FDA Pre-IND meeting supports an IND application for RAD 101
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
29 MAY 2023
Positive guidance from FDA Pre-IND meeting supports an IND application for
a Phase 2b/3 clinical trial Imaging Brain Metastasis
Sydney, Australia – 29 May 2023 – Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the
“Company”), a developer of a world-class platform of radiopharmaceutical products for
both diagnostic and therapeutic uses, is pleased to announce that it has completed a
positive pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug
Administration (FDA) for F18-pivalate (RAD 101).
This is a significant milestone towards our IND application for our late stage clinical trials.
Based on positive guidance received from the U.S. FDA, the Company will file an IND
application to initiate a multi-center trial for imaging brain metastasis during the third
quarter of 2023 and anticipates having the first patient dosed by the end of the year.
RAD 101 is a proprietary imaging agent composed of F18 radioisotope and pivalate, a small
molecule that targets fatty acid synthetase. In October 2022, positive data from the Imperial
College of London’s Phase IIa imaging trial of RAD 101 in patients with brain metastases
showed significant tumour uptake that was consistent with and independent from the
tumour of origin. This supports the potential use of pivalate to monitor cerebral metastasis.
“Pivalate represents a new class of targeted radiopharmaceuticals with RAD 101 data
demonstrating very positive performance in brain metastasis,” said Riccardo Canevari, CEO
and Managing Director of Radiopharm Theranostics. “We are engaging with the FDA to
expedite clinical development of RAD 101, considering the high unmet medical need in
around 300,000 patients that are diagnosed with brain mets in the U.S. every year. Being so
close to late stage development is highly exciting for us and for the medical community.”
Radiopharm holds an exclusive global license for the pivalate platform technology and also
has a collaboration in place with Imperial College of London to develop a therapeutic
candidate leveraging the same mechanism of action.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class
platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in
areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021.
The company has a pipeline of six distinct and highly differentiated platform technologies spanning
peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical
stages of development from some of the world’s leading universities and institutes. The pipeline has
been built based on the potential to be first to market or best in class. The clinical program includes
one Phase II and three Phase I trials in a variety of solid tumour cancers including breast, kidney and
brain. Learn more at RadiopharmTheranostics.com.
Authorised on behalf of the Radiopharm Theranostics board of directors by Executive Chairman
Paul Hopper.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT
29 MAY 2023
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Timothy McCarthy
Investor Relations
LifeSci Advisors, LLC
P: +1 917 679 9282
E: tim@lifesciadvisors.com
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
Twitter – https://twitter.com/TeamRadiopharm
Linked In – https://www.linkedin.com/company/radiopharm-theranostics/
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
Share your feedback
Discover