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 ALWAYS AT THE FOREFRONT FOR CDMO SERVICES

INDENA ALWAYS AT THE FOREFRONT FOR CDMO SERVICES

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

Products

View more

Webinars