News | Prostate Cancer | April 19, 2022

177Lutetium-labelled radiohybrid Prostate-Specific Membrane Antigen (177Lu-rhPSMA-10.1) is a highly optimized, next generation therapeutic radiopharmaceutical 

Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug Application (IND) application for 177Lu-rhPSMA-10.1.

Getty Images


April 19, 2022 — Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug Application (IND) application for 177Lu-rhPSMA-10.1. IND authorization to proceed enables Blue Earth Therapeutics to initiate a Phase 1/2 clinical study to evaluate the safety, tolerability, dosimetry and anti-tumor activity of 177Lu-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-rhPSMA-10.1 is the first clinical candidate in Blue Earth Therapeutics’ oncology development program of next generation therapeutic radiopharmaceuticals. Blue Earth Therapeutics holds exclusive worldwide rights to therapeutic applications of radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) radiopharmaceutical technology to help advance the treatment of patients with prostate cancer.

“Clearance to proceed with this first clinical study for 177Lu-rhPSMA-10.1 marks an exciting milestone for our new company, Blue Earth Therapeutics, and the patients with cancer that we hope to serve,” said David E. Gauden, D.Phil., Chief Executive Officer of the Company. “We consider 177Lu-rhPSMA-10.1 to be a next generation PSMA therapy with the potential to be best-in-class. 177Lu-rhPSMA-10.1 is the result of a careful optimization process which aimed to maximize therapeutic index by delivering high radiation doses to prostate cancer lesions while sparing normal tissues wherever possible. Excitingly, this optimized technology can be developed with both beta- and alpha-emitting therapeutic radioisotopes. We look forward initially to applying our proven radiopharmaceutical development expertise in advancing 177Lu-rhPSMA-10.1, and, over time, developing a pipeline of additional oncology therapeutics to help address significant unmet patient needs.”

The trial is an open-label, multi-center, integrated Phase 1 and 2 study to evaluate the safety, tolerability, radiation dosimetry and anti-tumor activity of 177Lu-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer. Phase 1 will investigate the safety, tolerability and dosimetry of multiple cycles of 177Lu-rhPSMA-10.1 in subjects with PSMA-positive mCRPC which has progressed following prior therapy. Results from Phase 1 will be used to determine the recommended treatment regimen to be tested in Phase 2. The Phase 1 study will be conducted at clinical sites in the United States, with further sites added for the Phase 2 component of the trial, in both the United States and Europe.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds are referred to as radiohybrid (“rh”), as each molecule possesses three distinct domains. The first consists of a Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells. It is attached to two labelling moieties which may be radiolabeled with either 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Therapeutics and Blue Earth Diagnostics work closely on the development of 177Lu-rhPSMA-10.1. Currently, rhPSMA compounds have not received regulatory approval.

For more information: https://www.blueearththerapeutics.com/

Related content:

Blue Earth Diagnostics Announces Key Results from Phase 3 SPOTLIGHT Study of 18F-rhPSMA-7.3

Majority of Recurrent Prostate Cancer Patients' Treatment Plan Changed Following Fluciclovine 18F PET/CT

Blue Earth Diagnostics Announces Dosing of Initial Patient in Phase 3 REVELATE Clinical Trial of 18F-Fluciclovine PET Imaging for Detection of Recurrent Brain Metastases

Blue Earth Diagnostics Highlights Presentations on Axumin (Fluciclovine F 18) and 18F-Fluciclovine at ASTRO21

 

Related Medical Radioisotopes Content:

University of Missouri Research Reactor Helps Supply Critical Medical Isotopes During Global Disruption

Update on Unplanned Outage of the HFR Reactor

SNMMI Issues Alert That HFR Outage Will Impact Isotope Supply

NorthStar Medical Radioisotopes Advances Focus on Therapeutic and Specialized SPECT Radiopharmaceuticals

How Nuclear Fusion is Revolutionizing Medical Isotope Production

FDA Approves Additional Molybdenum-99 (Mo-99) Filling Lines at NorthStar Medical Radioisotopes

Medical Isotope Industry Opposes Export of Highly Enriched Uranium for IRE

IBA and NorthStar Medical Radioisotopes Expand Collaboration to Enable Global Availability of Tc-99m

VIDEO: Advances in Radiopharmaceutical Therapy

Related Content

News | Image Guided Radiation Therapy (IGRT)

May 19, 2022 — Brainlab announced that clinicians at UZ Brussel are the first to treat patients with the company’s new ...

Time May 19, 2022
arrow
News | Radiation Oncology

May 19, 2022 — Robert L. Bard, M.D., an ITN editorial advisory board member, received one of the highest achievements of ...

Time May 19, 2022
arrow
News | Radiation Therapy

May 18, 2022 — RaySearch announced that the treatment control system RayCommand is in clinical use at the innovative ...

Time May 18, 2022
arrow
Feature | Coronavirus (COVID-19)

Clinical scientists used machine learning (ML) models to explore de-identified electronic health record (EHR) data in ...

Time May 18, 2022
arrow
News | Women's Health

May 18 2022 — Older breast cancer survivors with cardiometabolic risk factors who restricted food intake to eight hours ...

Time May 18, 2022
arrow
News | Radiation Oncology

May 17, 2022 — Radiation oncologists will meet with congressional leaders and staff today to ask for their support of ...

Time May 17, 2022
arrow
Videos | Proton Therapy

John C. Breneman, M.D., medical director of the Cincinnati Children's/UC Health Proton Therapy Center, and the principal ...

Time May 16, 2022
arrow
News | Magnetic Resonance Imaging (MRI)

May 13, 2022 — Alzheimer’s disease is the most common form of dementia, one of the major causes of dependency and ...

Time May 13, 2022
arrow
News | Radiology Business

May 12, 2022 — Abbott announced a new partnership with Women as One to launch a new program designed to train more ...

Time May 12, 2022
arrow
News | Focused Ultrasound Therapy

May 12, 2022 — Henry Ford Health is the first in Michigan to offer Robotic High Intensity Focused Ultrasound (HIFU) for ...

Time May 12, 2022
arrow
Subscribe Now