Sep 2023 to Sep 2024