Trial supplies of candidate breast cancer radio-mAb still stable after 5 years says study

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Cancer, Epidermal growth factor receptor

212Pb-TCMC-trastuzumab stable after 5 years
212Pb-TCMC-trastuzumab stable after 5 years
Trial supplies of a radio-immunotherapy drug made by Areva Med in compliance with GMP are stable five years after they were produced according to the results of new analysis.

The findings – published in the journal Pharmaceuticals​ – show that a candidate drug called 212Pb-TCMC-trastuzum – which combines a tumour targeting antibody attached to a radioactive lead marker – has remained within specifications for 10 of the 11 criteria tested for a period five years.

Only one criterion – protein concentration – fell outside specification, varying by 0.01mg/mL after 48 months.

Also results from ion-exchange chromatography testing and a competitive radioimmunoassay suggested the drug may be changing, although both measurements are still within specified limits.

The authors concluded that - while the protein concentration results merit further study - the conjugated molecule have remained stable and functional since being manufacturered by Areva Med and Dallas-based ligand contractor Macrocyclics.

The authors wrote that: “The immunoconjugate, the TCMC-trastuzumab, has proven to be a robust construct​.”

They added that: “Considering the resources financial, time and personnel required to translate a radioimmunoconjugate from the bench to bedside through to treating patients, these results are certainly encouraging​.”

The drug also performed well in the trial, which was a Phase I study of the safety, distribution, pharmacokinetics, immunogenicity and tumor response in patients with human epidermal growth factor receptor type 2 (HER-2)–expressing breast cancer.

According to preliminary results​ patients with carcinomatosis experienced minimal agent-related toxicity after five doses of 212​Pb-TCMC-trastuzumab.

Areva Med – which is a subsidiary of French nuclear and renewable energy firm Areva – acquired Macrocyclics in 2011.

Related news

Show more

Related products

show more

Using SDTM, ADaM, and SEND

Using SDTM, ADaM, and SEND

Formedix | 09-Nov-2022 | Technical / White Paper

This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how...



Indena | 25-Oct-2022 | Technical / White Paper

Indena is well known in the space of naturally derived molecules, with a know-how developed over its one hundred year history. At the same time, the company...

How to design an effective CRF

How to design an effective CRF

Formedix | 10-Oct-2022 | Technical / White Paper

CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical...

Related suppliers

Follow us


View more