Preclinical Phase 1 Phase 2 Phase 3 Reg. Filing Market

Radiopharmaceuticals

Prostate Cancer
      
Phase 3
     

TARGET:PSMA

ISOTOPE:177Lu

PNT2002 is a small molecule PSMA-targeted 177Lu-based radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC) which combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu. PNT2002 is currently in its Phase 3 clinical study designed to evaluate superiority to the standard of care in mCRPC pre-chemotherapy patients who have failed one androgen receptor pathway inhibitor (SPLASH study – NCT04647526).

PSMA = Prostate specific membrane antigen
Phase 2
     

TARGET:PSMA

ISOTOPE:131I

LNTH-1095 (also known as MIP-1095) is a small molecule PSMA-targeted 131I-based radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) which combines a PSMA-targeted ligand, LNTH-1095, with the beta-emitting radioisotope 131I.

PSMA = Prostate specific membrane antigen
Phase 3
     

TARGET:PSMA

ISOTOPE:99mTc

1404 is a Tc-99m-labeled 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.

Out-Licensed to Rotop Pharmaka GmbH.
PSMA = Prostate specific membrane antigen
Phase 1
     

TARGET:PSMA

ISOTOPE:225Ac

PSMA-TAC (225Ac-pelgifatamab) is a PSMA-targeted antibody in initial stage of development for the treatment of metastatic castration-resistant prostate cancer. PSMA-TAC is out-licensed to Bayer Pharmaceuticals.

Out-Licensed to Bayer Pharmaceuticals.
PSMA = Prostate specific membrane antigen
Preclinical
     

TARGET:PSMA

ISOTOPE:TBD

LNTH-1558 is a small molecule PSMA-targeted agent in pre-clinical development phase. Current work is aimed at obtaining a drug candidate with an optimal biodistribution profile.

PSMA = Prostate specific membrane antigen
Neuro-Endocrine Tumors       
Reg. Filing
     

TARGET:SSTR2

ISOTOPE:177Lu

PNT2003 is a somatostatin receptor (SSTR) targeted radioligand therapy with no-carrier-added 177Lu, in development for gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

SSTR2 = Somatostatin receptor 2
Tumor Micro-Environment       
Phase 2
     

TARGET:PD-L1

ISOTOPE:99mTc

NM-01 is a SPECT imaging agent that targets the PD-L1 receptor and can provide whole-body imaging assessment in a single examination. It is currently being developed for the assessment of PD-L1 expression in non-small cell lung cancer (NSCLC) patients and for its potential to identify patients who will respond to checkpoint inhibitor therapies.

PD-L1 = Programmed death-ligand 1
Phase 1
     

TARGET:FAP

ISOTOPE:64Cu

LNTH-1363S is an investigational fibroblast activation protein, alpha targeted, copper-64 labeled PET imaging agent candidate that we believe could have broad potential imaging applicability and use in oncology.

FAP = Fibroblast activation protein
Cardiology       
Reg. Filing
     

TARGET:MC-1

ISOTOPE:18F

Flurpiridaz is a 18F PET agent designed to assess myocardial perfusion. We have out-licensed Flurpiridaz to GE Healthcare, who is responsible for the completion and commercialization of the imaging agent.

Out-Licensed to GE Healthcare.
MC-1 = Mitochondrial complex 1
Neurology       
Phase 1
     

TARGET:Tau

ISOTOPE:18F

MK-6240 is a clinical stage 18F PET development candidate designed to detect Tau protein in the form of neurofibrillary tangles in the brains of patients with known or suspected Alzheimer’s disease. MK-6240, currently used as biomarker in Alzheimer’s disease clinical trials, has the potential to aid in diagnosing, staging, and informing treatment selection and response to therapy for Alzheimer’s disease.

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

*We are actively partnering with researchers on these assets to provide appropriate biomarkers in relevant studies.  If interested, please contact pharmasolutions@lantheus.com for more information.

References:
  1. DEFINITY® (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc.

Clinical Trials

Lantheus is committed to Find, Fight and Follow® disease for patients. As part of that commitment, we ensure that Diversity, Equity and Inclusion (DEI) is a top priority when it comes to clinical trials. Because we believe everyone should have access to the latest trials and treatments.

For more information about clinical trials involving products being developed by Lantheus, please contact our clinical team at 978-671-8350.

Information on all clinical trials involving products being developed by Lantheus is offered by the National Institutes of Health here.

Digital and Pharmaceutical Services

Our innovation includes the very latest technologies in digital and pharmaceutical services. We’re pioneering AI software platforms that use deep learning algorithms to help clinicians and researchers perform quantitative assessments in cancer imaging. This focus on data-driven solutions helps us partner with healthcare professionals to empower more informed diagnostic and treatment decisions that can lead to improved patient outcomes.

Expanded Access Program

Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease.

Lantheus is focused on conducting clinical trials required by regulatory authorities to thoroughly answer important scientific questions about the potential risks and benefits of our investigational products. A clinical trial is a research program conducted to comprehensively evaluate the safety and effectiveness of an investigational product to treat or diagnose a disease or condition. An investigational product is a product that has not been reviewed or approved by the regulatory authority responsible for determining safety and effectiveness in a particular country. In the United States, the regulatory authority is the Food and Drug Administration or FDA. The data from clinical trials is provided to a regulatory authority, such as the FDA, to obtain regulatory approval for the investigational product. After receiving regulatory approval, Lantheus can make the product commercially available and healthcare providers (HCPs) can prescribe the product for patients who are most likely to benefit from the product.