From Neutron to Patient™
The Grand Opening of POINT Biopharma's Indianapolis Manufacturing Facility
Our Journey Began With An Idea
The Power Of Precision
All common cancer treatments, such as chemotherapy, external beam radiotherapy and surgery, put a significant burden on both patients and their families. A new generation of radiopharmaceutical treatments are improving patient outcomes by precisely targeting tumors using ligands carrying radioisotopes. Lutetium-177 (Lu-177) has emerged as one of the radioisotopes of choice for the new generation of radiopharmaceutical treatments. Lu-177 does not appear naturally in nature; its production and usage is truly a remarkable feat.
The Creation of Lutetium-177
Rare minerals are mined that contain trace amounts of Ytterbium, a metal with the symbol Yb on the periodic table. Pure Yb is then purified from the mineral ore.
The purified Yb is sent to a Calutron, a machine similar to a mass spectrometer, which further separates the purified Yb based on its mass. This process creates a stock of stable isotope Yb-176.
The Yb-176 is transported to a nuclear reactor, where it is irradiated. The addition of neutrons turns a small amount of the Yb-176 into a new isotope, Lutetium-177.
Time is of the essence; the Lu-177 contained in the Yb-176 target has a half-life of only 6.6 days. It is therefore immediately transported to POINT's facility, where the Lu-177 will be purified, combined with the targeting ligand, and shipped to a treatment site for injection into the patient, all in ~4 days.
Welcome To Our 80,000 ft² State-Of-The-Art Production Facility
Located at the Crossroads of America in Indianapolis, Indiana, shipments from the facility can reach 50% of the US population within 10 hours by local ground transportation, and to the rest of North America and Western Europe within 48 hours by air.
To streamline construction and simplify air quality management, a “building in a building” design was adopted, with a three-tiered filtration system to condition the air prior to it reaching the inner building.
This inner building has a unique mezzanine structure that allows for maintenance access of all the HVAC equipment systems, fan filter units, and pneumatic and automation controls.
The large glass walls of the clean rooms serve a dual purpose – in addition to creating an open line of sight to all operations, they are also a key part of the ventilation systems, acting as transparent air ducts to return air back to the HEPA filters.
Designed for both maximum safety and flexibility, the walls separating the different areas of the analytical labs have been lined with lead to prevent radiation from one section impacting the operators and machinery located in another.
Airflow and ventilation are key features of a GMP pharmaceutical manufacturing facility, especially when radioactive materials are handled. Over 160 HEPA fan filter units work in unison to supply ISO-certified rooms with incredibly low particulate airflow.
As a manufacturer of sterile products each batch needs to be tested for the presence of micro-organisms. State-of-the-art equipment is used to ensure all manufactured products exceed the highest levels of quality.
Microscopic, Cancer-Seeking Missiles
Dr. Oliver Sartor, Tulane School of Medicine & Member of POINT Biopharma's Global Advisory Board:
If You Can See It, You Can Treat It
Diagnostic
First, a diagnostic scan using a camera that detects radioisotope emissions is performed on patients injected with the ligand carrying an imaging isotope such as Gallium-68 that targets a receptor in the tumor.
Therapeutic
The tumors illuminated in the imaging scan can be targeted using a similar ligand carrying a therapeutic isotope such as Lutetium-177, to deliver radiation directly to the tumor.
Radiopharmaceuticals Have A Bright Future Ahead
New tissues agnostic ligands have the potential to exponentially increase the number of cancer indications treated by radioligands. An example of a tissue agnostic ligand is our PNT2004 program, which targets Fibroblast activation protein-α (or FAP-α). Found across a wide variety of tumors, targeting FAP-α with a radioligand could significantly increase that number of patients which could benefit from this breakthrough technology.
In addition to new targeting innovations, technologies to further increase the precision of radioligands are being developed by POINT, like our CanSEEK™ technology that prevents radioligands from binding to targets in healthy tissue, limiting accumulation of radioactivity in undesired locations.
New radioisotopes like Actinium-225 and Astatine-211 are also beginning to enter clinical trials, each with a unique set of cancer fighting characteristics. More radioisotopes will enable new treatments, further improving patient outcomes.
A New Pillar of Oncology
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This promotional website 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 promotional website, 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 promotional website 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 promotional website 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, the outcome of any legal proceedings that may be instituted against POINT following the closing of the business combination, the risk that the business combination disrupts current plans and operations, the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on POINT’s business, the ability to maintain the listing of POINT’s 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 RACA’s definitive proxy statement filed with the SEC on June 9, 2021. Most 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 promotional website represent our views as of the date of this promotional website. 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 promotional website.