From the June 2022 issue of HealthCare Business News magazine

FDA gives nod to Novartis' 177Lu-PSMA-617 for metastatic prostate cancer
The FDA has given Novartis the green light to sell its long-studied drug, 177Lu-PSMA-617, a radiopharmaceutical therapy for metastatic castration-resistant prostate cancer (mCRPC).

Branded under the name, Pluvicto, the targeted radioligand therapy is designed to treat adult patients who have already undergone standard-of-care (SOC) treatments such as androgen receptor (AR) pathway inhibition and chemotherapy. It is a combination of a targeting compound or ligand with a radioactive particle that is delivered to the tumor tissue and emits a small amount of ionizing beta radiation. It does this at short distances to avoid hitting surrounding healthy tissue, while still inflicting damage on the cancer.
Prostate cancer is the second most common cancer in men, with more than 268,000 cases and approximately 34,500 deaths expected in 2022 in the U.S. While five-year survival for localized prostate cancer is close to 100%, for mCRPC patients it is only 30%.

Compared to SOC alone, the treatment reduces the risk of death by 38%, as well as risk of radiographic disease progression or death significantly, says Novartis. “Today’s approval builds upon our history in prostate cancer, a devastating disease where we believe our innovation can make a meaningful difference to patients,” said Susanne Schaffert, president of Novartis Oncology, in a statement.

The company obtained the rights to the radioisotope from drugmaker Endocyte when it acquired the latter in 2018 for $2.1 billion. The treatment depends on PET scans to identify patients whose mCRPC expresses prostate specific membrane antigen (PSMA), which is an important phenotypic biomarker that is highly expressed in more than 80% of prostate cancer patients.

SHINE Technologies to supply Lu-177 to ImaginAB for radiopharmaceutical therapies
SHINE Technologies announced in March it would supply its highly pure, non-carrier-added Lutetium-177 to ImaginAB to help it develop radiopharmaceutical therapies to treat various cancers in preclinical and clinical settings.

SHINE’s n.c.a. Lu-177 is a low-energy beta particle emitter that can be paired with a targeting molecule such as an antibody and peptide to directly target and deliver radiation to cancer cells. In the face of supply chain limitations caused by the recent shutdowns of nuclear reactors, the company’s fusion technology and production methods are expected to scale up the amount of n.c.a Lu-177-based therapies available to treat cancer patients.

ImaginAB plans to use it to develop RPTs with its proprietary minibody and cys-diabody platform technologies. The solutions are widely available with PET imaging technology and therapeutic isotopes, with the minibodies binding specifically to cell surface targets. This enhances immunity and the potential to treat cancer, with the technologies offering highly tumor-targeting selective features of larger antibodies and highly adjustable pharmacokinetics that spare rapid radiation exposure to healthy, surrounding tissue.

"Having a robust supply chain is key to the implementation of radiopharmaceutical therapy and partnering with SHINE for our Lu-177 supply offers access to what we feel will become one of the largest and most reliable sources in the world for this isotope. Lu-177 is a great fit for our platform technologies,” said Ian Wilson, CEO of ImaginAb, in a statement.

SHINE will begin supplying n.c.a. Lu-177 immediately for ImaginAB’s development plans and therapeutic clinical trials that will commence in 2023.

The company also recently entered into a similar arrangement with Telix Pharmaceuticals. It will supply Telix with n.c.a. Lu-177 also for clinical development of potential new therapeutics to treat prostate and kidney cancer.

June 2022 Magazine

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