NH TherAguix Announces the completion of Phase I Recruitment for the Pancreas Cohort and the entry into Phase II in the NANOSMART phase Ib/II trial.
July 01 2024 - 8:30AM
NH TherAguix Announces the completion of Phase I Recruitment for
the Pancreas Cohort and the entry into Phase II in the NANOSMART
phase Ib/II trial.
PRESS RELEASE
NH TherAguix Announces the completion of
Phase I Recruitment for the Pancreas Cohort and
the entry into Phase IIin the NANOSMART phase
Ib/II trial.
- Key
clinical milestone showcasing the potential of AGuIX®, a
next-generation nanodrug developed by NH TherAguix, to improve
tumor targeting and augment efficacy when combined with
radiotherapy in solid tumors.
-
NANOSMART is a phase Ib/II clinical trial investigating the
safety and efficacy of the combination of AGuIX® intravenous
injections with stereotactic magnetic resonance (MR)-guided
adaptive radiation therapy for the treatment of locally
advanced/unresectable pancreatic ductal adenocarcinoma (LAPC) and
of centrally located non-small cell lung cancer
lesions.
- The
Principal Investigator, Jonathan Leeman, MD, at Brigham &
Women’s Hospital and The Dana-Farber Cancer Institute, announce the
transition to the Phase II randomized part of the study in the
cohort of patient with pancreatic tumors.
Paris, France, July
1st, 2024 – NH TherAguix (NHT), a phase
II clinical-stage biotechnology company specializing in the
development of novel nanomedicine solutions for precision
radiotherapy in oncology, today announced the transition to the
Phase II randomized part of the NANOSMART study in the cohort of
patients with pancreatic tumors. The NANOSMART study, titled
"An adaptive phase I–II trial of AGuIX® gadolinium-based
nanoparticles with stereotactic magnetic resonance-guided adaptive
radiation therapy (SMART) for locally advanced unresectable
pancreatic ductal adenocarcinoma and centrally located lung
tumors," is currently ongoing to assess safety,
biodistribution and radio-enhancement efficacy of the combination
of AGuIX® intravenous injections.
AGuIX®: A Nanodrug Capable of Improving
the Precision and Effectiveness of Radiotherapy
The culmination of over a decade of research,
AGuIX® nanoparticles are designed to meet the critical medical need
for more effective cancer treatments, including pancreatic cancer.
These gadolinium-based nanoparticles enhance MRI contrast, allowing
for precise tumor visualization, and significantly amplify the
radiation dose delivered to tumor tissues, thereby improving the
efficacy of radiotherapy.
NANOSMART: A Monocentric, Randomized,
Open-Label Phase Ib/II Trial Conducted with the Dana-Farber Cancer
Institute/Brigham & Women’s Hospital Team
The aim of the dose escalation Phase I was to
determine the recommended dose of the experimental drug to be
evaluated in Phase II. Two dose levels of AGuIX® (75mg/kg and
100mg/kg) have been tested on twenty patients treated in the
pancreas cohort during Phase I. These patients with locally
advanced unresectable pancreatic ductal adenocarcinoma have
received two injections of AGuIX® in combination with SMART (40 Gy
in 5 fractions of 8 Gy). AGuIX® injections were well-tolerated.
Additionally, MRI analysis has confirmed that AGuIX® nanoparticles
selectively accumulated in pancreatic tumors.
A good safety profile of AGuIX® in
combination with SMART was confirmed.
“The transition to the Phase II randomized stage
of the study in the cohort of patients with pancreatic cancer was
approved by the institutional review board and the FDA at the
recommended dose of AGuIX at 100mg/kg,” said Dr Jonathan
Leeman, the study P.I., from Brigham & Women’s Hospital and The
Dana-Farber Cancer Institute.
The Phase II part of NANOSMART study will be
randomized within two arms: an experimental arm in which patients
will be treated with AGuIX® at a dose of 100 mg/kg in combination
with SMART (10 patients), and a control arm in which patients will
be treated with SMART alone (20 patients).
The primary endpoint of this Phase II is local
control at 12 months. Secondary endpoints include progression-free
survival, overall response rate, disease-specific survival, quality
of life and overall survival.
Dr. Olivier de Beaumont, CMO of NH
TherAguix, emphasized the significance of this
step: "AGuIX® Orphan Drug Designation was already
granted by FDA and EMA for pancreatic tumors in 2021, and we are
very happy to be able to continue the evaluation of AGuIX® in
combination with SMART after confirmation of the good safety
profile and biodistribution in patients with pancreatic tumors. I
would like to thank Dr. Jonathan Leeman very much for his strong
commitment to enrolling patients in the two cohorts (locally
advanced/unresectable pancreatic ductal adenocarcinoma (LAPC) and
centrally located non-small cell lung cancer lesions.”
Vincent Carrère, CEO of NH TherAguix,
commented: "We are thrilled to announce this important
next step of transition to the NANOSMART Phase II randomized part
in pancreatic tumors. I would like to thank Dr Jonathan Leeman and
the Dana-Farber Cancer Institute/Brigham & Women’s Hospital
team for this remarkable clinical and translational work. It
highlights the transformative potential of AGuIX® in enhancing
radiotherapy for pancreatic cancer patients. This promising next
step reinforces our commitment to advancing innovative cancer
treatments and improving patient outcomes in difficult-to-treat
indications."
About NH TherAguix:
www.nhtheraguix.com
NH TherAguix is a late-stage biotech company
developing AGuIX® to treat tumors and metastases in patients
undergoing radiotherapy. It is estimated that approximately 60% of
cancer patients receive radiotherapy. AGuIX® is currently being
assessed in multiple Phase II randomized trials across various
cancer types, including brain metastases, glioblastoma, and
pancreatic and lung cancers.
To date, over 190 patients have been treated
with AGuIX®. This innovation is protected by 18 patent families and
has been extensively tested in various preclinical models, with
results published in more than 80 high-impact publications.
NH TherAguix was established in 2015 following
10 years of academic research that led to the invention of AGuIX®
and the discovery of its radiosensitizing effect. The company has
raised approximately €40m of funds, including a €13m Series A in
2019 led by Bpifrance with Arbevel, Omnes, and Supernova.
Media contacts:NH TherAguixNewCap - Arthur
Rouilléarouille@newcap.fr+33 (0)1 44 71 00 15