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 BergerChief 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. DelpassandChairman
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 DodetPresident 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 RadioMedixRadioMedix, 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 MedOrano 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 SanofiWe 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 RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comEvan Berland |
+1 215 432 0234 | evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Sanofi Investor RelationsThomas Kudsk
Larsen |+ 44 7545 513 693 |
thomas.larsen@sanofi.comAlizé
Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.comMore contact information available
here.RadioMedixradiomedix@knbcomm.comOrano Med Media
RelationsSophie
Letournel | +33 6 38 44 34 11|
sophie.letournel@orano.groupOrano Press
Office | +33 (0)1 34 96 12 15|
press@orano.groupOrano Med Investor RelationsMarc
Quesnoy | investors@orano.group
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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.
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