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NanoMab Conducting Study of Lantheus' PD-L1 Imaging Agent

NEW YORK – Lantheus Holdings said Friday that patients are starting to receive NM-01, an imaging agent used to measure PD-L1 expression in cancer cells, in a Phase II trial.

NanoMab, Lantheus' partner conducting the so-called PELICAN trial, is evaluating how well NM-01, a technetium-99m-based radiotracer with an affinity for PD-L1, can identify advanced non-small cell lung cancer patients with PD-L1-expressing tumors who are expected to benefit from checkpoint inhibitors. So far, one patient has undergone CT imaging with NM-01, but NanoMab is aiming to enroll about 15 participants with untreated, metastatic NSCLC.

Researchers are primarily interested in comparing NM-01-based PD-L1 expression measurements against immunohistochemistry testing, which is the standard method used to gauge the biomarker.

IHC-based tests assess tumor samples obtained via needle biopsies, which many not fully capture heterogeneous PD-L1 expression in the tumor and the tumor microenvironment. In the PELICAN trial, Lantheus is hoping to show the advantages of NM-01 imaging over IHC in determining the heterogeneity of PD-L1 expression within and between tumors, and establish the product's safety.

As an exploratory objective, NanoMab will also attempt to correlate NM-01-based PD-L1 assessment with other diagnostic parameters including tumor mutational burden and look to see if patients develop anti-drug antibodies to NM-01.

North Billerica, Massachusetts-based Lantheus licensed development and commercialization rights to NM-01 from NanoMab in 2019. NanoMab, which started out in Shanghai, set up headquarters in London in 2020 and is working with King's College London to develop next-generation single-step radiolabeling.

"While checkpoint inhibitor therapies targeting PD-1 or PD-L1 have improved the prognosis for NSCLC patients, there are often unpredictable outcomes with these therapies for patients," Gary Cook, a radiology and nuclear medicine expert at King's College London and principal investigator of PELICAN, said in a statement. "PELICAN will help us determine if NM-01 can aid in selecting responders to checkpoint inhibitor therapies, thereby getting the right treatments to the right patients while sparing non-responders from unnecessary side effects, procedures and costs."

Lantheus' portfolio of medical imaging agents also includes Pylarify (piflufolastat F 18), a prostate-specific membrane antigen (PSMA)-directed PET imaging agent. Lantheus signed an agreement in March with Novartis to use Pylarify as a patient selection tool for clinical trials of the radiopharmaceutical Pluvicto (lutetium Lu 177 vipivotide tetraxetan).