Creating the platform for next-generation radiopharmaceuticals

Radiopharmaceuticals play a key role in medicine. In addition to being a diagnostic tool, they are also used therapeutically in the treatment of cancer; radioactive iodine-131 has been used

to treat thyroid cancer for more than 50 years. New technologies for targeting other cancer biomarkers are greatly expanding the use of radiopharmaceuticals beyond thyroid cancer into areas

of unmet need, such as prostate cancer. With indications expanding rapidly, radiopharmaceuticals could soon become a new pillar of cancer treatment. POINT Biopharma Global Inc.

(NASDAQ:PNT/POINTBiopharma.com) is a radiopharmaceutical company that is accelerating the development of these precision medicines for the treatment of cancer. With an exciting pipeline of

radiopharmaceuticals and a vertically integrated supply chain, POINT is uniquely positioned to bring radiopharmaceuticals to new, large cancer indications. POINT specializes in radioligands,

a type of radiopharmaceutical comprising a radioisotope, a linker and a ligand. The ligand acts like a heat-seeking missile, searching out receptors overexpressed by tumors and delivering

the linked radioisotope to them. The radioisotope emits ionizing radiation, which destroys the cancer cells. “Compared to chemotherapy, which can cause extensive damage to healthy cells,

radioligands precisely deliver a radioactive payload that kills cancer cells and largely leaves surrounding healthy tissue untouched,” explained POINT’s CEO, Joe McCann. Radioligand

therapies are very complex to develop, manufacture and distribute. With a usable life measured in days, they must be manufactured on demand and shipped directly to clinics. “Unlike most

pharmaceutical drugs, radioligands have unique regulatory and supply-chain barriers, which have historically limited availability to patients and success of the class,” said McCann. VERTICAL

INTEGRATION POINT was established to address the complexities of radiopharmaceuticals by building a multi-product, fully integrated platform for their development and delivery. Importantly,

the radiopharmaceuticals that POINT is developing are significantly easier for patients to access than previous-generation radiopharmaceuticals such as iodine-131, as they can be

administered in outpatient clinics in many regions. The company has assembled a seasoned team of experts in radiopharmaceutical clinical development and manufacturing, established strategic

partnerships in radioisotope supply, and invested heavily in manufacturing technology, production capacity and logistics. POINT has the capability to develop radioligands, conduct clinical

trials, and manufacture and deliver them at scale. The company has built a state-of-the-art radiopharmaceutical production facility in Indianapolis (Indiana, USA) capable of servicing North

America, Europe and many other locations. “By building our own manufacturing and supply chain, we de-risk the challenging pieces of radiopharmaceuticals, enabling an end-to-end process and

commercialization at scale,” said McCann. RADIOLIGANDS FOR MANY CANCERS POINT’s pipeline includes late-stage programs focused on validated targets with large market opportunities, driven by

an unmet need among cancer patients. This includes POINT’s lead product, PNT2002, a prostate-specific membrane antigen (PSMA)-targeted therapy for metastatic castration-resistant prostate

cancer (mCRPC), which is diagnosed in 52,000 men annually in the USA. SPLASH (NCT04647526; www.splashtrial.com) is a phase 3 trial underway to evaluate PNT2002 in patients with

PSMA-expressing mCRPC; the registrational phase 3 study started recruiting in September 2021. Also in late-stage development is POINT’s PNT2003, a somatostatin receptor (SSTR)-targeted

radioligand therapy for the treatment of patients with neuroendocrine cancer. Meanwhile, the company’s early-stage pipeline is highlighted by PNT2004, a pan-tumor radiopharmaceutical that

seeks out the enzyme fibroblast activation protein (FAP), a marker that is expressed on cancer-associated fibroblasts (CAFs) found in more than 90% of solid tumors. “This technology has

unmatched specificity and retention, representing a promising treatment of a variety of solid tumors, including pancreatic, colorectal, melanoma, breast and lung,” said McCann. “In addition,

CAFs are one of the main supporters of immune-suppressive environments that cause immune therapies to fail. Targeting CAFs in the tumor-associated microenvironment may also make them ideal

combination partners for immunotherapies such as checkpoint inhibitors.” THE FUTURE OF RADIOPHARMACEUTICALS POINT Biopharma’s supply chain and manufacturing expertise provides an ideal

platform to commercialize new and novel radiopharmaceutical assets. With the growing interest in radiopharmaceuticals globally, the company is keen to identify promising new ligands that can

be developed into radiopharmaceutical drugs through collaborations designed to advance these transformative products to eligible cancer patients worldwide. “Radioligands have the potential

to offer improved efficacy and superior safety profiles versus platform chemotherapy agents, providing the very best possible outcomes for the patient,” said McCann. “We are dedicated to

expanding access to these game-changing therapies, making them applicable to more cancers, accessible to more people, and improving the lives of patients and their families.”