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

By Gareth Macdonald

- Last updated on GMT

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 Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Related suppliers

Follow us

Products

View more

Webinars