Lu 177 PSMA I&T / Curium, PeptiDream - LARVOL DELTA

Curium Completes the Acquisition of Monrol as Part of its Plan to Significantly Expand Lutetium-177 Capacity and PET Footprint (GlobeNewswire) - "Curium Pharma...is pleased to announce the completion of its acquisition of Eczacıbaşı-Monrol Nuclear Products Co. (Monrol), a leading nuclear medicine player, which is headquartered in Istanbul, Turkey. The acquisition enhances Curium’s manufacturing capacity of Lutetium-177 (Lu-177) to meet the growing demand for isotope around the world and secure the supply for the future launch of Curium’s Lu-177 drug candidates, for Prostate Cancer (currently in development) and Neuroendocrine Tumours (pending approval)."

M&A • Neuroendocrine Tumor • Prostate Cancer

Curium Announces ECLIPSE Trial Has Met Primary Endpoint, Demonstrating a Statistically Significant and Clinically Meaningful Benefit for Patients With PSMA-Positive Metastatic Castration Resistant Prostate Cancer (GlobeNewswire) - P3 | N=439 | ECLIPSE (NCT05204927) | Sponsor: Curium US LLC | "Curium...announced today that its ECLIPSE trial met its primary endpoint....The ECLIPSE trial demonstrated a statistically significant and clinically meaningful improvement in the median radiographic progression-free survival (rPFS) of patients with prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with up to 6 doses of 200 mCi (7.4 GBq) of 177Lu-PSMA-I&T in patients previously treated with an androgen receptor pathway inhibitor (ARPI) compared to a change in ARPI."

P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer

CURLu177PSM0001: 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=439 | Active, not recruiting | Sponsor: Curium US LLC | Trial completion date: Jun 2029 ➔ Feb 2029

Metastases • Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Curium Announces the Official Opening its New Netherlands Facility for the Production of Lutetium-177 – a Game Changer Therapy Isotope for Cancer Patients Worldwide (GlobeNewswire) - "Curium...announced today that it has officially opened an additional and new facility in Petten, Netherlands to produce non-carrier added lutetium-177 (Lu-177) to meet the growing global demand for Lu-177 for the treatment of cancer patients...Using in-licensed technology from Turkey-based Eczacıbaşı-Monrol, the facility will initially include two production lines (with ability to scale via further lines as needed in the future) to supply Curium’s proprietary Lu-177 product pipeline, as well as external pharmaceutical and hospital customers....'Curium’s new facility will add 52 weeks of fully-redundant capacity, ensuring security of supply for patients. With more than 100 active clinical trials around the world using Lu-177 across more than 20 indications, the new facility will have a life-saving impact on numerous patients in their fight against cancer for many years to come.'"

Commercial • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Curium Announces Strategic Partnership with PeptiDream for Prostate Cancer Theranostics in Japan (GlobeNewswire) - "Curium...announced today that it has entered into a strategic partnership with PDRadiopharma...for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T. The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. Both target tumors with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair. Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer..."

Licensing / partnership • Prostate Cancer

Curium Adds the Institut Laue-Langevin Reactor to Global Irradiation Portfolio to Ensure Continuous Supply of Lutetium-177 to Benefit More Than 100,000 Cancer Patients Over the Next 5 Years (GlobeNewswire) - "Curium...announced today that it has signed a long-term partnership with the Institut Laue-Langevin (ILL) for irradiation services at their high-flux nuclear reactor in Grenoble, France to produce non-carrier added lutetium-177 (Lu-177)...The agreement announced today follows Curium’s announcement on 29th May 2024 to extend its irradiation partnership with NRG I PALLAS in the Netherlands. Curium’s Lu-177 program will benefit more than 100,000 critically ill patients worldwide over the next five years."

Licensing / partnership • Prostate Cancer

Dr Antonarakis on Community Enrollment in the ECLIPSE Trial in Prostate Cancer (OncLive) - "The study evaluated 177Lu-PSMA-I&T vs standard-of-care hormone therapy (abiraterone acetate [Zytiga] or enzalutamide [Xtandi]) in patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressive disease and received prior treatment with an androgen receptor (AR)–directed therapy. The trial enrolled 439 patients with mCRPC and documented positive prostate-specific membrane antigen PET imaging."

Enrollment status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=439 | Active, not recruiting | Sponsor: Curium US LLC | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2024 ➔ Jul 2024

Enrollment closed • Metastases • Trial primary completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Check out our new randomized controlled phase 1/2 trial opening at @MDAndersonNews @ChapinMD https://classic.clinicaltrials.gov/ct2/show/NCT06066437 Building on Lutectomy we plan to use Neoadjuvant Lu-177 PSMA with/without ADT to assess the need of ADT in earlier utilization of Lu-177 PSMA

P1/2 data

Curium Completes Patient Enrollment of Phase 3 ECLIPSE Trial Ahead of Schedule (GlobeNewswire) - "Curium...announced today the successful completion of patient enrollment in the pivotal Phase 3 ECLIPSE trial...ECLIPSE is a Phase 3, multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA I&T versus hormone therapy in patients with metastatic castration-resistant prostate cancer. The ECLIPSE trial enrolled over 400 patients, ahead of schedule, across 51 trial sites in the United States and Europe."

Enrollment closed • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Time interval between Radium-223 (223Ra) Therapy and Lutetium177-prostate-specific membrane antigen (177Lu-PSMA) Treatment for Metastatic Castrate-Resistant Prostate Cancer (mCRPC) and Outcomes in the RaLu Study (WSAUA 2023) - "Treating patients with 177Lu-PSMA within 6 months of completing 223Ra was clinically feasible and well tolerated. OS outcomes were similar in patients receiving 177Lu-PSMA <6 months vs ≥6 months after completing 223Ra."

Clinical data

PSMA-TRT, 225Ac-J591 and 177Lu-PSMA I&T in mCRPC (YouTube) - "'Scott Tagawa...provides an overview of a Phase I trial (NCT04886986) of PSMA-targeted radionuclide therapy, 225Ac-J591, an alpha-radiolabeled antibody, and 177Lu-PSMA I&T, a beta-radioligand, in patients with metastatic castration-resistant prostate cancer (mCRPC). Patients followed a similar dosing regiment found in the Phase III SPLASH trial (NCT04647526) and only two cases of dose-limiting toxicities were reported. The combination therapy was overall found to be feasible and tolerable. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL."

Interview • Video

Newly developed PSG score improves patient selection for PSMA radiopharmaceutical therapy (Eurekalert) - "The authors of 'PSMA PET Tumor-to-Salivary Gland Ratio to Predict Response to [177Lu]PSMA Radioligand Therapy: An International Multicenter Retrospective Study'...Johannes Czernin..."

Retrospective data

The ECLIPSE Phase III Trial of Lutetium PSMA-I&T Shows Promise in Advanced Prostate Cancer Treatment - Emmanuel Antonarakis (Urotoday) - "Emmanuel Antonarakis joins Alicia Morgans in a conversation about the trial in progress multicenter, open-label, randomized phase 3 ECLIPSE trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus standard-of-care hormone therapy in patients with metastatic castration-resistant prostate cancer...The delivery of this product takes two weeks or less, and there is no production or supply chain problem."

Video

Curium Confirms No Supply Challenges in North America and Europe for its Eclipse Phase 3 Clinical Trial (GlobeNewswire) - "Curium...confirmed today that the company has no foreseeable supply challenges of 177Lu-PSMA-I&T for the company’s ECLIPSE Phase 3 clinical trial...ongoing in the USA, France, Spain, and Italy. Since patient enrollment started in March 2022, the ECLIPSE Phase 3 trial has experienced reliable and uninterrupted supply of 177Lu-PSMA-I&T."

Commercial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Selectivity of patients, dosing play a role in the future evaluation of PSMA combinations in mCRPC (Urology Times) - "With the ongoing evaluation of prostate-specific membrane antigen-targeted radionuclide therapy (PSMA-TRT), physicians may be able to exploit the selectivity of PSMA expression to deliver high doses of radioactive particles to tumors, while relatively sparing normal organs, in patients with metastatic castration-resistant prostate cancer, according to Scott T. Tagawa, MD, MS, FACP."

Media quote

Blue Earth Therapeutics Announces Promising Results of Preclinical Biodistribution and Efficacy Evaluation of 177Lu-rhPSMA-10.1 in Treatment of Prostate Cancer (Businesswire) - '"Blue Earth Therapeutics’ Phase 1/2 clinical trial for 177Lu-rhPSMA-10.1 in treating men with metastatic castrate‑resistant prostate cancer was recently cleared to proceed, and we expect patient enrollment to commence shortly'...Data from longitudinal biodistribution analyses in preclinical models showed that the most significant organ uptake for both 177Lu-rhPSMA-10.1 and 177Lu-PSMA-I&T was observed in the kidney; however, kidney retention was lower for 177Lu-rhPSMA-10.1 than 177Lu-PSMA-I&T at all timepoints, and 6.5-fold lower than that for 177Lu-PSMA-I&T at 12 hours....The potential therapeutic efficacy of 177Lu-rhPSMA-10.1 and 177Lu-PSMA-I&T was compared in a PSMA-expressing prostate cancer xenograft model. Tumor volume was significantly reduced by 177Lu-rhPSMA-10.1 compared with the vehicle control (p=0.045 at 35 days after treatment)."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

"#Curium Confirms No Supply Challenges of #177LuPSMAIandT for #ECLIPSE Trial https://t.co/rG7Eq3gyRn" (@1stOncology)

Curium Confirms No Supply Challenges of 177Lu-PSMA-I&T for ECLIPSE Trial (GlobeNewswire) - "Curium confirmed today no supply challenges of 177Lu-PSMA-I&T for the Phase 3 ECLIPSE clinical trial (NCT05204927), evaluating Lutetium 177Lu-PSMA-I&T treatment compared to the standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer (mCRPC). Curium continues to provide clinical trial supply, and enroll patients in the ECLIPSE clinical trial with no disruptions."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Curium’s Phase 3 ECLIPSE Trial Starts Enrolling Patients (GlobeNewswire) - "Curium announced today it has successfully enrolled and dosed patients in the ECLIPSE Trial. ECLIPSE is a Phase 3, multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus standard of care hormone therapy in patients with metastatic castration-resistant prostate cancer. The clinical trial is enrolling patients at sites across the U.S. and will be opening clinical trial sites in Europe in 2022."

Enrollment status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Radionuclide conjugates 225Ac-J591 and 177Lu-PSMA-I&T for mCRPC (YouTube) - "Scott T. Tagawa...discusses results of a preclinical and initial Phase I study to evaluate the combined targeting of prostate-specific membrane antigen (PSMA) with alpha-radiolabeled antibody 225Ac-J591, and beta-radiolabeled ligand 177Lu-PSMA I&T in patients with metastatic castration-resistant prostate cancer (mCRPC)."

Interview • Video

Lu-177-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Curium US LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Lu-177-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P3; N=400; Not yet recruiting; Sponsor: Curium US LLC

New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Curium Initiates ECLIPSE, a Phase 3 Clinical Trial For Its Investigational Lu 177 PSMA I&T (GlobeNewswire) - "Curium announced today that the Company has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin its Phase 3 trial with its investigational product lutetium Lu 177 PSMA I&T, a therapeutic radiopharmaceutical that binds to the Prostate-Specific Membrane Antigen (PSMA) protein. Curium is working closely with sites across the U.S. to initiate the ECLIPSE trial (A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer)."

New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer