PRESS RELEASE
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.
* 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 1(st), 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 (http://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 EUR40m of funds, including a EUR13m
Series A in 2019 led by Bpifrance with Arbevel, Omnes, and Supernova.
Media contacts:
NH TherAguix
NewCap - Arthur Rouillé
arouille@newcap.fr (mailto:arouille@newcap.fr)
+33 (0)1 44 71 00 15
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