Pipeline Overview

Pipeline Overview

At Lantheus, we are dedicated to the development, manufacture and commercialization of innovative diagnostic imaging agents, targeted therapeutics, and artificial intelligence to find, fight, and follow disease.

Oncology


Prostate Cancer

PreclinicalPhase 1Phase 2Phase 3Reg. FilingMarket

PyL

PyL (also known as 18F-DCFPyL) is a fluorine 18-based PSMA-targeted PET imaging agent that enables visualization of primary tumors as well as bone and soft tissue metastases, with potential high clinical utility the initial assessment of high risk patients and detection of recurrent and/or metastatic prostate cancer. We have submitted an NDA for PyL which was accepted and granted priority review and assigned a PDUFA action date of May 28, 2021.

PSMA AI

PSMA-AI is an artificial intelligence based imaging analysis technology that assists readers in quantification and standardized reporting of PSMA-targeted PET/CT imaging, providing an objective understanding of disease status. The technology automatically analyzes the CT image to segment anatomical regions – 51 bones and 12 soft tissue organs. This CT segmentation enables automated localization, detection and quantification of potential PSMA-avid lesions in the PET image, which is incorporated into a standardized report for physicians. In a recent study, the technology demonstrated better consistency in quantitative assessment across multiple readers and high sensitivity (>90%) in detecting potential lesions in PSMA PET/CT. The clinical utility of the device is being investigated in multiple outcome-based studies.

1095

1095 (also known as I-131-1095) is a PSMA-targeted iodine-131 labeled small molecule that is designed to deliver a dose of beta radiation directly to prostate cancer cells with minimal impact on the surrounding healthy tissues. We are conducting a phase 2 trial of 1095 in subjects with metastatic castration resistant prostate cancer (mCRPC) in US and Canada.

1404

1404 is a Tc-99m labeled small molecule which binds to PSMA and is used as a SPECT/CT imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases. ROTOP has exclusive rights to develop, manufacture and commercialize 1404 in Europe.

PSMA TTC

PSMA TTC is a thorium-227 labeled PSMA-targeted antibody therapeutic. PSMA TTC is designed to deliver a dose of alpha radiation directly to prostate cancer cells with minimal impact on the surrounding healthy tissues. Bayer AG (“Bayer”) has exclusive worldwide rights to develop and commercialize products using our PSMA antibody platform in combination with Bayer’s alpha-emitting radionuclides. Bayer is conducting a Phase 1 trial of PSMA TTC in subjects with mCRPC and will use PyL to assess PSMA expression levels.

Neuroendocrine

PreclinicalPhase 1Phase 2Phase 3Reg. FilingMarket

LMI 1195

LMI 1195 is a fluorine 18-based PET imaging agent for the norepinephrine pathway. We have designed but not yet commenced two Phase 3 clinical trials for the use of LMI 1195 for the diagnosis and management of neuroendocrine tumors in pediatric and adult populations, respectively. The FDA has granted an Orphan Drug designation for the use of LMI 1195 in the management indication. We have also received notice of eligibility for a rare pediatric disease priority review voucher for a subsequent human drug application so long as LMI 1195 is approved by the FDA for its rare pediatric disease indication. Pursuant to federal legislation passed and signed into law in late 2020, the expiration date of the rare pediatric disease priority voucher program was extended from September 30, 2022 to September 30, 2026.

Other Oncology


Brain

PreclinicalPhase 1Phase 2Phase 3Reg. FilingMarket

CarThera Glioblastoma

CarThera will use our microbubbles in combination with SonoCloud®, a proprietary implantable device, in development for the treatment of recurrent glioblastoma (rGBM). Glioblastoma is a lethal and devastating form of brain cancer with median survival of 15 months after diagnosis.1

Insightec Glioblastoma

Insightec will use our microbubbles in connection with its MR-guided Focused Ultrasound (MRgFUS) platform to evaluate treatment of glioblastoma and neurodegenerative conditions. Glioblastoma is the most aggressive malignant primary brain tumor affecting 3.19 Americans patients per one hundred thousand and has a less than 5% five-year survival rate.2

Biomarkers

PreclinicalPhase 1Phase 2Phase 3Reg. FilingMarket

NM-01

NM-01 is a proprietary radiopharmaceutical biomarker using a camelid single-domain antibody that has demonstrated a high affinity for PD-L1 protein. NM-01 could provide a specific, non-invasive approach to patient assessment, including use in whole-body imaging, or virtual biopsy. NM-01 potentially allows detection of PD-L1 expression in tumors and could be used to evaluate patients before, during, or after treatment with immuno-oncology (I/O) agents in clinical trials. We licensed NM-01 from NanoMab in 2019 and plan to provide NM-01 as a clinical research tool, together with support and analytics, to pharmaceutical companies and the large academic centers conducting clinical research in I/O.

NTI-1309

NTI-1309 is an innovative imaging biomarker that targets fibroblast activation protein (FAP), an emerging target with broad potential imaging applicability and use in oncology. We licensed NTI-1309 from Noria in March of 2021. Noria will drive the early clinical development of NTI-1309 and upon completion of the Phase 1 study, NTI-1309 will be integrated into our portfolio of imaging biomarkers and included in our Pharma Services offering.

Cardiovascular / Vascular


Cardiovascular / Vascular

PreclinicalPhase 1Phase 2Phase 3Reg. FilingMarket

Flurpiridaz

Flurpiridaz F 18 is a fluorine 18-based PET MPI agent designed to assess blood flow to the heart. On April 25, 2017, we announced entering into a definitive, exclusive Collaboration and License Agreement with GE Healthcare for the agent’s continued Phase 3 development and worldwide commercialization. The second Phase 3 trial is now underway; however, because of the COVID-19 pandemic, enrollment in the global clinical development program had been delayed and has now resumed at a slower recruiting pace. GE Healthcare now expects to complete enrollment in the second half of 2021 and, assuming regulatory approval, begin commercialization in early 2023

Ceravast Retinal Vein Occlusion

Cerevast treatment for retinal vein occlusion will use our microbubble in combination with its ocular ultrasound device to target improving blood flow in occluded retinal veins in the eye. This therapy has the potential to reduce or eliminate the need for chronic maintenance therapy and improve the quality of life for those patients inflicted by RVO.


Each of these product candidates is an investigational drug that has not yet been approved as safe and effective.

Legend:
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References:

1. Koshy M, Villano JL, Dolecek TA, Howard A, Mahmood U, Chmura SJ, et al. Improved survival time trends of glioblastoma using the SEER 17 population-based registries. J Neuro Oncol. 2012;107(1):207-12. 2. Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, editor. Glioblastoma (Internet). Brisbane (AU): Codon Publications; 2017 Sep 27. Chapter 8.