ITM and POINT Biopharma Expand Global Supply Agreement for n.c.a. Lutetium-177
31 Juli 2023 - 3:00PM
ITM Isotope Technologies Munich SE (ITM), a leading
radiopharmaceutical biotech company and POINT Biopharma Global Inc.
(NASDAQ: PNT) (“POINT”), a company accelerating the discovery,
development, and global access to life-changing
radiopharmaceuticals, today announced the expansion of their
global supply agreements signed in 2020. The expanded agreement
broadens the supply of ITM’s non-carrier-added lutetium-177
(n.c.a. 177Lu) to POINT to enable its usage in the clinical
and potential future commercial development of the 177Lu-based
molecules in POINT’s development pipeline. Financial details of the
agreement were not disclosed.
“Since POINT launched in late 2019, ITM has been
a key partner to us as we have worked to establish a commercially
scalable, reliable and redundant n.c.a. lutetium-177 supply chain,”
said Joe McCann, Ph.D., CEO of POINT Biopharma.
“In building on this established trust and ITM’s position as the
world’s leading manufacturer of n.c.a. lutetium-177, we value the
ability to utilize ITM’s highly pure radioisotope across our
growing pipeline of next-generation radioligands for precision
oncology.”
Steffen Schuster, CEO of ITM
added, “It is our objective to make Targeted Radionuclide Therapy
as broadly available as possible, not only by advancing our own
pipeline, but also by supporting the whole industry with a stable
and scalable isotope supply. We look forward to enriching our
long-term collaboration with POINT by supplying our versatile
n.c.a. lutetium-177 for the development and commercialization of
various novel molecules.”
ITM holds a U.S. Drug Master File (DMF) with the
Food and Drug Administration (FDA) for n.c.a. 177Lu and has
marketing authorization in the EU (brand name EndolucinBeta®).
About Targeted Radionuclide
TherapyTargeted Radionuclide Therapy is an emerging class
of cancer therapeutics, which seeks to deliver radiation directly
to the tumor while minimizing radiation exposure to normal tissue.
Targeted radiopharmaceuticals are created by linking a therapeutic
radioisotope to a targeting molecule (e.g., peptide, antibody,
small molecule) that can precisely recognize tumor cells and bind
to tumor-specific characteristics, such as receptors on the tumor
cell surface. As a result, the radioisotope accumulates at the
tumor site and decays, releasing a small amount of ionizing
radiation, with the goal of destroying tumor tissue. The precise
localization enables targeted treatment with potentially minimal
impact to healthy surrounding tissue.
ITM Isotope Technologies Munich
SEITM, a leading radiopharmaceutical biotech company, is
dedicated to providing a new generation of radiomolecular precision
therapeutics and diagnostics for hard-to-treat tumors. We aim to
meet the needs of cancer patients, clinicians and our partners
through excellence in development, production and global supply.
With improved patient benefit as the driving principle for all we
do, ITM advances a broad precision oncology pipeline, including two
phase III studies, combining the company’s high-quality
radioisotopes with a range of targeting molecules. By leveraging
our nearly two decades of pioneering radiopharma expertise, central
industry position and established global network, ITM strives to
provide patients with more effective targeted treatment to improve
clinical outcome and quality of life. www.itm-radiopharma.com
About POINT BiopharmaPOINT
Biopharma Global Inc. is a globally focused radiopharmaceutical
company building a platform for the clinical development and
commercialization of radioligands that fight cancer. POINT aims to
transform precision oncology by combining a portfolio of targeted
radioligand assets, a seasoned management team, an industry-leading
pipeline, in-house manufacturing capabilities, and secured supply
for medical isotopes including actinium-225 and lutetium-177.
POINT’s active clinical trials include FRONTIER, a phase 1 trial
for PNT2004, a pan-cancer program targeting fibroblast activation
protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for
people with metastatic castration resistant prostate cancer (mCRPC)
after second-line hormonal treatment. Learn more about POINT
Biopharma Global Inc. at https://www.pointbiopharma.com/.
Forward Looking StatementsThis
press release contains forward-looking statements within the
meaning of the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995. In some cases, you can identify
forward-looking statements by the following words: “may,” “will,”
“could,” “would,” “should,” “expect,” “intend,” “plan,”
“anticipate,” “believe,” “estimate,” “predict,” “project,”
“potential,” “continue,” “ongoing” or the negative of these terms
or other comparable terminology, although not all forward-looking
statements contain these words. These statements involve risks,
uncertainties and other factors that may cause actual results,
levels of activity, performance or achievements to be materially
different from the information expressed or implied by these
forward-looking statements. Although we believe that we have a
reasonable basis for each forward-looking statement contained in
this press release, we caution you that these statements are based
on a combination of facts and factors currently known by us and our
projections of the future, about which we cannot be certain.
Forward-looking statements in this press release include, but are
not limited to, statements regarding the benefits of the recently
completed business combination, as well as statements about the
potential attributes and benefits of POINT’s product candidates and
the format and timing of POINT’s product development activities and
clinical trials. We cannot assure you that the forward-looking
statements in this press release will prove to be accurate. These
forward-looking statements are subject to a number of significant
risks and uncertainties that could cause actual results to differ
materially from expected results, including, among others, our
ability to grow and manage our growth profitably and retain our key
employees, the impact of COVID-19 on our business, the success,
cost and timing of our product development activities and clinical
trials, our ability to obtain and maintain regulatory approval for
our product candidates, our ability to obtain funding for our
operations, our the ability to maintain the listing of our common
stock on the NASDAQ, changes in applicable laws or regulations, the
possibility that POINT may be adversely affected by other economic,
business, and/or competitive factors, and other risks and
uncertainties, including those described in our Annual Report on
Form 10-K filed with the SEC on March 27, 2023. Many of these
factors are outside of POINT’s control and are difficult to
predict. Furthermore, if the forward-looking statements prove to be
inaccurate, the inaccuracy may be material. In light of the
significant uncertainties in these forward-looking statements, you
should not regard these statements as a representation or warranty
by us or any other person that we will achieve our objectives and
plans in any specified time frame, or at all. The forward-looking
statements in this press release represent our views as of the date
of this press release. We anticipate that subsequent events and
developments will cause our views to change. However, while we may
elect to update these forward-looking statements at some point in
the future, we have no current intention of doing so except to the
extent required by applicable law. You should, therefore, not rely
on these forward-looking statements as representing our views as of
any date subsequent to the date of this press release.
ITM Contact
Corporate Communications |
Investor Relations |
Julia Hofmann / Svenja Gärtner |
Ben Orzelek |
Phone: +49 89 329 8986 1500 |
Phone: +49 89 329 8986 1009 |
Email: communications@itm-radiopharma.com |
Email: Ben.Orzelek@itm-radiopharma.com |
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POINT Biopharma Contact
Investor Relations Contact:
Daniel PearlsteinDirector,
Strategyinvestors@pointbiopharma.com
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