Top 5 Target	Count

MMP14(Matrix metalloproteinase 14)	1
GRPR(Gastrin releasing peptide receptor)	1
DLL3(Delta-like protein 3)	1
SSTR(Somatostatin receptor)	1
TRPV6(Transient receptor potential cation channel subfamily V member 6)	1

Drugs associated with Orano Med LLC

212Pb-AR-RMX

Target

SSTR

Mechanism

SSTR modulators [+1]

Active Org.

Orano Med LLC [+1]

Originator Org.

Orano Med SAS

Active Indication

Somatostatin Receptor-Positive Neuroendocrine Tumor

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

212Pb-DOTAM-GRPR1

Target

GRPR

Mechanism

GRPR antagonists [+1]

Active Org.

Orano Med LLC

Originator Org.

Orano Med LLC

Active Indication

Breast Cancer [+5]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

DLL3(Molecular Partners)

Target

DLL3

Mechanism

DLL3 inhibitors

Active Org.

Orano Med LLC [+1]

Originator Org.

Orano Med LLC [+1]

Active Indication

Solid tumor

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Orano Med LLC

NCT05283330 / RecruitingPhase 1

A Phase 1 Open-Label Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, and Preliminary Efficacy of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors

Start Date22 Dec 2022

Sponsor / Collaborator

Orano Med LLC

NCT05153772 / Active, not recruitingPhase 2

A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in Subjects With Somatostatin Receptor Expressing Neuroendocrine Tumors

Multicenter Phase 2 study of 212Pb-DOTAMTATE enrolling adult subjects with positive somatostatin positive neuroendocrine tumors with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT)

Start Date21 Dec 2021

Sponsor / Collaborator

RadioMedix, Inc.

[+1]

NCT03466216 / Unknown statusPhase 1

A Phase 1, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness of AlphaMedix™ in Adult Subjects With SSRT(+) NETs.

AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications.
This drug addresses an unmet need in the field of peptide receptor radionuclide therapy (PRRT) for NETs. Substitution of an alpha emitter (²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumor cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side effects for subjects receiving the drug.

Start Date05 Feb 2018

Sponsor / Collaborator

RadioMedix, Inc.

[+1]

100 Clinical Results associated with Orano Med LLC

0 Patents (Medical) associated with Orano Med LLC

Literatures (Medical) associated with Orano Med LLC

01 Jun 2024·Journal of Clinical Oncology

Safety, tolerability and efficacy of ²¹²Pb-DOTAMTATE as a targeted alpha therapy for subjects with unresectable or metastatic somatostatin receptor-expressing gastroenteropancreatic neuroendocrine tumors (SSTR+ GEP-NETs): A phase 2 study.

Author: Maluccio, Mary Alice ; Strosberg, Jonathan R. ; Wagner, Volker Jean ; Cohn, Allen Lee ; Manuel, Allison ; Delpassand, Ebrahim S ; Naqvi, Shagufta ; Woloski, Rachel ; Tworowska, Izabela ; Torgue, Julien

4020 Background: 212Pb-DOTAMTATE is a Targeted Alpha Therapy (TAT) in clinical development for subjects with SSTR+ neuroendocrine tumors. A phase I dose-escalation study has already been completed (Delpassand et al. J Nucl Med 2022). TAT holds the promise to improve outcomes versus Peptide Receptor Radionuclide Therapy (PRRT) with beta-emitters like 177Lu-DOTATATE, currently considered the standard of care for subjects with GEP-NETs. Methods: ALPHAMEDIX 02 is a Phase II, open-label, multicenter study evaluating the safety, tolerability and efficacy of 212Pb-DOTAMTATE in PRRT-naïve (Cohort 1, N = 36) and PRRT-refractory (Cohort 2, Target N = 30) subjects with histologically confirmed unresectable or metastatic GEP-NETs, positive somatostatin analogue imaging and at least 1 site of measurable disease per RECIST 1.1. 212Pb-DOTAMTATE was administered at 67.6 μCi/kg per cycle, with a maximum activity administered per cycle of 5.5 mCi every 8 weeks, for up to 4 cycles. Primary endpoints include overall response rate (ORR) per RECIST1.1, and incidence and severity of adverse events (AEs). Secondary endpoints include progression free survival, overall survival , and health-related quality of life. Initial results of the already completed cohort 1 are presented. Results: In cohort 1, 17 out of 36 subjects with metastatic SSTR+ GEP-NETs achieved a confirmed response (ORR 47.2% (32.0-63.0%)). In the Phase I trial, five out of eight PRRT- naïve subjects with SSTR+ GEP-NETs treated with the same regimen of 212Pb-DOTAMTATE achieved a response (ORR 62.5% (30.6-86.3%)): the combined ORR from both studies is 50% (22 out of 44, 95%-CI:36% - 64%). Median Duration of Response (DOR) has not been reached in both studies. Four out of five subjects (80%) with confirmed response in Phase I had a DOR of ≥ 12 months. In the ongoing Phase II study the response follow-up for 10 subjects with confirmed response is currently shorter than 6 months: so far 7 out of 17 subjects (41%) with confirmed response had a DOR of ≥ 6 months, and one of these subjects had a DOR of ≥ 12 months. Lymphocytopenia is a lead cause of the 59% grade 3 and 4 AEs reported in subjects in cohort 1. Overall, 4 fatal AEs were reported: death / progressive disease (N = 2), carcinoid syndrome (N = 1) and sepsis (N = 1). Conclusions: In PRRT-naïve subjects with SSTR+ unresectable or metastatic GEP-NETs treatment with up to 4 cycles of ²¹²Pb-DOTAMTATE (67.6 μCi/kg/cycle) was well-tolerated, with a safety profile consistent with the underlying disease and expected toxicities of radioligand therapy, similar to 177Lu-DOTATATE. The ORR of 47.2% in cohort 1 (50% in the pooled dataset) appears to be substantially higher than the ORR previously reported for 177Lu-DOTATATE in the pivotal NETTER-1 study (ORR 18% (10–25%)). Clinical trial information: NCT05153772 .

04 Mar 2024·Inorganic Chemistry

Enhancing r₁ Relaxivity in GdDOTA-Monoamide Complexes through Polar Group-Mediated Ordering of Second-Sphere Water Molecules

Article

Author: Kretschmer, Jan ; Jurek, Paul ; Buchanan, Emily ; Chiaffarelli, Remy ; Paranawithana, Namini N ; Kiefer, Garry ; Sherry, A Dean ; Lopez, Katherine ; Martins, André F ; Zhao, Piyu

This study was designed to test whether the single appended phosphonate group in GdDOTA-1AmP is sufficient for catalyzing the exchange of proton from the single inner-sphere water-exchanging molecule. Unlike the other phosphonate derivatives in this series, GdDOTA-1AmP showed a surprisingly smooth increase in r₁ relaxivity from 3.0 to 6.3 mM^-1 s^-1 at 20 MHz as the pH was lowered from 9 to 2.5. In comparison to the bis-, tris-, and tetrakis-phosphonate analogues, which all show a biphasic dependence of r₁ with changes in pH, the unique r₁ versus pH characteristics of GdDOTA-1AmP are shown to closely parallel deprotonation of the single appended phosphonate group. Although the tissue biodistribution and clearance rates of GdDOTA-1AmP are more favorable than the other more highly charged phosphonate derivatives, the pH dependency of r₁ is substantially reduced at magnetic fields typically used for small animal imaging (7 and 9.4T), so the attractiveness of this new molecule for quantitative imaging of tissue pH is diminished. However, this study provides some new insights into the feasibility of designing pH-responsive MRI contrast agents based upon fundamental acid-base prototropic mechanisms.

01 Oct 2023·Cancer Biotherapy and RadiopharmaceuticalsQ4 · MEDICINE

Mathematical Modeling of In Vivo Alpha Particle Generators and Chelator Stability

Q4 · MEDICINE

Article

Author: Kletting, Peter ; Zaid, Nouran R.R. ; Stallons, Tania A. Rozgaja ; Beer, Ambros J. ; Torgue, Julien J. ; Glatting, Gerhard

Background: Targeted α particle therapy using long-lived in vivo α particle generators is cytotoxic to target tissues. However, the redistribution of released radioactive daughters through the circulation should be considered. A mathematical model was developed to describe the physicochemical kinetics of ²¹²Pb-labeled pharmaceuticals and its radioactive daughters. Materials and Methods: A bolus of ²¹²Pb-labeled pharmaceuticals injected in a developed compartmental model was simulated. The contributions of chelated and free radionuclides to the total released energy were investigated for different dissociation fractions of ²¹²Bi for different chelators, for example, 36% for DOTA. The compartmental model was applied to describe a ²¹²Bi retention study and to assess the stability of the ²¹²Bi-1,4,7,10-tetrakis(carbamoylmethyl)-1,4,7,10-tetraazacyclododecane (²¹²Bi-DOTAM) complex after β^- decay of ²¹²Pb. Results: The simulation of the injection showed that α emissions contribute 75% to the total released energy, mostly from ²¹²Po (72%). The simulation of the ²¹²Bi retention study showed that (16 ± 5)% of ²¹²Bi atoms dissociate from the ²¹²Bi-DOTAM complexes. The fractions of energies released by free radionuclides were 21% and 38% for DOTAM and DOTA chelators, respectively. Conclusion: The developed α particle generator model allows for simulating the radioactive kinetics of labeled and unlabeled pharmaceuticals being released from the chelating system due to a preceding disintegration.

News (Medical) associated with Orano Med LLC

25 Jul 2022

·www.prnewswire.com

Worldwide Emerging Isotopes Pipeline Analysis Industry Insights to 2029

DUBLIN, July 25, 2022 /PRNewswire/ -- The "Emerging Isotopes Pipeline Analysis and Global Market - Forecast To 2029" report has been added to ResearchAndMarkets.com's offering. This report gives comprehensive insights on the various emerging isotope based candidates being developed for the both diagnosis as well as treatment of various cancers and non-cancer indications. The report covers marketed products details (Lutathera and Pluvito) and also candidates that are in various phases of development (Preclinical, Phase 1, Phase 2 & Phase 3). The pipeline focuses on diagnostic isotopes (Ga-68, Zr-89, Cu-64 and Pb-203) and therapeutic isotopes, (Ac-225, Pb-212, At-211, Ra-223, Th-227, Lu-177, Y-90, Re-188, Re-186, Cu-67, and Ho-166). In case of Lu-177, Ga-68, Zr-89 and Cu-64, the report covers the patient population, treatment cost, total addressable market and penetration analysis for GEP-NET, Prostate cancer and Renal cancer. The pipeline analysis covers detailed analysis of name of candidates, list of companies, universities, and hospitals that are developing these agents, phase of development, nature of molecule, targets, and indications. This report enables Pharmaceutical/Biotech companies, Academic institutes, Individual researchers, Investors, Medical technology companies, Service providers and other associated stake holders to identify and analyze the available licensing/collaborative commercial opportunities in the emerging isotopes global market. The report also provides strategic insights on some of the molecules which will eventually be launched in the next few years. Market Analysis In market analysis, global GEP-NET, Prostate cancer and Renal cancer market are indicated along with the Ga-68, Cu-64 and Zr-89 diagnostics market, and Lu-177, therapy market size, eligible patients pool, total addressable market (TAM), market penetration, opportunity and demand for Emerging Isotope is forecasted from 2020 to 2029. Emerging Isotopes related deals analysis. Global, N.A., Europe, APAC and RoW prevalence rates (GEP-NET, Prostate and Renal cancer). Pipeline Analysis Pipeline Analysis based Isotopes Pipeline Analysis based on indications Pipeline analysis based on targets Pipeline analysis based on leading players Key Players Analysis The key player's analysis section provides an in-depth understanding of various companies working on Emerging Isotopes and their pipelines with development phase as well as understanding partnering strategies such as deals entered by the company. Key players overview Key players Pipeline data (Pre-clinical, Phase 1, Phase 2 & Phase 3) Key players deals (collaborations, partnership, licensing agreements, grants, funding etc.,) Key Topics Covered: 1 Executive Summary 2 Introduction 3 Emerging Isotopes 3.1 Introduction 3.2 Pipeline Analysis Overview 3.2.1 Diagnostic Isotopes Pipeline Analysis 3.2.2 Therapeutic Isotopes Pipeline Analysis 3.3 Demand Analysis of Emerging Isotopes 3.4 Lutetium (Lu-177) 3.4.1 Gep-Net Market Analysis 3.4.2 Prostate Cancer Market Analysis 3.4.3 Lutetium Pipeline Analysis 3.4.3.1 Demand and Production Analysis of Lutetium-177 (Lu-177) 3.4.4 Lu-177 - Deals, Approvals, and Funding 3.5 Gallium (Ga-68) 3.5.1 Supply Chain Analysis of Gallium-68 (Ga-68) 3.5.2 Ga-68 Market Characteristics of Current Ge-68/Ga-68 Generators 3.5.3 Gallium-68 (Ga-68) Pipeline Analysis 3.5.4 Ga-68 - Deals, Approvals, and Funding 3.6 Actinium (Ac-225) 3.6.1 Production Analysis of Actinium-225 (Ac-225) and Bismuth-213 (Bi-213) 3.6.2 Actinium (Ac-225) Pipeline Analysis 3.6.3 Ac-225 - Deals, Approvals, and Funding 3.7 Yttrium (Y-90) 3.7.1 Yttrium (Y-90) Pipeline Analysis 3.7.2 Y-90 - Deals, Approvals, and Funding 3.8 Zirconium (Zr-89) 3.8.1 Zirconium (Zr-89) Pipeline Analysis 3.8.2 Zr-89 - Deals, Approvals, and Funding 3.9 Lead (Pb-212)/Bismuth (Bi-212) 3.9.1 Lead (Pb-212) Pipeline Analysis 3.9.2 Pb-212 - Deals, Approvals, and Funding 3.10 Copper (Cu-64) 3.10.1 Copper 64 (Cu-64) Pipeline Analysis 3.10.2 Cu-64 - Deals, Approvals, and Funding 3.11 Copper (Cu-67) 3.11.1 Copper 67 (Cu-67) Pipeline Analysis 3.11.2 Cu-67 - Deals, Approvals, News, and Funding 3.12 Rhenium (Re-186) 3.12.1 Rhenium (Re-186) Pipeline Analysis 3.12.2 Re-186 - Deals, Approvals, News, and Funding 3.13 Rhenium-188 (Re-188) 3.13.1 Rhenium (Re-188) Pipeline Analysis 3.13.2 Re-188 - Deals, Approvals, News, and Funding 3.14 Astatine (At-211) 3.14.1 Astatine (At-211) Pipeline Analysis 3.14.2 At-211 - Deals, Approvals, News, and Funding 3.15 Holmium (Ho-166) 3.15.1 Holmium (Ho-166) Pipeline Analysis 3.15.2 Ho-166 - Deals, Approvals, and News 3.16 Radium (Ra-223) 3.16.1 Supply Chain Analysis of Radium-223 (Ra-223) 3.16.2 Radium (Ra-223) Pipeline Analysis 3.17 Radium (Ra-224) 3.17.1 Radium (Ra-224) Pipeline Analysis 3.17.2 Ra-224 - Deals, Approvals, News, and Funding 3.18 Thorium (Th-227) 3.18.1 Thorium (Th-227) Pipeline Analysis 3.19 Scandium (Sc-43, 44, 47) 3.20 Terbium (Tb-149,152,155, 161) 3.21 Arsenic (As-72, As-74, As-77) 3.22 Iron (Fe-52) 3.23 Barium-128 (Ba-128) 3.24 Barium-131 (Ba-131) 4 Major Player Profiles 4.1 Boston Scientific Corporation (Bsc) 4.2 Clarity Pharmaceuticals Limited 4.3 Curium Sas 4.4 Eckert & Ziegler Strahlen- Und Medizintechnik AG (Pentixapharm, Gmbh) 4.5 Fusion Pharmaceuticals, Inc. 4.6 Itm Isotope Technologies Munich Se 4.7 Novartis AG 4.8 Orano Med, LLC 4.9 Plus Theapeutics, Inc. 4.10 Point Biopharma Global, Inc. 4.11 Radiomedix, Inc. 4.12 Telix Pharmaceuticals, Ltd. For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

100 Deals associated with Orano Med LLC

100 Translational Medicine associated with Orano Med LLC

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

212Pb-AR-RMX ( SSTR )	Somatostatin Receptor-Positive Neuroendocrine Tumor More	Phase 2
212Pb-DOTAM-GRPR1 ( GRPR )	Melanoma, Cutaneous Malignant More	Phase 1
Pb-BCY20603 ( MMP14 )	Neoplasms More	Preclinical
DLL3(Molecular Partners) ( DLL3 )	Solid tumor More	Preclinical
212Pb peptide receptor radionuclide therapy (Orano Med) ( TRPV6 )	Solid tumor More	Discovery

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