ADME (absorption, distribution, metabolism and excretion) studies are essential in the drug development process and one efficient method is to radiolabel the drug using Carbon-14, essentially allowing the tracking of the candidate as it goes through the animal mode in preclinical tests.
With the race to develop ADCs seeing Novartis, Roche, Eli Lilly and AstraZeneca alone invest in technology over the last couple of months, Almac has launched a Carbon-14 labeling service it says is unique in the field.
Outsourcing-Pharma.com met with Michael Cannarsa, Director Business Development at Almac, at AAPS, San Antonio yesterday about the new service who said: “An ADC is a small molecule connected to an antibody (big peptide),and so when a company wants to develop ADCs and wants to do this Carbon-14 ADME study, they have to find somebody who can put the Carbon-14 into their ADC and do the study.”
While putting Carbon-14 in a small molecule drug or a peptide is a relatively straight forward thing, Cannarsa told us working with an ADC requires a combination of capabilities.
He asked: “Can you handle Carbon-14, do you know how to do small molecule synthesis, do you know how to do peptide synthesis, do you know how to handle biologics, do you know how to develop this drug product so that it can be in a form that it can be administered to the animal?”
That’s Almac’s strength, he argued, adding it left the company in a unique position in the ADME service industry.
“Anyone of those pieces by itself, you’d say what’s the big deal but companies realise it’s not going to be easy to get this done other than at a company that has all those capabilities in-house.”
Cannarsa told us Almac had already carried out an ADME project on behalf of Pharma Giant Pfizer which the firm presented as a case study at the ACS North East regional meeting in Newhaven, Connecticut a couple of weeks ago.
Pfizer were the first company to have an ADC approved, with leukaemia drug Mylotarg getting the nod from the US Food and Drug Administration (FDA) in 2000. Ten years on, Pfizer voluntarily withdrew the drug after a post-marketing clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
Like a lot of Big Pharma, Pfizer invested in ADC tech this year in a deal with CytomX in June worth up to $635m for the small biotech.
Not on the bandwagon
We asked Cannarsa whether Almac would be tempted to follow the trend and move into the actual manufacture of ADCs.
“We feel like we are contributing quite a lot right now and there are others who on the biologic side are good at doing that piece of it,” he said. “I don’t think we would see a huge value in making that next step at this point.”