On December 9, 2020 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, reported it has entered into a strategic collaboration with POINT Biopharma, Inc. (POINT) to use Lantheus’ investigational prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent, PyL, to determine PSMA-avidity during patient selection in POINT’s Phase 3 clinical trial to treat metastatic castration resistant prostate cancer (mCRPC) (Press release, Lantheus Medical Imaging, DEC 9, 2020, View Source [SID1234572535]). The collaboration directly aligns with an important Lantheus strategy to advance cancer precision medicine by enabling partners to use PyL in prostate cancer therapeutic trials.
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As part of the agreement with POINT, Lantheus’ subsidiary, Progenics Pharmaceuticals, Inc., will supply PyL at a predetermined supply price.
"While there have been great advances in the treatment of prostate cancer, there remains an important unmet medical need for therapies that can more specifically target metastatic prostate cancer," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "The inclusion of PyL in POINT’s Phase 3 trial reinforces our belief in the potential utility of PyL, not just in assessing metastatic disease, but also in selecting the most appropriate patients for PSMA-targeted therapy."
POINT will conduct a Phase 3, multicenter, open-label, randomized clinical trial to evaluate the efficacy and safety of their novel PSMA-targeted radioligand, 177Lu-PNT2002, in patients with mCRPC. PyL will be used to select patients with PSMA-avid tumors for treatment with 177Lu-PNT2002, and in a subset of patients also be used to evaluate progression.
"The combination of diagnostic imaging and radioligand therapy is a validated approach and an important development in cancer treatment," said Joe McCann, Chief Executive Officer of POINT. "POINT is very excited to be enrolling our study using PyL. We believe this promising biomarker will help identify the patients with prostate cancer who will best respond to PNT 2002, our next generation radioligand therapy."
About PSMA
PSMA is a protein that has been found to be amplified on the surface of greater than 95% of prostate cancer cells and is a validated target for the detection of primary and metastatic prostate cancer.1
About PyL for PET Imaging of Prostate Cancer
PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. On September 29, 2020, Lantheus filed with the U.S. Food and Drug Administration a New Drug Application for PyL.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 192,000 new cases of prostate cancer will be diagnosed, and 33,000 men will die of the disease. Approximately 3.2 million men in the U.S. currently count themselves among prostate cancer survivors.3