Press Release




ESMO: AlphaMedixTM phase 2 data support first-in-class
potential of new targeted alpha therapy in
gastroenteropancreatic neuroendocrine tumors
• New AlphaMedix data showed sustained and clinically meaningful responses across both RLT-
naïve and RLT-exposed patients with unresectable or metastatic GEP-NETs
• First phase 2 study to evaluate TAT with lead-212 supporting its potential to address high
unmet medical needs in difficult-to-treat, rare cancers
• Phase 2 study met all primary efficacy endpoints and was presented across two oral
presentations at the 2025 ESMO Congress in Berlin, Germany

Paris, October 20, 2025. New data from the ALPHAMEDIX-02 phase 2 study (clinical study
identifier: NCT05153772) evaluating AlphaMedix (212Pb-DOTAMTATE), an investigational
somatostatin receptor (SSTR) targeted alpha therapy (TAT) using the lead-212 isotope,
underscore the first-in-class potential of this investigational medicine for the treatment of
patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Detailed
results from the phase 2 study, the first to evaluate a TAT across both radioligand therapy (RLT)-
naïve and RLT-exposed patients affected by GEP-NETs, were presented in two oral presentations
at the 2025 European Society for Medical Oncology (ESMO) Congress, Berlin, Germany.

“Lead-212-based Targeted Alpha Therapy (TAT) could have a transformative impact
across a broad range of solid tumors. With AlphaMedix’s consistent and clinically
meaningful responses across both RLT-naïve and RLT-exposed gastroenteropancreatic
neuroendocrine tumor (GEP-NET) patients, the positive results underscore its potential
in this rare and difficult-to-treat cancer,” said Volker Wagner, MD, PhD, Chief Medical
Officer at Orano Med. “These data strongly encourage us to further advance the clinical
development of AlphaMedix, and jointly with our partner, Sanofi, make this innovative
TAT available to patients in need.”

ALPHAMEDIX-02 phase 2 study
ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety
of AlphaMedix in patients with unresectable or metastatic SSTR+ GEP-NETs. The study included
two cohorts evaluating RLT-naïve and RLT-exposed patients. The primary efficacy endpoint
across both cohorts was the overall response rate (ORR). Secondary endpoints included
progression-free survival (PFS) and overall survival (OS).

The study's efficacy endpoints are based on local investigator assessment, per protocol. In
addition, a blinded independent central review (BICR) was conducted subsequently. The key
efficacy endpoints were met within both the investigator-assessed and BICR results.




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The following results were presented:

RLT-Naïve
(n=35)
Investigator assessment Independent assessment
(BICR)
*DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST 1.1
**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1
***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a
ORR 60.0% 57.1%
(95% CI: 42.1-76.1) (95% CI: 39.4-73.7)
Duration of Response 71.9% for ≥ 24 months 81.7% for ≥ 24 months
(DoR) per Kaplan-Meier (95% CI: 44.6-87.4) (95% CI: 53.1-93.8)
(KM) estimate (95% CI)*
Complete Response (CR) - 2.9%
Partial Response (PR) 60.0% 54.3%
Stable Disease (SD) 34.3% 28.6%
Disease control rate 94.3% 85.7%
(DCR)** (95% CI: 80.8-99.3) (95% CI: 69.7-95.2)
PFS 36-month PFS rate of 72.3% 36-month PFS rate of 63.3%
(95% CI: 53.3-84.5) (95% CI: 40.3-79.4)
OS 36-month OS rate of 88.2% Not applicable***
(95% CI: 71.5-95.4)

RLT-Exposed
(n=26)
Investigator assessment Independent assessment
(BICR)
*DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST 1.1
**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1
***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a
ORR 34.6% 19.2%
(95% CI: 17.2-55.7) (95% CI: 6.6-39.4)
Duration of Response 100% for ≥ 18 months 100% for ≥ 18 months
(DoR) per Kaplan-Meier (95% CI: 100-100) (95% CI: 100-100)
(KM) estimate (95% CI)*
Partial Response (PR) 34.6% 19.2%
Stable Disease (SD) 61.5% 80.8%
Disease control rate 96.2% 100%
(DCR)** (95% CI: 80.4-99.9) (95% CI: 86.8-100)
PFS 18-month PFS rate of 82.6% 18-month PFS rate of 88%
(95% CI: 59.0-93.3) (95% CI: 67.3-96.0)
OS 18-month OS rate of 85.1% Not applicable***
(95% CI: 58.5-95.2)

AlphaMedix™ had a similar safety profile across both cohorts. Within the RLT-naïve cohort,
85.7% of patients received all four doses of AlphaMedix, and 84.6% of patients within the RLT-
exposed cohort. All GEP-NET patients experienced at least one treatment-emergent adverse
event (TEAE). Grade ≥3 TEAEs occurred in 42.3% of RLT-exposed patients and 54.3% of RLT-
naïve patients. The most common Grade ≥3 TEAEs in both groups was lymphocyte count
decrease (25.7% of RLT-naïve patients and 15.4% of RLT-exposed patients).

“The future of oncology research will be driven by cutting-edge science and next-
generation modalities, such as radioligand therapies. AlphaMedix, a promising targeted
alpha therapy, embodies the type of solution Sanofi is working to advance,” said
Christopher Corsico, MD, Global Head of Development at Sanofi. “We are excited to
share these robust scientific findings at ESMO as the data could represent a significant
advancement in how we treat gastroenteropancreatic neuroendocrine tumors. As we
engage with health authorities and advance the clinical program, we remain focused on
bringing this innovative modality to patients who need new treatment options”




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Advancing AlphaMedix in GEP-NETs
RLTs, which work by delivering radiation directly to tumor cells, represent an emerging area of
oncology research. While current approved beta-emitting RLTs have improved outcomes in
patients with GEP-NETs, there remains a critical gap in care, including in those who have
progressed following previous RLT.

TAT represents an innovative modality in RLT, harnessing high-energy, short-range alpha
emissions to precisely target cancer cells while reducing potential exposure to surrounding
tissue.

"The results observed in the ALPHAMEDIX-02 trial clearly demonstrate exceptional
levels of efficacy for a Targeted Alpha Therapy (TAT), based on current available
therapies, in both radioligand therapy (RLT)-naïve and RLT-exposed populations and
could potentially set new expectations when treating gastroenteropancreatic
neuroendocrine tumor (GEP-NET) patients with RLTs” said Ebrahim Delpassand, MD,
Founder and Chairman, CEO of RadioMedix. “For too long, this patient population has
experienced inadequate disease control with current approved therapies. This important
work provides hope for a new treatment for GEP-NET patients, their caregivers, and
their healthcare providers.”

In February 2024, AlphaMedix™ was designated as a breakthrough therapy by the US Food and
Drug Administration in RLT-naïve patients with unresectable or metastatic GEP-NETs,
recognizing the potential clinical benefits of lead-212–based TATs. The ALPHAMEDIX-02 results
will form the basis for further discussions with health authorities.

An international phase 3 study to further evaluate AlphaMedix in GEP-NETs is actively being
planned. AlphaMedix is an investigational medicine and has not been approved by any regulatory
authority.

In September 2024, Sanofi entered an exclusive licensing agreement with Orano Med and
RadioMedix to globally commercialize AlphaMedix.

About the ALPHAMEDIX-02 study
ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety
of AlphaMedix (212Pb-DOTAMTATE) in patients with histologically confirmed unresectable or
metastatic GEP-NETs, positive somatostatin analogue imaging and at least one site of
measurable disease. The study included two cohorts evaluating RLT-naïve (n=35) and RLT-
exposed (n=26) GEP-NET patients. RLT-exposed patients had progressive disease after receiving
up to four doses of 177Lu-DOTATATE and received their last dose at least six months prior to Day
1. In both cohorts, AlphaMedix was administered at 67.6 µCi/kg every eight weeks for up to four
cycles (6 mCi maximum per cycle). The primary efficacy endpoint across both cohorts was ORR
per RECIST 1.1. Secondary endpoints included PFS and OS.

About NETs
NETs are a heterogeneous group of 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 the ovaries, heart, and prostate.
Most NETs strongly express somatostatin receptors. 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. In the United States, around 12,000 patients annually are
expected to be diagnosed with neuroendocrine tumors, with an average five-year survival rate
of 60% at a metastatic stage.

About Orano Med
Orano Med is a subsidiary of the Orano Group. Orano Med 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 Therapy (TAT). Leveraging
its unique and secured access to 212Pb, the company is developing several 212Pb-based

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radioligand therapies 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
expanding its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North
America and Europe.

About RadioMedix
RadioMedix, Inc., a clinical-stage biotechnology company and former sponsor of the AlphaMedix
trial, is 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.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives
and delivering compelling growth. We apply our deep understanding of the immune system to
invent medicines and vaccines that treat and protect millions of people around the world, with
an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we
chase the miracles of science to improve people’s lives; this inspires us to drive progress and
deliver positive impact for our people and the communities we serve, by addressing the most
urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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