[F-18]siPSMA and [F-18]siTATE:
Ready to substitute Ga-68 Tracers ?
[F-18]siPSMA and [F-18]siTATE:
a pair of SiFA-based ligands ready to compete with the clinically established Ga-68 ligands.
F-18 is ready to compete with Ga-68
The development of theranostic radiohybrid PSMA inhibitors (rhPSMAs) by A.Wurzer and H.J.Wester at the Institute for Pharmaceutical Radiochemistry, Technical University Munich (TUM) and the subsequently clinical evaluation of [F-18]rhPSMAs by M. Eiber and colleagues at the Department of Nuclear Medicine (TUM) demonstrated for the very first time that an F-18-labeled silicone fluorine acceptor based radiopharmaceutical is stable against defluorination in-vivo and, if carefully designed, can show pharmacokinetics suitable for PET imaging even at early time points after injection. Due to the outstanding labeling and imaging characteristics, [F-18]rhPSMA are being clinically developed by Blueearth Diagnostics (UK). Based on this initial success story, a series of purely diagnostic [F-18]siPSMA inhibitors have been developed by the same group.
In addition, an automated process has been developed allowing to produce F-18-labeled SiFA-cinjugated radiopharmaceuticals in <1000sec (from end of bombardment to end of production/completed formulation). The process was established on a cassette system comprising of two stopcock manifolds.
Moreover, F-18-labeled SiFA-conjugated ocreotate, named [F-18]SiFAlin-TATE (siTATE), has been successfully compared with [Ga-68]DOTA-TOC in 13 patients with NET. The authors concluded that the favorable characteristics of [F-18]SiFAlin-TATE, the simple labeling procedure, and the promising clinical performance enable improved logistics and diagnostic possibilities for PET imaging of NET.
In summary, and taking into accout that additional SiFA-peptides are being currently evaluated, we can conclude that the number of clinically revevant, SiFA-based F-18-labeled peptide and peptide-like radiopharmaceuticals will rapidly grow. The ease of production of F-18-labeled SiFA-conjugated radiopharmaceuticals will make them enormously competitive. It seems that the time has come to take a close look whether and to what extend F-18 can substitute Ga-68 in the rapidly-growing field of theranostics.
References:
siPSMA: Di Carlo D. et al. Eur J Nucl Med Mol Imaging (2019) 46 (Suppl 1): S16 (
patent application been filed)
siTATE: Ilhan H et al., Eur J Nucl Med Mol Imaging. 2019 Sep 6.
GMP Production of
[F-18]siPSMA and [F-18]siTATE:
• very fast production (<15min)
• at room temperature, thus without volatile 18F-activity
• high yields
• small and simple module
• small and simple cassette and reagent kit
• unparalleled cost efficiency
Radiochemical yield: | 50 % (*) |
Synthesis Time : | < 15 min |
Specific activity: | 300 GBq/µmol (**) |
applicable to: | all SiFA tracers |
** results from >400 clinical GMP production (starting activities from 30-100GBq)
* using 100 GBq [18F]fluoride and 150 nmol precursor (typical value)
References:
Wurzer A et al. J Nucl Med. 2019 (accepted)
siGRP Module
For production of the [F-18]siPSMA and [F-18]SiFAlin-TATE and new upcoming SiFA-Tracers we have designed a dedicated GRP Module that provide considerable advantages:
Production of [F-18]SiFA-based radiopharmaceuticals
The labeling process:
• SPE of [18F]F- on QMA
• on-cartridge drying of
[F-18]fluoride
(patent protected)
• elution of QMA
• labeling at room
temerature for 5 min
• dilution and SPE
• washing, elution, filtration
and dilution
• automated on a module
especially designed for
SiFA-labeling
The siGRP Module
References:
Wurzer A et al. (manuscript in preparation)
A successful enterprise is in a constant state of change ...
... that´s why we now have also became pink.
EANM Barcelona, Oct. 2019
At the EANM 2019 att/Scintomics announced that it has started with the installation of siGRP modules.
att/Scintomics has completed the necessary technical preparations of the new siGRP module and has already started with the installation of siGRP modules.
Tailor made offers that meet your needs and wishes
Switching from Ga-68 to F-18 by means of siPSMA and siTATE is carried out in a few hours.
You are welcome to give us a call us to learn more about our attractive and tailor made offers.
siGRP Module | on stock |
GMP cassette | on stock |
GMP kit | on stock |
Precursor | on stock (R&D grade; |
Training Courses: Production of
F-18-siPSMA and F-18-siTATE
The first training course was held in Fürstenfeldbruck/Bavaria in September. Further courses are helt monthly and will cover:
- siGRP module: installation, production, service
- siPSMA: chemistry and radiopharmacy
- siTATAE: chemistry and radiopharmacy;
- SiFA-Tracers: what is in the pipeline?
EANM Barcelona, Oct. 2019
We want to thank all visitors at the EANM2019 booth for their intensive interest and the wonderful and useful conversations.
Sarah Baum (left; Radiochemist and Product Manager siGRP and SiFA-based tracers) and Alina Biberacher (right, Sales Dept.) at the att-EANM booth.
Munich/Berlin, May 16, 2019
Scintomics and 1717 Life Science Ventures Team up in the Joint Venture PENTIXAPHARM to Develop CXCR4-Targeted Theranostics
>> Scintomics GmbH and 1717 Life Science Ventures GmbH announced today to have signed an agreement to collaborate in the development of the theranostic pair PentixaFor / PentixaTher.
PentixaPharm GmbH, based in Würzburg, is committed to develop PentixaFor and PentixaTher as a theranostic radiopharmaceutical pair, specifically targeting the CXCR4-receptor expressed in most fast progressing diseases, particularly malignant cancers.
“We are delighted that in 1717 LSV we have found a strong partner with an outstanding expertise in the clinical development of precision oncologics. Taking the various recent and successful proof-of-concept studies with PentixaFor and PentixaTher in men into account, this joint venture creates optimal conditions for the effective and swift clinical development of this unrivalled and unique pair of theranostic drugs”, said Prof. Hans-Jürgen Wester, PhD, Founder of Scintomics and Chair for Pharmaceutical Radiochemistry at the Technical University of Munich (TUM), Germany.
“The introduction of 68Ga-PentixaFor may be regarded as a milestone for clinical PET imaging of CXCR4 expressing malignancies”, added Dr. Hakim Bouterfa Co-founder of 1717 LSV GmbH and CEO of PentixaPharm. “Now we will focus on the next major step to provide CXCR4-directed endoradiotherapy in prospective clinical trials.”
att/Scintomics, June 2019
Andrea Maugg appointed CEO
Andrea Maugg has been appointed Chief Executive Officer of Scintomics and ATT (Scintomics Molecular/Applied Theranostics), with effect from July 2019.
Saskia Kropf and Dorothea Wester will continue as CEO of Scintomics, and will focus on business development, licensing and finance.
Munich, June 26, 2019
TUM Presidential Entrepreneurship Award 2019 went to Scintomics
Munich, June 26, 2019
This year the Technical University of Munich (TUM) has presented its Presidential Entrepreneurship Award to Scintomics GmbH.
>> The company develops, produces and markets innovative radio-pharmaceutical and nuclear medicine technologies for tumor diagnostics and tumor therapy. Scintomics has been selling and installing fully automated production systems for established radio-pharmaceuticals in clinical facilities around the world since 2006. In recent years Scintomics has been capturing increasing shares of the pharmaceuticals sector with highly-innovative radio diagnostics and therapeutic solutions, most of which have been developed and patented at TUM. Scintomics accompanies the entire process from production all the way to regulatory approval of new radio-pharmaceuticals. TUM is also the hub of the expertise behind the company’s interdisciplinary entrepreneurial strategy: Its founder Prof. Hans-Jürgen Wester holds the TUM Chair of Pharmaceutical Radiochemistry, while CEO Saskia Kropf is a TUM graduate in Mechanical Engineering.<< (TUM press release)
"We are very pleased that this year the Technical University of Munich (TUM) has presented its Presidential Entrepreneurship Award to Scintomics GmbH. Many innovative TUM spin-offs applied and competed for the 10.000 Euro endowed award. We are honoured to have received this award and proud of the strong partnership with TUM”, said Hans-J. Wester, founder of Scintomics. "We want to thank TUM for this award, the great cooperation and for the confidence in the performance capability of our company.”
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