Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials by 2014.
Synthon’s initial antibody drug-conjugate (ADC) program is focusing on tumors that over-express HER2. In preclinical studies the company found that in several xenograft models, including breast cancer and non-small-cell lung cancer xenografts, its HER2-ADC dosed alone induced complete tumor remission, whereas with the antibody alone produced no effect.
“We strongly believe that advancing this second generation ADC technology will lead to a new class of effective, targeted medicines in oncology,” Marco Timmers, chief scientific officer at Synthon Biopharmaceuticals said: “Our GMP plant will also accelerate future patient access to oncology products based on this pioneering technology.”
The ADC program “incorporates the HER2-binding antibody trastuzumab,” which aims to target tumors that over-express HER2, Dr. Timmers added.
Sabienne Douven, a spokesperson for Synthon, told this publication, that the new facility includes:
- Full view of all ADC activities taking place in the grade C clean room and fumehoods from all directions;
- A flexible design allowing for multiple unit operations at multiple scales, including chromatography if required;
- Access to buffer supply without bringing these into the ADC clean room and therefore minimizing transportation in and out the ADC clean room;
- Fully integrated facility including IPC lab and connected ADC development laboratories, quality control and warehouse.
- Application of single use product contact materials only, which eliminates cleaning activities; and
- In-house manufacturing of both linker-drug and ADC.
The new production facility will also work to develop two other ADCs, Douven said. The facility is “built to develop our ADCs, but we’re also open for partnering with other companies,” she added.
Earlier this month, Lonza announced plans to double its ADC capacity by 2014, while last July, Novasep increased its investment in a French ADC plant by €3m. Fujifilm Diosynth Biotechnologies also entered the ADC manufacturing sector with a partnership with Indian CRO Piramal Healthcare.
Menarini and Oxford BioTherapeutics also recently hammered out a clinical development and manufacturing deal focusing on ADCs that is reported to be worth more than €800m.
But the investment in ADCs comes as the US Food and Drug Administration has only approved two – Pfizer’s Mylotarg (gemtuzumab ozogamicin), which was withdrawn from the US market in 2010 but it has remained available in other markets such as Japan, and Seattle Genetics’ Adcetris, which was also approved in the EU.