Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today
announces the successful completion of CUPID1, a first-in-human
Phase I dose escalation study of TLX592 in patients with advanced
prostate cancer.
TLX592 (225Ac-PSMA-RADmAb®) is Telix’s
investigational “next generation” targeted alpha therapy (TAT) for
the treatment of prostate cancer and is the first clinical program
to utilise Telix’s proprietary RADmAb® engineered antibody
technology. The RADmAb® approach accelerates blood clearance and
reduces bone marrow residence time compared with standard
monoclonal antibodies (mAbs), while retaining target selectivity,
internalisation and retention. The RADmAb® platform is currently
under pre-clinical and clinical evaluation for multiple cancer
targets.
The CUPID (64Cu
PSMA Imaging and (Bio)
Distribution) study is a 3+3 mass dose escalation
study with four patient cohorts intended to evaluate the safety,
tolerability, pharmacokinetics, biodistribution and radiation
dosimetry of TLX592. The study utilises copper-64 (64Cu) which is
detectable by Positron Emission Tomography (PET) as a surrogate for
actinium-225 (225Ac), enabling a successful proof-of-targeting
study as well as predictive dosimetry calculations for future
studies with 225Ac. Preliminary results in 11 evaluable patients
enrolled in the study demonstrated accelerated blood kinetics
compared to the standard antibody TLX591, while demonstrating
similar (favourable) on-target and off-target biodistribution and
hepatic clearance. There were no serious adverse events observed in
the study.
Based on these encouraging results, Telix
expects to advance TLX592 into a therapeutic Phase I/II study with
225Ac in the second half of 2024, subject to regulatory approval.
TLX592 further deepens Telix’s PSMA2-targeting prostate cancer
therapy portfolio and supplements its lead investigational radio
antibody-drug conjugate (rADC) TLX591 (177Lu rosopatamab
tetraxetan), currently being investigated in the ProstACT GLOBAL
Phase III study. The Company intends to publish and present
non-clinical and clinical data supporting these results at several
upcoming symposia.
Dr David N. Cade, Group Chief Medical Officer at
Telix stated, “The CUPID study demonstrated clearly how theranostic
approaches can be used to streamline novel radiopharmaceutical drug
development. In this case, PET imaging was used to dose-find a
targeting agent for future use with an alpha emitter, while
establishing basic safety and utility parameters that will greatly
inform ongoing development of this product candidate.
“There is a significant unmet need for novel
targeting platforms that may be used with alpha emitting isotopes
and avoid renal toxicity and other off-target effects, such as the
exocrine gland uptake typical of PSMA small molecule agents. We are
excited to progress TLX592 into therapeutic studies where our aim
is to develop this agent for both early metastatic prostate cancer
and late-stage patients who are no longer responding to lutetium
therapy. We would like to thank all participants for their
commitment to the CUPID study.”
________________________1 ClinicalTrials.gov ID:
NCT04726033.2 Prostate-specific membrane antigen.
About Telix
Pharmaceuticals LimitedTelix is a biopharmaceutical
company focused on the development and commercialisation of
diagnostic and therapeutic radiopharmaceuticals and associated
medical devices. Telix is headquartered in Melbourne, Australia,
with international operations in the United States, Europe (Belgium
and Switzerland), and Japan. Telix is developing a portfolio of
clinical and commercial stage products that aims to address
significant unmet medical needs in oncology and rare diseases.
Telix is listed on the Australian Securities Exchange (ASX:
TLX).
Telix’s lead imaging product, gallium-68 (68Ga)
gozetotide injection (also known as 68Ga PSMA-11 and marketed under
the brand name Illuccix®), has been approved by the U.S. Food and
Drug Administration (FDA)3, by the Australian Therapeutic Goods
Administration (TGA) 4, and by Health Canada5. No other Telix
product has received a marketing authorisation in any
jurisdiction.
Visit www.telixpharma.com for further
information about Telix, including details of the latest share
price, announcements made to the ASX, investor and analyst
presentations, news releases, event details and other publications
that may be of interest. You can also follow Telix on X and
LinkedIn.
________________________3 Telix ASX disclosure
20 December 2021.4 Telix ASX disclosure 2 November 2021.5 Telix ASX
disclosure 14 October 2022.
Telix Investor Relations
Ms. Kyahn WilliamsonTelix Pharmaceuticals
LimitedSVP Investor Relations and Corporate CommunicationsEmail:
kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix
Pharmaceuticals Limited Disclosure Committee on behalf of the
Board.
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